Tadalafil Mylan

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 2.5 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each tablet contains 2.5 mg tadalafil. 

 

Excipient with known effect: 

Each film-coated tablet contains 29.74 mg of lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet (tablet). 

 

A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm) debossed with ‘M’ on one side of the 

tablet and ‘TL over 1’ on the other side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Treatment of erectile dysfunction in adult males. 

 

In order for tadalafil to be effective, sexual stimulation is required. 

 

Tadalafil Mylan is not indicated for use by women. 

 

4.2 Posology and method of administration 

 

Posology 

 

Adult men 

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without 

food. 

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. 

It may be taken at least 30 minutes prior to sexual activity. 

 

The maximum dose frequency is once per day. 

 

Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for 

continuous daily use. 

 

In patients who anticipate a frequent use of tadalafil (i.e., at least twice weekly) a once daily regimen with 

the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s 

judgement. 

 

In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The 

dose may be decreased to 2.5 mg once a day based on individual tolerability. 

 

The appropriateness of continued use of the daily regimen should be reassessed periodically. 



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Special populations 

 

Elderly men 

Dose adjustments are not required in elderly patients. 

 

Men with renal impairment 

Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with 

severe renal impairment 10 mg is the maximum recommended dose. Once-a-day dosing of tadalafil is not 

recommended in patients with severe renal impairment (see sections 4.4 and 5.2). 

 

Men with hepatic impairment 

The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without 

food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment 

(Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the 

prescribing physician. There are no available data about the administration of doses higher than 10 mg of 

tadalafil to patients with hepatic impairment. Once-a-day dosing has not been evaluated in patients with 

hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken 

by the prescribing physician (see sections 4.4 and 5.2). 

 

Men with diabetes 

Dose adjustments are not required in diabetic patients. 

 

Paediatric population 

There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile 

dysfunction. 

 

Method of administration 

 

Tadalafil Mylan is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to 

result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. 

Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated 

(see section 4.5). 

 

Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. 

Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing 

cardiovascular disease. 

 

The following groups of patients with cardiovascular disease were not included in clinical trials and the use 

of tadalafil is therefore contraindicated: 

- patients with myocardial infarction within the last 90 days, 

- patients with unstable angina or angina occurring during sexual intercourse, 

- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, 

- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, 

- patients with a stroke within the last 6 months. 

 

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior 

ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with 

previous PDE5 inhibitor exposure (see section 4.4). 

 



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The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as 

riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5). 

 

4.4 Special warnings and precautions for use 

 

Before treatment with Tadalafil Mylan 

 

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and 

determine potential underlying causes, before pharmacological treatment is considered. 

 

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status 

of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has 

vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as 

such potentiates the hypotensive effect of nitrates (see section 4.3). 

 

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the 

identification of appropriate treatment following an appropriate medical assessment. It is not known if 

tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve sparing 

prostatectomy. 

 

Cardiovascular 

 

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina 

pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, 

have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events 

have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively 

determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a 

combination of these or other factors. 

 

In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure 

decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given 

to a possible dose adjustment of the antihypertensive therapy. 

 

In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic 

hypotension in some patients (see section 4.5). The combination of tadalafil and doxazosin is not 

recommended. 

 

Vision 

 

Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other 

PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with 

erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all 

patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should 

stop taking Tadalafil Mylan and consult a physician immediately (see section 4.3). 

 

Decreased or sudden hearing loss 

 

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were 

present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should 

be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss 

of hearing. 

 

Renal and hepatic impairment 

 

Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence 

clearance by dialysis, once-a-day dosing of tadalafil is not recommended in patients with severe renal 

impairment. 



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There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe 

hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients 

with hepatic insufficiency. If Tadalafil Mylan is prescribed, a careful individual benefit/risk evaluation 

should be undertaken by the prescribing physician. 

 

Priapism and anatomical deformation of the penis 

 

Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical 

assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may 

result. 

 

Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as 

angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may 

predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). 

 

Use with CYP3A4 inhibitors 

 

Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors 

(ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) 

has been observed if the medicinal products are combined (see section 4.5). 

 

Tadalafil and other treatments for erectile dysfunction 

 

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for 

erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil Mylan in 

such combinations. 

 

Lactose content 

 

Tadalafil Mylan contains lactose. Patients with rare hereditary problems of galactose intolerance, total 

lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 

 

Sodium content 

 

Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to 

those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at 

higher doses cannot be completely ruled out. 

 

Effects of other substances on tadalafil 

 

Cytochrome P450 inhibitors 

Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg 

daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax 
values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold 

and Cmax by 22%. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, 

CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in 

Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and 

other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be 

co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see 

section 4.4). 

Consequently the incidence of the adverse reactions listed in section 4.8 might be increased. 

 



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Transporters 

The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known. 

Therefore there is the potential of drug interactions mediated by inhibition of transporters. 

 

Cytochrome P450 inducers 

A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil 

alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude 

of decreased efficacy is unknown. Other inducers of CYP3A4 such as phenobarbital, phenytoin and 

carbamazepine, may also decrease plasma concentrations of tadalafil. 

 

Effects of tadalafil on other medicinal products 

 

Nitrates 

In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. 

Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated 

(see section 4.3). Based on the results of a clinical study in which 150 subjects receiving daily doses of 

tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for 

more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. 

Thus, in a patient prescribed any dose of tadalafil (2.5 mg-20 mg), where nitrate administration is deemed 

medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of 

tadalafil before nitrate administration is considered. In such circumstances, nitrates should only be 

administered under close medical supervision with appropriate haemodynamic monitoring. 

 

Anti-hypertensives (including calcium channel blockers) 

The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single 

dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect 

lasts at least twelve hours and may be symptomatic, including syncope. Therefore this combination is not 

recommended (see section 4.4). 

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported 

with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated 

with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and 

progressively adjusted. 

 

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of 

antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products 

were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) 

inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics 

(bendroflumethiazide), and angiotensin II receptor blockers (various types and doses, alone or in 

combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil 

(10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was 

applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology 

study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects 

taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of 

blood-pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction 

was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not 

controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms 

in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 

20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in 

general, minor and not likely to be clinically relevant. Analysis of phase 3 clinical trial data showed no 

difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. 

However, appropriate clinical advice should be given to patients regarding a possible decrease in blood 

pressure when they are treated with antihypertensive medicinal products. 

 

Riociguat 

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were 

combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of 

PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population 



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studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see 

section 4.3).   

 

5-alpha reductase inhibitors 

In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus 

finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a 

formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors 

(5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 

5-ARIs. 

 

CYP1A2 substrates (e.g. theophylline) 

When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a 

clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect 

was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance 

in this study, it should be considered when co-administering these medicinal products. 

 

Ethinylestradiol and terbutaline 

Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a 

similar increase may be expected with oral administration of terbutaline, although the clinical consequence 

of this is uncertain. 

 

Alcohol 

Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration 

with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after 

co-administration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol 

absorption (overnight fast with no food until 2 hours after alcohol). 

Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or 

approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and 

orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol 

(0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. 

The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg). 

 

Cytochrome P450 metabolised medicinal products 

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal 

products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce 

CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19. 

 

CYP2C9 substrates (e.g. R-warfarin) 

Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or 

R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin. 

 

Aspirin 

Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid. 

 

Antidiabetic medicinal products 

Specific interaction studies with antidiabetic medicinal products were not conducted. 

 

4.6 Fertility, pregnancy and lactation 

 

Tadalafil Mylan is not indicated for use by women. 

 

Pregnancy 

 

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or 

indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal 

development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tadalafil 

Mylan during pregnancy. 



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Breastfeeding 

 

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. 

A risk to the suckling child cannot be excluded. Tadalafil Mylan should not be used during breast feeding. 

 

Fertility 

 

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest 

that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see 

sections 5.1 and 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports 

of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they 

react to tadalafil before driving or using machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile 

dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the 

incidences increase with increasing dose of tadalafil. The adverse reactions reported were transient, and 

generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are 

experienced within the first 10 to 30 days of starting treatment. 

 

Tabulated summary of adverse reactions 

 

The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled 

clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand 

and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic 

hyperplasia. 

 

Frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), 

rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available 

data). 

Very common Common  Uncommon  Rare  

Immune system disorders 

  Hypersensitivity reactions Angioedema2 

Nervous system disorders 

 Headache Dizziness  Stroke1 

(including haemorrhagic 

events), 

Syncope, 

Transient ischaemic attacks1, 

Migraine2, 

Seizures2, 

Transient amnesia  

Eye disorders 



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  Blurred vision, 

Sensations described as 

eye pain 

Visual field defect,  

Swelling of eyelids, 

Conjunctival hyperaemia, 

Non-arteritic anterior ischemic 

optic neuropathy (NAION)2, 

Retinal vascular occlusion2 

Ear and labyrinth disorders 

  Tinnitus Sudden hearing loss 

Cardiac disorders1 

  Tachycardia, 

Palpitations 

Myocardial infarction, 

Unstable angina pectoris2, 

Ventricular arrhythmia2 

Vascular disorders 

 Flushing Hypotension3, 

Hypertension  

 

Respiratory, thoracic and mediastinal disorders 

 Nasal 

congestion 

Dyspnoea, 

Epistaxis  

 

Gastrointestinal disorders 

 Dyspepsia 

 

Abdominal pain, 

Vomiting, Nausea, 

Gastro-oesophageal reflux  

 

Skin and subcutaneous tissue disorders 

  Rash Urticaria, 

Stevens-Johnson syndrome2, 

Exfoliative dermatitis2, 

Hyperhydrosis (sweating) 

 

Musculoskeletal and connective tissue disorders 

 Back pain, 

Myalgia,  

Pain in 

extremity 

  

Renal and urinary disorders 

  Haematuria  

Reproductive system and breast disorders 

  Prolonged erections 

 

Priapism, Penile haemorrhage, 

Haematospermia  

 

General disorders and administration site conditions 



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  Chest pain1, Peripheral 

oedema, Fatigue 

Facial oedema2, 

Sudden cardiac death1, 2 

 (1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4). 

(2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials. 

(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive 

medicinal products. 

 

Description of selected adverse reactions 

 

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients 

treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not 

associated with adverse reactions. 

 

Other special populations 

 

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile 

dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken 

on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 

65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic 

hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age. 

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 

to report any suspected adverse reactions via the national reporting system listed in Appendix V. 

 

4.9 Overdose 

 

Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg 

have been given to patients. Adverse events were similar to those seen at lower doses. 

In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes 

negligibly to tadalafil elimination. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC Code: G04BE08. 

 

Mechanism of action 

 

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific 

phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition 

of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth 

muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no 

effect in the absence of sexual stimulation. 

 

Pharmacodynamic effects 

 

Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in 

corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, 

lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
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Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found 

in the heart, brain, blood vessels, liver, and other organs. Tadalafil is > 10,000-fold more potent for PDE5 

than for PDE3, an enzyme found in the heart and blood vessels. 

This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac 

contractility. Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an 

enzyme which is found in the retina and is responsible for phototransduction. Tadalafil is also > 10,000-fold 

more potent for PDE5 than for PDE7 through PDE10. 

 

Clinical efficacy and safety 

 

Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of 

responsiveness to tadalafil on demand. Tadalafil demonstrated statistically significant improvement in 

erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as 

well as patients’ ability to attain and maintain erections for successful intercourse compared to placebo as 

early as 16 minutes following dosing. 

 

Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine 

systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing 

systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no 

significant change in heart rate. 

 

In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) 

was detected using the Farnsworth-Munsell 100-hue test. This finding is consistent with the low affinity of 

tadalafil for PDE6 compared to PDE5. Across all clinical studies, reports of changes in colour vision were 

rare (< 0.1%). 

 

Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 10 mg 

(one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily. In two of these 

studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely 

clinical relevance. These effects were not associated with changes in other parameters such as motility, 

morphology and FSH. 

 

Tadalafil at doses of 2.5, 5, and 10 mg taken once a day was initially evaluated in 3 clinical studies involving 

853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various 

severities (mild, moderate, severe) and etiologies. In the two primary efficacy studies of general populations, 

the mean per-subject proportion of successful intercourse attempts were 57 and 67% on tadalafil 5 mg, 50% 

on tadalafil 2.5 mg as compared to 31 and 37% with placebo. In the study in patients with erectile 

dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% 

on tadalafil 5 mg and 2.5 mg, respectively, as compared to 28% with placebo. Most patients in these three 

studies were responders to previous on-demand treatment with PDE5 inhibitors. In a subsequent study, 

217 patients who were treatment-naïve to PDE5 inhibitors were randomised to tadalafil 5 mg once a day vs. 

placebo. The mean per-subject proportion of successful sexual intercourse attempts was 68% for tadalafil 

patients compared to 52% for patients on placebo. 

 

In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary 

to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject 

proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 

48% as compared to 17% with placebo. 

 

Paediatric population 

 

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in 

which no evidence of efficacy was seen. The randomised, double-blind, placebo-controlled, parallel, 3-arm 

study of tadalafil was conducted in 331 boys aged 7-14 years with DMD receiving concurrent corticosteroid 

therapy. The study included a 48-week double-blind period where patients were randomised to tadalafil 

0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. Tadalafil did not show efficacy in slowing the decline in 

ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean 



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change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the 

tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538). In addition, 

there was no evidence of efficacy from any of the secondary analyses performed in this study. The overall 

safety results from this study were generally consistent with the known safety profile of tadalafil and with 

adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids. 

 

The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of 

the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information on 

paediatric use. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma 

concentration (Cmax) is achieved at a median time of 2 hours after dosing. Absolute bioavailability of tadalafil 

following oral dosing has not been determined. 

The rate and extent of absorption of tadalafil are not influenced by food, thus tadalafil may be taken with or 

without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and 

extent of absorption. 

 

Distribution 

 

The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues. At 

therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. Protein binding is not affected by 

impaired renal function. 

Less than 0.0005% of the administered dose appeared in the semen of healthy subjects. 

 

Biotransformation 

 

Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform. The major circulating 

metabolite is the methylcatechol glucuronide. This metabolite is at least 13,000-fold less potent than tadalafil 

for PDE5. Consequently, it is not expected to be clinically active at observed metabolite concentrations. 

 

Elimination 

 

The mean oral clearance for tadalafil is 2.5 l/h and the mean half-life is 17.5 hours in healthy subjects. 

Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the 

dose) and to a lesser extent in the urine (approximately 36% of the dose). 

 

Linearity/non-linearity 

 

Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose. Over a dose range of 

2.5 to 20 mg, exposure (AUC) increases proportionally with dose. Steady-state plasma concentrations are 

attained within 5 days of once-daily dosing. 

 

Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to 

pharmacokinetics in subjects without erectile dysfunction. 

 

Special populations 

 

Elderly 

Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25% higher 

exposure (AUC) relative to healthy subjects aged 19 to 45 years. This effect of age is not clinically 

significant and does not warrant a dose adjustment. 

 



13 

Renal insufficiency 

In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) 

approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine 

clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis. In 

haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects. Haemodialysis 

contributes negligibly to tadalafil elimination. 

 

Hepatic insufficiency 

Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and 

B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered. There is limited 

clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C). 

There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic 

impairment. If tadalafil is prescribed once-a-day, a careful individual benefit/risk evaluation should be 

undertaken by the prescribing physician. 

 

Patients with diabetes 

Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for 

healthy subjects. This difference in exposure does not warrant a dose adjustment. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 

repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. 

There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 

1000 mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 

30 mg/kg/day. In the pregnant rat the AUC for calculated free drug at this dose was approximately 18 times 

the human AUC at a 20 mg dose. 

There was no impairment of fertility in male and female rats. In dogs given tadalafil daily for 6 to 12 months 

at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 – 18.6] than seen in 

humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium 

that resulted in a decrease in spermatogenesis in some dogs. See also section 5.1. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core: 

 

Lactose, anhydrous 

Poloxamer 188 

Cellulose, microcrystalline (pH101) 

Povidone (K-25) 

Croscarmellose sodium 

Magnesium stearate 

Sodium laurilsulfate 

Silica, colloidal anhydrous 

 

Film-coat: 

 

Lactose monohydrate 

Hypromellose (E464) 

Titanium dioxide (E171) 

Iron oxide yellow (E172) 

Triacetin 

 



14 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 

PVC/PE/PVdC-Alu blisters. 

 

Pack sizes of 28 and 56 tablets. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/961/008 

EU/1/14/961/009 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 21 November 2014 

Date of latest renewal: 31 July 2019 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

 

http://www.ema.europa.eu/
http://www.ema.europa.eu/


15 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 5 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each tablet contains 5 mg tadalafil. 

 

Excipient with known effect: 

Each film-coated tablet contains 59.48 mg of lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet (tablet). 

 

A light yellow, film-coated, round, biconvex tablet (6.3 ± 0.3 mm) debossed with ‘M’ on one side of the 

tablet and ‘TL over 2’ on the other side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Treatment of erectile dysfunction in adult males. 

 

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. 

 

Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. 

 

Tadalafil Mylan is not indicated for use by women. 

 

4.2 Posology and method of administration 

 

Posology 

 

Erectile dysfunction in adult men 

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without 

food. 

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. 

It may be taken at least 30 minutes prior to sexual activity. 

 

The maximum dose frequency is once per day. 

 

Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for 

continuous daily use. 

 

In patients who anticipate a frequent use of tadalafil (i.e., at least twice weekly) a once daily regimen with 

the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s 

judgement. 

 

In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The 

dose may be decreased to 2.5 mg once a day based on individual tolerability. 



16 

The appropriateness of continued use of the daily regimen should be reassessed periodically. 

 

Benign prostatic hyperplasia in adult men 

The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For 

adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose 

is also 5 mg taken at approximately the same time every day. Patients who are unable to tolerate tadalafil 

5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy 

of tadalafil 2.5 mg for the treatment of benign prostatic hyperplasia has not been demonstrated. 

 

Special populations 

 

Elderly men 

Dose adjustments are not required in elderly patients. 

 

Men with renal impairment 

Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with 

severe renal impairment 10 mg is the maximum recommended dose for on-demand treatment. 

 

Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic 

hyperplasia is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2). 

 

Men with hepatic impairment 

For the treatment of erectile dysfunction using on-demand tadalafil the recommended dose of tadalafil is 

10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the 

safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful 

individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available 

data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment. 

 

Once-a-day dosing of tadalafil both for the treatment of erectile dysfunction and benign prostatic hyperplasia 

has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual 

benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2). 

 

Men with diabetes 

Dose adjustments are not required in diabetic patients. 

 

Paediatric population 

There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile 

dysfunction. 

 

Method of administration 

 

Tadalafil Mylan is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to 

result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. 

Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated 

(see section 4.5). 

 

Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. 

Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing 

cardiovascular disease. 

 



17 

The following groups of patients with cardiovascular disease were not included in clinical trials and the use 

of tadalafil is therefore contraindicated: 

- patients with myocardial infarction within the last 90 days, 

- patients with unstable angina or angina occurring during sexual intercourse, 

- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, 

- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, 

- patients with a stroke within the last 6 months. 

 

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior 

ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with 

previous PDE5 inhibitor exposure (see section 4.4). 

 

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as 

riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5). 

 

4.4 Special warnings and precautions for use 

 

Before treatment with Tadalafil Mylan 

 

A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign 

prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is 

considered. 

 

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status 

of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has 

vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as 

such potentiates the hypotensive effect of nitrates (see section 4.3). 

 

Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to 

rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see 

section 4.3). 

 

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the 

identification of appropriate treatment following an appropriate medical assessment. It is not known if 

tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve sparing 

prostatectomy. 

 

Cardiovascular 

 

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina 

pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, 

have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events 

have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively 

determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a 

combination of these or other factors. 

 

In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure 

decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given 

to a possible dose adjustment of the antihypertensive therapy. 

 

In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic 

hypotension in some patients (see section 4.5). The combination of tadalafil and doxazosin is not 

recommended. 

 

Vision 

 



18 

Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other 

PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with 

erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all 

patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should 

stop taking Tadalafil Mylan and consult a physician immediately (see section 4.3). 

 

Decreased or sudden hearing loss 

 

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were 

present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should 

be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss 

of hearing. 

 

Renal and hepatic impairment 

 

Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence 

clearance by dialysis, once-a-day dosing of tadalafil is not recommended in patients with severe renal 

impairment. 

 

There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe 

hepatic insufficiency (Child-Pugh Class C). Once-a-day administration either for the treatment of erectile 

dysfunction or benign prostatic hyperplasia has not been evaluated in patients with hepatic insufficiency. If 

Tadalafil Mylan is prescribed, a careful individual benefit/risk evaluation should be undertaken by the 

prescribing physician. 

 

Priapism and anatomical deformation of the penis 

 

Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical 

assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may 

result. 

 

Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as 

angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may 

predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). 

 

Use with CYP3A4 inhibitors 

 

Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors 

(ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) 

has been observed if the medicinal products are combined (see section 4.5). 

 

Tadalafil and other treatments for erectile dysfunction 

 

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for 

erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil Mylan in 

such combinations. 

 

Lactose content 

 

Tadalafil Mylan contains lactose. Patients with rare hereditary problems of galactose intolerance, total 

lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 

 

Sodium content 

 

Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 



19 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to 

those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at 

higher doses cannot be completely ruled out. 

 

Effects of other substances on tadalafil 

 

Cytochrome P450 inhibitors 

Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg 

daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax 

values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold 

and Cmax by 22%. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, 

CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in 

Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and 

other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be 

co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see 

section 4.4). 

Consequently the incidence of the adverse reactions listed in section 4.8 might be increased. 

 

Transporters 

The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known. 

Therefore there is the potential of drug interactions mediated by inhibition of transporters. 

 

Cytochrome P450 inducers 

A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil 

alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude 

of decreased efficacy is unknown. Other inducers of CYP3A4 such as phenobarbital, phenytoin and 

carbamazepine, may also decrease plasma concentrations of tadalafil. 

 

Effects of tadalafil on other medicinal products 

 

Nitrates 

In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. 

Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated 

(see section 4.3). Based on the results of a clinical study in which 150 subjects receiving daily doses of 

tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for 

more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. 

Thus, in a patient prescribed any dose of tadalafil (2.5 mg-20 mg), where nitrate administration is deemed 

medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of 

tadalafil before nitrate administration is considered. In such circumstances, nitrates should only be 

administered under close medical supervision with appropriate haemodynamic monitoring. 

 

Anti-hypertensives (including calcium channel blockers) 

The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single 

dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect 

lasts at least twelve hours and may be symptomatic, including syncope. Therefore this combination is not 

recommended (see section 4.4). 

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported 

with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated 

with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and 

progressively adjusted. 

 

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of 

antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products 

were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) 



20 

inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and 

angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium 

channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg except for studies with angiotensin 

II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant 

interaction with any of these classes. In another clinical pharmacology study tadalafil (20 mg) was studied in 

combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the 

ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control. In this regard, 

study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen 

in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater 

although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients 

receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure 

decrease, which (with the exception of alpha blockers -see above-) is, in general, minor and not likely to be 

clinically relevant. Analysis of phase 3 clinical trial data showed no difference in adverse events in patients 

taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice 

should be given to patients regarding a possible decrease in blood pressure when they are treated with 

antihypertensive medicinal products. 

 

Riociguat 

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were 

combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of 

PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population 

studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see 

section 4.3).   

 

5-alpha reductase inhibitors 

In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus 

finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a 

formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors 

(5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 

5-ARIs. 

 

CYP1A2 substrates (e.g. theophylline) 

When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a 

clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect 

was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance 

in this study, it should be considered when co-administering these medicinal products. 

 

Ethinylestradiol and terbutaline 

Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a 

similar increase may be expected with oral administration of terbutaline, although the clinical consequence 

of this is uncertain. 

 

Alcohol 

Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration 

with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after 

co-administration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol 

absorption (overnight fast with no food until 2 hours after alcohol). 

Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or 

approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and 

orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol 

(0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. 

The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg). 

 

Cytochrome P450 metabolised medicinal products 

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal 

products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce 

CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19. 



21 

 

CYP2C9 substrates (e.g. R-warfarin) 

Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or 

R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin. 

 

Aspirin 

Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid. 

 

Antidiabetic medicinal products 

Specific interaction studies with antidiabetic medicinal products were not conducted. 

 

4.6 Fertility, pregnancy and lactation 

 

Tadalafil Mylan is not indicated for use by women. 

 

Pregnancy 

 

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or 

indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal 

development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tadalafil 

Mylan during pregnancy. 

 

Breastfeeding 

 

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. 

A risk to the suckling child cannot be excluded. Tadalafil Mylan should not be used during breast feeding. 

 

Fertility 

 

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest 

that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see 

sections 5.1 and 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports 

of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they 

react to tadalafil before driving or using machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile 

dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the 

incidences increase with increasing dose of tadalafil. The adverse reactions reported were transient, and 

generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are 

experienced within the first 10 to 30 days of starting treatment. 

 

Tabulated summary of adverse reactions 

 

The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled 

clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand 

and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic 

hyperplasia. 

 



22 

Frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), 

rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available 

data). 

Very common Common Uncommon Rare  

Immune system disorders 

  Hypersensitivity 

reactions 

Angioedema2 

Nervous system disorders 

 Headache Dizziness  Stroke1 

(including haemorrhagic 

events), 

Syncope, 

Transient ischaemic attacks1, 

Migraine2, 

Seizures2, 

Transient amnesia  

Eye disorders 

  Blurred vision, 

Sensations described 

as eye pain 

Visual field defect, 

Swelling of eyelids, 

Conjunctival hyperaemia, 

Non-arteritic anterior ischemic 

optic neuropathy (NAION)2, 

Retinal vascular occlusion2 

Ear and labyrinth disorders 

  Tinnitus Sudden hearing loss  

Cardiac disorders1 

  Tachycardia, 

Palpitations 

Myocardial infarction, 

Unstable angina pectoris2, 

Ventricular arrhythmia2 

Vascular disorders 

 Flushing Hypotension3, 

Hypertension  

 

Respiratory, thoracic and mediastinal disorders 

 Nasal congestion Dyspnoea, 

Epistaxis  

 

Gastrointestinal disorders 

 Dyspepsia 

 

Abdominal pain, 

Vomiting, Nausea, 

 



23 

Gastro-oesophageal 

reflux,  

Skin and subcutaneous tissue disorders 

  Rash  Urticaria, 

Stevens-Johnson syndrome2, 

Exfoliative dermatitis2 

Hyperhydrosis (sweating) 

Musculoskeletal and connective tissue disorders 

 Back pain, 

Myalgia, 

Pain in extremity 

  

Renal and urinary disorders 

  Haematuria  

Reproductive system and breast disorders 

  Prolonged erections 

 

Priapism, Penile haemorrhage, 

Haematospermia  

General disorders and administration site conditions 

  Chest pain1, 

Peripheral oedema, 

Fatigue 

Facial oedema2, 

Sudden cardiac death1, 2 

 (1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4). 

(2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials. 

(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive 

medicinal products. 

 

Description of selected adverse reactions 

 

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients 

treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not 

associated with adverse reactions. 

 

Other special populations 

 

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile 

dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken 

on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 

65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic 

hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age. 

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 

to report any suspected adverse reactions via the national reporting system listed in Appendix V. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


24 

4.9 Overdose 

 

Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg 

have been given to patients. Adverse events were similar to those seen at lower doses. 

In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes 

negligibly to tadalafil elimination. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC Code: G04BE08. 

 

Mechanism of action 

 

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific 

phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition 

of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth 

muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no 

effect in the treatment of erectile dysfunction in the absence of sexual stimulation. 

 

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the 

smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation 

increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia 

are reduced. These vascular effects may be complemented by inhibition of bladder afferent nerve activity 

and smooth muscle relaxation of the prostate and bladder. 

 

Pharmacodynamic effects 

 

Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in 

corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, 

lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. 

Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found 

in the heart, brain, blood vessels, liver, and other organs. Tadalafil is > 10,000-fold more potent for PDE5 

than for PDE3, an enzyme found in the heart and blood vessels. 

This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac 

contractility. Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an 

enzyme which is found in the retina and is responsible for phototransduction. Tadalafil is also > 10,000-fold 

more potent for PDE5 than for PDE7 through PDE10. 

 

Clinical efficacy and safety 

 

Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine 

systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing 

systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no 

significant change in heart rate. 

 

In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) 

was detected using the Farnsworth-Munsell 100-hue test. This finding is consistent with the low affinity of 

tadalafil for PDE6 compared to PDE5. Across all clinical studies, reports of changes in colour vision were 

rare (< 0.1%). 

 

Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 10 mg 

(one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily. In two of these 

studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely 



25 

clinical relevance. These effects were not associated with changes in other parameters such as motility, 

morphology and FSH. 

 

Erectile dysfunction 

For tadalafil on demand, three clinical studies were conducted in 1054 patients in an at-home setting to 

define the period of responsiveness. Tadalafil demonstrated statistically significant improvement in erectile 

function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as 

patients’ ability to attain and maintain erections for successful intercourse compared to placebo as early as 

16 minutes following dosing. 

 

In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary 

to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject 

proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 

48% as compared to 17% with placebo. 

 

For once-a-day evaluation of tadalafil at doses of 2.5, 5, and 10 mg 3 clinical studies were initially conducted 

involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of 

various severities (mild, moderate, severe) and etiologies. In the two primary efficacy studies of general 

populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67% on tadalafil 

5 mg, 50% on tadalafil 2.5 mg as compared to 31 and 37% with placebo. In the study in patients with erectile 

dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% 

on tadalafil 5 mg and 2.5 mg, respectively, as compared to 28% with placebo. Most patients in these three 

studies were responders to previous on-demand treatment with PDE5 inhibitors. In a subsequent study, 

217 patients who were treatment-naïve to PDE5 inhibitors were randomised to tadalafil 5 mg once a day vs. 

placebo. The mean per-subject proportion of successful sexual intercourse attempts was 68% for tadalafil 

patients compared to 52% for patients on placebo. 

 

Benign prostatic hyperplasia 

Tadalafil was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and 

symptoms of benign prostatic hyperplasia. The improvement in the total international prostate symptom 

score with tadalafil 5 mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2, -3.6, -3.8 

and -4.2 with placebo. The improvements in total international prostate symptom score occurred as early as 

1 week. In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the 

improvement in total international prostate symptom score with tadalafil 5 mg, tamsulosin and placebo were 

-6.3, -5.7 and -4.2 respectively. 

 

One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign 

prostatic hyperplasia in patients with both conditions. The improvements in the erectile function domain of 

the international index of erectile function and the total international prostate symptom score in this study 

were 6.5 and -6.1 with tadalafil 5 mg compared to 1.8 and -3.8 with placebo, respectively. The mean per-

subject proportion of successful sexual intercourse attempts was 71.9% with tadalafil 5 mg compared to 

48.3% with placebo. 

 

The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed 

that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up 

to 1 additional year of treatment with tadalafil 5 mg. 

 

Paediatric population 

 

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in 

which no evidence of efficacy was seen. The randomised, double-blind, placebo-controlled, parallel, 3-arm 

study of tadalafil was conducted in 331 boys aged 7-14 years with DMD receiving concurrent corticosteroid 

therapy. The study included a 48-week double-blind period where patients were randomised to tadalafil 

0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. Tadalafil did not show efficacy in slowing the decline in 

ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean 

change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the 

tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538). In addition, 



26 

there was no evidence of efficacy from any of the secondary analyses performed in this study. The overall 

safety results from this study were generally consistent with the known safety profile of tadalafil and with 

adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids. 

 

The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of 

the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information on 

paediatric use. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma 

concentration (Cmax) is achieved at a median time of 2 hours after dosing. Absolute bioavailability of tadalafil 

following oral dosing has not been determined. 

The rate and extent of absorption of tadalafil are not influenced by food, thus Tadalafil may be taken with or 

without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and 

extent of absorption. 

 

Distribution 

 

The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues. At 

therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. Protein binding is not affected by 

impaired renal function. 

Less than 0.0005% of the administered dose appeared in the semen of healthy subjects. 

 

Biotransformation 

 

Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform. The major circulating 

metabolite is the methylcatechol glucuronide. This metabolite is at least 13,000-fold less potent than tadalafil 

for PDE5. Consequently, it is not expected to be clinically active at observed metabolite concentrations. 

 

Elimination 

 

The mean oral clearance for tadalafil is 2.5 l/h and the mean half-life is 17.5 hours in healthy subjects. 

Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the 

dose) and to a lesser extent in the urine (approximately 36% of the dose). 

 

Linearity/non-linearity 

 

Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose. Over a dose range of 

2.5 to 20 mg, exposure (AUC) increases proportionally with dose. Steady-state plasma concentrations are 

attained within 5 days of once-daily dosing. 

 

Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to 

pharmacokinetics in subjects without erectile dysfunction. 

 

Special populations 

 

Elderly 

Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25% higher 

exposure (AUC) relative to healthy subjects aged 19 to 45 years. This effect of age is not clinically 

significant and does not warrant a dose adjustment. 

 

Renal insufficiency 

In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) 

approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine 



27 

clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis. In 

haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects. 

Haemodialysis contributes negligibly to tadalafil elimination. 

 

Hepatic insufficiency 

Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and 

B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered. There is limited 

clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C). 

There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic 

impairment. If tadalafil is prescribed once-a-day, a careful individual benefit/risk evaluation should be 

undertaken by the prescribing physician. 

 

Patients with diabetes 

Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for 

healthy subjects. This difference in exposure does not warrant a dose adjustment. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 

repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. 

 

There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 

1000 mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 

30 mg/kg/day. In the pregnant rat the AUC for calculated free drug at this dose was approximately 18 times 

the human AUC at a 20 mg dose. 

 

There was no impairment of fertility in male and female rats. In dogs given tadalafil daily for 6 to 12 months 

at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 – 18.6] than seen in 

humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium 

that resulted in a decrease in spermatogenesis in some dogs. See also section 5.1. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core: 

 

Lactose, anhydrous 

Poloxamer 188 

Cellulose, microcrystalline (pH101) 

Povidone (K-25) 

Croscarmellose sodium 

Magnesium stearate 

Sodium laurilsulfate 

Silica, colloidal anhydrous 

 

Film-coat: 

 

Lactose monohydrate 

Hypromellose (E464) 

Titanium dioxide (E171) 

Iron oxide yellow (E172) 

Triacetin 

 



28 

6.2 Incompatibilities 

 

Not applicable.  

 

6.3 Shelf life 

 

3 years 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 

PVC/PE/PVdC-Alu blisters. 

 

Pack sizes of 14, 28, 30, 56, 84 and 98 tablets. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/961/012 

EU/1/14/961/013 

EU/1/14/961/014 

EU/1/14/961/015 

EU/1/14/961/016 

EU/1/14/961/017 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 21 November 2014 

Date of latest renewal: 31 July 2019 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

 

http://www.ema.europa.eu/
http://www.ema.europa.eu/


29 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 10 mg film-coated tablets 

Tadalafil Mylan 20 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Tadalafil Mylan 10 mg film-coated tablets 

 

Each tablet contains 10 mg tadalafil. 

 

Excipient with known effect: 

Each film-coated tablet contains 118.96 mg of lactose. 

 

Tadalafil Mylan 20 mg film-coated tablets 

 

Each tablet contains 20 mg tadalafil. 

  

Excipient with known effect: 

Each film-coated tablet contains 237.92 mg of lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet (tablet). 

 

Tadalafil Mylan 10 mg film-coated tablets 

 

A light yellow, film-coated, round, biconvex tablet (8.1 ± 0.3 mm) debossed with ‘M’ on one side of the 

tablet and ‘TL3’ on the other side. 

 

Tadalafil Mylan 20 mg film-coated tablets 

 

A light yellow, film-coated, round, biconvex tablet (10.7 ± 0.3 mm) debossed with ‘M’ on one side of the 

tablet and ‘TL4’ on the other side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Treatment of erectile dysfunction in adult males. 

 

In order for tadalafil to be effective, sexual stimulation is required. 

 

Tadalafil Mylan is not indicated for use by women. 

 



30 

4.2 Posology and method of administration 

 

Posology 

 

Adult men 

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without 

food. 

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. 

It may be taken at least 30 minutes prior to sexual activity. 

 

The maximum dose frequency is once per day. 

 

Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for 

continuous daily use. 

 

In patients who anticipate a frequent use of tadalafil (i.e., at least twice weekly) a once daily regimen with 

the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s 

judgement. 

 

In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The 

dose may be decreased to 2.5 mg once a day based on individual tolerability. 

 

The appropriateness of continued use of the daily regimen should be reassessed periodically. 

 

Special populations 

 

Elderly men 

Dose adjustments are not required in elderly patients. 

 

Men with renal impairment 

Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with 

severe renal impairment 10 mg is the maximum recommended dose. Once-a-day dosing of tadalafil is not 

recommended in patients with severe renal impairment (see sections 4.4 and 5.2). 

 

Men with hepatic impairment 

The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without 

food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment 

(Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the 

prescribing physician. There are no available data about the administration of doses higher than 10 mg of 

tadalafil to patients with hepatic impairment. Once-a-day dosing has not been evaluated in patients with 

hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken 

by the prescribing physician (see sections 4.4 and 5.2). 

 

Men with diabetes 

Dose adjustments are not required in diabetic patients. 

 

Paediatric population 

There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile 

dysfunction. 

 

Method of administration 

 

Tadalafil Mylan 10 mg and 20 mg film-coated tablets cannot be divided and should be swallowed whole.  

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 



31 

 

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to 

result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. 

Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated 

(see section 4.5). 

 

Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. 

Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing 

cardiovascular disease. 

 

The following groups of patients with cardiovascular disease were not included in clinical trials and the use 

of tadalafil is therefore contraindicated: 

- patients with myocardial infarction within the last 90 days, 

- patients with unstable angina or angina occurring during sexual intercourse, 

- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, 

- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, 

- patients with a stroke within the last 6 months. 

 

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior 

ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with 

previous PDE5 inhibitor exposure (see section 4.4). 

 

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as 

riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5). 

 

4.4 Special warnings and precautions for use 

 

Before treatment with Tadalafil Mylan 

 

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and 

determine potential underlying causes, before pharmacological treatment is considered. 

 

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status 

of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has 

vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as 

such potentiates the hypotensive effect of nitrates (see section 4.3). 

 

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the 

identification of appropriate treatment following an appropriate medical assessment. It is not known if 

tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve sparing 

prostatectomy. 

 

Cardiovascular 

 

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina 

pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, 

have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events 

have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively 

determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a 

combination of these or other factors. 

 

In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic 

hypotension in some patients (see section 4.5). The combination of tadalafil and doxazosin is not 

recommended. 

 

Vision 

 



32 

Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other 

PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with 

erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all 

patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should 

stop taking Tadalafil Mylan and consult a physician immediately (see section 4.3). 

 

Decreased or sudden hearing loss 

 

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were 

present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should 

be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss 

of hearing. 

 

Hepatic impairment 

 

There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe 

hepatic insufficiency (Child-Pugh Class C). If Tadalafil Mylan is prescribed, a careful individual benefit/risk 

evaluation should be undertaken by the prescribing physician. 

 

Priapism and anatomical deformation of the penis 

 

Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical 

assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may 

result. 

 

Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as 

angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may 

predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). 

 

Use with CYP3A4 inhibitors 

 

Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors 

(ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) 

has been observed if the medicinal products are combined (see section 4.5). 

 

Tadalafil and other treatments for erectile dysfunction 

 

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for 

erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil Mylan in 

such combinations. 

 

Lactose content 

 

Tadalafil Mylan contains lactose. Patients with rare hereditary problems of galactose intolerance, total 

lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 

 

Sodium content 

 

Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to 

those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at 

higher doses cannot be completely ruled out. 

 



33 

Effects of other substances on tadalafil 

 

Cytochrome P450 inhibitors 

Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg 

daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax 

values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold 

and Cmax by 22%. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, 

CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in 

Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and 

other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be 

co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see 

section 4.4). 

Consequently the incidence of the adverse reactions listed in section 4.8 might be increased. 

 

Transporters 

The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known. 

Therefore there is the potential of drug interactions mediated by inhibition of transporters. 

 

Cytochrome P450 inducers 

A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil 

alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude 

of decreased efficacy is unknown. Other inducers of CYP3A4 such as phenobarbital, phenytoin and 

carbamazepine, may also decrease plasma concentrations of tadalafil. 

 

Effects of tadalafil on other medicinal products 

 

Nitrates 

In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. 

Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated 

(see section 4.3). Based on the results of a clinical study in which 150 subjects receiving daily doses of 

tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for 

more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. 

Thus, in a patient prescribed any dose of tadalafil (2.5 mg-20 mg), where nitrate administration is deemed 

medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of 

tadalafil before nitrate administration is considered. In such circumstances, nitrates should only be 

administered under close medical supervision with appropriate haemodynamic monitoring. 

 

Anti-hypertensives (including calcium channel blockers) 

The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single 

dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect 

lasts at least twelve hours and may be symptomatic, including syncope. Therefore this combination is not 

recommended (see section 4.4). 

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported 

with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated 

with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and 

progressively adjusted. 

 

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of 

antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products 

were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) 

inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics 

(bendroflumethiazide), and angiotensin II receptor blockers (various types and doses, alone or in 

combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil 

(10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was 

applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology 

study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects 

taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of 



34 

blood-pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction 

was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not 

controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms 

in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 

20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in 

general, minor and not likely to be clinically relevant. Analysis of phase 3 clinical trial data showed no 

difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. 

However, appropriate clinical advice should be given to patients regarding a possible decrease in blood 

pressure when they are treated with antihypertensive medicinal products. 

 

Riociguat 

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were 

combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of 

PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population 

studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see 

section 4.3).   

 

5- alpha reductase inhibitors 

In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus 

finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a 

formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors 

(5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 

5-ARIs. 

 

CYP1A2 substrates (e.g. theophylline) 

When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a 

clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect 

was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance 

in this study, it should be considered when co-administering these medicinal products. 

 

Ethinylestradiol and terbutaline 

Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a 

similar increase may be expected with oral administration of terbutaline, although the clinical consequence 

of this is uncertain. 

 

Alcohol 

Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration 

with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after 

co-administration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol 

absorption (overnight fast with no food until 2 hours after alcohol). 

Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or 

approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and 

orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol 

(0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. 

The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg). 

 

Cytochrome P450 metabolised medicinal products 

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal 

products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce 

CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19. 

 

CYP2C9 substrates (e.g. R-warfarin) 

Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or 

R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin. 

 

Aspirin 

Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid. 



35 

 

Antidiabetic medicinal products 

Specific interaction studies with antidiabetic medicinal products were not conducted. 

 

4.6 Fertility, pregnancy and lactation 

 

Tadalafil Mylan is not indicated for use by women. 

 

Pregnancy 

 

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or 

indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal 

development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tadalafil 

Mylan during pregnancy. 

 

Breastfeeding 

 

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. 

A risk to the suckling child cannot be excluded. Tadalafil Mylan should not be used during breast feeding. 

 

Fertility 

 

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest 

that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see 

sections 5.1 and 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports 

of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they 

react to tadalafil before driving or using machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile 

dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the 

incidences increase with increasing dose of tadalafil. The adverse reactions reported were transient, and 

generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are 

experienced within the first 10 to 30 days of starting treatment. 

 

Tabulated summary of adverse reactions 

 

The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled 

clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand 

and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic 

hyperplasia. 

 



36 

Frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), 

rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available 

data). 

Very common Common  Uncommon  Rare  

Immune system disorders 

  Hypersensitivity reactions Angioedema2 

Nervous system disorders 

 Headache Dizziness  Stroke1 

(including haemorrhagic 

events), 

Syncope, 

Transient ischaemic attacks1, 

Migraine2, 

Seizures2, 

Transient amnesia  

Eye disorders 

  Blurred vision, 

Sensations described as 

eye pain 

Visual field defect,  

Swelling of eyelids, 

Conjunctival hyperaemia, 

Non-arteritic anterior  

ischemic optic neuropathy 

(NAION)2, 

Retinal vascular occlusion2 

Ear and labyrinth disorders 

  Tinnitus Sudden hearing loss  

Cardiac disorders1 

  Tachycardia, 

Palpitations 

Myocardial infarction, 

Unstable angina pectoris2, 

Ventricular arrhythmia2 

Vascular disorders 

 Flushing Hypotension3, 

Hypertension  

 

Respiratory, thoracic and mediastinal disorders 

 Nasal 

congestion 

Dyspnoea, 

Epistaxis  

 

Gastrointestinal disorders 

 Dyspepsia 

 

Abdominal pain, 

Vomiting, Nausea, 

Gastro-oesophageal 

reflux,  

 



37 

Skin and subcutaneous tissue disorders 

  Rash Urticaria, 

Stevens-Johnson syndrome2, 

Exfoliative dermatitis2, 

Hyperhydrosis (sweating) 

 

Musculoskeletal and connective tissue disorders 

 Back pain, 

Myalgia, 

Pain in 

extremity 

  

Renal and urinary disorders 

  Haematuria  

Reproductive system and breast disorders 

  Prolonged erections Priapism ,Penile haemorrhage, 

Haematospermia 

General disorders and administration site conditions 

  Chest pain1, Peripheral 

oedema, Fatigue 

Facial oedema2, 

Sudden cardiac death1, 2 

 (1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4). 

(2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials. 

(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive 

medicinal products. 

 

Description of selected adverse reactions 

 

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients 

treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not 

associated with adverse reactions. 

 

Other special populations 

 

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile 

dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken 

on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 

65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic 

hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age. 

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 

to report any suspected adverse reactions via the national reporting system listed in Appendix V. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38 

4.9 Overdose 

 

Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg 

have been given to patients. Adverse events were similar to those seen at lower doses. 

In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes 

negligibly to tadalafil elimination. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC Code: G04BE08. 

 

Mechanism of action 

 

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific 

phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition 

of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth 

muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no 

effect in the absence of sexual stimulation. 

 

Pharmacodynamic effects 

 

Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in 

corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, 

lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. 

Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found 

in the heart, brain, blood vessels, liver, and other organs. Tadalafil is > 10,000-fold more potent for PDE5 

than for PDE3, an enzyme found in the heart and blood vessels.  

This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac 

contractility. Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an 

enzyme which is found in the retina and is responsible for phototransduction. Tadalafil is also > 10,000-fold 

more potent for PDE5 than for PDE7 through PDE10. 

 

Clinical efficacy and safety 

 

Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of 

responsiveness to tadalafil. Tadalafil demonstrated statistically significant improvement in erectile function 

and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients’ 

ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes 

following dosing. 

 

Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine 

systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing 

systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no 

significant change in heart rate. 

 

In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) 

was detected using the Farnsworth Munsell 100 hue test. This finding is consistent with the low affinity of 

tadalafil for PDE6 compared to PDE5. Across all clinical studies, reports of changes in colour vision were 

rare (< 0.1%). 

 

Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 10 mg 

(one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily. In two of these 

studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely 



39 

clinical relevance. These effects were not associated with changes in other parameters such as motility, 

morphology and FSH. 

 

Tadalafil at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including 

patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 

years), and ethnicities. Most patients reported erectile dysfunction of at least 1 year in duration. In the 

primary efficacy studies of general populations, 81% of patients reported that tadalafil improved their 

erections as compared to 35% with placebo. Also, patients with erectile dysfunction in all severity categories 

reported improved erections whilst taking tadalafil (86%, 83% and 72% for mild, moderate, and severe, 

respectively, as compared to 45%, 42% and 19% with placebo). In the primary efficacy studies, 75% of 

intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo. 

 

In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary 

to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject 

proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 

48% as compared to 17% with placebo. 

 

Paediatric population 

 

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in 

which no evidence of efficacy was seen. The randomised, double-blind, placebo-controlled, parallel, 3-arm 

study of tadalafil was conducted in 331 boys aged 7-14 years with DMD receiving concurrent corticosteroid 

therapy. The study included a 48-week double-blind period where patients were randomised to tadalafil 

0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. Tadalafil did not show efficacy in slowing the decline in 

ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean 

change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the 

tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538). In addition, 

there was no evidence of efficacy from any of the secondary analyses performed in this study. The overall 

safety results from this study were generally consistent with the known safety profile of tadalafil and with 

adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids. 

 

The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of 

the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information on 

paediatric use. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma 

concentration (Cmax) is achieved at a median time of 2 hours after dosing. Absolute bioavailability of tadalafil 

following oral dosing has not been determined. 

The rate and extent of absorption of tadalafil are not influenced by food, thus tadalafil may be taken with or 

without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and 

extent of absorption. 

 

Distribution 

 

The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues. At 

therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. Protein binding is not affected by 

impaired renal function. 

Less than 0.0005% of the administered dose appeared in the semen of healthy subjects. 

 

Biotransformation 

 



40 

Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform. The major circulating 

metabolite is the methylcatechol glucuronide. This metabolite is at least 13,000-fold less potent than tadalafil 

for PDE5. Consequently, it is not expected to be clinically active at observed metabolite concentrations. 

 

Elimination 

 

The mean oral clearance for tadalafil is 2.5 l/h and the mean half-life is 17.5 hours in healthy subjects. 

Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the 

dose) and to a lesser extent in the urine (approximately 36% of the dose). 

 

Linearity/non-linearity 

 

Tadalafil pharmacokinetics in healthy subjects is linear with respect to time and dose. Over a dose range of 

2.5 to 20 mg, exposure (AUC) increases proportionally with dose. Steady-state plasma concentrations are 

attained within 5 days of once-daily dosing. 

 

Pharmacokinetics determined with a population approach in patients with erectile dysfunction is similar to 

pharmacokinetics in subjects without erectile dysfunction. 

 

Special populations 

 

Elderly 

Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25% higher 

exposure (AUC) relative to healthy subjects aged 19 to 45 years. This effect of age is not clinically 

significant and does not warrant a dose adjustment. 

 

Renal insufficiency 

In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) 

approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine 

clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis. In 

haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects. 

Haemodialysis contributes negligibly to tadalafil elimination. 

 

Hepatic insufficiency 

Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and 

B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered. There is limited 

clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C). If 

tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing 

physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to 

patients with hepatic impairment.  

 

Patients with diabetes 

Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for 

healthy subjects. This difference in exposure does not warrant a dose adjustment. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 

repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. 

There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 

1000 mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 

30 mg/kg/day. In the pregnant rat the AUC for calculated free drug at this dose was approximately 18 times 

the human AUC at a 20 mg dose. 

There was no impairment of fertility in male and female rats. In dogs given tadalafil daily for 6 to 12 months 

at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7-–-18.6] than seen in 

humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium 

that resulted in a decrease in spermatogenesis in some dogs. See also section 5.1. 



41 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core: 

 

Lactose, anhydrous 

Poloxamer 188 

Cellulose, microcrystalline (pH101) 

Povidone (K-25) 

Croscarmellose sodium 

Magnesium stearate 

Sodium laurilsulfate 

Silica, colloidal anhydrous 

 

Film-coat: 

 

Lactose monohydrate 

Hypromellose (E464) 

Titanium dioxide (E171) 

Iron oxide yellow (E172) 

Triacetin 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 

PVC/PE/PVdC-Alu blisters. 

 

Tadalafil Mylan 10 mg film-coated tablets 

 

Pack sizes of 4, 12 and 24 tablets. 

 

Tadalafil Mylan 20 mg film-coated tablets  

 

Pack sizes of 2, 4, 8,12 and 24 tablets 

 

Not all pack sizes may be marketed.  

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

. 



42 

 

7. MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

Tadalafil Mylan 10 mg film-coated tablets 

 

EU/1/14/961/001 

EU/1/14/961/010 

EU/1/14/961/011 

 

Tadalafil Mylan 20 mg film-coated tablets 

 

EU/1/14/961/002 

EU/1/14/961/003 

EU/1/14/961/004 

EU/1/14/961/005 

EU/1/14/961/006 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 21 November 2014 

Date of latest renewal: 31 July 2019 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

 

  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


43 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 



44 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

 

McDermott Laboratories Limited t/a Gerard Laboratories 

Unit 35/36 Baldoyle Industrial Estate 

Grange Road, Dublin 13 

Ireland 

 

Mylan Hungary Kft. 

Mylan utca 1 

Komárom 2900 

Hungary 

 

Generics [UK] Limited 

Station Close 

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan UK Healthcare Limited 

Building 20, Station Close  

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 

 

 

The printed package leaflet of the medicinal product must state the name and address of the manufacturer 

responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 

 

• Periodic safety update reports (PSURs) 

 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal.  

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT 

 

• Risk management plan (RMP) 

 



45 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and 

interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any 

agreed subsequent updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 

(pharmacovigilance or risk minimisation) milestone being reached. 

 

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same 

time. 

  



46 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



47 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 2.5 mg film-coated tablets 

tadalafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 2.5 mg tadalafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose.  

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

28 film-coated tablets 

56 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

Once daily 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



49 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/961/008 

EU/1/14/961/009 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Tadalafil Mylan 2.5 mg    

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 

  



50 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 2.5 mg tablets 

tadalafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 5 mg film-coated tablets 

tadalafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 5 mg tadalafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 film-coated tablets 

28 film-coated tablets 

30 film-coated tablets 

56 film-coated tablets 

84 film-coated tablets 

98 film-coated tablets 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use 

Once daily 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



52 

9. SPECIAL STORAGE CONDITIONS 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/961/012 

EU/1/14/961/013 

EU/1/14/961/014 

EU/1/14/961/015 

EU/1/14/961/016 

EU/1/14/961/017 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Tadalafil Mylan 5 mg   

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



53 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 5 mg tablets 

tadalafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 10 mg film-coated tablets 

tadalafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 10 mg tadalafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose.  

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

4 film-coated tablets 

12 film-coated tablets 

24 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



55 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/961/001 

EU/1/14/961/010 

EU/1/14/961/011 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Tadalafil Mylan 10 mg   

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 

  



56 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 10 mg tablets 

tadalafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

  



57 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 20 mg film-coated tablets 

tadalafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 20 mg tadalafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose.  

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

2 film-coated tablets 

4 film-coated tablets 

8 film-coated tablets 

12 film-coated tablets 

24 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 



58 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/14/961/002 

EU/1/14/961/003 

EU/1/14/961/004 

EU/1/14/961/005 

EU/1/14/961/006 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Tadalafil Mylan 20 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



59 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Tadalafil Mylan 20 mg tablets 

tadalafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

  



60 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



61 

Package leaflet: Information for the patient 

 

Tadalafil Mylan 2.5 mg film-coated tablets 

tadalafil 

 

Read all of this leaflet carefully before you start taking this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Tadalafil Mylan is and what it is used for  

2. What you need to know before you take Tadalafil Mylan  

3. How to take Tadalafil Mylan  

4. Possible side effects  

5. How to store Tadalafil Mylan 

6. Contents of the pack and other information 

 

 

1. What Tadalafil Mylan is and what it is used for 

 

Tadalafil Mylan is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or 

keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the 

ability of obtaining a hard erect penis suitable for sexual activity. 

 

Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called 

phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Mylan works by helping the 

blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is 

improved erectile function. Tadalafil Mylan will not help you if you do not have erectile dysfunction. 

 

It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will 

need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. 

 

 

2. What you need to know before you take Tadalafil Mylan  

 

Do not take Tadalafil Mylan 

- if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). 

- if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group 

of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been 

shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell 

your doctor. 

- if you have serious heart disease or recently had a heart attack within the last 90 days. 

- if you had a stroke within the last 6 months. 

- if you have low blood pressure or uncontrolled high blood pressure. 

- if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a 

condition described as “stroke of the eye”. 

- if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood 

pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure 

in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to 



62 

increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your 

doctor. 

 

Warnings and precautions  

Talk to your doctor before taking Tadalafil Mylan. 

 

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra 

strain on your heart. If you have a heart problem you should tell your doctor. 

 

Before taking the tablets, tell your doctor if you have: 

- sickle cell anaemia (an abnormality of red blood cells). 

- multiple myeloma (cancer of the bone marrow). 

- leukaemia (cancer of the blood cells). 

- any deformation of your penis. 

- a serious liver problem. 

- a severe kidney problem. 

 

It is not known if tadalafil is effective in patients who have had: 

- pelvic surgery. 

- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non -nerve-

sparing prostatectomy). 

 

If you experience sudden decrease or loss of vision, stop taking Tadalafil Mylan and contact your doctor 

immediately. 

 

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known 

if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking 

Tadalafil Mylan and contact your doctor immediately. 

 

Tadalafil Mylan is not intended for use by women. 

 

Children and adolescents 

Tadalafil Mylan is not intended for use by children and adolescents under the age of 18. 

 

Other medicines and Tadalafil Mylan 

Tell your doctor if you are taking, have recently taken or might take any other medicines. 

 

Do not take Tadalafil Mylan if you are already taking nitrates. 

 

Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan will work. 

Tell your doctor or pharmacist if you are already taking: 

- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign 

prostatic hyperplasia). 

- other medicines to treat high blood pressure. 

- riociguat. 
- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia). 

- medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment 

of AIDS or HIV infection. 

- phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines). 

- rifampicin, erythromycin, clarithromycin or itraconazole. 

- other treatments for erectile dysfunction. 

 

Tadalafil Mylan with drink and alcohol 

Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution. Talk to 

your doctor for further information. 

 



63 

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take 

Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase 

the risk of dizziness when standing up. 

 

Fertility 

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen 

in some men. These effects are unlikely to lead to a lack of fertility. 

 

Driving and using machines 

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the 

tablets before driving or using machines. 

 

Tadalafil Mylan contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 

taking this medicine. 

 

Tadalafil Mylan contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 

 

 

3. How to take Tadalafil Mylan 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 

are not sure. 

 

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your 

doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Mylan. This will be given as a 

2.5 mg tablet. 

Do not take Tadalafil Mylan more than once a day. 

 

Tadalafil Mylan tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets 

can be taken with or without food. 

 

Once a day dosing of Tadalafil Mylan may be useful to men who anticipate having sexual activity two or 

more times per week. 

 

When taken once a day Tadalafil Mylan allows you to obtain an erection, when sexually stimulated, at any 

time point during the 24 hours of the day. 

 

If you take more Tadalafil Mylan than you should 

Contact your doctor. You may experience side effects described in section 4. 

 

If you forget to take Tadalafil Mylan 

Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. 

You should not take Tadalafil Mylan more than once a day. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are 

normally mild to moderate in nature. 

 

If you experience any of the following side effects stop using the medicine and seek medical help 

immediately: 

- allergic reactions including rashes (frequency uncommon). 



64 

-  chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon). 

- priapism, a prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have 

such an erection, which lasts continuously for more than 4 hours you should contact a doctor 

immediately. 

- sudden loss of vision (frequency rare). 

 

Other side effects have been reported: 

 

Common (may affect up to 1 in 10 people) 

- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and 

indigestion. 

 

Uncommon (may affect up to 1 in 100 people) 

- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty 

in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart 

rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, 

feet or ankles and feeling tired. 

 

Rare (may affect up to 1 in 1,000 people) 

- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss 

of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in 

semen and increased sweating.  

 

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known 

heart problems before taking this medicine. 

 

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. 

 

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical 

trials. These include: 

- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, 

serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and 

sudden cardiac death. 

 

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. 

Diarrhoea has been reported more frequently in men over the age of 65 taking tadalafil. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 

in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 

V. By reporting side affects you can help provide more information on the safety of this medicine. 

 

 

5. How to store Tadalafil Mylan 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 

refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 

away medicines you no longer use. These measures will help protect the environment. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


65 

6. Contents of the pack and other information 

 

What Tadalafil Mylan contains  

- The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.  
- The other ingredients are: 

Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose’), poloxamer 188, 

cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, 

sodium laurilsulfate, silica colloidal anhydrous. 

Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow 

(E172), triacetin. 

 

What Tadalafil Mylan looks like and contents of the pack 

Tadalafil Mylan 2.5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M’ on one side of 

the tablet and ‘TL over 1’ on the other side. 

 

Tadalafil Mylan 2.5 mg is available in blister packs containing 28 and 56 tablets. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer 

 

Marketing Authorisation Holder 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

Manufacturer 

McDermott Laboratories Ltd. t/a Gerard Laboratories 

35/36 Baldoyle Industrial Estate, Grange Road 

Dublin 13 

Ireland 

 

Mylan Hungary Kft. 

Mylan utca 1 

Komárom, 2900 

Hungary 

 

Generics [UK] Limited 

Station Close 

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan UK Healthcare Limited 

Building 20, Station Close  

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 

 

 

 

For any information about this medicine, please contact the local representative of the Marketing 



66 

Authorisation Holder. 

 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

Lietuva (Lithuania) 

BGP Products UAB 

Tel: + 370 5 205 1288 

 

  

България (Bulgaria) 

Майлан ЕООД 

Тел: + 359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00  

(Belgique/Belgien) 

  

Česká republika 

Mylan Healthcare CZ  s.r.o. 

Tel: + 420 222 004 400 

Magyarország (Hungary) 

Mylan EPD Kft. 

Tel: + 36 1 465 2100 

  

Danmark 

Mylan Denmark ApS 

Tel: + 45 28 11 69 32 

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

  

Deutschland 

Mylan Healthcare GmbH 

Tel: + 49 800 0700 800 

Nederland 

Mylan BV 

Tel: + 31 (0)20 426 3300 

  

Eesti (Estonia) 

BGP Products Switzerland GmbH Eesti filiaal 

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

Ελλάδα (Greece) 

Generics Pharma Hellas EPE 

Τηλ: + 30 210 993 6410 

Österreich 

Arcana Arzneimittel GmbH 

Tel: + 43 1 416 2418 

  

España 

Mylan Pharmaceuticals, S.L. 

Tel: + 34 900 102 712 

Polska 

Mylan Healthcare Sp. z o.o. 

Tel: + 48 22 546 64 00 

  

France 

Mylan S.A.S 

Tel: + 33 4 37 25 75 00 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

  

Hrvatska (Croatia) 

Mylan Hrvatska d.o.o.   

Tel: + 385 1 23 50 599   

România 

BGP Products SRL 

Tel: + 40 372 579 000 

  

Ireland 

Mylan Ireland Limited 

Tel: + 353 (0) 87 1694982 

Slovenija 

Mylan Healthcare d.o.o. 

Tel: + 386 1 23 63 180 

 

Ísland 

Icepharma hf 

Tel: + 354 540 8000 

 

Slovenská republika 

Mylan s.r.o. 

Tel: + 421 2 32 199 100 

  



67 

Italia 

Mylan Italia S.r.l. 

Tel: + 39 02 612 46921 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: + 358 20 720 9555 

  

Κύπρος (Cyprus) 

 Varnavas Hadjipanayis LtdTel: + 357 22207723 

Sverige 

Mylan AB 

Tel: + 46 855 522 750 

  

Latvija 

Mylan Healthcare SIA  

Tel: + 371 676 05580 

United Kingdom 

Generics [UK] Ltd. 

Tel: + 44 1707 853000 

 

This leaflet was last revised in 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu.  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


68 

Package leaflet: Information for the patient 

 

Tadalafil Mylan 5 mg film-coated tablets 

tadalafil 

 

Read all of this leaflet carefully before you start taking this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Tadalafil Mylan is and what it is used for 

2. What you need to know before you take Tadalafil Mylan 

3. How to take Tadalafil Mylan 

4. Possible side effects 

5. How to store Tadalafil Mylan 

6. Contents of the pack and other information 

 

 

1. What Tadalafil Mylan is and what it is used for 

 

Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called 

phosphodiesterase type 5 inhibitors. 

 

Tadalafil Mylan is used to treat adult men with: 

- erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual 

activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis 

suitable for sexual activity. Following sexual stimulation Tadalafil Mylan works by helping the blood 

vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is 

improved erectile function. Tadalafil Mylan will not help you if you do not have erectile dysfunction. 

It is important to note that Tadalafil Mylan for the treatment of erectile dysfunction does not work if 

there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would 

if you were not taking a medicine for erectile dysfunction. 

 

- urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is 

when the prostate gland gets bigger with the age. Symptoms include difficulty in starting to pass 

water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at 

night. Tadalafil improves blood flow to, and relaxes the muscles of, the prostate and bladder which 

may reduce symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these 

urinary symptoms as early as 1-2 weeks after starting treatment. 

 

 

2. What you need to know before you take Tadalafil Mylan 

 

Do not take Tadalafil Mylan 

- if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). 

- if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group 

of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been 

shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell 

your doctor. 

- if you have serious heart disease or recently had a heart attack within the last 90 days. 



69 

- if you had a stroke within the last 6 months. 

- if you have low blood pressure or uncontrolled high blood pressure. 

- if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a 

condition described as “stroke of the eye”. 

- if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood 

pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure 

in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to 

increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your 

doctor. 

 

Warnings and precautions  

Talk to your doctor before taking Tadalafil Mylan. 

 

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra 

strain on your heart. If you have a heart problem you should tell your doctor. 

 

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check 

you for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil 

does not treat prostate cancer. 

 

Before taking the tablets, tell your doctor if you have: 

- sickle cell anaemia (an abnormality of red blood cells). 

- multiple myeloma (cancer of the bone marrow). 

- leukaemia (cancer of the blood cells). 

- any deformation of your penis. 

- a serious liver problem. 

- a severe kidney problem. 

 

It is not known if tadalafil is effective in patients who have had: 

- pelvic surgery. 

- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-

sparing prostatectomy). 

 

If you experience sudden decrease or loss of vision, stop taking Tadalafil Mylan and contact your doctor 

immediately. 

 

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known 

if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking 

Tadalafil Mylan and contact your doctor immediately. 

 

Tadalafil Mylan is not intended for use by women. 

 

Children and adolescents 

Tadalafil Mylan is not intended for use by children and adolescents under the age of 18. 

 

Other medicines and Tadalafil Mylan 

Tell your doctor if you are taking, have recently taken or might take any other medicines. 

 

Do not take Tadalafil Mylan if you are already taking nitrates. 

 

Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan will work. 

Tell your doctor or pharmacist if you are already taking: 

- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign 

prostatic hyperplasia). 

- other medicines to treat high blood pressure. 

- riociguat. 

- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia). 



70 

- medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment 

of AIDS or HIV infection. 

- phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines). 

- rifampicin, erythromycin, clarithromycin or itraconazole. 

- other treatments for erectile dysfunction. 

 

Tadalafil Mylan with drink and alcohol 

Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution. Talk to 

your doctor for further information. 

 

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take 

Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase 

the risk of dizziness when standing up. 

 

Fertility 

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen 

in some men. These effects are unlikely to lead to a lack of fertility. 

 

Driving and using machines 

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the 

tablets before driving or using machines. 

 

Tadalafil Mylan contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 

taking this medicine. 

 

Tadalafil Mylan contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 

 

 

3. How to take Tadalafil Mylan 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 

are not sure.  

 

For the treatment of erectile dysfunction 

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your 

doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Mylan. This will be given as a 

2.5 mg tablet. 

Do not take Tadalafil Mylan more than once a day. 

 

When taken once a day Tadalafil Mylan allows you to obtain an erection, when sexually stimulated, at any 

time point during the 24 hours of the day. Once a day dosing of Tadalafil Mylan may be useful to men who 

anticipate having sexual activity two or more times per week. 

 

For the treatment of benign prostatic hyperplasia 

The dose is one 5 mg tablet taken once a day at approximately the same time of the day. 

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken 

once a day. 

Do not take Tadalafil Mylan more than once a day. 

 

Tadalafil Mylan tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets 

can be taken with or without food. 

 

If you take more Tadalafil Mylan than you should 

Contact your doctor. You may experience side effects described in section 4. 

 



71 

If you forget to take Tadalafil Mylan 

Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. 

You should not take Tadalafil Mylan more than once a day. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are 

normally mild to moderate in nature. 

 

If you experience any of the following side effects stop using the medicine and seek medical help 

immediately: 

- allergic reactions including rashes (frequency uncommon). 

-  chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon). 

- priapism, a prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have 

such an erection, which lasts continuously for more than 4 hours you should contact a doctor 

immediately. 

- sudden loss of vision (frequency rare). 

 

Other side effects have been reported: 

 

Common (may affect up to 1 in 10 people) 

- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and 

indigestion. 

 

Uncommon (may affect up to 1 in 100 people) 

- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty 

in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart 

rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, 

feet or ankles and feeling tired. 

 

Rare (may affect up to 1 in 1,000 people) 

- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss 

of hearing and hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in 

the semen and increased sweating.  

 

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known 

heart problems before taking this medicine. 

 

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. 

 

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical 

trials. These include: 

- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, 

serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and 

sudden cardiac death. 

 

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. 

Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 

in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 

V. By reporting side effects you can help provide more information on the safety of this medicine. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


72 

 

5. How to store Tadalafil Mylan 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 

refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 

away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Tadalafil Mylan contains 

- The active substance is tadalafil. Each tablet contains 5 mg of tadalafil. 
- The other ingredients are: 

Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose’), poloxamer 188, 

cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, 

sodium laurilsulfate, silica colloidal anhydrous. 

Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow 

(E172), triacetin. 

 

What Tadalafil Mylan looks like and contents of the pack 

Tadalafil Mylan 5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M’ on one side of 

the tablet and ‘TL over 2’ on the other side. 

 

Tadalafil Mylan 5 mg is available in blister packs containing 14, 28, 30, 56, 84 and 98 tablets. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer 

 

Marketing Authorisation Holder 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

Manufacturer 

McDermott Laboratories Ltd. t/a Gerard Laboratories 

35/36 Baldoyle Industrial Estate, Grange Road  

Dublin 13 

Ireland 

 

Mylan Hungary Kft. 

Mylan utca 1 

Komárom, 2900 

Hungary 

 

Generics [UK] Limited 

Station Close 

Potters Bar, EN6 1TL 

United Kingdom 

 



73 

Mylan UK Healthcare Limited 

Building 20, Station Close  

Potters Bar, EN6 1TL 

United Kingdom 

 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 

 

 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

 

 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

Lietuva (Lithuania) 

BGP Products UAB 

Tel: + 370 5 205 1288 

 

  

България (Bulgaria) 

Майлан ЕООД 

Тел: + 359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00  

(Belgique/Belgien) 

  

Česká republika 

Mylan Healthcare CZ  s.r.o. 

Tel: + 420 222 004 400 

Magyarország (Hungary) 

Mylan EPD Kft. 

Tel: + 36 1 465 2100 

  

Danmark 

Mylan Denmark ApS 

Tel: + 45 28 11 69 32 

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

  

Deutschland 

Mylan Healthcare GmbH 

Tel: + 49 800 0700 800 

Nederland 

Mylan BV 

Tel: + 31 (0)20 426 3300 

  

Eesti (Estonia) 

BGP Products Switzerland GmbH Eesti filiaal 

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

Ελλάδα (Greece) 

Generics Pharma Hellas EPE 

Τηλ: + 30 210 993 6410 

Österreich 

Arcana Arzneimittel GmbH 

Tel: + 43 1 416 2418 

  

España 

Mylan Pharmaceuticals, S.L. 

Tel: + 34 900 102 712 

Polska 

Mylan Healthcare Sp. z o.o. 

Tel: + 48 22 546 64 00 

  



74 

France 

Mylan S.A.S 

Tel: + 33 4 37 25 75 00 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

  

Hrvatska (Croatia) 

Mylan Hrvatska d.o.o.   

Tel: + 385 1 23 50 599   

România 

BGP Products SRL 

Tel: + 40 372 579 000 

  

Ireland 

Mylan Ireland Limited 

Tel: + 353 (0) 87 1694982 

Slovenija 

Mylan Healthcare d.o.o. 

Tel: + 386 1 23 63 180 

 

Ísland 

Icepharma hf 

Tel: + 354 540 8000 

 

Slovenská republika 

Mylan s.r.o. 

Tel: + 421 2 32 199 100 

  

Italia 

Mylan Italia S.r.l. 

Tel: + 39 02 612 46921 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: + 358 20 720 9555 

  

Κύπρος (Cyprus) 

 Varnavas Hadjipanayis Ltd 

Tel: + 357 222 077 23 

Sverige 

Mylan AB 

Tel: + 46 855 522 750 

  

Latvija 

Mylan Healthcare SIA  

Tel: + 371 676 05580 

United Kingdom 

Generics [UK] Ltd. 

Tel: + 44 1707 853000 

 

 

This leaflet was last revised in 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu.  

 

 

  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


75 

Package leaflet: Information for the patient 

 

Tadalafil Mylan 10 mg film-coated tablets 

tadalafil 

 

Read all of this leaflet carefully before you start taking this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Tadalafil Mylan is and what it is used for  

2. What you need to know before you take Tadalafil Mylan  

3. How to take Tadalafil Mylan  

4. Possible side effects  

5. How to store Tadalafil Mylan 

6. Contents of the pack and other information 

 

 

1. What Tadalafil Mylan is and what it is used for 

 

Tadalafil Mylan is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or 

keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the 

ability of obtaining a hard erect penis suitable for sexual activity. 

 

Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called 

phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Mylan works by helping the 

blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is 

improved erectile function. Tadalafil Mylan will not help you if you do not have erectile dysfunction. 

 

It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will 

need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. 

 

 

2. What you need to know before you take Tadalafil Mylan 

 

Do not take Tadalafil Mylan 

- if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). 

- if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group 

of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been 

shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell 

your doctor. 

- if you have serious heart disease or recently had a heart attack within the last 90 days. 

- if you had a stroke within the last 6 months. 

- if you have low blood pressure or uncontrolled high blood pressure. 

- if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a 

condition described as “stroke of the eye”. 

- if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood 

pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure 

in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to 



76 

increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your 

doctor. 

 

Warnings and precautions  

Talk to your doctor before taking Tadalafil Mylan. 

 

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra 

strain on your heart. If you have a heart problem you should tell your doctor. 

 

Before taking the tablets, tell your doctor if you have: 

- sickle cell anaemia (an abnormality of red blood cells). 

- multiple myeloma (cancer of the bone marrow). 

- leukaemia (cancer of the blood cells). 

- any deformation of your penis. 

- a serious liver problem. 

- a severe kidney problem. 

 

It is not known if tadalafil is effective in patients who have had: 

- pelvic surgery. 

- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-

sparing prostatectomy). 

 

If you experience sudden decrease or loss of vision, stop taking Tadalafil Mylan and contact your doctor 

immediately. 

 

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known 

if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking 

Tadalafil Mylan and contact your doctor immediately. 

 

Tadalafil Mylan is not intended for use by women. 

 

Children and adolescents 

Tadalafil Mylan is not intended for use by children and adolescents under the age of 18. 

 

Other medicines and Tadalafil Mylan 

Tell your doctor if you are taking, have recently taken or might take any other medicines. 

 

Do not take Tadalafil Mylan if you are already taking nitrates. 

 

Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan will work. 

Tell your doctor or pharmacist if you are already taking: 

- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign 

prostatic hyperplasia). 

- other medicines to treat high blood pressure. 

- riociguat. 

- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia). 

- medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment 

of AIDS or HIV infection. 

- phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines). 

- rifampicin, erythromycin, clarithromycin or itraconazole. 

- other treatments for erectile dysfunction. 

 

Tadalafil Mylan with drink and alcohol 

Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution. Talk to 

your doctor for further information. 

 



77 

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take 

Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase 

the risk of dizziness when standing up. 

 

Fertility 

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen 

in some men. These effects are unlikely to lead to a lack of fertility. 

 

Driving and using machines 

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the 

tablets before driving or using machines. 

 

Tadalafil Mylan contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 

taking this medicine. 

 

Tadalafil Mylan contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 

 

3. How to take Tadalafil Mylan 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 

are not sure.  

 

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too 

weak your doctor may increase the dose to 20 mg. Tadalafil Mylan is for oral use. 

 

You may take tadalafil at least 30 minutes before sexual activity. 

Tadalafil may still be effective up to 36 hours after taking the tablet. 

 

Do not take Tadalafil Mylan more than once a day. Tadalafil Mylan 10 mg and 20 mg is intended for use 

prior to anticipated sexual activity and is not recommended for continuous daily use. 

 

Tadalafil Mylan tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets 

can be taken with or without food. 

 

If you take more Tadalafil Mylan than you should 

Contact your doctor. You may experience side effects described in section 4. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are 

normally mild to moderate in nature. 

 

If you experience any of the following side effects stop using the medicine and seek medical help 

immediately: 

- allergic reactions including rashes (frequency uncommon). 

-  chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon). 

- priapism, a prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have 

such an erection, which lasts continuously for more than 4 hours you should contact a doctor 

immediately. 

- sudden loss of vision (frequency rare). 

 

Other side effects have been reported: 



78 

 

Common (may affect up to 1 in 10 people) 

- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and 

indigestion. 

 

Uncommon (may affect up to 1 in 100 people) 

- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty 

in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart 

rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, 

feet or ankles and feeling tired. 

 

Rare (may affect up to 1 in 1,000 people) 

- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss 

of hearing and hives (itchy red welts on the surface of the skin) penile bleeding, presence of blood in 

semen and increased sweating.  

 

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known 

heart problems before taking this medicine. 

 

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. 

 

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical 

trials. These include: 

- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, 

serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and 

sudden cardiac death. 

 

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. 

Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 

in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 

V. By reporting side effects you can help provide more information on the safety of this medicine. 

 

 

5. How to store Tadalafil Mylan 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 

refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 

away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Tadalafil Mylan contains  

- The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.  
- The other ingredients are: 

Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose’), poloxamer 188, 

cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, 

sodium laurilsulfate, silica colloidal anhydrous. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


79 

Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow 

(E172), triacetin. 

 

What Tadalafil Mylan looks like and contents of the pack 

Tadalafil Mylan 10 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M’ on one side of 

the tablet and ‘TL3’ on the other side. 

 

Tadalafil Mylan 10 mg is available in blister packs containing 4, 12 and 24 tablets. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer 

 

Marketing Authorisation Holder 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

 

Manufacturer 

McDermott Laboratories Ltd. t/a Gerard Laboratories 

35/36 Baldoyle Industrial Estate, Grange Road 

Dublin 13 

Ireland 

 

Mylan Hungary Kft. 

Mylan utca 1 

Komárom, 2900 

Hungary 

 

Generics [UK] Limited 

Station Close 

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan UK Healthcare Limited 

Building 20, Station Close  

Potters Bar, EN6 1TL 

United Kingdom 

 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 

 

 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

Lietuva (Lithuania) 

BGP Products UAB 

Tel: + 370 5 205 1288 

 



80 

  

България (Bulgaria) 

Майлан ЕООД 

Тел: + 359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00  

(Belgique/Belgien) 

  

Česká republika 

Mylan Healthcare CZ s.r.o. 

Tel: + 420 222 004 400 

Magyarország (Hungary) 

Mylan EPD Kft. 

Tel: + 36 1 465 2100 

  

Danmark 

Mylan Denmark ApS 

Tel: + 45 28 11 69 32 

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

  

Deutschland 

Mylan Healthcare GmbH 

Tel: + 49 800 0700 800 

Nederland 

Mylan BV 

Tel: + 31 (0)20 426 3300 

  

Eesti (Estonia) 

BGP Products Switzerland GmbH Eesti filiaal 

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

Ελλάδα (Greece) 

Generics Pharma Hellas EPE 

Τηλ: + 30 210 993 6410 

Österreich 

Arcana Arzneimittel GmbH 

Tel: + 43 1 416 2418 

  

España 

Mylan Pharmaceuticals, S.L. 

Tel: + 34 900 102 712 

Polska 

Mylan Healthcare Sp. z o.o. 

Tel: + 48 22 546 64 00 

  

France 

Mylan S.A.S 

Tel: + 33 4 37 25 75 00 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

  

Hrvatska (Croatia) 

Mylan Hrvatska d.o.o.   

Tel: + 385 1 23 50 599   

România 

BGP Products SRL 

Tel: + 40 372 579 000 

  

Ireland 

Mylan Ireland Limited 

Tel: + 353 (0) 87 1694982 

Slovenija 

Mylan Healthcare d.o.o. 

Tel: + 386 1 23 63 180 

 

Ísland 

Icepharma hf 

Tel: + 354 540 8000 

 

Slovenská republika 

Mylan s.r.o. 

Tel: + 421 2 32 199 100 

  

Italia 

Mylan Italia S.r.l. 

Tel: + 39 02 612 46921 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: + 358 20 720 9555 

  

Κύπρος (Cyprus) 

 Varnavas Hadjipanayis Ltd 

Tel: + 357 222 077 23 

Sverige 

Mylan AB 

Tel: + 46 855 522 750 

  



81 

Latvija 

Mylan Healthcare SIA  

Tel: + 371 676 05580 

United Kingdom 

Generics [UK] Ltd. 

Tel: + 44 1707 853000 

 

 

This leaflet was last revised in 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

http://www.ema.europa.eu/
http://www.ema.europa.eu/


82 

Package leaflet: Information for the patient 

 

Tadalafil Mylan 20 mg film-coated tablets 

tadalafil 

 

Read all of this leaflet carefully before you start taking this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Tadalafil Mylan is and what it is used for 

2. What you need to know before you take Tadalafil Mylan 

3. How to take Tadalafil Mylan 

4. Possible side effects 

5. How to store Tadalafil Mylan 

6. Contents of the pack and other information 

 

 

1. What Tadalafil Mylan is and what it is used for 

 

Tadalafil Mylan is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or 

keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the 

ability of obtaining a hard erect penis suitable for sexual activity. 

 

Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called 

phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Mylan works by helping the 

blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is 

improved erectile function. Tadalafil Mylan will not help you if you do not have erectile dysfunction. 

 

It is important to note that tadalafil does not work if there is no sexual stimulation. You and your partner will 

need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. 

 

 

2. What you need to know before you take Tadalafil Mylan 

 

Do not take Tadalafil Mylan 

- if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). 

- if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group 

of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been 

shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell 

your doctor. 

- if you have serious heart disease or recently had a heart attack within the last 90 days. 

- if you had a stroke within the last 6 months. 

- if you have low blood pressure or uncontrolled high blood pressure. 

- if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a 

condition described as “stroke of the eye”. 

- if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood 

pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure 

in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to 



83 

increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your 

doctor. 

 

Warnings and precautions 

Talk to your doctor before taking Tadalafil Mylan. 

 

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra 

strain on your heart. If you have a heart problem you should tell your doctor. 

 

Before taking the tablets, tell your doctor if you have: 

- sickle cell anaemia (an abnormality of red blood cells). 

- multiple myeloma (cancer of the bone marrow). 

- leukaemia (cancer of the blood cells). 

- any deformation of your penis. 

- a serious liver problem. 

- a severe kidney problem. 

 

It is not known if tadalafil is effective in patients who have had: 

- pelvic surgery. 

- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-

sparing prostatectomy). 

 

If you experience sudden decrease or loss of vision, stop taking Tadalafil Mylan and contact your doctor 

immediately. 

 

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known 

if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop 

takingTadalafil Mylan and contact your doctor immediately. 

 

Tadalafil Mylan is not intended for use by women. 

 

Children and adolescents 

Tadalafil Mylan is not intended for use by children and adolescents under the age of 18. 

 

Other medicines and Tadalafil Mylan 

Tell your doctor if you are taking, have recently taken or might take any other medicines. 

 

Do not take Tadalafil Mylan if you are already taking nitrates. 

 

Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan will work. 

Tell your doctor or pharmacist if you are already taking: 

- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign 

prostatic hyperplasia). 

- other medicines to treat high blood pressure. 

- riociguat. 

- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia). 

- medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment 

of AIDS or HIV infection. 

- phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines). 

- rifampicin, erythromycin, clarithromycin or itraconazole. 

- other treatments for erectile dysfunction. 

 

Tadalafil Mylan with drink and alcohol 

Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution. Talk to 

your doctor for further information. 

 



84 

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take 

Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase 

the risk of dizziness when standing up. 

 

Fertility 

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen 

in some men. These effects are unlikely to lead to a lack of fertility. 

 

Driving and using machines 

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the 

tablets before driving or using machines. 

 

Tadalafil Mylan contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 

taking this medicine. 

 

Tadalafil Mylan contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 

 

 

3. How to take Tadalafil Mylan 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 

are not sure.  

 

The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given 

the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak. 

 

You may take tadalafil at least 30 minutes before sexual activity. 

Tadalafil may still be effective up to 36 hours after taking the tablet. 

 

Do not take Tadalafil Mylan more than once a day. Tadalafil Mylan 10 mg and 20 mg is intended for use 

prior to anticipated sexual activity and is not recommended for continuous daily use. 

 

Tadalafil Mylan tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets 

can be taken with or without food. 

 

If you take more Tadalafil Mylan than you should 

Contact your doctor. You may experience side effects described in section 4. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are 

normally mild to moderate in nature. 

 

If you experience any of the following side effects stop using the medicine and seek medical help 

immediately: 

- allergic reactions including rashes (frequency uncommon). 

- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon). 

- priapism, a prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have 

such an erection, which lasts continuously for more than 4 hours you should contact a doctor 

immediately. 

- sudden loss of vision (frequency rare). 

 



85 

Other side effects have been reported: 

 

Common (may affect up to 1 in 10 people) 

- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and 

indigestion.  

 

Uncommon (may affect up to 1 in 100 people) 

- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty 

in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart 

rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, 

feet or ankles and feeling tired. 

 

Rare (may affect up to 1 in 1,000 people) 

- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss 

of hearing and hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in 

semen and increased sweating.  

 

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known 

heart problems before taking this medicine. 

 

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. 

 

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical 

trials. These include: 

- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, 

serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and 

sudden cardiac death. 

 

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. 

Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 

in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 

V. By reporting side effects you can help provide more information on the safety of this medicine. 

 

 

5. How to store Tadalafil Mylan 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 

refers to the last day of that month. 

 

This medicine does not require any special storage conditions.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 

away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Tadalafil Mylan contains  

- The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.  
- The other ingredients are: 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


86 

Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose’), poloxamer 188, 

cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, 

sodium laurilsulfate, silica colloidal anhydrous. 

Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow 

(E172), triacetin. 

 

What Tadalafil Mylan looks like and contents of the pack 

Tadalafil Mylan 20 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M’ on one side of 

the tablet and ‘TL4’ on the other side. 

 

Tadalafil Mylan 20 mg is available in blister packs containing 2, 4, 8, 12 and 24 tablets. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer 

 

Marketing Authorisation Holder 

Mylan S.A.S. 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 

Manufacturer 

McDermott Laboratories Ltd. t/a Gerard Laboratories 

35/36 Baldoyle Industrial Estate, Grange Road 

Dublin 13 

Ireland 

 

Mylan Hungary Kft. 

Mylan utca 1 

Komárom, 2900 

Hungary 

 

Generics [UK] Limited 

Station Close 

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan UK Healthcare Limited 

Building 20, Station Close  

Potters Bar, EN6 1TL 

United Kingdom 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 

 

 

 



87 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

Lietuva (Lithuania) 

BGP Products UAB 

Tel: + 370 5 205 1288 

 

  

България (Bulgaria) 

Майлан ЕООД 

Тел: + 359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00  

(Belgique/Belgien) 

  

Česká republika 

Mylan Healthcare CZ s.r.o. 

Tel: + 420 222 004 400 

Magyarország (Hungary) 

Mylan EPD Kft. 

Tel: + 36 1 465 2100 

  

Danmark 

Mylan Denmark ApS 

Tel: + 45 28 11 69 32 

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

  

Deutschland 

Mylan Healthcare GmbH 

Tel: + 49 800 0700 800 

Nederland 

Mylan BV 

Tel: + 31 (0)20 426 3300 

  

Eesti (Estonia) 

BGP Products Switzerland GmbH Eesti filiaal 

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

Ελλάδα (Greece) 

Generics Pharma Hellas EPE 

Τηλ: + 30 210 993 6410 

Österreich 

Arcana Arzneimittel GmbH 

Tel: + 43 1 416 2418 

  

España 

Mylan Pharmaceuticals, S.L. 

Tel: + 34 900 102 712 

Polska 

Mylan Healthcare Sp. z o.o. 

Tel: + 48 22 546 64 00 

  

France 

Mylan S.A.S 

Tel: + 33 4 37 25 75 00 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

  

Hrvatska (Croatia) 

Mylan Hrvatska d.o.o.   

Tel: + 385 1 23 50 599   

România 

BGP Products SRL 

Tel: + 40 372 579 000 

  

Ireland 

Mylan Ireland Limited 

Tel: + 353 (0) 87 1694982 

Slovenija 

Mylan Healthcare d.o.o. 

Tel: + 386 1 23 63 180 

 

Ísland 

Icepharma hf 

Tel: + 354 540 8000 

 

Slovenská republika 

Mylan s.r.o. 

Tel: + 421 2 32 199 100 

  



88 

Italia 

Mylan Italia S.r.l. 

Tel: + 39 02 612 46921 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: + 358 20 720 9555 

  

Κύπρος (Cyprus) 

 Varnavas Hadjipanayis LtdTel: + 357  222 077 23 

Sverige 

Mylan AB 

Tel: + 46 855 522 750 

  

Latvija 

Mylan Healthcare SIA  

Tel: + 371 676 05580 

United Kingdom 

Generics [UK] Ltd. 

Tel: + 44 1707 853000 

 

 

 

This leaflet was last revised in 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

 

http://www.ema.europa.eu/
http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET