Duloxetine Mylan

1 
 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

  



2 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

30 mg capsules 

 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 

 

Excipient(s) with known effect 

 

Each capsule contains 62.1 mg sucrose. 

 

For the full list of excipients, see section 6.1. 

 

60 mg capsules 

 

Each capsule contains 60 mg of duloxetine (as hydrochloride). 

 

Excipient(s) with known effect 

 

Each capsule contains 124.2 mg sucrose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Hard gastro-resistant capsule 

 

30 mg capsules 

 

Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN’ 

over ‘DL 30’ on both the cap and the body. 

 

60 mg capsules 

 

Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN’ 

over ‘DL 60’ on both the cap and the body. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Treatment of major depressive disorder. 

Treatment of diabetic peripheral neuropathic pain. 

Treatment of generalised anxiety disorder. 

 

Duloxetine Mylan is indicated in adults. 



3 
 

For further information see section 5.1. 

 

4.2 Posology and method of administration 

 

Posology 

 

Major depressive disorder  

The starting and recommended maintenance dose is 60 mg once daily with or without food.  Dosages 

above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety 

perspective in clinical trials.  However, there is no clinical evidence suggesting that patients not 

responding to the initial recommended dose may benefit from dose up-titrations. 

 

Therapeutic response is usually seen after 2-4 weeks of treatment. 

 

After consolidation of the antidepressive response, it is recommended to continue treatment for several 

months, in order to avoid relapse. In patients responding to duloxetine, and with a history of repeated 

episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be 

considered. 

 

Generalised anxiety disorder 

The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or 

without food.  In patients with insufficient response the dose should be increased to 60 mg, which is the 

usual maintenance dose in most patients. 

 

In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once 

daily (please see also dosing recommendation above). 

 

Doses up to 120 mg per day have been shown to be efficacious and have been evaluated from a safety 

perspective in clinical trials.  In patients with insufficient response to 60 mg, escalation up to 90 mg or 

120 mg may therefore be considered.  Dose escalation should be based upon clinical response and 

tolerability. 

 

After consolidation of the response, it is recommended to continue treatment for several months, in order 

to avoid relapse. 

 

Diabetic peripheral neuropathic pain 

The starting and recommended maintenance dose is 60 mg daily with or without food.  Dosages above 

60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have 

been evaluated from a safety perspective in clinical trials.  The plasma concentration of duloxetine 

displays large inter-individual variability (see section 5.2).  Hence, some patients that respond 

insufficiently to 60 mg may benefit from a higher dose. 

 

Response to treatment should be evaluated after 2 months.  In patients with inadequate initial response, 

additional response after this time is unlikely. 

 

The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1). 

 

Special populations 

 

Elderly 

No dosage adjustment is recommended for elderly patients solely on the basis of age.  However, as with 

any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Mylan 



4 
 

120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited 

(see sections 4.4 and 5.2). 

 

Hepatic impairment 

Duloxetine Mylan must not be used in patients with liver disease resulting in hepatic impairment (see 

sections 4.3 and 5.2). 

 

Renal impairment 

No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine 

clearance 30 to 80 ml/min).  Duloxetine Mylan must not be used in patients with severe renal impairment 

(creatinine clearance <30 ml/min; see section 4.3). 

 

Paediatric population 

Duloxetine should not be used in children and adolescents under the age of 18 years for the treatment of 

major depressive disorder because of safety and efficacy concerns (see sections 4.4, 4.8 and 5.1). 

 

The safety and efficacy of duloxetine for the treatment of generalised anxiety disorder in paediatric 

patients aged 7-17 years have not been established. Current available data are described in sections 4.8, 

5.1 and 5.2. 

 

The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not 

been studied. No data are available. 

 

Discontinuation of treatment 

Abrupt discontinuation should be avoided.  When stopping treatment with Duloxetine Mylan the dose 

should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of 

withdrawal reactions (see sections 4.4 and 4.8).  If intolerable symptoms occur following a decrease in the 

dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be 

considered.  Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. 

 

Method of administration 

 

For oral use. 

 

4.3 Contraindications 

 

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

 

Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors 

(MAOIs) is contraindicated (see section 4.5). 

 

Liver disease resulting in hepatic impairment (see section 5.2). 

 

Duloxetine Mylan should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. 

potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine 

(see section 4.5). 

 

Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4). 

 

The initiation of treatment with Duloxetine Mylan is contraindicated in patients with uncontrolled 

hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8). 

 



5 
 

4.4 Special warnings and precautions for use 

 

Mania and seizures 

 

Duloxetine Mylan should be used with caution in patients with a history of mania or a diagnosis of bipolar 

disorder, and/or seizures. 

 

Mydriasis 

 

Mydriasis has been reported in association with duloxetine, therefore, caution should be used when 

prescribing Duloxetine Mylan to patients with increased intraocular pressure, or those at risk of acute 

narrow-angle glaucoma. 

 

Blood pressure and heart rate 

 

Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension 

in some patients.  This may be due to the noradrenergic effect of duloxetine.  Cases of hypertensive crisis 

have been reported with duloxetine, especially in patients with pre-existing hypertension.  Therefore, in 

patients with known hypertension and/or other cardiac disease, blood pressure monitoring is 

recommended, especially during the first month of treatment.  Duloxetine should be used with caution in 

patients whose conditions could be compromised by an increased heart rate or by an increase in blood 

pressure.  Caution should also be exercised when duloxetine is used with medicinal products that may 

impair its metabolism (see section 4.5).  For patients who experience a sustained increase in blood 

pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered 

(see section 4.8).  In patients with uncontrolled hypertension duloxetine should not be initiated (see 

section 4.3). 

 

Renal impairment 

 

Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on 

haemodialysis (creatinine clearance <30 ml/min).  For patients with severe renal impairment, see 

section 4.3.  See section 4.2 for information on patients with mild or moderate renal dysfunction. 

 

Serotonin syndrome 

 

As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur 

with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including 

SSRIs, SNRIs, tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such 

as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic 

neurotransmitter systems (see sections 4.3 and 4.5). 

 

Serotonin syndrome symptoms may include mental status changes (e.g. agitation, hallucinations, coma), 

autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations 

(e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). 

 

If concomitant treatment with duloxetine and other serotonergic agents that may affect the serotonergic 

and/or dopaminergic neurotransmitter systems is clinically warranted, careful observation of the patient is 

advised, particularly during treatment initiation and dose increases. 

 

St John’s wort 

 

Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal 

preparations containing St John’s wort (Hypericum perforatum). 



6 
 

 

Suicide 

 

Major depressive disorder and Generalised anxiety disorder  

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related 

events).  This risk persists until significant remission occurs.  As improvement may not occur during the 

first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.  

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. 

 

Other psychiatric conditions for which Duloxetine Mylan is prescribed can also be associated with an 

increased risk of suicide-related events.  In addition, these conditions may be co-morbid with major 

depressive disorder.  The same precautions observed when treating patients with major depressive 

disorder should therefore be observed when treating patients with other psychiatric disorders. 

 

Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal 

thoughts prior to commencement of treatment are known to be at greater risk of suicidal thoughts or 

suicidal behaviour, and should receive careful monitoring during treatment.  A meta-analysis of 

placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an 

increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 

25 years old. 

 

Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early 

after treatment discontinuation (see section 4.8). 

 

Close supervision of patients and in particular those at high risk should accompany medicinal product 

therapy especially in early treatment and following dose changes.  Patients (and caregivers of patients) 

should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and 

unusual changes in behaviour and to seek medical advice immediately if these symptoms present. 

 

Diabetic peripheral neuropathic pain  

As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of 

suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after 

treatment discontinuation.  Concerning risk factors for suicidality in depression, see above.  Physicians 

should encourage patients to report any distressing thoughts or feelings at any time. 

 

Use in children and adolescents under 18 years of age 

 

Duloxetine Mylan should not be used in the treatment of children and adolescents under the age of 

18 years. Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly 

aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among 

children and adolescents treated with antidepressants compared to those treated with placebo.  If, based on 

clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the 

appearance of suicidal symptoms (see section 5.1). In addition, long-term safety data in children and 

adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see 

section 4.8). 

 

Haemorrhage 

 

There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal 

haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake 

inhibitors (SNRIs), including duloxetine. Duloxetine may increase the risk of postpartum haemorrhage 

(see section 4.6). Caution is advised in patients taking anticoagulants and/or medicinal products known to 



7 
 

affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding 

tendencies. 

 

Hyponatraemia 

 

Hyponatraemia has been reported when administering Duloxetine Mylan, including cases with serum 

sodium lower than 110 mmol/l.  Hyponatraemia may be due to a syndrome of inappropriate anti-diuretic 

hormone secretion (SIADH).  The majority of cases of hyponatraemia were reported in the elderly, 

especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance. 

Caution is required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, or 

dehydrated patients or patients treated with diuretics. 

 

Discontinuation of treatment 

 

Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is 

abrupt (see section 4.8).  In clinical trials adverse events seen on abrupt treatment discontinuation occurred 

in approximately 45% of patients treated with duloxetine and 23% of patients taking placebo.  The risk of 

withdrawal symptoms seen with SSRI’s and SNRI’s may be dependent on several factors including the 

duration and dose of therapy and the rate of dose reduction.  The most commonly reported reactions are 

listed in section 4.8.  Generally these symptoms are mild to moderate, however, in some patients they may 

be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there 

have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally 

these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may 

be prolonged (2-3 months or more).  It is therefore advised that duloxetine should be gradually tapered 

when discontinuing treatment over a period of no less than 2 weeks, according to the patient’s needs (see 

section 4.2). 

 

Elderly 

 

Data on the use of duloxetine 120 mg in elderly patients with major depressive disorder and generalised 

anxiety disorder are limited.  Therefore, caution should be exercised when treating the elderly with the 

maximum dosage (see sections 4.2 and 5.2). 

 

Akathisia/psychomotor restlessness 

 

The use of duloxetine has been associated with the development of akathisia, characterised by a 

subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to 

sit or stand still.  This is most likely to occur within the first few weeks of treatment. In patients who 

develop these symptoms, increasing the dose may be detrimental. 

 

Medicinal products containing duloxetine 

 

Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic 

pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence). The use of 

more than one of these products concomitantly should be avoided. 

 

Hepatitis/increased liver enzymes 

 

Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), 

hepatitis and jaundice have been reported with duloxetine (see section 4.8).  Most of them occurred during 

the first months of treatment.  The pattern of liver damage was predominantly hepatocellular.  Duloxetine 

should be used with caution in patients treated with other medicinal products associated with hepatic 

injury. 



8 
 

 

Sexual dysfunction 

 

Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may 

cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual 

dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs. 

 

Excipients 

 

Duloxetine Mylan hard gastro-resistant capsules contain sucrose and sodium. 

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or 

sucrase-isomaltase insufficiency should not take this medicine. 

This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 

‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Monoamine oxidase inhibitors (MAOIs) 

 

Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective 

irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment 

with an MAOI.  Based on the half-life of duloxetine, at least 5 days should be allowed after stopping 

Duloxetine Mylan before starting an MAOI (see section 4.3). 

 

The concomitant use of Duloxetine Mylan with selective, reversible MAOIs, like moclobemide, is not 

recommended (see section 4.4).  The antibiotic linezolid is a reversible non-selective MAOI and should 

not be given to patients treated with Duloxetine Mylan (see section 4.4). 

 

Inhibitors of CYP1A2 

Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent 

inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.  Fluvoxamine (100 mg 

once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by 

about 77% and increased AUCo-t 6-fold.  Therefore Duloxetine Mylan should not be administered in 

combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3). 

 

CNS medicinal products 

 

The risk of using duloxetine in combination with other CNS-active medicinal products has not been 

systematically evaluated, except in the cases described in this section.  Consequently, caution is advised 

when Duloxetine Mylan is taken in combination with other centrally acting medicinal products or 

substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, 

antipsychotics, phenobarbital, sedative antihistamines). 

 

Serotonergic agents 

 

In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with 

serotonergic agents.  Caution is advisable if Duloxetine Mylan is used concomitantly with serotonergic 

agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like 

moclobemide or linezolid, St John’s wort (Hypericum perforatum) or triptans, tramadol, pethidine and 

tryptophan (see section 4.4). 

 



9 
 

Effect of duloxetine on other medicinal products 

 

Medicinal products metabolised by CYP1A2 

The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by 

co-administration with duloxetine (60 mg twice daily). 

 

Medicinal products metabolised by CYP2D6 

Duloxetine is a moderate inhibitor of CYP2D6. When duloxetine was administered at a dose of 60 mg 

twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 

3-fold.  The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine 

(2 mg twice daily) by 71%, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite 

and no dosage adjustment is recommended.  Caution is advised if Duloxetine Mylan is co-administered 

with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic 

antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a 

narrow therapeutic index (such as flecainide, propafenone and metoprolol). 

 

Oral contraceptives and other steroidal agents 

Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.  

Specific in vivo drug interaction studies have not been performed. 

 

Anticoagulants and antiplatelet agents 

Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents 

due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.  Furthermore, 

increases in INR values have been reported when duloxetine was co-administered to patients treated with 

warfarin.  However, concomitant administration of duloxetine with warfarin under steady state conditions, 

in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant 

change in INR from baseline or in the pharmacokinetics of R- or S-warfarin. 

 

Effects of other medicinal products on duloxetine 

 

Antacids and H2 antagonists 

Co-administration of duloxetine with aluminium- and magnesium-containing antacids or duloxetine with 

famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 

40 mg oral dose. 

 

Inducers of CYP1A2 

Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma 

concentrations of duloxetine compared with non-smokers. 

 

4.6 Fertility, pregnancy and lactation 

 

Fertility  

 

In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at 

doses that caused maternal toxicity. 

 

Pregnancy  

 

There are no adequate data on the use of duloxetine in pregnant women.  Studies in animals have shown 

reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical 

exposure (see section 5.3). 

 

The potential risk for humans is unknown. 



10 
 

 

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, 

may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).  Although no studies 

have investigated the association of PPHN to SNRI treatment, this potential risk cannot be ruled out with 

duloxetine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin). 

 

As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate after 

maternal duloxetine use near term.  Discontinuation symptoms seen with duloxetine may include 

hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures.  The majority of cases 

have occurred either at birth or within a few days of birth. 

 

Observational data have provided evidence of an increased risk (less than 2-fold) of postpartum 

haemorrhage following duloxetine exposure within the month prior to birth. 

 

Duloxetine Mylan should be used in pregnancy only if the potential benefit justifies the potential risk to 

the foetus.  Women should be advised to notify their physician if they become pregnant, or intend to 

become pregnant, during therapy. 

 

Breast feeding 

 

Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not 

breast feed their children.  The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the 

maternal dose (see section 5.2).  As the safety of duloxetine in infants is not known, the use of Duloxetine 

Mylan while breast-feeding is not recommended. 

 

4.7 Effects on ability to drive and use machines 

 

No studies on the effects on the ability to drive and use machines have been performed.  Duloxetine 

Mylan may be associated with sedation and dizziness.  Patients should be instructed that if they experience 

sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating 

machinery. 

 

4.8 Undesirable effects 
 

Summary of the safety profile 

 

The most commonly reported adverse reactions in patients treated with duloxetine were nausea, headache, 

dry mouth, somnolence, and dizziness.  However, the majority of common adverse reactions were mild to 

moderate, they usually started early in therapy, and most tended to subside even as therapy was continued. 

 

Tabulated summary of adverse reactions 

 

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled 

clinical trials. 

 

Table 1: Adverse reactions 

Frequency estimate: 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). 

 

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 

 



11 
 

Very common Common Uncommon Rare Very rare 

Infections and infestations 

  Laryngitis   

Immune system disorders 

   Anaphylactic 

reaction  

Hyper-sensitivity 

disorder  

 

Endocrine disorders 

   Hypo-thyroidism  

Metabolism and nutrition disorders 

 Decreased 

Appetite 

Hyperglycaemia 

(reported 

especially in 

diabetic patients) 

Dehydration  

Hyponatraemia  

SIADH6 

 

Psychiatric disorders 

 Insomnia 

Agitation  

Libido decreased  

Anxiety  

Orgasm abnormal  

Abnormal dreams  

Suicidal 

ideation5,7  

Sleep disorder  

Bruxism  

Disorientation  

Apathy  

Suicidal  

behaviour5,7  

Mania  

Hallucinations  

Aggression and 

anger4  

 

Nervous system disorders 

Headache  

Somnolence  

Dizziness  

Lethargy  

Tremor  

Paraesthesia 

Myoclonus  

Akathisia7  

Nervousness  

Disturbance in 

attention  

Dysgeusia  

Dyskinesia  

Restless legs 

syndrome  

Poor quality sleep  

Serotonin syndrome6  

Convulsion1  

Psychomotor 

restlessness6  

Extra-pyramidal 

symptoms6  

 

Eye disorders 

 Blurred vision Mydriasis  

Visual impairment  

Glaucoma   

Ear and labyrinth disorders 

 Tinnitus1  Vertigo  

Ear pain  

  

Cardiac disorders 

 Palpitations  Tachycardia  

Supra-ventricular 

arrhythmia, 

mainly atrial 

fibrillation  

  

Vascular disorders 

 Blood pressure 

increase3  

Flushing  

Syncope2  

Hypertension3,7  

Orthostatic 

hypotension2  

Peripheral 

coldness  

Hypertensive 

crisis3,6  

 



12 
 

Very common Common Uncommon Rare Very rare 

Respiratory, thoracic and mediastinal disorders 

 Yawning Throat tightness  

Epistaxis  

Interstitial lung 

disease8 

Eosinophilic 

pneumonia6 

 

Gastrointestinal disorders 

Nausea  

Dry mouth  

Constipation 

Diarrhoea  

Abdominal pain  

Vomiting  

Dyspepsia  

Flatulence  

Gastrointestinal 

haemorrhage7  

Gastroenteritis  

Eructation  

Gastritis  

Dysphagia  

Stomatitis  

Haematochezia  

Breath odour 

Microscopic colitis9 

 

 

Hepato-biliary disorders 

  Hepatitis3  

Elevated liver 

enzymes (ALT, 

AST, alkaline 

phosphatase)  

Acute liver injury  

Hepatic failure6 

Jaundice6  

 

Skin and subcutaneous tissue disorders 

 Sweating 

increased  

Rash  

Night sweats  

Urticaria  

Dermatitis contact  

Cold sweat  

Photo-sensitivity 

reactions  

Increased 

tendency to bruise  

Stevens-Johnson 

Syndrome6  

Angio-neurotic 

oedema6  

Cutaneous 

vasculitis 

Musculoskeletal and connective tissue disorders 

 Musculo-skeletal 

pain  

Muscle spasm  

Muscle tightness  

Muscle twitching  

Trismus   

Renal and urinary disorders 

 Dysuria  

Pollakiuria  

Urinary retention  

Urinary hesitation  

Nocturia  

Polyuria  

Urine flow 

decreased  

Urine odour 

abnormal  

 

Reproductive system and breast disorders 

 Erectile 

dysfunction  

Ejaculation 

disorder  

Ejaculation 

delayed  

Gynaecological 

haemorrhage  

Menstrual 

disorder  

Sexual 

dysfunction  

Testicular pain  

Menopausal 

symptoms  

Galactorrhoea  

Hyperprolactinaemia 

Postpartum 

haemorrhage6  

 



13 
 

Very common Common Uncommon Rare Very rare 

General disorders and administration site conditions 

 Falls10  

Fatigue  

Chest pain7  

Feeling abnormal  

Feeling cold  

Thirst  

Chills  

Malaise  

Feeling hot  

Gait disturbance  

  

Investigations  

 Weight decrease  Weight increase  

Blood creatine 

phosphokinase 

increased  

Blood potassium 

increased  

Blood cholesterol 

increased  

 

 
1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.  
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.  
3 See section 4.4. 
4 Cases of aggression and anger have been reported particularly early in treatment or after treatment 

discontinuation.  
5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early 

after treatment discontinuation (see section 4.4).  
6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in 

placebo-controlled clinical trials.  
7 Not statistically significantly different from placebo.  
8 Estimated frequency based on placebo-controlled clinical trials.  
9 Estimated frequency based on all clinical trial data. 
10 Falls were more common in the elderly (≥65 years old). 

 

Description of selected adverse reactions  

 

Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.  

Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in 

the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or 

anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and 

vertigo are the most commonly reported reactions. 

 

Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some 

patients they may be severe and/or prolonged.  It is therefore advised that when duloxetine treatment is no 

longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4). 

 

In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, 

small but statistically significant increases in fasting blood glucose were observed in duloxetine-treated 

patients.  HbA1c was stable in both duloxetine-treated and placebo-treated patients.  In the extension 

phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine 

and routine care groups, but the mean increase was 0.3% greater in the duloxetine-treated group.  There 

was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients 

while those laboratory tests showed a slight decrease in the routine care group. 

 



14 
 

The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in 

placebo treated patients.  No clinically significant differences were observed for QT, PR, QRS, or QTcB 

measurements between duloxetine-treated and placebo-treated patients. 

 

Paediatric population 

 

A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric 

patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials.  

In general, the adverse reaction profile of duloxetine in children and adolescents was similar to that seen 

for adults. 

 

A total of 467 paediatric patients initially randomized to duloxetine in clinical trials, experienced a 0.1 kg 

mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebo-treated 

patients.  Subsequently, over the four- to six-month extension period, patients on average trended toward 

recovery to their expected baseline weight percentile based on population data from age- and 

gender-matched peers. 

 

In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in 

children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetine- 

treated paediatric patients (see section 4.4). 

 

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 
 

Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 

5400 mg were reported.  Some fatalities have occurred, primarily with mixed overdoses, but also with 

duloxetine alone at a dose of approximately 1000 mg.  Signs and symptoms of overdose (duloxetine alone 

or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, 

seizures, vomiting and tachycardia. 

 

No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as 

with cyproheptadine and/or temperature control) may be considered.  A free airway should be established.  

Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and 

supportive measures.  Gastric lavage may be indicated if performed soon after ingestion or in symptomatic 

patients.  Activated charcoal may be useful in limiting absorption.  Duloxetine has a large volume of 

distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Other antidepressants. ATC code: N06AX21. 

 

Mechanism of action  

 

Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.  It weakly inhibits 

dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and 

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


15 
 

adrenergic receptors.  Duloxetine dose-dependently increases extracellular levels of serotonin and 

noradrenaline in various brain areas of animals. 

 

Pharmacodynamic effects 

 

Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain 

and attenuated pain behaviour in a model of persistent pain. The pain inhibitory action of duloxetine is 

believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous 

system. 

 

Clinical efficacy and safety  

 

Major depressive disorder 

Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) 

meeting DSM-IV criteria for major depression.  The efficacy of duloxetine at the recommended dose of 

60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, 

fixed dose acute studies in adult outpatients with major depressive disorder.  Overall, duloxetine’s efficacy 

has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, 

double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive 

disorder. 

 

Duloxetine demonstrated statistical superiority over placebo as measured by improvement in the 17-item 

Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic 

symptoms of depression).  Response and remission rates were also statistically significantly higher with 

duloxetine compared with placebo.  Only a small proportion of patients included in pivotal clinical trials 

had severe depression (baseline HAM-D>25). 

 

In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label 

duloxetine 60 mg once daily were randomised to either duloxetine 60 mg once daily or placebo for a 

further 6-months.  Duloxetine 60 mg once daily demonstrated a statistically significant superiority 

compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as 

measured by time to relapse.  The incidence of relapse during the 6-months double-blind follow-up period 

was 17% and 29% for duloxetine and placebo, respectively. 

 

During 52 weeks of placebo-controlled double blind treatment, duloxetine-treated patients with recurrent 

MDD had a significantly longer symptom free period (p<0.001) compared with patients randomised to 

placebo.  All patients had previously responded to duloxetine during open-label duloxetine treatment (28 

to 34 weeks) at a dose of 60 to 120 mg/day.  During the 52-week placebo-controlled double blind 

treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients 

experience a return of their depressive symptoms (p<0.001). 

 

The effect of duloxetine 60 mg once a day in elderly depressed patients (≥65 years) was specifically 

examined in a study that showed a statistically significant difference in the reduction of the HAMD17 

score for duloxetine-treated patients compared to placebo.  Tolerability of duloxetine 60 mg once daily in 

elderly patients was comparable to that seen in the younger adults.  However, data on elderly patients 

exposed to the maximum dose (120 mg per day) are limited and thus, caution is recommended when 

treating this population. 

 

Generalised anxiety disorder 

Duloxetine demonstrated statistically significant superiority over placebo in five out of five studies 

including four randomised, double-blind, placebo-controlled acute studies and a relapse prevention study 

in adult patients with generalised anxiety disorder. 

 



16 
 

Duloxetine demonstrated statistically significant superiority over placebo as measured by improvement in 

the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global 

functional impairment score.  Response and remission rates were also higher with duloxetine compared to 

placebo.  Duloxetine showed comparable efficacy results to venlafaxine in terms of improvements on the 

HAM-A total score. 

 

In a relapse prevention study, patients responding to 6 months of acute treatment with open-label 

duloxetine were randomised to either duloxetine or placebo for a further 6-months.  Duloxetine 60 mg to 

120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the 

prevention of relapse, as measured by time to relapse.  The incidence of relapse during the 6-months 

double-blind follow-up period was 14% for duloxetine and 42% for placebo. 

 

The efficacy of duloxetine 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with 

generalised anxiety disorder was evaluated in a study that demonstrated statistically significant 

improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated 

patients.  The efficacy and safety of duloxetine 30-120 mg once daily in elderly patients with generalised 

anxiety disorder was similar to that seen in studies of younger adult patients.  However, data on elderly 

patients exposed to the maximum dose (120 mg per day) are limited and, thus, caution is recommended 

when using this dose with the elderly population. 

 

Diabetic peripheral neuropathic pain 

The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 

12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic 

neuropathic pain for at least 6 months.  Patients meeting diagnostic criteria for major depressive disorder 

were excluded from these trials.  The primary outcome measure was the weekly mean of 24-hour average 

pain, which was collected in a daily diary by patients on an 11-point Likert scale. 

 

In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared 

with placebo.  The effect in some patients was apparent in the first week of treatment.  The difference in 

mean improvement between the two active treatment arms was not significant.  At least 30% reported pain 

reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.  The 

corresponding figures for at least 50% pain reduction were 50% and 26% respectively.  Clinical response 

rates (50% or greater improvement in pain) were analysed according to whether or not the patient 

experienced somnolence during treatment.  For patients not experiencing somnolence, clinical response 

was observed in 47% of patients receiving duloxetine and 27% of patients on placebo.  Clinical response 

rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.  Patients not 

demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during 

further treatment. 

 

In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of 

acute treatment of duloxetine 60 mg once daily was maintained for a further 6-months as measured by 

change on the Brief Pain Inventory (BPI) 24-hour average pain item. 

 

Paediatric population  

 

Duloxetine has not been studied in patients under the age of 7.   

 

Two randomized, double-blind, parallel clinical trials were performed in 800 paediatric patients aged 7 to 

17 years with major depressive disorder (see section 4.2).  These two studies included a 10 week placebo 

and active (fluoxetine) controlled acute phase followed by six months period of active controlled 

extension treatment.  Neither duloxetine (30-120 mg) nor the active control arm (fluoxetine 20-40 mg) 

statistically separated from placebo on change from baseline to endpoint in the Children´s Depression 

Rating Scale-Revised (CDRS-R) total score.  Discontinuation due to adverse events was higher in patients 



17 
 

taking duloxetine compared with those treated with fluoxetine, mostly due to nausea.  During the 10-week 

acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 

[0.9%], placebo 1/220 [0.5%]).  Over the entire 36-week course of the study, 6 out of 333 patients initially 

randomized to duloxetine and 3 out of 225 patients initially randomized to fluoxetine experienced suicidal 

behaviour (exposure adjusted incidence 0.039 events per patient year for duloxetine and 0.026 for 

fluoxetine).  In addition, one patient who transitioned from placebo to duloxetine experienced a suicidal 

behaviour while taking duloxetine. 

 

A randomised, double-blind, placebo-controlled study was performed in 272 patients aged 7-17 years with 

generalised anxiety disorder.  The study included a 10 week placebo-controlled acute phase, followed by 

an 18 week extension treatment period.  A flexible dose regimen was used in this study, to allow for slow 

dose escalation from 30 mg once daily to higher doses (maximum 120 mg once daily).  Treatment with 

duloxetine showed a statistically significantly greater improvement in GAD symptoms, as measured by 

PARS severity score for GAD (mean difference between duloxetine and placebo of 2.7 points [95% CI 

1.3-4.0]), after 10 weeks of treatment.  The maintenance of the effect has not been evaluated.  There was 

no statistically significant difference in discontinuation due to adverse events between duloxetine and 

placebo groups during the 10 week acute treatment phase.  Two patients who transitioned from placebo to 

duloxetine after the acute phase experienced suicidal behaviours while taking duloxetine during the 

extension phase.  A conclusion on the overall benefit/risk in this age group has not been established (see 

also sections 4.2 and 4.8). 

 

A single study has been performed in paediatric patients with juvenile primary fibromyalgia syndrome 

(JPFS) in which the duloxetine-treated group did not separate from placebo group for the primary efficacy 

measure. Therefore, there is no evidence of efficacy in this paediatric patient population. The randomised, 

double-blind, placebo-controlled, parallel study of duloxetine was conducted in 184 adolescents aged 13 

to 18 years (mean age 15.53 years) with JPFS. The study included a 13-week double-blind period where 

patients were randomised to duloxetine 30 mg/60 mg, or placebo daily. Duloxetine did not show efficacy 

in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain 

score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was -

0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052). The safety 

results from this study were consistent with the known safety profile of duloxetine. 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

duloxetine in all subsets of the paediatric population in the treatment of major depressive disorder, 

diabetic neuropathic pain and generalised anxiety disorder. See section 4.2 for information on paediatric 

use. 

 

5.2 Pharmacokinetic properties 

 

Duloxetine is administered as a single enantiomer.  Duloxetine is extensively metabolised by oxidative 

enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.  The pharmacokinetics of 

duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, 

smoking status and CYP2D6 metaboliser status. 

 

Absorption 

 

Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.  The 

absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).  Food delays the time 

to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption 

(approximately 11%).  These changes do not have any clinical significance. 

 

Distribution 

 



18 
 

Duloxetine is approximately 96% bound to human plasma proteins.  Duloxetine binds to both albumin and 

alpha-l acid glycoprotein.  Protein binding is not affected by renal or hepatic impairment. 

 

Biotransformation 

 

Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.  Both 

cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide 

conjugate of 4-hydroxy duloxetine and sulfate conjugate of 5-hydroxy 6-methoxy duloxetine.  Based upon 

in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.  The 

pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not 

been specifically investigated.  Limited data suggest that the plasma levels of duloxetine are higher in 

these patients. 

 

Elimination 

 

The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).  After an 

intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr).  After 

an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr). 

 

Special populations 

 

Gender 

Pharmacokinetic differences have been identified between males and females (apparent plasma clearance 

is approximately 50% lower in females).  Based upon the overlap in the range of clearance, gender-based 

pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients. 

 

Age 

Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC 

increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these 

changes is not sufficient to justify adjustments to the dose.  As a general recommendation, caution should 

be exercised when treating the elderly (see sections 4.2 and 4.4). 

 

Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher 

duloxetine Cmax and AUC values compared with healthy subjects.  Pharmacokinetic data on duloxetine is 

limited in patients with mild or moderate renal impairment. 

 

Hepatic impairment 

Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.  Compared with 

healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal 

half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.  

The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or 

severe hepatic insufficiency. 

 

Breast-feeding mothers 

The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.  

Duloxetine is detected in breast milk, and steady-state concentrations in breast milk are about one-fourth 

those in plasma.  The amount of duloxetine in breast milk is approximately 7 μg/day while on 40 mg twice 

daily dosing.  Lactation did not influence duloxetine pharmacokinetics. 

 

Paediatric population 

Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder 

following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population 



19 
 

modelling analyses based on data from 3 studies.  The model-predicted duloxetine steady state plasma 

concentrations in paediatric patients were mostly within the concentration range observed in adult patients. 

 

5.3 Preclinical safety data 

 

Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.  

Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat 

carcinogenicity study.  The underlying mechanism and the clinical relevance are unknown.  Female mice 

receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at 

the high dose only (144 mg/kg/day), but these were considered to be secondary to hepatic microsomal 

enzyme induction.  The relevance of this mouse data to humans is unknown.  Female rats receiving 

duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food 

consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny 

survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at 

maximum clinical exposure (AUC). In an embryotoxicity study in the rabbit, a higher incidence of 

cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum 

clinical exposure (AUC).  No malformations were observed in another study testing a higher dose of a 

different salt of duloxetine.  In prenatal/postnatal toxicity studies in the rat, duloxetine induced adverse 

behavioural effects in the offspring at exposures below maximum clinical exposure (AUC). 

 

Studies in juvenile rats reveal transient effects on neurobehaviour, as well as significantly decreased body 

weight and food consumption; hepatic enzyme induction; and hepatocellular vacuolation at 45 mg/kg/day.  

The general toxicity profile of duloxetine in juvenile rats was similar to that in adult rats. The no-adverse 

effect level was determined to be 20 mg/kg/day. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Capsule content 

 

Sugar spheres (sucrose, maize starch) 

Hypromellose 

Macrogol 

Crospovidone 

Talc 

Sucrose  

Hypromellose phthalate 

Diethyl phthalate 

 

30 mg capsules 

 

Capsule shell 

 

Brilliant blue (E133) 

Titanium dioxide (E171) 

Gelatin 

Gold ink 

 

Gold ink contains 

 

Shellac 



20 
 

Propylene glycol 

Strong ammonia solution 

Yellow iron oxide (E172) 

 

60 mg capsules 

 

Capsule shell 

 

Brilliant blue (E133) 

Yellow iron oxide (E172) 

Titanium dioxide (E171) 

Gelatin 

White ink 

 

White ink contains 

 

Shellac 

Propylene glycol 

Sodium hydroxide 

Povidone 

Titanium dioxide (E171) 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years 

 

Bottle packs only: 

Once opened, use within 180 days. 

 

6.4 Special precautions for storage 

 

Store in the original package in order to protect from moisture. 

 

6.5 Nature and contents of container 
 

30 mg capsules 

 

PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium blister pack containing 7, 14, 28, 98 and 

multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules. 

PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 

packs of 49) hard gastro-resistant capsules. 

PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium perforated unit dose blister pack 

containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules.  

PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard 

gastro-resistant capsules. 

HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro-resistant capsules 

 

60 mg capsules 

 



21 
 

PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium blister pack containing 14, 28, 84, 98 

and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules. 

PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs 

of 49) hard gastro-resistant capsules. 

PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium perforated unit dose blister pack 

containing 28 x 1, 30 x 1 and 100 x 1 hard gastro-resistant capsules 

PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 28 x 1 hard gastro-resistant 

capsules. 

HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro-resistant capsules 

 

Not all packs sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

No special requirements 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)  

 

30 mg capsules 

 

EU/1/15/1010/001 7 hard gastro-resistant capsules 

EU/1/15/1010/002 28 hard gastro-resistant capsules 

EU/1/15/1010/003 98 hard gastro-resistant capsules 

EU/1/15/1010/004 7 x 1 hard gastro-resistant capsules 

EU/1/15/1010/005 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/006 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/007 30 hard gastro-resistant capsules 

EU/1/15/1010/008 100 hard gastro-resistant capsules 

EU/1/15/1010/009 250 hard gastro-resistant capsules 

EU/1/15/1010/010 500 hard gastro-resistant capsules 

EU/1/15/1010/021 14 hard gastro-resistant capsules 

EU/1/15/1010/022 7 hard gastro-resistant capsules 

EU/1/15/1010/023 14 hard gastro-resistant capsules 

EU/1/15/1010/024 28 hard gastro-resistant capsules 

EU/1/15/1010/025 98 hard gastro-resistant capsules 

EU/1/15/1010/026 7 x 1 hard gastro-resistant capsules 

EU/1/15/1010/027 28 x 1 hard gastro-resistant capsules) 

EU/1/15/1010/028 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/037 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/038 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/041 7 hard gastro-resistant capsules 

EU/1/15/1010/042 7 x 1 hard gastro-resistant capsules 



22 
 

EU/1/15/1010/043 14 hard gastro-resistant capsules 

EU/1/15/1010/044 28 hard gastro-resistant capsules 

EU/1/15/1010/045 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/046 49 hard gastro-resistant capsules 

EU/1/15/1010/047 98 hard gastro-resistant capsules 

EU/1/15/1010/048 98 hard gastro-resistant capsules (2 packs of 49) 

 

60 mg capsules 

 

EU/1/15/1010/011 28 hard gastro-resistant capsules 

EU/1/15/1010/012 84 hard gastro-resistant capsules 

EU/1/15/1010/013 98 hard gastro-resistant capsules 

EU/1/15/1010/014 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/015 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/016 100 x 1 hard gastro-resistant capsules 

EU/1/15/1010/017 30 hard gastro-resistant capsules 

EU/1/15/1010/018 100 hard gastro-resistant capsules 

EU/1/15/1010/019 250 hard gastro-resistant capsules 

EU/1/15/1010/020 500 hard gastro-resistant capsules 

EU/1/15/1010/029 28 hard gastro-resistant capsules 

EU/1/15/1010/030 84 hard gastro-resistant capsules 

EU/1/15/1010/031 98 hard gastro-resistant capsules 

EU/1/15/1010/032 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/033 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/034 100 x 1 hard gastro-resistant capsules 

EU/1/15/1010/035 14 hard gastro-resistant capsules 

EU/1/15/1010/036 14 hard gastro-resistant capsules 

EU/1/15/1010/039 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/040 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/049 14 hard gastro-resistant capsules 

EU/1/15/1010/050 28 hard gastro-resistant capsules 

EU/1/15/1010/051 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/052 49 hard gastro-resistant capsules 

EU/1/15/1010/053 98 hard gastro-resistant capsules 

EU/1/15/1010/054 98 hard gastro-resistant capsules (2 packs of 49) 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 19 June 2015 

Date of latest renewal: 

 

 

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/


23 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 



24 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

 

McDermott Laboratories Ltd t/a Gerard Laboratories t/a Mylan Dublin 

Unit 35/36 Baldoyle Industrial Estate 

Grange Road 

Dublin 13 

Ireland 

 

Mylan Hungary Kft 

Mylan utca 1 

Komárom 

2900 

Hungary 

 

Mylan BV 

Dieselweg 25 

3752 LB Bunschoten 

The Netherlands 

 

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. 

 

 



25 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT   

 

• Risk management plan (RMP) 
 

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. 

  



26 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



27 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



28 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BLISTER CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

7 hard gastro-resistant capsules 

14 hard gastro-resistant capsules  

28 hard gastro-resistant capsules 

49 hard gastro-resistant capsules 

98 hard gastro-resistant capsules 

7 x 1 hard gastro-resistant capsules 

28 x 1 hard gastro-resistant capsules 

30 x 1 hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

 



29 
 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/001 7 hard gastro-resistant capsules 

EU/1/15/1010/002 28 hard gastro-resistant capsules 

EU/1/15/1010/003 98 hard gastro-resistant capsules 

EU/1/15/1010/004 7 x 1 hard gastro-resistant capsules 

EU/1/15/1010/005 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/006 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/021 14 hard gastro-resistant capsules 

EU/1/15/1010/022 7 hard gastro-resistant capsules 
EU/1/15/1010/023 14 hard gastro-resistant capsules 

EU/1/15/1010/024 28 hard gastro-resistant capsules 

EU/1/15/1010/025 98 hard gastro-resistant capsules 

EU/1/15/1010/026 7 x 1 hard gastro-resistant capsules 

EU/1/15/1010/027 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/028 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/041 7 hard gastro-resistant capsules 

EU/1/15/1010/042 7 x 1 hard gastro-resistant capsules 

EU/1/15/1010/043 14 hard gastro-resistant capsules 

EU/1/15/1010/044 28 hard gastro-resistant capsules 

EU/1/15/1010/045 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/046 49 hard gastro-resistant capsules 

EU/1/15/1010/047 98 hard gastro-resistant capsules 

 

 



30 
 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Duloxetine Mylan 30 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

 

 

 

  



31 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT 

CAPSULES, WITH BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

Multipack: 98 (2 packs of 49) hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

 



32 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/037 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/038 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/048 98 hard gastro-resistant capsules (2 packs of 49) 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Duloxetine Mylan 30 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 



33 
 

PC  

SN  

NN  

 

  



34 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT 

CAPSULES, WITHOUT BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

49 hard gastro-resistant capsules 

Component of a multipack, can’t be sold separately. 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 



35 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/037 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/038 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/048 98 hard gastro-resistant capsules (2 packs of 49) 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

  



36 
 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER FOR 30 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



37 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

30 hard gastro-resistant capsules 

100 hard gastro-resistant capsules 

250 hard gastro-resistant capsules 

500 hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 



38 
 

 

Use within 6 months after opening. 

 

Opening date:………… 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/007 30 hard gastro-resistant capsules 

EU/1/15/1010/008 100 hard gastro-resistant capsules 

EU/1/15/1010/009 250 hard gastro-resistant capsules 

EU/1/15/1010/010 500 hard gastro-resistant capsules 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Duloxetine Mylan 30 mg 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 



39 
 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

 

 

  



40 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL FOR 30 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

30 hard gastro-resistant capsules 

100 hard gastro-resistant capsules 

250 hard gastro-resistant capsules 

500 hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 



41 
 

 

Use within 6 months after opening. 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/007 30 hard gastro-resistant capsules 

EU/1/15/1010/008 100 hard gastro-resistant capsules 

EU/1/15/1010/009 250 hard gastro-resistant capsules 

EU/1/15/1010/010 500 hard gastro-resistant capsules 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 



42 
 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

 

 

 

 

  



43 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BLISTER CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 60 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

14 hard gastro-resistant capsules 

28 hard gastro-resistant capsules 

49 hard gastro-resistant capsules  

84 hard gastro-resistant capsules 

98 hard gastro-resistant capsules 

28 x 1 hard gastro-resistant capsules 

30 x 1 hard gastro-resistant capsules 

100 x 1 hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

 



44 
 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/011 28 hard gastro-resistant capsules 

EU/1/15/1010/012 84 hard gastro-resistant capsules 

EU/1/15/1010/013 98 hard gastro-resistant capsules 

EU/1/15/1010/014 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/015 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/016 100 x 1 hard gastro-resistant capsules 

EU/1/15/1010/029 28 hard gastro-resistant capsules 

EU/1/15/1010/030 84 hard gastro-resistant capsules 

EU/1/15/1010/031 98 hard gastro-resistant capsules 

EU/1/15/1010/032 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/033 30 x 1 hard gastro-resistant capsules 

EU/1/15/1010/034 100 x 1 hard gastro-resistant capsules 

EU/1/15/1010/035 14 hard gastro-resistant capsules 

EU/1/15/1010/036 14 hard gastro-resistant capsules 

EU/1/15/1010/049 14 hard gastro-resistant capsules 

EU/1/15/1010/050 28 hard gastro-resistant capsules) 

EU/1/15/1010/051 28 x 1 hard gastro-resistant capsules 

EU/1/15/1010/052 49 hard gastro-resistant capsules 

EU/1/15/1010/053 98 hard gastro-resistant capsules 

 

 

13. BATCH NUMBER 

 

Lot 



45 
 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Duloxetine Mylan 60 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

  



46 
 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT 

CAPSULES, WITH BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 60 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

Multipack: 98 (2 packs of 49) hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 



47 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/039 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/040 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/054 98 hard gastro-resistant capsules (2 packs of 49) 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Duloxetine Mylan 60 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included 

 

 



48 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

  



49 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT 

CAPSULES, WITHOUT BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 60 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

49 hard gastro-resistant capsules 

Component of a multipack, can’t be sold separately. 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 



50 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/039 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/040 98 hard gastro-resistant capsules (2 packs of 49) 

EU/1/15/1010/054 98 hard gastro-resistant capsules (2 packs of 49) 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

  



51 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER FOR 60 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



52 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 60 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

30 hard gastro-resistant capsules  

100 hard gastro-resistant capsules 

250 hard gastro-resistant capsules 

500 hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 



53 
 

 

Use within 6 months after opening. 

 

Opening date:………… 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/017 30 hard gastro-resistant capsules 

EU/1/15/1010/018 100 hard gastro-resistant capsules 

EU/1/15/1010/019 250 hard gastro-resistant capsules 

EU/1/15/1010/020 500 hard gastro-resistant capsules 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Duloxetine Mylan 60 mg 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 



54 
 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

 

  



55 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL FOR 60 MG HARD GASTRO RESISTANT CAPSULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each capsule contains 60 mg of duloxetine (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sucrose. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Hard gastro-resistant capsules 

 

30 hard gastro-resistant capsules  

100 hard gastro-resistant capsules 

250 hard gastro-resistant capsules 

500 hard gastro-resistant capsules 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 



56 
 

 

Use within 6 months after opening. 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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/1/15/1010/017 30 hard gastro-resistant capsules 

EU/1/15/1010/018 100 hard gastro-resistant capsules 

EU/1/15/1010/019 250 hard gastro-resistant capsules 

EU/1/15/1010/020 500 hard gastro-resistant capsules 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

 



57 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

 

 

  



58 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

  



59 
 

Package leaflet: Information for the user 

 

Duloxetine Mylan 30 mg hard gastro-resistant capsules 

Duloxetine Mylan 60 mg hard gastro-resistant capsules 

duloxetine 

 

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 Duloxetine Mylan is and what it is used for 

2. What you need to know before you take Duloxetine Mylan 

3. How to take Duloxetine Mylan 

4. Possible side effects 

5. How to store Duloxetine Mylan 
6. Contents of the pack and other information 

 

 

1. What Duloxetine Mylan is and what it is used for 
 

Duloxetine Mylan contains the active substance duloxetine.  Duloxetine Mylan increases the levels of 

serotonin and noradrenaline in the nervous system. 

 

Duloxetine Mylan is used in adults to treat: 

• depression 

• generalised anxiety disorder (chronic feeling of anxiety or nervousness) 

• diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like 
an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, 

heat, cold or pressure may cause pain) 

 

Duloxetine Mylan starts to work in most people with depression or anxiety within two weeks of starting 

treatment, but it may take 2-4 weeks before you feel better.  Tell your doctor if you do not start to feel 

better after this time.  Your doctor may continue to give you Duloxetine Mylan when you are feeling 

better to prevent your depression or anxiety from returning. 

 

In people with diabetic neuropathic pain it can take some weeks before you feel better.  Talk to your 

doctor if you do not feel better after 2 months. 

 

 

2. What you need to know before you take Duloxetine Mylan 
 

Do not take Duloxetine Mylan if you: 

- are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) 
- have liver disease 
- have severe kidney disease 



60 
 

- are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase 
inhibitor (MAOI) (see ‘Other medicines and Duloxetine Mylan’) 

- are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which 
are used to treat some infections 

- are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan’) 
 

Talk to your doctor if you have high blood pressure or heart disease.  Your doctor will tell you if you 

should be taking Duloxetine Mylan. 

 

Warnings and precautions 

The following are reasons why Duloxetine Mylan may not be suitable for you.  Talk to your doctor before 

you take Duloxetine Mylan if you: 

- are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Mylan’) 
- are taking St. John’s Wort, a herbal treatment (Hypericum perforatum) 
- have kidney disease 
- have had seizures (fits) 
- have had mania 
- suffer from bipolar disorder 
- have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) 
- have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant 

(see ‘Pregnancy and breast-feeding) 

- are at risk of low sodium levels (for example if you are taking diuretics, especially if you are 
elderly) 

- are currently being treated with another medicine which may cause liver damage 
- are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan’) 
 

Duloxetine Mylan may cause a sensation of restlessness or an inability to sit or stand still.  You should tell 

your doctor if this happens to you. 

 

Medicines like Duloxetine Mylan  (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction 

(see section 4). In some cases, these symptoms have continued after stopping treatment. 

 

Thoughts of suicide and worsening of your depression or anxiety disorder 

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing 

yourself.  These may be increased when first starting antidepressants, since these medicines all take time 

to work, usually about two weeks but sometimes longer. 

You may be more likely to think like this if you: 

- have previously had thoughts about killing or harming yourself 
- are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour 

in adults aged less than 25 years with psychiatric conditions who were treated with an 

antidepressant 

 

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a 

hospital straight away. 

 

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, 

and ask them to read this leaflet.  You might ask them to tell you if they think your depression or anxiety 

is getting worse, or if they are worried about changes in your behaviour. 

 

Children and adolescents under 18 years of age 

Duloxetine Mylan should normally not be used for children and adolescents under 18 years.  Also, you 

should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal 

thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this 



61 
 

class of medicines.  Despite this, your doctor may prescribe Duloxetine Mylan for patients under 18 

because he/she decides that this is in their best interests.  If your doctor has prescribed Duloxetine Mylan 

for a patient under 18 and you want to discuss this, please go back to your doctor.  You should inform 

your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking 

Duloxetine Mylan.  Also, the long-term safety effects concerning growth, maturation, and cognitive and 

behavioural development of Duloxetine Mylan in this age group have not yet been demonstrated. 

 

Other medicines and Duloxetine Mylan 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, 

including medicines obtained without a prescription. 

 

The main ingredient of Duloxetine Mylan, duloxetine, is used in other medicines for other conditions: 

• diabetic neuropathic pain, depression, anxiety and urinary incontinence 
 

Using more than one of these medicines at the same time should be avoided.  Check with your doctor if 

you are already taking other medicines containing duloxetine. 

 

Your doctor should decide whether you can take Duloxetine Mylan with other medicines.  Do not start or 

stop taking any medicines, including those bought without a prescription and herbal remedies, 

before checking with your doctor. 

 

You should also tell your doctor if you are taking any of the following: 

 

Monoamine oxidase inhibitors (MAOIs): You should not take Duloxetine Mylan if you are taking, or 

have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase 

inhibitor (MAOI).  Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an 

antibiotic). Taking a MAOI together with many prescription medicines, including Duloxetine Mylan, can 

cause serious or even life-threatening side effects.  You must wait at least 14 days after you have stopped 

taking an MAOI before you can take Duloxetine Mylan.  Also, you need to wait at least 5 days after you 

stop taking Duloxetine Mylan before you take a MAOI. 

 

Medicines that cause sleepiness: These include medicines prescribed by your doctor including 

benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines. 

 

Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine 

and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, 

amitriptyline), pethidine, St John’s Wort and MAOIs (such as moclobemide and linezolid).  These 

medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines 

together with Duloxetine Mylan, you should see your doctor. 

 

Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from 

clotting.  These medicines might increase the risk of bleeding. 

 

Duloxetine Mylan with food, drink and alcohol 

Duloxetine Mylan may be taken with or without food.  Care should be taken if you drink alcohol while 

you are being treated with Duloxetine Mylan. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 

doctor or pharmacist for advice before taking this medicine. 

 



62 
 

• Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are 
taking Duloxetine Mylan.  You should use Duloxetine Mylan only after discussing the potential 

benefits and any potential risks to your unborn child with your doctor. 

 

• Make sure your midwife and/or doctor knows you are on Duloxetine Mylan.  When taken during 
pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called 

persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and 

appear bluish.  These symptoms usually begin during the first 24 hours after the baby is born.  If 

this happens to your baby you should contact your midwife and/or doctor immediately. 

 

• If you take Duloxetine Mylan near the end of your pregnancy, your baby might have some 
symptoms when it is born.  These usually begin at birth or within a few days of your baby being 

born.  These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, 

trouble with breathing and fits.  If your baby has any of these symptoms when it is born, or you are 

concerned about your baby’s health, contact your doctor or midwife who will be able to advise you. 

 

• If you take Duloxetine Mylan near the end of your pregnancy there is an increased risk of excessive 

vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your 

doctor or midwife should be aware that you are taking duloxetine so they can advise you. 

 

• Tell your doctor if you are breast-feeding.  The use of Duloxetine Mylan while breast-feeding is not 
recommended.  You should ask your doctor or pharmacist for advice. 

 

Driving and using machines 

Duloxetine Mylan may make you feel sleepy or dizzy.  Do not drive or use any tools or machines until 

you know how Duloxetine Mylan affects you. 

 

Duloxetine Mylan contains sucrose and sodium 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 

before taking this medicinal product. 

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-

free’. 

 

 

3. How to take Duloxetine Mylan 
 

Always take this medicine exactly as your doctor or pharmacist has told you.  Check with your doctor or 

pharmacist if you are not sure. 

 

Duloxetine Mylan is for oral use. You should swallow your capsule whole with a drink of water. 

 

For depression and diabetic neuropathic pain: 

The usual dose of Duloxetine Mylan is 60 mg once a day, but your doctor will prescribe the dose that is 

right for you. 

 

For generalised anxiety disorder:  

The usual starting dose of Duloxetine Mylan is 30 mg once a day after which most patients will receive 

60 mg once a day, but your doctor will prescribe the dose that is right for you.  The dose may be adjusted 

up to 120 mg a day based on your response to Duloxetine Mylan. 

 

To help you remember to take Duloxetine Mylan, you may find it easier to take it at the same times every 

day. 

 



63 
 

Talk with your doctor about how long you should keep taking Duloxetine Mylan.  Do not stop taking 

Duloxetine Mylan, or change your dose, without talking to your doctor.  Treating your disorder properly is 

important to help you get better.  If it is not treated, your condition may not go away and may become 

more serious and difficult to treat. 

 

If you take more Duloxetine Mylan than you should 

Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Mylan 

prescribed by your doctor.  Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare 

reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of 

being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate. 

 

If you forget to take Duloxetine Mylan 

If you miss a dose, take it as soon as you remember.  However, if it is time for your next dose, skip the 

missed dose and take only a single dose as usual.  Do not take a double dose to make up for a forgotten 

dose.  Do not take more than the daily amount of Duloxetine Mylan that has been prescribed for you in 

one day. 

 

If you stop taking Duloxetine Mylan 

DO NOT stop taking your capsules without the advice of your doctor even if you feel better.  If your 

doctor thinks that you no longer need Duloxetine Mylan he or she will ask you to reduce your dose over at 

least 2 weeks before stopping treatment altogether. 

 

Some patients who stop taking Duloxetine Mylan suddenly have had symptoms such as: 

• dizziness, tingling feelings like pins and needles or electric shock like feelings (particularly in the 
head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling 

restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking 

(tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo. 

 

These symptoms are usually not serious and disappear within a few days, but if you have symptoms that 

are troublesome you should ask your doctor for advice. 

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 and often disappear after a few weeks. 

 

Very common side effects (may affect more than 1 in 10 people) 

• headache, feeling sleepy 
• feeling sick (nausea), dry mouth 
 

Common side effects (may affect up to 1 in 10 people) 

• lack of appetite 
• trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, 

unusual dreams 

• dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin 
• blurred eyesight 
• tinnitus (hearing sound in the ear when there is no external sound) 
• feeling the heart pumping in the chest, 
• increased blood pressure, flushing 
• increased yawning 



64 
 

• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking 
wind 

• increased sweating, (itchy) rash 
• muscle pain, muscle spasm 
• painful urination, frequent urination 
• problems getting an erection, changes in ejaculation 
• falls (mostly in elderly people), fatigue  
• weight loss 
 

Children and adolescents under 18 years of age with depression treated with this medicine had some 

weight loss when they first start taking this medicine.  Weight increased to match other children and 

adolescents of their age and sex after 6 months of treatment. 

 

Uncommon side effects (may affect up to 1 in 100 people) 

• throat inflammation that causes a hoarse voice 
• suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of 

motivation 

• sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or 
stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling 

movement e.g. lack of coordination or involuntary movements of the muscles, restless legs 

syndrome, poor sleep quality 

• large pupils (the dark centre of the eye), problems with eyesight 
• feeling of dizziness or “spinning” (vertigo), ear pain 
• fast and/or irregular heart beat 
• fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes 
• throat tightness, nose bleeds 
• vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing 
• inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the 

eyes 

• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise 
• muscle tightness, muscle twitching 
• difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the 

night, needing to pass more urine than normal, having a decreased urine flow 

• abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged 
periods, unusually light or missed periods, sexual dysfunction, pain in the testicles or scrotum 

• chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait 
• weight gain 
• Duloxetine Mylan may cause effects that you may not be aware of, such as increases in liver 

enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol 

 

Rare side effects (may affect up to 1 in 1,000 people) 

• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or 
lips, allergic reactions 

• decreased thyroid gland activity which can cause tiredness or weight gain 
• dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may 

include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious 

symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone 

(SIADH) 

• suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), 
hallucinations, aggression and anger 

• “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, 
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits 

• increased pressure in the eye (glaucoma) 



65 
 

• inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the 
large intestine (leading to diarrhoea) 

• liver failure, yellowing of the skin or whites of the eyes (jaundice) 
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), 

serious allergic reaction which causes swelling of the face or throat (angioedema) 

• contraction of the jaw muscle 
• abnormal urine odour 
• menopausal symptoms, abnormal production of breast milk in men or women 
• coughing, wheezing and shortness of breath which may be accompanied by a high temperature  
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage) 

 

 

Very rare side effects (may affect up to 1 in 10,000 people) 

• inflammation of the blood vessels in the skin (cutaneous vasculitis) 
 

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 Duloxetine 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. 

 

Store in the original package in order to protect from moisture. 

 

Bottle packs only:  

Use within 6 months of opening. 

 

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 Duloxetine Mylan contains 

The active substance is duloxetine. 

Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). 

 

The other ingredients are: 

Capsule content: Sugar spheres (sucrose, maize starch), hypromellose, Macrogol, Crospovidone, talc, 

sucrose, hypromellose phthalate, diethyl phthalate. 

 

Capsule shell: Brilliant blue (E133), yellow iron oxide (E172) (60 mg only), titanium dioxide (E171), 

gelatin and edible gold ink (30 mg only) or edible white ink (60 mg only). 

Edible gold ink: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172). 

Edible white ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171). 

 

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


66 
 

What Duloxetine Mylan looks like and contents of the pack 

Duloxetine Mylan is hard gastro-resistant capsule.  Each capsule of Duloxetine Mylan contains pellets of 

duloxetine hydrochloride with a covering to protect them from stomach acid.   

 

Duloxetine Mylan is available in 2 strengths: 30 mg and 60 mg. 

The 30 mg capsules have an opaque blue cap and opaque white body, imprinted in gold ink with 

‘MYLAN’ over ‘DL 30’ on both the cap and the body. 

The 60 mg capsules have an opaque blue cap and opaque yellow body, imprinted in white ink with 

‘MYLAN’ over ‘DL 60’ on both the cap and the body. 

 

Duloxetine Mylan 30 mg is available in blister packs of 7, 14, 28, 49, 98 and in a multipack of 98 

comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 7 x1, 28 x 1, 30 x 

1 capsules and in bottles containing 30, 100, 250, 500 capsules and a desiccant.  Do not eat the desiccant. 

Duloxetine Mylan 60 mg is available in blister packs of 14, 28, 49, 84, 98 and in a multipack of 98 

comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 28 x 1, 30 x 1, 

and 100 x 1capsules and bottles containing 30, 100, 250 and 500 capsules and a desiccant. Do not eat the 

desiccant. 

 

Not all pack sizes may be marketed.   

 

Marketing Authorisation Holder 

Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France 

 

Manufacturers 

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle 

Industrial Estate, Grange Road, Dublin 13, Ireland 

 

Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary 

 

Mylan BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands 

 

 

For any further 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 

BGP Products UAB  

Tel:  +370 5 205 1288 

 

България 

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 

Mylan EPD Kft 

Tel: + 36 1 465 2100  



67 
 

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 

BGP Products Switzerland GmbH Eesti 

filiaal  

Tel: +372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: +47 66 75 33 00 

 

Ελλάδα  

Generics Pharma Hellas ΕΠΕ  

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 

Mylan Hrvatska d.o.o. 

Tel: +385 1 23 50 599  

România 

BGP Products SRL 

Tel: + 4 0372 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 

Varnavas Hadjipanayis Ltd  

Τηλ: +357 2220 7700 

 

Sverige 

Mylan AB  

Tel: + 46 855 522 750 

 



68 
 

Latvija 

Mylan Healthcare SIA 

Tel: + 371 676 055 80 

 

United Kingdom 

Generics [UK] Ltd 

Tel: +44 1707 853000  

 

This leaflet was last revised in 

 

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