Silodyx

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Silodyx 4 mg hard capsules 
Silodyx 8 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Silodyx 4 mg hard capsules 
Each hard capsule contains 4 mg silodosin. 
 
Silodyx 8 mg hard capsules 
Each hard capsule contains 8 mg silodosin. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule. 
 
Silodyx 4 mg hard capsules 
Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm). 
 
Silodyx 8 mg hard capsules 
White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.  
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is one capsule of Silodyx 8 mg daily. For special patient populations, one 
capsule of Silodyx 4 mg daily is recommended (see below). 
 
Elderly 
No dose adjustment is required in the elderly (see section 5.2). 
 
Renal impairment 
No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).  
A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment 
(CLCR ≥ 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, 
depending on the individual patient’s response. The use in patients with severe renal impairment 
(CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).  
 
Hepatic impairment 
No dose adjustment is required for patients with mild to moderate hepatic impairment.  
As no data are available, the use in patients with severe hepatic impairment is not recommended (see 
sections 4.4 and 5.2). 
 

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Paediatric population 
There is no relevant use of Silodyx in the paediatric population for the indication of benign prostatic 
hyperplasia (BPH). 
 
Method of administration 
 
Oral use. 
The capsule should be taken with food, preferably at the same time every day. The capsule should not 
be broken or chewed but swallowed whole, preferably with a glass of water. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use  
 
Intraoperative Floppy Iris Syndrome (IFIS) 
IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on 
α1-blockers or previously treated with α1-blockers. This may lead to increased procedural 
complications during the operation.  
The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is 
scheduled. Discontinuing treatment with an α1-blocker 1-2 weeks prior to cataract surgery has been 
recommended, but the benefit and duration of stopping the therapy prior to cataract surgery has not yet 
been established.  
During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients 
scheduled for cataract surgery are being or have been treated with silodosin, in order to ensure that 
appropriate measures will be in place to manage IFIS during surgery.  
 
Orthostatic effects 
The incidence of orthostatic effects with silodosin is very low. However, a reduction in blood pressure 
can occur in individual patients, leading in rare cases to syncope. At the first signs of orthostatic 
hypotension (such as postural dizziness), the patient should sit or lie down until the symptoms have 
disappeared. In patients with orthostatic hypotension, treatment with silodosin is not recommended. 
 
Renal impairment  
The use of silodosin in patients with severe renal impairment (CLCR <30 ml/min) is not recommended 
(see sections 4.2 and 5.2).  
 
Hepatic impairment 
Since no data are available in patients with severe hepatic impairment, the use of silodosin in these 
patients is not recommended (see sections 4.2 and 5.2).  
 
Carcinoma of the prostate 
Since BPH and prostate carcinoma may present the same symptoms and can co-exist, patients thought 
to have BPH should be examined prior to starting therapy with silodosin, to rule out the presence of 
carcinoma of the prostate. Digital rectal examination and, when necessary, determination of prostate 
specific antigen (PSA) should be performed before treatment and at regular intervals afterwards. 
 
Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may 
temporarily affect male fertility. This effect disappears after discontinuation of silodosin (see 
section 4.8). 
 
Sodium 
This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say 
essentially ‘sodium-free’. 
 

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4.5 Interaction with other medicinal products and other forms of interaction  
 
Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7. 
Silodosin is also a substrate for P-glycoprotein. Substances that inhibit (such as ketoconazole, 
itraconazole, ritonavir or cyclosporine) or induce (such as rifampicin, barbiturates, carbamazepine, 
phenytoin) these enzymes and transporters may affect the plasma concentrations of silodosin and its 
active metabolite. 
 
Alpha-blockers 
There is inadequate information about the safe use of silodosin in association with other 
α-adrenoreceptor antagonists. Consequently, the concomitant use of other α-adrenoreceptor 
antagonists is not recommended. 
 
CYP3A4 inhibitors 
In an interaction study, a 3.7-fold increase in maximum silodosin plasma concentrations and a 3.1-fold 
increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent 
CYP3A4 inhibitor (ketoconazole 400 mg). Concomitant use with potent CYP3A4 inhibitors (such as 
ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended. 
When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, 
an increase in silodosin AUC of approximately 30% was observed, but Cmax and half-life were not 
affected. This change is clinically not relevant and no dose adjustment is required. 
 
PDE-5 inhibitors 
Minimal pharmacodynamic interactions have been observed between silodosin and maximum doses of 
sildenafil or tadalafil. In a placebo-controlled study in 24 subjects 45-78 years of age receiving 
silodosin, the co-administration of sildenafil 100 mg or tadalafil 20 mg induced no clinically 
meaningful mean decreases in systolic or diastolic blood pressure, as assessed by orthostatic tests 
(standing versus supine). In the subjects over 65 years, the mean decreases at the various time points 
were between 5 and 15 mmHg (systolic) and 0 and 10 mmHg (diastolic). Positive orthostatic tests 
were only slightly more common during co-administration; however, no symptomatic orthostasis or 
dizziness occurred. Patients taking PDE-5 inhibitors concomitantly with silodosin should be monitored 
for possible adverse reactions. 
 
Antihypertensives 
In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly 
agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) 
without experiencing an increase in the incidence of orthostatic hypotension. Nevertheless, caution 
should be exercised when starting concomitant use with antihypertensives and patients should be 
monitored for possible adverse reactions.  
 
Digoxin 
Steady state levels of digoxin, a substrate of P-glycoprotein, were not significantly affected by 
co-administration with silodosin 8 mg once daily. No dose adjustment is required. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy and breast-feeding 
Not applicable as silodosin is intended for male patients only. 
 
Fertility 
In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during 
treatment with silodosin (see section 4.8), due to the pharmacodynamic properties of silodosin. Before 
starting treatment, the patient should be informed that this effect may occur, temporarily affecting 
male fertility.  
 

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4.7 Effects on ability to drive and use machines 
 
Silodyx has minor or moderate influence on the ability to drive and use machines. Patients should be 
informed about the possible occurrence of symptoms related to postural hypotension (such as 
dizziness) and should be cautioned about driving or operating machines until they know how silodosin 
will affect them. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies 
(with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two 
long-term open-label extension phase studies. In total, 1,581 patients have received silodosin at a dose 
of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 
1 year. 
 
The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and 
during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation 
(ejaculatory volume reduced or absent), with a frequency of 23%. This may temporarily affect male 
fertility. It is reversible within a few days upon discontinuation of treatment (see section 4.4). 
 
Tabulated list of adverse reactions  
In the table below, adverse reactions reported in all clinical studies and in the worldwide 
post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA 
system organ class and frequency: 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), not known (cannot be 
estimated from available data). Within each frequency grouping the observed adverse reactions are 
presented in order of decreasing seriousness. 
 
 
System organ 
class 

 
Very 
common 
 

 
Common 
 

 
Uncommon 
 

 
Rare 

 
Very rare 

 
Not known 

Immune system 
disorders 

    Allergic-type 
reactions 
including 
facial 
swelling, 
swollen 
tongue and 
pharyngeal 
oedema1 

 

Psychiatric 
disorders 

  Libido 
decreased 

   

Nervous system 
disorders 

 Dizziness   Syncope 
Loss of 
consciousness1 

  

Cardiac 
disorders 

  Tachycardia1 Palpitations1   

Vascular 
disorders 

 Orthostatic 
hypotension  

Hypotension1    

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Nasal 
congestion 

    

Gastrointestinal 
disorders 

 Diarrhoea  Nausea  
Dry mouth  

   

Hepatobiliary 
disorders 

  Abnormal 
liver function 
tests1 

   

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System organ 
class 

 
Very 
common 
 

 
Common 
 

 
Uncommon 
 

 
Rare 

 
Very rare 

 
Not known 

Skin and 
subcutaneous 
tissue disorders 
 

  Skin rash1, 
Pruritus1 
Urticaria1 
Drug 
eruption1 

   

Reproductive 
system and 
breast 
disorders 

Ejaculatory 
disorders, 
including 
retrograde 
ejaculation, 
anejaculation 

 Erectile 
dysfunction 

   

Injury, 
poisoning and 
procedural 
complication 

     Intraoperative 
Floppy Iris 
Syndrome 

1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from 
events reported in Phase I-IV clinical trials and non-interventional studies). 
 
Description of selected adverse reactions  
 
Orthostatic hypotension 
The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2% with 
silodosin and 1.0% with placebo. Orthostatic hypotension may occasionally lead to syncope (see 
section 4.4). 
 
Intraoperative Floppy Iris Syndrome (IFIS) 
IFIS has been reported during cataract surgery (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 
 
Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting 
adverse reaction was postural hypotension. If ingestion is recent, induction of vomiting or gastric 
lavage may be considered. Should overdose of silodosin lead to hypotension, cardiovascular support 
has to be provided. Dialysis is unlikely to be of significant benefit since silodosin is highly (96.6%) 
protein bound. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties  
 
Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists, ATC code: G04CA04. 
 
Mechanism of action 
Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, 
bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these 
α1A-adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet 
resistance, without affecting detrusor smooth muscle contractility. This causes an improvement of both 

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storage (irritative) and voiding (obstructive) symptoms (Lower urinary tract symptoms, LUTS) 
associated with benign prostatic hyperplasia. 
Silodosin has a substantially lower affinity for the α1B-adrenoreceptors that are primarily located in the 
cardiovascular system. It has been demonstrated in vitro that the α1A:α1B binding ratio of silodosin 
(162:1) is extremely high.  
 
Clinical efficacy and safety 
In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg 
once daily, a greater improvement in American Urologic Association (AUA) symptom index score 
was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg 
(-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83). 
 
Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, 
IPSS, baseline value ≥ 13) received silodosin 8 mg once daily in two Phase III placebo-controlled 
clinical studies conducted in the United States and in one placebo- and active-controlled clinical study 
conducted in Europe. In all studies, patients who did not respond to placebo during a 4-week placebo 
run-in phase were randomised to receive the study treatment. In all studies, patients treated with 
silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of 
BPH as compared to placebo as assessed after 12 weeks of treatment. Data observed in the 
Intent-to-treat populations of each study are shown below:  
 

Study Treatment arm 
No. of 
patients 

IPSS 
Total score 

IPSS 
Irritative symptoms 

IPSS 
Obstructive 
symptoms 

Baseline 
value 
(± SD) 

Change 
from 
baseline 

Difference 
(95% CI) 
vs  
placebo 

Change 
from 
baseline 

Difference 
(95% CI) 
vs  
placebo 

Change  
from 
baseline 

Difference 
(95% CI) 
vs  
placebo 

US-1 
Silodosin 
 
Placebo 

233 
 

228 

22 ± 5 
 

21 ± 5 

-6.5 
 

-3.6 

-2.8* 
(-3.9, -1.7) 

-2.3 
 

-1.4 

-0.9* 
(-1.4, -0.4) 

-4.2 
 

-2.2 

-1.9* 
(-2.6, -1.2) 

US-2 
Silodosin 
 
Placebo 

233 
 

229 

21 ± 5 
 

21 ± 5 

-6.3 
 

-3.4 

-2.9* 
(-4.0, -1.8) 

-2.4 
 

-1.3 

-1.0* 
(-1.5, -0.6) 

-3.9 
 

-2.1 

-1.8* 
(-2.5, -1.1) 

Europe 

 
Silodosin 
 
 
Tamsulosin 
 
 
Placebo 

 
371 

 
 

376 
 
 

185 

 
19 ± 4 

 
 

19 ± 4 
 
 

19 ± 4 

 
-7.0 

 
 

-6.7 
 
 

-4.7 

 
-2.3* 

(-3.2, -1.4) 
 

-2.0* 
(-2.9, -1.1) 

 
 
 

 
-2.5 

 
 

-2.4 
 
 

-1.8 

 
-0.7° 

(-1.1, -0.2) 
 

-0.6° 
(-1.1, -0.2) 

 
 
 

 
-4.5 

 
 

-4.2 
 
 

-2.9 

 
-1.7* 

(-2.2, -1.1) 
 

-1.4* 
(-2.0, -0.8) 

 
 
 

* p < 0.001 vs Placebo;°p = 0.002 vs Placebo 
 
In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be 
non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total 
Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1). The responder rate (i.e. 
improvement in the IPSS total score by at least 25%) was significantly higher in the silodosin (68%) 
and tamsulosin group (65%), as compared to placebo (53%). 
 
In the long-term open-label extension phase of these controlled studies, in which patients received 
silodosin for up to 1 year, the symptom improvement induced by silodosin at week 12 of treatment 
was maintained over 1 year. 
 
In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 
77.1% were responders to silodosin (as assessed by a change from baseline in the IPSS total score of 

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at least 25%). Approximately half of the patients reported an improvement in the most bothersome 
symptoms complained at baseline by the patients (i.e. nocturia, frequency, decreased stream, urgency, 
terminal dribbling and incomplete emptying), as assessed by the ICS-male questionnaire. 
 
No significant reduction in supine blood pressure was observed in all clinical studies conducted with 
silodosin.  
 
Silodosin 8 mg and 24 mg daily had no statistically significant effect on ECG intervals or cardiac 
repolarisation relative to placebo.  
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Silodyx in all subsets of the paediatric population in BPH (see section 4.2 for information on 
paediatric use). 
 
5.2 Pharmacokinetic properties  
 
The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects 
with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 
48 mg per day. The pharmacokinetics of silodosin is linear throughout this dose range. 
The exposure to the main metabolite in plasma, silodosin glucuronide (KMD-3213G), at steady-state 
is about 3-fold that of the parent substance. Silodosin and its glucuronide reach steady-state after 
3 days and 5 days of treatment, respectively. 
 
Absorption 
Silodosin administered orally is well absorbed and absorption is dose proportional. The absolute 
bioavailability is approximately 32%. 
An in vitro study with Caco-2 cells showed that silodosin is a substrate for P-glycoprotein. 
Food decreases Cmax by approximately 30%, increases tmax by approximately 1 hour and has little 
effect on AUC. 
In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral 
administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic 
parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), 
AUC 433 ± 286 ng • h/mL. 
 
Distribution 
Silodosin has a volume of distribution of 0.81 L/kg and is 96.6% bound to plasma proteins. It does not 
distribute into blood cells. 
Protein binding of silodosin glucuronide is 91%. 
 
Biotransformation 
Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde 
dehydrogenase and oxidative pathways, mainly CYP3A4. The main metabolite in plasma, the 
glucuronide conjugate of silodosin (KMD-3213G), that has been shown to be active in vitro, has an 
extended half-life (approximately 24 hours) and reaches plasma concentrations approximately four 
times higher than those of silodosin. In vitro data indicate that silodosin does not have the potential to 
inhibit or induce cytochrome P450 enzyme systems. 
 
Elimination  
Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was 
approximately 33.5% in urine and 54.9% in faeces. Body clearance of silodosin was approximately 
0.28 L/h/kg. Silodosin is excreted mainly as metabolites, very low amounts of unchanged drug are 
recovered in urine. The terminal half-life of parent drug and its glucuronide is approximately 11 hours 
and 18 hours, respectively. 
 

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Special populations 
 
Elderly 
Exposure to silodosin and its main metabolites does not change significantly with age, even in subjects 
of age over 75 years. 
 
Paediatric population 
Silodosin has not been evaluated in patients less than 18 years of age. 
 
Hepatic impairment 
In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with 
moderate hepatic impairment (Child-Pugh scores 7 to 9), compared to nine healthy subjects. Results 
from this study should be interpreted with caution, since enrolled patients had normal biochemistry 
values, indicating normal metabolic function, and they were classified as having moderate liver 
impairment based on ascites and hepatic encephalopathy.  
The pharmacokinetics of silodosin in patients with severe hepatic impairment has not been studied. 
 
Renal impairment 
In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate 
renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) 
relative to subjects with normal renal function (n = 8). In subjects with severe renal impairment (n = 5) 
increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC. Exposure to the main metabolites, 
silodosin glucuronide and KMD3293, was also increased. 
Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks 
of treatment did not change in patients with mild impairment (n = 70), compared to patients with 
normal renal function (n = 155), while the levels were doubled on average in patients with moderate 
impairment (n = 7). 
A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal 
impairment (n = 487) poses an additional safety risk during silodosin therapy (such as an increase in 
dizziness or orthostatic hypotension) as compared to patients with normal renal function (n = 955). 
Accordingly, no dose adjustment is required in patients with mild renal impairment. Since only limited 
experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is 
recommended. In patients with severe renal impairment administration of Silodyx is not 
recommended.  
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, carcinogenic, mutagenic and teratogenic potential. Effects in animals (affecting the 
thyroid gland in rodents) were observed only at exposures considered sufficiently in excess of the 
maximum human exposure, indicating little relevance to clinical use. 
In male rats, decreased fertility was observed from exposures which were approximately twice the 
exposure at the maximum recommended human dose. The observed effect was reversible. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients  
 
Silodyx 4 mg and 8 mg hard capsules  
 
Capsule content 
Starch, pregelatinised (maize) 
Mannitol (E421) 
Magnesium stearate 
Sodium laurilsulfate 
 

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Capsule shell 
Gelatin 
Titanium dioxide (E171) 
Yellow iron oxide (E172) (4 mg capsules only) 
 
6.2 Incompatibilities  
 
Not applicable.  
 
6.3 Shelf life  
 
3 years. 
 
6.4 Special precautions for storage  
 
Do not store above 30 °C. 
Store in the original package in order to protect from light and moisture. 
 
6.5 Nature and contents of container  
 
The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons. 
 
Packs of 5, 10, 20, 30, 50, 90, 100 capsules. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements..  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork  
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/09/607/001 
EU/1/09/607/002 
EU/1/09/607/003 
EU/1/09/607/004 
EU/1/09/607/005 
EU/1/09/607/006 
EU/1/09/607/007 
EU/1/09/607/008 
EU/1/09/607/009 
EU/1/09/607/010 
EU/1/09/607/011 
EU/1/09/607/012 
EU/1/09/607/013 
EU/1/09/607/014 
 
 

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 29/01/2010 
Date of latest renewal: 18/09/2014 
 
 
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. 
 

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ANNEX II 
 
A. MANUFACTURERS 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 

 
 

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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Recordati Industria Chimica e Farmaceutica S.p.A. 
Via M. Civitali 1 
20148 Milan 
Italy 
 
Laboratoires Bouchara-Recordati 
Parc Mécatronic 
03410 Saint Victor 
France 
 
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 
 
The requirements for submission of marketing authorisation holder shall submit periodic safety 
update reports for this medicinal product in accordance with the requirements set out in the list 
of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 

 
The 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. 

 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Silodyx 4 mg hard capsules  
 
silodosin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 4 mg silodosin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
5 hard capsules 
10 hard capsules 
20 hard capsules 
30 hard capsules 
50 hard capsules 
90 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 

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9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30 °C.  
Store in the original package in order to protect from light and 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 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork  
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/09/607/001 
EU/1/09/607/002 
EU/1/09/607/003 
EU/1/09/607/004 
EU/1/09/607/005 
EU/1/09/607/006 
EU/1/09/607/007 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Silodyx 4 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 

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18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
PVC/PVDC/ALUMINIUM FOIL BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Silodyx 4 mg hard capsules 
 
silodosin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Ireland Ltd. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Silodyx 8 mg hard capsules  
 
silodosin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 8 mg silodosin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
5 hard capsules 
10 hard capsules 
20 hard capsules 
30 hard capsules 
50 hard capsules 
90 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 

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9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30 °C.  
Store in the original package in order to protect from light and 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 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork  
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/09/607/008 
EU/1/09/607/009 
EU/1/09/607/010 
EU/1/09/607/011 
EU/1/09/607/012 
EU/1/09/607/013 
EU/1/09/607/014 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Silodyx 8 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 

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18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
PVC/PVDC/ALUMINIUM FOIL BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Silodyx 8 mg hard capsules  
 
silodosin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Ireland Ltd. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

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B. PACKAGE LEAFLET 
 

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Package Leaflet: Information for the patient 

 
Silodyx 8 mg hard capsules  
Silodyx 4 mg hard capsules 

Silodosin 
 

Read all of this leaflet carefully before you start using 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 Silodyx is and what it is used for 
2. What you need to know before you take Silodyx 
3. How to take Silodyx 
4. Possible side effects 
5. How to store Silodyx 
6. Contents of the pack and other information 
 
 
1. What Silodyx is and what it is used for 
 
What Silodyx is 
 
Silodyx belongs to a group of medicines called alpha1A-adrenoreceptor blockers. 
Silodyx is selective for the receptors located in the prostate, bladder and urethra. By blocking these 
receptors, it causes smooth muscle in these tissues to relax. This makes it easier for you to pass water 
and relieves your symptoms. 
 
What Silodyx is used for 
 
Silodyx is used in adult men to treat the urinary symptoms associated with benign enlargement of the 
prostate (prostatic hyperplasia), such as: 
• difficulty in starting to pass water, 
• a feeling of not completely emptying the bladder, 
• a more frequent need to pass water, even at night. 
 
 
2. What you need to know before you take Silodyx 
 
Do not take Silodyx 
 
if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6). 
 
Warnings and precautions  
 
Talk to your doctor or pharmacist before taking Silodyx 
 
• If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is 

important that you immediately inform your eye specialist that you are using or have previously 

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used Silodyx. This is because some patients treated with this kind of medicine experienced a 
loss of muscle tone in the iris (the coloured circular part of the eye) during such a surgery. The 
specialist can take appropriate precautions with respect to medicine and surgical techniques to 
be used. Ask your doctor whether or not you should postpone or temporarily stop taking 
Silodyx when undergoing cataract surgery. 

 
• If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor 

before taking Silodyx.  
Dizziness when standing up and occasionally fainting may occur when taking Silodyx, 
particularly when starting treatment or if you are taking other medicines that lower blood 
pressure. If this occurs, make sure you sit or lie down straight away until the symptoms have 
disappeared and inform your doctor as soon as possible (see also section “Driving and using 
machines”).  

 
• If you have severe liver problems, you should not take Silodyx, as it was not tested in this 

condition. 
 
• If you have problems with your kidneys, please ask your doctor for advice.  

If you have moderate kidney problems, your doctor will start Silodyx with caution and possibly 
with a lower dose (see section 3 “Dose”).  
If you have severe kidney problems, you should not take Silodyx. 

 
• Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, 

your doctor will check you for prostate cancer before starting treatment with Silodyx. Silodyx 
does not treat prostate cancer. 

 
The treatment with Silodyx may lead to an abnormal ejaculation (decrease in the amount of semen 
released during sex) that may temporarily affect male fertility. This effect disappears after 
discontinuation of Silodyx. Please inform your doctor if you are planning to have children.  
 
Sodium 
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 
‘sodium-free’. 
 
Children and adolescents 
 
• Do not give this medicine to children and adolescents below 18 years since there is no relevant 

indication for this age group. 
 
Other medicines and Silodyx 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Tell your doctor in particular, if you take: 
• medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such 

as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is 
increased whilst taking Silodyx. 

• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS 
(such as ritonavir) or medicines used after transplants to prevent organ rejection (such as 
cyclosporin) because these medicines can increase the blood concentration of Silodyx. 

• medicines used for treating problems in getting or keeping an erection (such as sildenafil or 
tadalafil), since the concomitant use with Silodyx might lead to a slight decrease in blood 
pressure.  

• medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of 
Silodyx may be reduced. 

 

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Pregnancy and breast-feeding 
 
Silodyx is not intended for use by women. 
 
Fertilty 
 
Urorec may reduce the amount of sperm, and so could temporarily affect your ability to father a child. 
If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this 
medicine. 
 
Driving and using machines 
 
Do not drive or operate machines if you feel faint, dizzy, drowsy or have blurred vision. 
 
 
3. How to take Silodyx 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is one capsule of Silodyx 8 mg per day by oral administration.  
 
Take the capsule always with food, preferably at the same time every day. Do not break or chew the 
capsule, but swallow it whole, preferably with a glass of water. 
 
Patients with kidney problems  
If you have moderate kidney problems, your doctor may prescribe a different dose. For this purpose 
Silodyx 4 mg hard capsules are available. 
 
If you take more Silodyx than you should 
 
If you have taken more than one capsule, inform your doctor as soon as possible. If you become dizzy 
or feel weak, tell your doctor straight away. 
 
If you forget to take Silodyx 
 
You may take your capsule later the same day if you have forgotten to take it earlier. If it is almost 
time for the next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten 
capsule. 
 
If you stop taking Silodyx 
 
If you stop treatment, your symptoms may re-appear. 
 
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.  
 
Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the 
face or throat, difficulty in breathing, feeling faint, itchy skin or hives since the consequences could 
become serious. 
 

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The most common side effect is a decrease in the amount of semen released during sex. This effect 
disappears after discontinuation of Silodyx. Please inform your doctor if you are planning to have 
children. 
 
Dizziness, including dizziness when standing up, and occasionally fainting, may occur.  
If you do feel weak or dizzy, make sure you sit or lie down straight away until the symptoms have 
disappeared. If dizziness when standing up or fainting occurs, please inform your doctor as soon as 
possible. 
 
Silodyx may cause complications during a cataract surgery (eye surgery because of cloudiness of the 
lens, see section “Warnings and precautions”).  
It is important that you immediately inform your eye specialist if you are using or have previously 
used Silodyx. 
 
The possible side effects are listed below:  
 
Very common side effects (may affect more than 1 in 10 people) 
• Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings 

and precautions”) 
 
Common side effects (may affect up to 1 in 10 people) 
• Dizziness, including dizziness when standing up (see also above, in this section) 
• Runny or blocked nose 
• Diarrhoea 
 
Uncommon side effects (may affect up to 1 in 100 people) 
• Decreased sexual drive 
• Nausea 
• Dry mouth 
• Difficulties in getting or keeping an erection 
• Faster heart rate 
• Symptoms of allergic reaction affecting the skin like rash, itching, hives and rash caused by a 

medicine 
• Abnormal results of liver function tests 
• Low blood pressure 
 
Rare side effects (may affect up to 1 in 1,000 people) 
• Fast or irregular heart beats (called palpitations) 
• Fainting/ Loss of consciousness 
 
Very rare side effects (may affect up to 1 in 10,000 people) 
• Other allergic reactions with swelling of the face or throat 
 
Not known (frequency cannot be estimated from the available data) 
• Floppy pupil during cataract surgery (see also above, in this section) 
 
If you feel that your sexual life is affected, please tell your doctor.  
 
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. 
 
 

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28 

5. How to store Silodyx 
 
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 and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 30 °C.  
Store in the original package in order to protect from light and moisture. 
 
Do not use this medicine if you notice that is damaged or shows signs of tampering. 
 
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 Silodyx contains 
 
Silodyx 8 mg 
The active substance is silodosin. Each capsule contains 8 mg of silodosin.  
 
The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium 
laurilsulfate, gelatin, titanium dioxide (E171).  
 
Silodyx 4 mg 
The active substance is silodosin. Each capsule contains 4 mg of silodosin.  
 
The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium 
laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172). 
 
What Silodyx looks like and contents of the pack 
 
Silodyx 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm). 
 
Silodyx 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm). 
 
Silodyx is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules. Not all pack sizes may be 
marketed. 
 
Marketing Authorisation Holder 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork 
Ireland 
 

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Manufacturer 
 
Recordati Industria Chimica e Farmaceutica S.p.A. 
Via Matteo Civitali 1 
20148 Milan 
Italy 
 
Laboratoires Bouchara-Recordati 
Parc Mécatronic 
03410 Saint Victor 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:  
 
België/Belgique/Belgien 
ZAMBON nv-sa 
Tél/Tel: + 32 2 777 02 00 
 

Lietuva 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

България 
Recordati Ireland Ltd. 
Teл.: + 353 21 4379400 
 

Luxembourg/Luxemburg 
ZAMBON nv-sa 
Tél/Tel: + 32 2 777 02 00 
 

Česká republika 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Magyarország 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Danmark 
Recordati Ireland Ltd. 
Tlf: + 353 21 4379400 
 

Malta 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Deutschland 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Nederland 
Zambon Nederland B.V. 
Tel: + 31 33 4504370 
 

Eesti 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Norge 
Recordati Ireland Ltd. 
Tlf: + 353 21 4379400 
 

Ελλάδα 
ΒΙΑΝΕΞ Α.Ε. 
Τηλ: + 30 210 8009111 
 

Österreich 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

España 
Almirall, S.A. 
Tel: +34 93 291 30 00 
 

Polska 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

France 
ZAMBON France 
Tél: + 33 (0)1 58 04 41 41 
 

Portugal 
Tecnimede Sociedade 
Técnico-Medicinal, S.A 
Tel: +351 21 041 41 00 
 

Hrvatska 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 

România 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

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Ireland 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Slovenija 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Ísland 
Recordati Ireland Ltd. 
Sími: + 353 21 4379400 
 

Slovenská republika 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Italia 
Takeda Italia S.p.A. 
Tel: +39 06 502601 
 

Suomi/Finland 
Recordati Ireland Ltd. 
Puh/Tel: + 353 21 4379400 
 

Κύπρος 
Recordati Ireland Ltd. 
Τηλ: + 353 21 4379400 
 

Sverige 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Latvija 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

United Kingdom 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

 
 
This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS 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