Leaflet: information for the patient

Silodyx 8 mg hard capsules

Silodyx 4 mg hard capsules

Silodosina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Silodyx

Silodyx belongs to a group of medications called alpha 1A adrenergic receptor blockers.

Silodyx is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, it causes relaxation of the smooth muscle in these tissues. This makes it easier for you to urinate and alleviates your symptoms.

What is Silodyx used for

Silodyx is used in adult males to treat urinary symptoms associated with benign prostatic hyperplasia (BPH), such as:

• difficulty starting urination
• sensation of not fully emptying the bladder
• more frequent need to urinate, even at night

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

Consult your doctor or pharmacist before starting to take Silodyx.

• If you are to undergo eye surgery for cataract (cataract surgery), it is essential that you inform your ophthalmologist immediately that you are using or have used Silodyx previously. This is because some patients treated with this type of medication have suffered a loss of iris muscle tone (the circular colored part of the eye) during this type of surgery. Your ophthalmologist may then take appropriate precautions regarding medical and surgical techniques. Ask your doctor if you need to postpone or interrupt Silodyx treatment temporarily when undergoing cataract surgery.

• If you have fainted or felt dizzy at any time when standing up suddenly, inform your doctor before taking Silodyx.

When taking Silodyx, you may experiencedizzinessand, occasionally, asyncope, especially when starting treatment or taking other medications that lower blood pressure. If this occurs,sit or lie downimmediately until the symptoms disappear andinform your doctor as soon as possible(see also the section “Driving and operating machines”).

• If you havesevere liver problems, do not take Silodyx, as it has not been evaluated in this situation.

• If you havekidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will start Silodyx treatment with caution and possibly with a lower dose (see section 3 “Dose”).

If your kidney problems are severe, do not take Silodyx.

• Since benign prostatic hyperplasia and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting Silodyx treatment. Silodyx is not intended to treat prostate cancer.

• Silodyx treatment may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. Inform your doctor if you are planning to have children.

Silodyx contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Children and adolescents

Do not administer this medicine to children and adolescents under 18 years of age, as there are no relevant indications for this age group.

Taking Silodyx with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Inform your doctorin particular if you take:

• blood pressure-lowering medications(especially alpha1 blockers, such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during Silodyx use.
• antifungal medications(such as ketoconazole or itraconazole),medications used to treat HIV/AIDS(such as ritonavir), ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase Silodyx blood concentrations.
• medications used to treat erectile dysfunction(such as sildenafil or tadalafil), as their concurrent use with Silodyx may lead to a slight decrease in blood pressure.
• medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of Silodyx may be reduced.

Pregnancy and breastfeeding

Silodyx is not indicated for use by women.

Fertility

Silodyx may reduce semen volume and temporarily affect your ability to conceive a child. If you intend to have a child, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Do not drive or operate machines if you feel dizziness, drowsiness, or blurred vision.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one Silodyx 8 mg capsule per day taken orally.

Take the capsule always accompanied by food, preferably at the same time every day. Do not break or chew the capsule; 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.

To this end, the Silodyx 4 mg hard capsules presentation is 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 notice dizziness or feel weak, inform your doctor immediately.

If you forget to take Silodyx

You can take the capsule later the same day if you forgot to take it earlier. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed capsule.

If you interrupt treatment with Silodyx

If you interrupt treatment, it is possible that symptoms will reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you experience any of the following allergic reactions, as their consequences could be serious: swelling of the face or throat, difficulty breathing, feeling of fainting, itching on the skin or urticaria.

The most frequent side effect is a reduction in the amount of semen expelled during sexual intercourse. This side effect disappears after stopping treatment with Silodyx. Inform your doctor if you are planning to have children.

You may experiencedizziness, including dizziness when standing up, and, occasionally,fainting.

If you notice weakness or dizziness,sit or lie downimmediately until the symptoms disappear. If you experience dizziness when standing up or fainting,inform your doctor as soon as possible.

Silodyx may cause complications duringcataract surgery(eye surgery for cloudy lens; see "Warnings and precautions").

It is essential thatyou inform your ophthalmologist immediatelyif 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 negligible amount of semen is expelled during sexual intercourse; see "Warnings and precautions")

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

• Dizziness, including dizziness when standing up (also see above, in this section)
• Nasal secretion or obstruction
• Diarrhea

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

• Loss of sexual appetite
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin allergy symptoms, such as rash, itching, urticaria, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

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

• Fast or irregular heartbeats (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

Unknown frequency (frequency cannot be estimated from available data)

• Flaccid pupil during cataract surgery (also see above, in this section)

Inform your doctor if you notice that your sexual relations are affected.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from light and moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been improperly handled.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Silodyx

Silodyx 8 mg

The active ingredient is silodosin. Each capsule contains 8 mg of silodosin.

The other components are pregelatinized maize starch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E171).

Silodyx 4 mg

The active ingredient is silodosin. Each capsule contains 4 mg of silodosin.

The other components are pregelatinized maize starch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Silodyx 8 mg are hard gelatin capsules, opaque and white, size 0 (21.7 x 7.6 mm, approximately).

Silodyx 4 mg are hard gelatin capsules, opaque and yellow, size 3 (15.9 x 5.8 mm, approximately).

Silodyx is available in packs of 5, 10, 20, 30, 50, 90 and 100 capsules and in multiple packs with 2 packs of 100 capsules each. Some pack sizes may not be marketed.

Marketing Authorization Holder

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

Ireland

Responsible for manufacturing

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.