SILODYX 8 mg HARD CAPSULES

Introduction

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 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.

Contents of the pack:

1. What is Silodyx and what is it used for
2. What you need to know before you take Silodyx
3. How to take Silodyx
4. Possible side effects
5. Storage of Silodyx
6. Contents of the pack and other information

1. What is Silodyx and what is it used for

What is Silodyx

Silodyx belongs to a group of medicines 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 of these tissues. This makes it easier for you to urinate and alleviates your symptoms.

What Silodyx is used for

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

• difficulty starting urination
• feeling of not emptying the bladder completely
• need to urinate more frequently, 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

Tell your doctor or pharmacist before you start taking Silodyx

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

• If you have ever fainted or felt dizzy when standing up, inform your doctor before taking Silodyx.

When taking Silodyx, dizziness and, occasionally, fainting may occur when standing up, especially when starting treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until the symptoms disappear and inform your doctor as soon as possible (see also the section "Driving and using machines").

• If you have severe liver problems, you should not take Silodyx, as it has not been evaluated in this situation.

• If you have kidney problems, ask your doctor for advice.

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

If your kidney problems are severe, you should 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 treatment with Silodyx. Silodyx is not used to treat prostate cancer.

• Treatment with Silodyx may lead to abnormal ejaculation (reduced amount of semen expelled during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping treatment with Silodyx. 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 give 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

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

Inform your doctor in particular if you are taking:

• medicines that lower blood pressure(especially alpha-1 blockers, such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines increases during the use of Silodyx.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection(such as ritonavir), or medicines used after transplants to prevent organ rejection(such as cyclosporine), as these medicines may increase the blood levels of Silodyx.
• medicines used to treat problems in achieving or maintaining an erection(such as sildenafil or tadalafil), as their concomitant use with Silodyx may lead to a slight decrease in blood pressure.
• medicines for epilepsy or rifampicin(a medicine used to treat tuberculosis), as the effect of Silodyx may be reduced.

Pregnancy and breastfeeding

Silodyx is not indicated for use in women.

Fertility

Silodyx may reduce the amount of semen 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 using machines

Do not drive or operate machinery if you feel faint, dizzy, or have blurred vision.

3. How to take Silodyx

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one Silodyx 8 mg capsule per day by oral administration.

Take the capsule always with food, preferably at the same time each day. Do not break or chew the capsule; swallow it whole, preferably with a glass of water.

Patient with kidney problems

If you have moderate kidney problems, your doctor may prescribe a different dose.

To this end, the Silodyx 4 mg hard capsule 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 feel dizzy or weak, inform your doctor immediately.

If you forget to take Silodyx

You can take the capsule later the same day if you forget to take it before. 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 stop taking Silodyx

If you stop treatment, it is possible that the symptoms may reappear.

If you have any other questions about 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.

Get in touch with your doctor immediately 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 of the skin, or hives.

The most common side effect is abnormal ejaculation (reduced amount of semen expelled during sexual intercourse). This effect disappears after stopping treatment with Silodyx. Inform your doctor if you are planning to have children.

Dizziness, including dizziness when standing up, and, occasionally, fainting may occur.

If you feel weak or dizzy, sit or lie down immediately until the symptoms disappear. If you experience dizziness when standing up or fainting, inform your doctor as soon as possible.

Silodyx may cause complications during cataract surgery (eye surgery for cataracts; see section "Warnings and precautions").

It is important that you inform your ophthalmologist immediately 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 (smaller or negligible amount of semen expelled during sexual intercourse; 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)
• Nasal congestion or obstruction
• Diarrhea

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

• Loss of sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin reactions, such as rash, itching, hives, and drug-induced rash
• Abnormal liver function tests
• 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

Frequency not known (frequency cannot be estimated from the available data)

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

Inform your doctor if you notice that your sexual intercourse is affected.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 is the last day of the month shown.

Do not store above 30°C.

Store in the original package to protect from light and moisture.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silodyx

Silodyx 8 mg

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

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

Silodyx 4 mg

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

The other ingredients are pregelatinized corn 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 in color, size 0 (21.7 x 7.6 mm, approximately).

Silodyx 4 mg are hard gelatin capsules, opaque and yellow in color, 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 multipacks with 2 packs of 100 capsules each. Not all pack sizes may be marketed.

Marketing authorization holder

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

Ireland

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

You can obtain further information on this medicine from the representative of the marketing authorization holder in your country:

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.