Silodyx 4 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Silodyx 8 mg hard capsules

Silodyx 4 mg hard capsules

Silodosin

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

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

Leaflet Contents:

1. What Silodyx is and what it is used for
2. What you need to know before taking 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-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 relieves your symptoms.

What Silodyx is used for

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

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

2. What you need to know before taking Silodyx

Do not take Silodyx

if you are allergic to silodosin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Silodyx

• If you are scheduled for eye surgery due to clouding of the lens (cataract surgery), it is important that you immediately inform your ophthalmologist that you are currently taking or have previously taken Silodyx. This is because some patients treated with this type of medicine have experienced loss of iris muscle tone (the colored circular part of the eye) during this type of surgery. The ophthalmologist can then take appropriate precautions regarding the medical and surgical techniques required. Ask your doctor whether you need to postpone or temporarily interrupt treatment with Silodyx prior to undergoing cataract surgery.

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

When taking Silodyx, you may experience dizziness and, occasionally, fainting, especially when starting treatment or if you are taking other medicines that lower blood pressure. If this occurs, sit or lie down immediately until symptoms subside and inform your doctor as soon as possible (see also section “Driving and use of machines”).

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

• If you have kidney problems, consult your doctor.

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

If your kidney problems are severe, you should not take Silodyx.

• Since benign enlargement of the prostate 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 effective for treating prostate cancer.

• Treatment with Silodyx may lead to abnormal ejaculation (reduced amount of semen released during sexual intercourse), which may temporarily affect male fertility. This effect resolves after discontinuation of 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; therefore, 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 need to take any other medicines.

In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially alpha1-blockers such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines increases during use of Silodyx.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of Silodyx.
• medicines used to treat erectile dysfunction (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 intended for use by women.

Fertility

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

Driving and use of machines

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

3. How to take Silodyx

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg Silodyx capsule daily, taken orally.

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.

Patients with renal problems

If you have moderate renal impairment, your doctor may prescribe a different dose.

For this purpose, the 4 mg Silodyx hard capsule formulation 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 experience dizziness or feel weak, tell your doctor immediately.

If you forget to take Silodyx

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

If you stop taking Silodyx

If you stop treatment, your symptoms may return.

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

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of the following allergic reactions, as they may have serious consequences: swelling of the face or throat, difficulty breathing, feeling faint, skin itching, or hives.

The most common adverse effect is a reduction in the amount of semen released during sexual intercourse. This effect resolves after stopping treatment with Silodyx. Inform your doctor if you are planning to have children.

Dizziness, including dizziness upon standing, and occasionally fainting, may occur.

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

Silodyx may cause complications during cataract surgery (eye surgery for lens clouding; see section “Warnings and precautions”).

It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken Silodyx.

The possible adverse effects are listed below:

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

• Abnormal ejaculation (a reduced or negligible amount of semen is expelled during sexual intercourse; see section “Warnings and precautions”)

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

• Dizziness, including dizziness upon standing (see also above in this section)
• Nasal discharge or nasal congestion
• Diarrhea

Uncommon adverse 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 allergic reaction symptoms such as rash, pruritus, urticaria, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

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

• Fast or irregular heartbeats (called palpitations)
• Fainting/Loss of consciousness

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

• Other allergic reactions with swelling of the face or throat

Frequency not known (cannot be estimated from available data)

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodyx

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Store in the original packaging 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 components 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 components 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 colour, size 0 (approximately 21.7 x 7.6 mm).

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

Silodyx is available in packs of 5, 10, 20, 30, 50, 90 and 100 capsules, and in multiple packs containing 2 packs of 100 capsules each. Only some 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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet

Other sources of information

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