Silodyx

Package leaflet: Information for the patient

Silodyx 8 mg hard capsules, 4 mg hard capsules

silodosin
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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 alpha-adrenoceptor blockers.
Silodyx is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, the medicine relaxes the smooth muscle in these tissues. This makes urination easier and relieves symptoms.

What Silodyx is used for
Silodyx is used in adult men for the treatment of urinary symptoms associated with benign enlargement of the prostate (benign prostatic hyperplasia), such as:

• difficulty starting to urinate,
• feeling of incomplete bladder emptying,
• frequent need to urinate, including during the 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 taking 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 a loss of iris muscle tone (the coloured circular part of the eye) during such surgery. The ophthalmologist will take appropriate precautions regarding the medicines and surgical techniques to be used. Ask your doctor whether it may be necessary to postpone or temporarily discontinue treatment with Silodyx prior to cataract surgery.

• If you have previously fainted or experienced dizziness upon standing up suddenly, inform your doctor before taking Silodyx. Dizziness when standing up may occur while taking Silodyx, and occasionally fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and using machines”).

• If you have severe liver problems, do not take Silodyx, as the medicine has not been studied in patients with this condition.

• If you have kidney problems, consult your doctor. If you have moderate kidney problems, your doctor will start treatment with Silodyx cautiously and may consider a reduced dose (see section 3 “Dosage”). If you have severe kidney disease, you must not take Silodyx.

• Since benign enlargement of the prostate and prostate cancer may present with similar symptoms, your doctor will check whether you have prostate cancer before starting treatment with Silodyx. Silodyx is not a treatment for prostate cancer.

• Treatment with Silodyx may lead to abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily impair male fertility. This effect reverses after discontinuation of Silodyx. Inform your doctor if you wish to father children.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially
‘sodium-free’.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as there is no indication for use in this age group.

Other medicines and Silodyx
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially medicines called alpha-blockers such as prazosin or doxazosin), because there is a potential risk that the effect of these medicines may be increased during treatment with Silodyx.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used to treat HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), because these medicines may increase the concentration of Silodyx in the blood.
• medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Silodyx may cause a slight reduction in blood pressure.
• medicines used to treat epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodyx may be reduced.

Pregnancy and breastfeeding
Silodyx is not intended for use in women.

Fertility
Silodyx may reduce the amount of sperm and therefore could temporarily impair the ability to conceive. If you wish to father children, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Do not drive and do not operate machinery if you feel faint, dizzy or sleepy, or if you have blurred vision.

3. How to take Silodyx

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Silodyx 8 mg capsule daily, taken orally.
Take the capsule always with a meal, preferably at the same time each day. Do not crush 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. For these cases,
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 feel dizzy or weak,
contact your doctor immediately.
If you forget to take Silodyx
If you have forgotten to take a capsule, you may take it later the same day. If it is almost time for the next dose,
skip 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, symptoms may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty breathing, feeling faint, skin itching or hives, as these may become severe.

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

Dizziness may occur, even when standing up, and occasionally fainting. If you feel weak or dizzy, sit or lie down immediately until symptoms resolve. If you experience dizziness upon standing or episodes of fainting, inform your doctor as soon as possible.

Silodyx may cause complications during cataract surgery (surgical eye procedure to treat lens opacity; 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 side effects are listed below:

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

• Abnormal ejaculation (reduced or absent semen emission during sexual intercourse; see section “Warnings and precautions”)

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

• Dizziness, even when standing up (also see above in this section)
• Runny or stuffy nose
• Diarrhoea

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

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin allergic reaction symptoms such as rash, itching, hives, and drug-induced skin eruption
• Abnormal liver function tests
• Low blood pressure

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

• Rapid or irregular heartbeat (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)

• Intraoperative floppy iris syndrome (IFIS) during cataract surgery (also see above in this section)

If you feel that this medicine is affecting your sexual life, inform your doctor.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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/EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 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).

Description of the appearance of Silodyx and pack contents
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 and in multiple packs containing 2 packs, each with 100 capsules. 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
I-20148 Milan
Italy
Laboratoires Bouchara-Recordati
Parc Mécatronic
03410 Saint Victor
France

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

België/Belgique/Belgien Lietuva
Recordati bv Recordati Ireland Ltd.
Tél/Tel: +32 2 461 01 36 Tel: +353 21 4379400

България Luxembourg/Luxemburg
Recordati Ireland Ltd. Recordati bv
Тел.: +353 21 4379400 Tél/Tel: +32 2 461 01 36

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

Danmark Malta
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tlf: +353 21 4379400 Tel: +353 21 4379400

Deutschland Nederland
Recordati Ireland Ltd. Recordati bv
Tel: +353 21 4379400 Tel: +32 2 461 01 36

Eesti Norge
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tlf: +353 21 4379400

Ελλάδα Österreich
ΒΙΑΝΕΞ A.E. Recordati Ireland Ltd.
Τηλ: +30 210 8009111 Tel: +353 21 4379400

España Polska
Almirall, S.A. Recordati Ireland Ltd.
Tel: +34 93 291 30 00 Tel: +353 21 4379400

France Portugal
ZAMBON France Tecnimede Sociedade Técnico-Medicinal, S.A.
Tél: +33 (0)1 58 04 41 41 Tel: +351 21 041 41 00

Hrvatska România
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tel: +353 21 4379400

Ireland Slovenija
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tel: +353 21 4379400

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

Italia Suomi/Finland
Takeda Italia S.p.A. Recordati Ireland Ltd.
Tel: +39 06 502601 Puh/Tel: +353 21 4379400

Κύπρος Sverige
Recordati Ireland Ltd. Recordati Ireland Ltd.
Τηλ: +353 21 4379400 Tel: +353 21 4379400

Latvija United Kingdom (Northern Ireland)
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tel: +353 21 4379400

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.