Urorec

Package leaflet: Information for the patient

Urorec 8 mg hard capsules, 4 mg hard capsules

silodosin
Please 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 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 yours, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Urorec is and what it is used for

What Urorec is
Urorec belongs to a group of medicines called alpha-adrenoceptor blockers.
Urorec is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, the medicine causes relaxation of the smooth muscle in these tissues. This makes urination easier and relieves symptoms.

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

• difficulty starting to urinate,
• feeling of not having completely emptied the bladder,
• frequent need to urinate, including during the night.

2. What you need to know before taking Urorec

Do not take Urorec
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 Urorec

• If you are scheduled to undergo eye surgery due to lens opacity ( cataract surgery ), it is important that you immediately inform your ophthalmologist
  that you are currently taking or have previously taken Urorec. This is because some patients treated with this
  type of medicine have experienced 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 is necessary to postpone or temporarily interrupt treatment with Urorec in case of cataract surgery.

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

• If you have severe liver problems , do not take Urorec, 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 Urorec cautiously and possibly at a reduced dose (see section 3 “Dosage”). Do not take Urorec if you have severe kidney disease.

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

• Treatment with Urorec may lead to abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily impair male fertility. This effect disappears after stopping treatment with Urorec. Inform your doctor if you intend to have 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 Urorec 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 Urorec.

• 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 Urorec in the blood.

• medicines used for difficulty in achieving or maintaining an erection (such as sildenafil or tadalafil), because concomitant use with Urorec may slightly reduce blood pressure.

• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Urorec may be reduced. Pregnancy and breastfeeding Urorec is not intended for use in women. Fertility Urorec may reduce the amount of sperm and therefore could temporarily impair the ability to father children. If you wish to have children, consult your doctor or pharmacist before taking this medicine. Driving and use of 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 Urorec

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Urorec 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, 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 these cases,
Urorec 4 mg hard capsules are available.
If you take more Urorec 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 Urorec
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 Urorec
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 serious.

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

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

Urorec may cause complications during cataract surgery (surgical procedure on the eye performed to correct 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 Urorec.

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)

• Fast 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 think you are experiencing any effects on your sexual life, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Urorec

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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.
Store 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 Urorec contains
Urorec 8 mg
The active substance 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).
Urorec 4 mg
The active substance 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).

Description of the appearance of Urorec and contents of the pack
Urorec 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Urorec 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Urorec is available in packs containing 5, 10, 20, 30, 50, 90, 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 Milano
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 Ireland Ltd. PharmaSwiss UAB
Tél/Tel: + 353 21 4379400 Tel: + 370 5 2790762

България Luxembourg/Luxemburg
PharmaSwiss EOOD Recordati Ireland Ltd.
Тел.: + 359 2 895 21 10 Tél/Tel: + 353 21 4379400

Česká republika Magyarország
Herbacos Recordati s.r.o. Recordati Ireland Ltd.
Tel: + 420 466 741 915 Tel: + 353 21 4379400

Danmark Malta
Recordati Ireland Ltd. Focused Pharma Ltd
Tlf: + 353 21 4379400 Tel: + 356 79426930

Deutschland Nederland
Recordati Pharma GmbH Recordati Ireland Ltd.
Tel: + 49 731 70470 Tel: + 353 21 4379400

Eesti Norge
PharmaSwiss Eesti OÜ Recordati Ireland Ltd.
Tel: + 372 6827400 Tlf: + 353 21 4379400

Ελλάδα Österreich
Recordati Hellas Pharmaceuticals A.E. Haemo Pharma GmbH
Τηλ: + 30 210-6773822 Tel: + 43 2689 31160

España Polska
Casen Recordati, S.L. RECORDATI POLSKA sp. z o.o.
Tel: + 34 91 659 15 50 Tel: + 48 22 206 84 50

France Portugal
Laboratoires Bouchara-Recordati Jaba Recordati, S.A.
Tél: + 33 1 45 19 10 00 Tel: + 351 21 432 95 00

Hrvatska România
PharmaSwiss d.o.o. Recordati România S.R.L.
Tel: +385 1 63 11 833 Tel: + 40 21 667 17 41

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

Ísland Slovenská republika
Recordati Ireland Ltd. Herbacos Recordati s.r.o.
Sími: + 353 21 4379400 Tel: + 420 466 741 915

Italia Suomi/Finland
Recordati Industria Chimica e Farmaceutica S.p.A. SwanMedica Oy
Tel: + 39 02 487871 Puh/Tel: +358 17 3690033

Κύπρος Sverige
G.C. Papaloisou Ltd. Recordati Ireland Ltd.
Τηλ: + 357 22 49 03 05 Tel: + 353 21 4379400

Latvija United Kingdom
PharmaSwiss UAB Recordati Pharmaceuticals Ltd.
Tel: + 370 5 2790762 Tel: + 44 1491 576336

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.