UROREC 4 мг Капсулы твердые

Содержание инструкции

1. Urorec 8 mg hard capsules, 4 mg hard capsules
   1. What is Urorec and what is it 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

Urorec 8 mg hard capsules, 4 mg hard capsules

silodosin

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Urorec and what is it for

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

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

• difficulty starting to urinate,
• feeling of not completely emptying the bladder,
• frequent need to urinate, even at night.

2. What you need to know before taking Urorec

Do not take Urorec
if you are allergic to silodosin or 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 to undergo eye surgery for a cataract (cataract surgery), it is important that you immediately inform your ophthalmologist

that you are using or have used in the past Urorec. This is because some patients treated with this
type of medicine have experienced a loss of iris muscle tone (the circular colored
part of the eye) during such surgery. The ophthalmologist will take appropriate precautions
regarding the medicines and surgical techniques that will be used. Ask your doctor if 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 getting up suddenly, tell your doctor before taking Urorec. Taking Urorec may cause dizzinesswhen standing up and, occasionally, fainting, particularly 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 the symptoms disappear and inform your doctor as soon as possible (see also section “Driving and operating machinery”).
• If you have severe liver problems, you should not take Urorec, because the medicine has not been studied in patients with these conditions.
• If you have kidney problems, ask your doctor for advice. If you have moderate kidney problems, your doctor will start treatment with Urorec with caution and possibly with a reduced dose (see section 3 “Dosage”). If you have a severe kidney disease, you should not take Urorec.
• Since an enlarged prostate and prostate cancer can present the same 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 (reduction in the amount of semen released during sexual intercourse), which may temporarily impair male fertility. This effect disappears after stopping treatment with Urorec. Tell your doctor if you wish 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 adolescentsDo not give this medicine to children and adolescents under the age of 18, because there is no indication for this age group. Other medicines and UrorecTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell 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 againstHIV/AIDS infection(such as ritonavir) or medicines used after a transplant toprevent organ rejection(such as cyclosporine), because these medicines may increase the concentration of Urorec in the blood.
• medicines used if you have problems getting 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 breastfeedingUrorec is not intended for use by women. FertilityUrorec may reduce the number of sperm and therefore may temporarily impair the ability to procreate. If you wish to have children, ask your doctor or pharmacist for advice before taking this medicine. Driving and operating machineryDo not drive and do not use machines if you feel faint, dizzy or sleepy, or if your vision is blurred.

3. How to take Urorec

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Urorec 8 mg capsule daily by oral route.
Always take the capsule 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,
inform your doctor immediately.

If you forget to take Urorec
If you have forgotten to take a capsule, you can take it later, on the same day. If it is almost
time for the next dose, skip the forgotten dose. Do not take a double dose to make up for the
forgotten capsule.

If you stop taking Urorec
If you stop the treatment, the symptoms may reappear.
If you have any doubts 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.
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,
because the consequences can become serious.
The most common side effect is a reduction in the amount of semen emitted during sexual
activity. This effect disappears after stopping treatment with Urorec. Tell your doctor if
you wish to have children.
Dizzinessmay occur, even when getting up, and, occasionally, fainting.
If you feel weak or dizzy, sit or lie down immediately until the symptoms disappear.
If you feel dizzy when standing up or in case of fainting, tell your doctor as soon as
possible.
Urorec can cause complications during a cataract surgery(surgical procedure
on the eye performed to correct lens opacity, see section “Warnings and
precautions”).
It is important that you immediately inform the ophthalmologist if you are using or have used Urorec previously.
The possible side effects are listed below:

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

• Abnormal ejaculation (reduction or absence of semen emission during sexual activity, see section “Warnings and precautions”) Common side effects (may affect up to 1 in 10 people)
• Dizziness, even when getting up (see also above, in this paragraph)
• Runny or stuffy nose
• Diarrhea Uncommon side effects (may affect up to 1 in 100 people)
• Decreased libido
• Nausea
• Dry mouth
• Difficulty getting or maintaining an erection
• Fast heart rate
• Symptoms of an allergic reaction affecting the skin, 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 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 available data)

• Flag pupil during cataract surgery (see also above, in this paragraph) If you think there are effects on your sex life, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed 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 which is stated on the package and on the blister after
Exp/EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light and moisture.
Do not use this medicine if you notice that the package is damaged or if it shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Urorec contains
Urorec 8 mg
The active ingredient 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).

Urorec 4 mg
The active ingredient 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 Urorec and contents of the pack
Urorec 8 mg are hard, gelatin capsules, white, opaque, size 0 (approximately
21.7 x 7.6 mm).
Urorec 4 mg are hard, gelatin capsules, yellow, opaque, 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 Authorisation 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Recordati Ireland Ltd.
Tél/Tel: + 353 21 4379400

Lietuva
PharmaSwiss UAB
Tel: + 370 5 2790762

България
PharmaSwiss EOOD
Тел.: + 359 2 895 21 10

Luxembourg/Luxemburg
Recordati Ireland Ltd.
Tél/Tel: + 353 21 4379400

Česká republika
Herbacos Recordati s.r.o.
Tel: + 420 466 741 915

Magyarország
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Danmark
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

Malta
Focused Pharma Ltd
Tel: + 356 79426930

Deutschland
Recordati Pharma GmbH
Tel: + 49 731 70470

Nederland
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Eesti
PharmaSwiss Eesti OÜ
Tel: + 372 6827400

Norge
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

Ελλάδα
Recordati Hellas Pharmaceuticals A.E.
Τηλ: + 30 210-6773822

Österreich
Haemo Pharma GmbH
Tel: + 43 2689 31160

España
Casen Recordati, S.L.
Tel: + 34 91 659 15 50

Polska
RECORDATI POLSKA sp. z o.o.
Tel: + 48 22 206 84 50

France
Laboratoires Bouchara-Recordati
Tél: + 33 1 45 19 10 00

Portugal
Jaba Recordati, S.A.
Tel: + 351 21 432 95 00

Hrvatska
PharmaSwiss d.o.o.
Tel: +385 1 63 11 833

România
Recordati România S.R.L.
Tel: + 40 21 667 17 41

Ireland
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Slovenija
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Slovenská republika
Herbacos Recordati s.r.o.
Tel: + 420 466 741 915

Ísland
Recordati Ireland Ltd.
Sími: + 353 21 4379400

Suomi/Finland
SwanMedica Oy
Puh/Tel: +358 17 3690033

Italia
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: + 39 02 487871

Κύπρος
G.C. Papaloisou Ltd.
Τηλ: + 357 22 49 03 05

Sverige
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Latvija
PharmaSwiss UAB
Tel: + 370 5 2790762

United Kingdom
Recordati Pharmaceuticals Ltd.
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.