SILODOSINA 4 mg Hard Capsules

Зміст інструкції

1. Silodosina Recordati 8 mg hard capsules, 4 mg hard capsules
   1. What is Silodosina Recordati and what is it used for
   2. What you need to know before taking Silodosina Recordati
   3. How to take Silodosina Recordati
   4. Possible side effects
   5. How to store Silodosina Recordati
   6. Contents of the pack and other information

Silodosina Recordati 8 mg hard capsules, 4 mg hard capsules

silodosina

Read this leaflet carefully before you start using 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Silodosina Recordati and what is it used for

What is Silodosina Recordati
Silodosina Recordati belongs to a group of medicines called alpha-adrenoceptor inhibitors.
Silodosina Recordati 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
urination easier and relieves symptoms.

What is Silodosina Recordati used for
Silodosina Recordati 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 Silodosina Recordati

Do not take Silodosina Recordati
if you are allergic to silodosina 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 Silodosina Recordati

• 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 Silodosina Recordati. 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 Silodosina Recordati in case of cataract surgery.
• If you have fainted or felt dizzy when getting up suddenly in the past, tell your doctor before taking Silodosina Recordati. Taking Silodosina Recordati may cause dizzinesswhen getting up 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 the symptoms disappear and inform your doctor as soon as possible (see also section “Driving and using machines”).
• If you have severe liver problems, you should not take Silodosina Recordati, 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 Silodosina Recordati with caution and possibly with a reduced dose (see section 3 “Dose”). If you have a severe kidney disease, you should not take Silodosina Recordati.
• Since an enlarged benign prostate and prostate cancer can present the same symptoms, your doctor will check that you do not have prostate cancer before starting treatment with Silodosina Recordati. Silodosina Recordati is not a treatment for prostate cancer.
• Treatment with Silodosina Recordati 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 Silodosina Recordati. Tell your doctor if you wish to have children.

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

Other medicines and Silodosina Recordati
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you take:

• 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 Silodosina Recordati.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used againstHIV/AIDS infection(such as ritonavir) or medicines used after a transplant to

prevent organ rejection(such as cyclosporine), because these medicines can
increase the concentration of Silodosina Recordati in the blood.

• medicines used if you have problems getting or maintaining an erection(such as sildenafil or tadalafil), because concomitant use with Silodosina Recordati may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin(a medicine used to treat tuberculosis), because the effect of Silodosina Recordati may be reduced.

Pregnancy and breastfeeding
The use of Silodosina Recordati is not intended for women.

Fertility
Silodosina Recordati may reduce the amount 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 using machines
Do not drive and do not use machines if you feel faint, dizzy or sleepy or if you have
blurred vision.

Silodosin Recordati contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say it is essentially
‘sodium-free’.

3. How to take Silodosina Recordati

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Silodosina Recordati 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, it is
available Silodosina Recordati 4 mg hard capsules.

If you take more Silodosina Recordati 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 Silodosina Recordati
If you have forgotten to take a capsule before, 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 Silodosina Recordati
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 Silodosina Recordati.
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 getting up or in case of fainting, tell your doctor as soon as
possible.
Silodosina Recordati may cause complications during a cataract surgery(surgery
on the eye performed to correct lens opacity, see the section
“Warnings and precautions”).
It is important that you immediately inform the ophthalmologist if you are using or have used Silodosina Recordati in
the past.
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 heartbeat
• Symptoms of an allergic skin reaction, 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 sign 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, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 Silodosina Recordati

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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Silodosina Recordati contains
Silodosina Recordati 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 and titanium dioxide (E171). Refer to section 2 “Silodosin Recordati
contains sodium”.

Silodosina Recordati 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) and yellow iron oxide (E172). Refer to the
section 2 “Silodosin Recordati contains sodium”.

Description of the appearance of Silodosina Recordati and contents of the pack
Silodosina Recordati 8 mg are rigid, gelatin capsules, white, opaque, size 0
(approximately 21.7 x 7.6 mm).
Silodosina Recordati 4 mg are rigid, gelatin capsules, yellow, opaque, size 3
(approximately 15.9 x 5.8 mm).
Silodosina Recordati is available in packs containing 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
Recordati Ireland Ltd.
Tel: + 353 21 4379400

България
Recordati Ireland Ltd.
Тел.: + 353 21 4379400

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
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Deutschland
Recordati Pharma GmbH
Tel: + 49 731 70470

Nederland
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Eesti
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Norge
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

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

Österreich
Recordati Ireland Ltd.
Tel: + 353 21 4379400

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
Recordati Ireland Ltd.
Tel: + 353 21 4379400

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

Ísland
Recordati Ireland Ltd.
Sími: + 353 21 4379400

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

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

Suomi/Finland
Recordati Ireland Ltd.
Puh/Tel: + 353 21 4379400

Κύπρος
Recordati Ireland Ltd.
Τηλ: + 353 21 4379400

Sverige
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Latvija
Recordati Ireland Ltd.
Tel: + 353 21 4379400

United Kingdom (Northern Ireland)
Recordati Ireland Ltd.
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 .