InfoCons Consumer Protection informs you – Silodosin Recordati – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

ℹ️ 1. What Silodosin Recordati is and what it is used for

What Silodosin Recordati is Silodosin Recordati belongs to a group of medicines called alpha 1A-adrenoreceptor blockers.

Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra. By blocking these receptors, it causes smooth muscle in these tissues to relax. This makes it easier for you to pass water and relieves your symptoms.

What Silodosin Recordati is used for

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

• difficulty in starting to pass water,
• a feeling of not completely emptying the bladder,
• a more frequent need to pass water, even at night.

⚠️ 2. What you need to know before you take Silodosin Recordati

Do not take Silodosin Recordati

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 Silodosin Recordati

• If you are undergoing eye surgery because of cloudiness of the lens ( cataract surgery ), it is important that you immediately inform your eye specialist that you are using or have previously 26 used Silodosin Recordati . This is because some patients treated with this kind of medicine experienced a loss of muscle tone in the iris (the coloured circular part of the eye) during such a surgery. The specialist can take appropriate precautions with respect to medicine and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop takin g Silodosin Recordati when undergoing cataract surgery.
• If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodosin Recordati.

Dizziness when standing up and occasionally fainting may occur when tak ing Silodosin Recordati , particularly when starting treatment or if you are taking other medicines that lower blood pressure. If this occurs , make sure you sit or lie down straight away until the symptoms have disappeared 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 Silodosin Recordati, as it was not tested in this condition.
• If you have problems with your kidneys , please ask your doctor for advice.

If you have moderate kidney problems, your doctor will start Silodosin Recordati with caution and possibly with a lower dose (see section 3 “Dose”).

If you have severe kidney problems, you should not take Silodosin Recordati.

• Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer b efore starting treatment with Silodo sin Recordati . Silodosin Recordati does not treat prostate cancer.
• The treatment with Silodosin Recordati may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility. This effect disappears after discontinuation of Silodosin Recordati. Please inform your doctor if you are planning to have children.

Children and adolescents

Do not give this medicine to children and adolescents below 18 years since there is no relevant indication for this age group. Other medicines and Silodosin Recordati Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.

Tell your doctor in particular, if you take:

• medicines which lower blood pressure (in particular, medicines called alpha 1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodosin Recordati.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV -AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodosin Recordati .
• medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodosin Recordati might lead to a slight decrease in blood pressure.
• medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodosin Recordati may be r educed.

27 Pregnancy and breast -feeding Silodosin Recordati is not intended for use by women.

Fertilty Silodosin Recordati may reduce the amount of sperm , and so could temporarily affect your ability to father a child. If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machines if you feel faint, dizzy, drowsy or have blurred vision.

Silodosin Recordati contains sodium

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

💊 3. How to take Silodosin Recordati

Always use this medicine exactly as your doctor or pharmacist has told you. C heck with your doctor or pharmacist if you are not sure.

The recommended dose i s one capsule of Silodosin Recordati 8 mg per day by oral administration.

Take the capsule always with food, preferably at the same time every day. Do not break o r 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 this purpose Silodosin Recordati 4 mg hard capsules are available.

If you take more Silodosin Recordati than you should

If you have taken more than one capsule, inform your doctor as soon as possible. If you become dizzy or feel weak, tell your doctor straight away.

If you forget to take Silodosin Recordati

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

If you stop taking Silodosin Recordati

If you stop treatment, your symptoms may re- appear.

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

❗ 4. P ossible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

28 Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty in breathing, feeling faint, itchy skin or hives since the consequences could become serious.

The most common side effect is a decrease in the amount of semen released during sex. This effect disappears after discontinuation of Silodosin Recordati. Please inform your doctor if you are planning to have children.

Dizziness , including dizziness when standing up, and occasionally fainting , may occur.

If you do feel weak or dizzy, make sure you sit or lie down straight away until the symptoms have disappeared. If dizziness when standing up or fainting occurs, please inform your doctor as soon as possible.

Silodosin Recordati may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “ Warnings and precautions ”).

It is important that you immediately inform your eye specialist if you are using or have previously used Silodosin Recordati.

The possible side effects are listed below:

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

• Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings and precautions”)

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

• Dizziness, including dizziness when standing up (see also above, in this section)
• Runny or blocked nose
• Diarrhoea

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

• Decreased sexual drive
• Nausea
• Dry mouth
• Difficulties in getting or keeping an erection
• Faster heart rate
• Symptoms of allergic reaction affecting the skin like rash , itching , hives and rash caused by a medicine
• Abnormal results of liver function tests
• Low blood pressure

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

• Fast or irregular heart beats (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 )

• Floppy pupil during cataract surgery ( see also above, in this section ) If you feel that your sexual life is affected, please 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 via the national reporting system 29 listed in Appendix V . By reporting si de effects you can help provide more information on the safety of this medicine.

🌡️ 5. H ow to store Silodosin 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 carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Store in the original package in order to protect from light and moisture.

Do not use this medicine if you notice that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use . These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Silodosin Recordati contains

Silodosin Recordati 8 mg The active substance is silodosin. Each capsule contains 8 mg of silodosin.

The other ingredients are pregelatini sed maize starch, mannitol (E421), magnesium stearate, sodium laurilsulf ate, gelatin and titanium dioxide (E171). P lease refer to section 2 “Silodosin Recordati contains sodium”.

Silodosin Recordati 4 mg The active substance is silodosin. Each capsule contains 4 mg of silodosin.

The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate gelatin, titanium dioxide (E171), and yellow iron oxide (E172). P lease refer to section 2 “Silodosin Recordati contains sodium ”.

What Silodosin Recordati looks like and contents of the pack

Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules , size 0 (approximately 21.7 x 7.6 mm) .

Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules , size 3 (approximately 15.9 x 5.8 mm) .

Silodosin 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 30 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 any information about this medicine, please 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 31 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

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Silodosin Recordati (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/18/1343).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.