Silodosin: package leaflet

What Silodyx is

Silodyx belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Silodyx 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 Silodyx is used for

Silodyx 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.

Do not take Silodyx

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 Silodyx

• 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

used Silodyx. 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 taking Silodyx when undergoing cataract surgery.

- If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodyx.
Dizziness when standing up and occasionally fainting may occur when taking Silodyx, 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 Silodyx, 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 Silodyx with caution and possibly with a lower dose (see section 3 “Dose”).
If you have severe kidney problems, you should not take Silodyx.

• Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Silodyx. Silodyx does not treat prostate cancer.

The treatment with Silodyx 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 Silodyx. Please inform your doctor if you are planning to have children.

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

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 Silodyx

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 alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodyx.
- 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 Silodyx.
- medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodyx might lead to a slight decrease in blood pressure.
- medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodyx may be reduced.

Pregnancy and breast-feeding

Silodyx is not intended for use by women.

Fertilty

Urorec 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.

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

The recommended dose is one capsule of Silodyx 8 mg per day by oral administration.

Take the capsule always with food, preferably at the same time every day. Do not break 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 this purpose 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 become dizzy or feel weak, tell your doctor straight away.

If you forget to take Silodyx

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 Silodyx

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.

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 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 Silodyx. 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.

Silodyx 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 Silodyx.

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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Silodyx contains

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

The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).

Silodyx 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), yellow iron oxide (E172).

What Silodyx looks like and contents of the pack

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 multipacks comprising 2 cartons, each containing 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
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 bv
Tél/Tel: +32 2 461 01 36
Lietuva
Recordati Ireland Ltd.
Tel: + 353 21 4379400

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

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

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

Eesti
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Norge
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111

Österreich
Recordati Ireland Ltd.
Tel: + 353 21 4379400

España
Almirall, S.A.
Tel: +34 93 291 30 00

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

France
ZAMBON France
Tél: + 33 (0)1 58 04 41 41

Portugal
Tecnimede Sociedade
Técnico-Medicinal, S.A
Tel: +351 21 041 41 00

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

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
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601

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

This leaflet was last revised in {MM/YYYY}.

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

What Urorec is

Urorec belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Urorec 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 Urorec is used for

Urorec 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.

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 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

used Urorec. 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 taking Urorec when undergoing cataract surgery.

- If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Urorec.
Dizziness when standing up and occasionally fainting may occur when taking Urorec, 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 Urorec, 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 Urorec with caution and possibly with a lower dose (see section 3 “Dose”).
If you have severe kidney problems, you should not take Urorec.

• Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Urorec. Urorec does not treat prostate cancer.

• The treatment with Urorec 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 Urorec. Please inform your doctor if you are planning to have children.

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

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 Urorec

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 alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec.
- 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 Urorec.
- medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Urorec might lead to a slight decrease in blood pressure.
- medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Urorec may be reduced.

Pregnancy and breast-feeding

Urorec is not intended for use by women.

Fertility

Urorec 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.

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

The recommended dose is one capsule of Urorec 8 mg per day by oral administration.

Take the capsule always with food, preferably at the same time every day. Do not break 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 this purpose 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 become dizzy or feel weak, tell your doctor straight away.

If you forget to take Urorec

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 Urorec

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.

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 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 Urorec. 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.

Urorec 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 Urorec.

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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Urorec contains

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

The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).

Urorec 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), yellow iron oxide (E172).

What Urorec looks like 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 Authorisation Holder

Recordati Ireland Ltd.
Raheens East
Ringaskiddy Co. Cork
Ireland

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

България
Recordati Bulgaria Ltd.
Тел.: + 359 2 829 39 37

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

Norge
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

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

Österreich
Recordati Austria GmbH
Tel: + 43 664 128 4879

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
Altamedics d.o.o.
Tel: +385 1 3702 860

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
SwanMedica Oy
Puh/Tel: +358 17 3690033
Κύπρος
G.C. Papaloisou Ltd.
Τηλ: + 357 22 49 03 05

Sverige
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Latvija
Recordati Polska sp. z o.o.
Tel: +48 22 206 84 50

This leaflet was last revised in {MM/YYYY}.

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