Author: Recordati Ireland Ltd.


Long information

What is it and how is it used?

What Silodyx is

Silodyx belongs to a group of medicines called alpha 1A-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 male patients 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.
Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do NOT take Silodyx

  • You must not take Silodyx if you are allergic (hypersensitive) to silodosin or any of the other ingredients of this medicine.
Take special care with 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.
  • Silodyx is not recommended for use in patients aged below 18 years since there is no relevant indication for this age group.
Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

Taking Silodyx with food and drink

Take Silodyx always with food (see section 3 ?When and how to take Silodyx?).

Driving and using machines

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

How is it used?

Always use Silodyx exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dose

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

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.

When and how to take Silodyx

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.

If you use 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 use 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 using Silodyx

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

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

What are possible side effects?

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

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 aspossible.

Silodyx may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section ?Take special care with Silodyx?).
It is important that you immediately inform your eye specialist if you are using or have previously used Silodyx.

The frequency of possible side effects listed below is defined using the following convention:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Not known frequency cannot be estimated from the available data

Very common side effects

  • Abnormal ejaculation (less or no noticeable semen is released during sex, see section ?Take special care with Silodyx?)
Common side effects

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

  • Decreased sexual drive
  • Nausea
  • Dry mouth
  • Difficulties in getting or keeping an erection
Not known

  • Floppy pupil during cataract surgery (see also above, in this section)
  • Fainting

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you feel that your sexual life is affected, please tell your doctor.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Silodyx 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 any Silodyx pack that is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

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.

Silodyx 4 mg are yellow, opaque, hard gelatin capsules.

Silodyx 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 Milan
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien ZAMBON nv-sa Tel 32 2 777 02 00 LuxembourgLuxemburg ZAMBON nv-sa Tel 32 2 777 02 00 Recordati Ireland Ltd. Tel 353 21 4379400 Magyarország Recordati Ireland Ltd. Tel 353 21 4379400 eská republika Recordati Ireland Ltd. Tel 353 21 4379400 Malta Recordati Ireland Ltd. Tel 353 21 4379400 Danmark Recordati Ireland Ltd. Tel 353 21 4379400 Nederland Zambon Nederland B.V. Tel 31 33 4504370 Deutschland Recordati Ireland Ltd. Tel 353 21 4379400 Norge Recordati Ireland Ltd. Tel 353 21 4379400

Eesti Recordati Ireland Ltd. Tel 353 21 4379400 Österreich Recordati Ireland Ltd. Tel 353 21 4379400 .. Tel 30 210 8009111 Polska Recordati Ireland Ltd. Tel 353 21 4379400 España Almirall, S.A. Tel 34 93 291 30 00 Portugal Nycomed Portugal - Produtos Farmacêuticos, Lda.Tel 351 214 460 200 France ZAMBON France Tel 33 01 58 04 41 41 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. Tel 353 21 4379400 Slovenská republika Recordati Ireland Ltd. Tel 353 21 4379400 Italia Nycomed S.p.A. Tel 39 02 641601 SuomiFinland Recordati Ireland Ltd. Tel 353 21 4379400 Recordati Ireland Ltd. Tel 353 21 4379400 Sverige Recordati Ireland Ltd. Tel 353 21 4379400 Latvija Recordati Ireland Ltd. Tel 353 21 4379400 United Kingdom Recordati Ireland Ltd. Tel 353 21 4379400 Lietuva Recordati Ireland Ltd. Tel 353 21 4379400

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

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