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PACKAGE LEAFLET: INFORMATION FOR THE USER

Talk to your doctor before taking this product if any of the above applies to you.

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Pinexel PR 400 micrograms Prolonged-Release Hard Capsules Tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

- Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your doctor or nurse.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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.

The name of your medicine is Pinexel PR 400 micrograms Prolonged-Release Hard Capsules. In the rest of this leaflet it is called Pinexel PR Capsules.

In this leaflet:

1.    What Pinexel PR Capsules are and what they are used for

2.    Before you take Pinexel PR Capsules

3.    How to take Pinexel PR Capsules

4.    Possible side effects

5.    How to store Pinexel PR Capsules

6.    Further information

1. WHAT PINEXEL PR CAPSULES ARE AND WHAT THEY ARE USED FOR

The active substance in Pinexel PR Capsules is tamsulosin (as hydrochloride), which belongs to a group of medicines called alpha-blockers (alpha-adrenoreceptor antagonists). Tamsulosin is used for the treatment of urination symptoms caused by benign prostatic hyperplasia (BPH).

BPH means that the prostate gland enlarges (hypertrophy) but the growth is not cancerous (it is benign).

The prostate gland is just underneath the bladder. The urethra (the tube through which urine passes from the bladder to the outside of the body) runs through the prostate gland. If the prostate enlarges, it presses on the urethra, causing it to narrow. This makes it difficult to pass urine.

Pinexel PR Capsules relax the muscle of the prostate gland widening the urethra and so ease the passing of urine.

2. BEFORE YOU TAKE PINEXEL PR CAPSULES

Do not take Pinexel PR Capsules if:

•    you are allergic to tamsulosin hydrochloride, or any of the other ingredients of Pinexel PR Capsules (see list under ‘What Pinexel PR Capsules contain’ in section 6). Hypersensitivity can express itself as sudden swelling of face, hands and feet, difficulties in breathing and/or itch and rash (angio-oedema).

•    you have experienced dizziness or have fainted due to an abnormal decrease in blood pressure when standing up (orthostatic hypotension)

•    you suffer from severe liver problems.

Take special care with Pinexel PR Capsules if:

•    you suffer from severe kidney problems

•    you are due to have surgery to remove a cataract.

Children

Do not give this medicine to children or adolescent under 18 years because it does not work in this population.

If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking Pinexel PR Capsules and they will decide what to do.

STOP TAKING PINEXEL PR CAPSULES AND CONTACT YOUR DOCTOR OR PHARMACIST IMMEDIATELY IF:

•    you experience dizziness or fainting during the use of Pinexel PR Capsules. Please sit or lie down straight away until the symptoms disappear

•    you experience sudden swelling of face, hands or feet, difficulties in breathing and/or itch and rash, caused by an allergic reaction (angio-oedema) whilst taking Pinexel PR Capsules.

Taking other medicines

Taking other medicines when taking Pinexel PR Capsules can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking.

Do not take any other medicines while you are taking Pinexel PR Capsules unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself without a prescription.

Please check with your doctor if you are taking any of the following (or any other medication):

•    Any medicines which are used to reduce inflammation in the body (anti-inflammatory medicines e.g. ibuprofen).

•    Any medicines used to prevent the clotting of blood (anticoagulants e.g. warfarin).

•    Other medicines used to reduce blood pressure, including anaesthetics and other alpha-blocker (alpha-adrenoceptor antagonists, e.g. doxazosin, prazosin and indoramin).

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start drugs for erectile dysfunction.

If you have any doubts about whether you should be given this medicine, then talk to your doctor.

Pregnancy and breast-feeding

Not applicable as Pinexel PR Capsules are intended for male patients only.

Driving and using machines

Pinexel PR Capsules may cause drowsiness, blurred vision and dizziness. If you are affected you should not drive or operate machinery.

3. HOW TO TAKE PINEXEL PR CAPSULES

Always take Pinexel PR Capsules exactly as your doctor has instructed you to. You should check with your doctor or pharmacist if you are not sure.

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