PACKAGE LEAFLET: INFORMATION FOR THE USER

Cositam XL 400 microgram prolonged-release tablets

tamsulosin hydrochloride

In this leaflet:

1.    What Cositam XL is and what it is used for

2.    Before you take Cositam XL

3.    How to take Cositam XL

4.    Possible side effects

5.    How to store Cositam XL

6.    Further information

1. WHAT COSITAM XL IS AND WHAT IT IS USED FOR

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing these muscles, tamsulosin lets urine pass more readily and helps urination. In addition, it diminishes sensations of urge.

Tamsulosin is prescribed in men to alleviate urinary symptoms caused by an enlarged prostrate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day.

2. BEFORE YOU TAKE COSITAM XL

Do not take Cositam XL if you:

•    are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Cositam XL. Hypersensitivity may present as a sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficult in breathing and/or itching and rash (angioedema).

•    have a history of a fall in blood pressure on standing up, which causes dizziness, light-headedness or fainting.

•    have severe liver problems.

Take special care with Cositam XL if you:

•    experience dizziness or light-headedness, especially after standing up. Cositam XL may lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms have gone.

•    suffer from severe kidney problems, tell your doctor.

•    are undergoing eye surgery because of cloudiness of the lens (cataract). An eye condition called Intraoperative Floppy Iris Syndrome may occur (see section 4, Possible side effects). Please inform your eye specialist that you are using or have previously used tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.

Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.

You may observe a remnant of the tablet in your faeces. Since the active ingredient of the tablet has already been released, there is no risk of the tablet being less effective.

Taking other medicines

Other medicines may be affected by Cositam XL or in turn may affect how well it works.

Cositam XL can interact with:

•    diclofenac, a pain killer and anti-inflammatory medicine. This medicine can speed up the removal of Cositam XL from your body, thereby shortening the time Cositam XL is effective.

•    warfarin, a medicine to prevent blood clotting. This medicine can speed up the removal of Cositam XL from your body, thereby shortening the time Cositam XL is effective.

•    another OC_1A-adrenoreceptor blocker. The combination may lower your blood pressure, causing dizziness or lightheadedness.

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

Taking Cositam XL with food and drink

Cositam XL can be taken with or without food.

Driving and using machines

There is no evidence that Cositam XL affects the ability to drive and use machines. You should take into account that Cositam XL may cause dizziness and light-headedness. Only drive or use machines if you feel alright.

3. HOW TO TAKE COSITAM XL

Always take Cositam XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet per day. You can take Cositam XL with or without food, preferably at the same time each day.

Swallow the tablet whole. It is important that you do not crunch or chew the tablet as this may influence how well Cositam XL works.

Cositam XL is not intended for use in children.

If you take more Cositam XL than you should

Your blood pressure may suddenly drop if you take more Cositam XL than you should. You may experience dizziness, weakness, vomiting, diarrhoea and fainting. Lie down to minimise the effects of low blood pressure and then contact your doctor.

If you forget to take Cositam XL

You may take your daily Cositam XL tablet later the same day if you have forgotten to take it as recommended. If you have missed a day, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cositam XL

When treatment with Cositam XL is stopped prematurely, your original complaints may return. Therefore use Cositam XL for as long as your doctor prescribes, even if your complaints have already disappeared . Always consult your doctor, if you consider stopping this therapy.

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

4. POSSIBLE SIDE EFFECTS

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

Serious reactions are rare. Contact your doctor immediately if you experience a serious allergic reaction which causes swelling of the face or throat

(angioedema).

Common (affects 1 to 10 users in 100)

•    Dizziness

•    Ejaculation disorders

Uncommon (affects 1 to 10 users in 1,000)

•    Headache

•    Feeling your heart beat (palpitations)

•    a Fall in blood pressure on standing up, which causes dizziness, light-headedness or fainting (orthostatic hypotension)

•    Swelling and irritation inside the nose (rhinitis)

•    Constipation

•    Diarrhoea

•    Feeling sick (nausea)

•    Vomiting

•    Rash

•    Itching

•    Hives (urticaria)

•    Feeling of weakness (asthenia)

Rare (affects 1 to 10 users in 10,000)

•    Fainting (syncope)

Very rare (affects less than 1 user in 10,000)

•    Painful erection (priapism)

•    Serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

Not known (frequency cannot be estimated from the available data)

•    Abnormal heart rhythm

•    Irregular heart beat

•    Faster heart beat

•    Difficulty in breathing

During eye surgery a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery. For more information see section 2, Take special care.

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

5. HOW TO STORE COSITAM XL

Keep out of the reach and sight of children.

Do not use Cositam XL after the expiry date which is stated on the packaging after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.

Store in the original package to protect from light.

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.

6. FURTHER INFORMATION

What Cositam XL contains

•    The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 400 micrograms tamsulosin hydrochloride, equivalent to 367 micrograms tamsulosin.

•    The other ingredients are:

Inner tablet: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, iron oxide red (E172), magnesium stearate

Outer tablet: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate

What Cositam XL looks like and contents of the pack

White, round tablets with the inscription “T9SL” on one side and “0.4” on the other side.

They are supplied in blister packs of 10,18,20, 28,30,50, 60,90,98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Synthon BV,

Microweg 22,6545 CM Nijmegen, The Netherlands.

Manufacturer: Synthon BV,

Microweg 22,6545 CM Nijmegen, The Netherlands.

Distributed by: Consilient Health (UK) Ltd,

500 Chiswick High Road, London, W4 5RG.

This leaflet was last revised in June 2012