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PATIENT INFORMATION LEAFLET

Losinate MR 400 microgram modified-release capsules

Tamsulosin hydrochloride

In this leaflet:

1.    What Losinate MR is and what it is used for

2.    Before you take Losinate MR

3.    How to take Losinate MR

4.    Possible side effects

5.    Howto store Losinate MR

6.    Further information

1.    What Losinate MR is and what it is used for

Losinate MR contains tamsulosin which is an alpha1A-adrenoreceptor blocker. It relaxes the muscles in the prostate and urinary tract.

Tamsulosin is prescribed to alleviate urinary symptoms caused by an enlarged prostate. By relaxing the muscle it enables easier passage of urine and helps urination.

2. Before you take Losinate MR

Do not take Losinate MR if you:

•    are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Losinate MR capsules (symptoms may include: swelling of your face and throat).

•    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 Losinate MR if you:

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

•    suffer from severe kidney problems. The normal dose of tamsulosin may not have the expected effect when your kidneys are not functioning normally.

•    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.

Before starting therapy with Losinate MR, your doctor should examine you to confirm your symptoms are truly caused by an enlarged prostate.

Taking other medicines

Other medicines may be affected by tamsulosin. They, in turn, may affect how well tamsulosin works. Tamsulosin can interact with:

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

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

•    another alpha 1A-adrenoreceptor blocker. The

combination may lower your blood pressure, causing dizziness or light-headedness.

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.

Driving and using machines

There is no information on the effects of tamsulosin on the ability to drive and use machines. You should take into account that tamsulosin may cause dizziness and lightheadedness. Only drive or use machines if you feel alright.

3.How to take Losinate MR

Always take Losinate MR 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 capsule per day taken after breakfast or after your first meal of the day.

Swallow the capsule whole with a glass of water, while standing or sitting (not while lying down). It is important that you do not break or crush the capsule as this may influence how well tamsulosin works. If you suffer from mild to moderate kidney or liver disease, you can take the usual dose of tamsulosin.

Tamsulosin is not meant for use in children.

If you take more Losinate MR than you should

Your blood pressure may suddenly drop if you take more tamsulosin than you should. You may experience

dizziness, weakness and fainting, vomiting and diarrhoea. Lie down to minimise the effects of low blood pressure and then contact your doctor. Your doctor may give you medicines to restore your blood pressure and fluid level, and may monitor your body function.

If you forget to take Losinate MR

Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, Losinate MR 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. You should not be restarted on Losinate MR (see Section 2 Do not take Losinate MR).

•    Long lasting and painful erection. This occurs in less than 1 per 10,000 treated patients.

Common (occurring in less than 1 per 10 treated patients)

•    Dizziness

•    Ejaculation disorders

Uncommon (occurring in less than 1 per 100 treated patients)

•    Headache

•    Feeling your heart beat

•    A fall in blood pressure on standing up, which causes dizziness, light-headedness or fainting

•    Swelling and irritation inside the nose

•    Constipation

•    Diarrhoea

•    Feeling sick

•    Vomiting

•    Rash

•    Hives

•    Feeling of weakness

•    Itching

Rare (occurring in less than 1 per 1000 treated patients)

•    Fainting

•    Serious illness with blistering of the skin, mouth, eyes and genitals

Not known (cannot be estimated from the available data) During eye surgery a condition called 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 Losinate MR

Keep out of the reach and sight of children.

Do not use Losinate MR after the expiry date which is stated on the carton and the blister or container 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 the blisters in the original package.

Keep the container tightly closed.

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

6.Further information

What Losinate MR contains

•    The active substance is 400 microgram tamsulosin hydrochloride equivalent to 367 microgram tamsulosin.

•    The other ingredients are:

Capsule: Microcrystalline cellulose, Methacrylic acid-ethyl acrylate copolymer, Polysorbate 80, Sodium laurilsulfate, Triethyl citrate, Talc Capsule body: Gelatine, Indigotine (E 132), Titanium dioxide (E 171), Yellow iron oxide (E 172), Red iron oxide (E 172), Black iron oxide (E 172)

What Losinate MR looks like and contents of the pack

Orange/olive-green modified-release capsule.

The capsules contain white to off-white pellets.

They are supplied in blister packs or containers with 10, 14, 20, 28, 30, 50, 56, 60, 90,100 or 200 modified release capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Kiron Pharmaceutica BV, Sterreschansweg 79, 6522 GM,

Nijmegen, The Netherlands

Manufacturer(s):

Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands or

Synthon Hispania S.L., Castello, Polfgono las Salinas, 08830 Sant Boi de Llobregat, Spain or Quinta-Analytica s.r.o., Prazska 1486/18c,

102 00 Prague 10, Czech Republic.

Distributor:

Aspire Pharma Limited, Antrobus House Business Centre, 18 College Street, Petersfield, Hampshire, GU31 4AD, United Kingdom.

This leaflet was prepared in

06/2013

Aspire

1010097-P4.2    Pharma

Artwork for:	Aspire Pharma Limited
Product name:	Losinate MR 400 microgram modified-release capsules
Size:
PL/PA no:	PL22983/0004
Type:	Leaflet
Artworkdimensions:	240mm x 170mm
Profile supplied:	Yes
Date offirstartwork:	9June 2010
Reason for request:	Textdeletion
Version no:	4.3
Date ofrevision:	21June 2013
Colours:	Asswatch
Font(s):	Text9ptHelveticaCondensed Headings/subheadingsVAG Rounded
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