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Relosorb Xl 60mg Tablets

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Relosorb XL 60mg Tablets

Isosorbide 5-mononitrate



PACKAGE LEAFLET: INFORMATION FOR THE USER


Read all of this leaflet carefully before you start

taking this medicine

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

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

In this leaflet

1.    What Relosorb XL 60mg Tablets are and what they are used for

2.    Before you take Relosorb XL 60mg Tablets

3.    How to take Relosorb XL 60mg Tablets

4.    Possible side effects

5.    How to store Relosorb XL 60mg Tablets

6.    Further information


1.    WHAT RELOSORB XL 60MG TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Relosorb XL 60mg Tablets. Relosorb XL 60mg tablets contain the active ingredient isosorbide mononitrate.

Isosorbide mononitrate is a type of medicine called a nitrate. They work by relaxing the smooth venous muscle. This can help prevent an attack of angina (chest pain).

2.    BEFORE YOU TAKE RELOSORB XL 60MG TABLETS


Do not take Relosorb XL 60mg Tablets

•    If you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients in Relosorb XL 60mg tablets (see Section 6 Further Information)

•    If you suffer from increased intracranial pressure (high pressure within your skull, e.g. from a blow to your head) or cerebral haemorrhage bleeding from a ruptured blood vessel in the brain

•    If you are taking sildenafil or similar products e.g. Viagra for male erectile dysfunction

•    If you have been diagnosed with any of the

following:    hypertrophic obstructive

cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade or aortic/mitral valve stenosis

•    If you have very low iron levels in your blood (severe anaemia)

•    If you suffer from high pressure in the eye (closed angle glaucoma)

•    If you have low blood pressure


Take special care with Relosorb XL 60mg Tablets

Tell your doctor or pharmacist if:

•    you suffer from malnutrition

•    you suffer from hypothermia    (body

temperature which is lower than normal)

•    you are pregnant, think you might be pregnant, considering becoming pregnant or are breast feeding

•    you have severe liver or kidney disease

•    your thyroid gland is underactive or you are taking thyroxine

•    you have recently suffered from a heart attack

•    you are taking any other medication, even those you may have bought for yourself without prescription

Relosorb XL 60mg tablets should not be used for the relief of sudden (acute) attacks of angina. If you have an attack of angina you should speak to your doctor or pharmacist who may supply you with other medicines for this. Treatment with this medicine should not be discontinued suddenly. Withdrawal from Relosorb XL 60mg tablets should be tapered gradually.

Taking other medicines

Relosorb XL 60mg tablets may lower blood pressure (you may experience this as dizziness, tiredness or feeling sick) so take special care when taking other medicines that may also lower blood pressure.

Do not take Relosorb XL 60mg tablets if you are taking sildenafil or similar products, e.g. Viagra for male erectile dysfunction. When taken together a severe and possibly dangerous fall in blood pressure can occur, which may result in collapse, unconsciousness and could be fatal.

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

Taking Relosorb XL 60mg Tablets with food and drink:

You are advised NOT to drink alcohol with this medicine, as the effects of alcohol may become worse. Alcohol may also increase the side effects of this medicine and make you feel dizzy or lightheaded if you stand up or move suddenly.

Pregnancy and breast- feeding

Ask your doctor or pharmacist for advice before taking any medicine.


Driving and using machines

Do not drive or operate machinery when taking Relosorb XL 60mg tablets if you develop low blood pressure (you may experience this as dizziness, tiredness or feeling sick)

Important information about some of the ingredients of Relosorb XL 60mg Tablets

This product contains lactose. If you have been told by your doctor that you have intolerance to some sugars, then contact your doctor before taking this medicinal product.

3. HOW TO TAKE RELOSORB XL 60mg TABLETS

Always take Relosorb XL 60mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets must not be chewed or crushed and should be swallowed whole with half a glass of water.

Adults

The usual dose is one or sometimes two tablets a day taken in the morning. The dose can be titrated to minimise the possibility of a headache by starting treatment with half a tablet for the first 2-4 days.

The Elderly

Usual adult dosage can be given.

Children

These tablets should not be given to children.

Very occasionally some people find that the tablet appears in their bowel motions (faeces).This is quite normal and does not mean that the medicine has not been released.

If you take more Relosorb XL 60mg Tablets than you should.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

Symptoms of an overdose can include:

Headache, excitation, cold sweat, nausea (feeling sick), vomiting (being sick), vertigo (a feeling of dizziness or "spinning"), fainting, racing pulse.

If you forget to take Relosorb XL 60mg Tablets

If you forget to take a dose take it as soon as you remember. However if it is almost time for your next dose, just take the next dose at the usual time. Do not take two doses together.

If you stop taking Relosorb XL 60mg Tablets

Angina is a condition which may need treatment for life, always talk to your doctor or pharmacist before stopping using Relosorb XL 60mg tablets.

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


4. POSSIBLE SIDE EFFECTS


Like all medicines, Relosorb XL 60mg Tablets can cause side effects, although not everybody gets them.

•    Headaches may occur when treatment is first started but usually disappear after I to 2 weeks.

•    Low blood pressure may occasionally occur (you may experience this as dizziness, faintness on standing, tiredness, feeling sick and vomiting).

•    More rarely, becoming flushed and allergic reactions (including rashes) can occur.

•    Increased and decreased neart rate have also been reported.

•    Muscle pain has been reported very rarely.

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 RELOSORB XL 60mg TABLETS


Keep out of the reach and sight of children.

Do not use Relosorb XL 60mg Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

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


6. FURTHER INFORMATION


What Relosorb XL 60mg Tablets contain

•    The    active    substance    is    isosorbide

mononitrate. Each tablet contains 60mg of isosorbide mononitrate.

•    The    other    ingredients    are lactose

monohydrate, hydroxypropylmethyl cellulose, maize starch, glyceryl pafmitostearate and magnesium stearate

What Relosorb XL 60mg Tablets look like and the contents of the pack

Each tablet has a white body with a score line and marked JM1 on one side. Relosorb XL 60mg Tablets are supplied in blister packs of 7, 14, 28 or 98 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 ORR U.K.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DEI2 7DT, U.K.

PL 20395/0039    |POM|

This leaflet was last revised in October 2012.

CRIMN.XL.60T.RC.V3P2