ISOTARD 25 MG XL TABLETS

Active substance: ISOSORBIDE 5-MONONITRATE

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Patient Information Leaflet

Isotard 25 mg XL® Tablets
Isotard 40 mg XL® Tablets
Isotard 50 mg XL® Tablets
Isotard 60 mg XL® Tablets
Isosorbide mononitrate

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 further questions, please 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 Isotard XL is and what it is used for
2. Before you take Isotard XL
3. How to take Isotard XL
4. Possible side effects
5. How to store Isotard XL
6. Further information

Take special care with Isotard XL:
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
Isotard XL 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 Isotard XL should be
tapered gradually.
Taking other medicines with Isotard XL
Isotard XL 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 Isotard XL 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.

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

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

Isotard XL prolonged release tablets are used to prevent attacks of angina (chest pain). Isotard XL works
by opening up blood vessels and reducing the pain.

Taking Isotard XL 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 light-headed if you
stand up or move suddenly.

Isotard tablets contain the active substance isosorbide mononitrate (ISMN). ISMN belongs to a group of
medicines called organic nitrates.

2. Before you take Isotard XL

Do not take Isotard XL if:
• you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients in Isotard XL
prolonged release tablets (see Section 6 Further Information)
• 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
• you are taking sildenafil or similar products e.g. Viagra for male erectile dysfunction
• you have been diagnosed with any of the following: hypertrophic obstructive cardiomyopathy (HOCM),
constrictive pericarditis, cardiac tamponade or aortic/mitral valve stenosis
• you have very low iron levels in your blood (severe anaemia)
• you suffer from high pressure in the eye (closed angle glaucoma)
• you have low blood pressure

Pregnancy and breast-feeding
In pregnancy or when breast feeding, Isotard XL should only be used under medical supervision. Ask your
doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or operate machinery when taking Isotard XL if you develop low blood pressure (you may
experience this as dizziness, tiredness or feeling sick) or if you have blurred vision.
Important information about some of the ingredients of Isotard XL
Isotard XL contains lactose, which is a type of sugar. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking Isotard XL.

3. How to take Isotard XL

Always take Isotard XL exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
Very occasionally, some people see the remains of the tablet in their bowel motions. This is quite normal
and does not mean the medicine has not been released.
Adults, elderly, children and adolescents 12 years of age and over - 1 or 2 tablets daily, ideally in the
morning. Swallow Isotard XL tablets whole with water. Do not crush or chew.

6. Further information

What Isotard XL contains
Each tablet contains 25, 40, 50 or 60 mg isosorbide-5-mononitrate. It also contains macrogol,
hypromellose, stearic acid, talc, silica colloidal anhydrous, lactose monohydrate, carnauba wax,
magnesium stearate and the colourings titanium dioxide (E171) and yellow iron oxide (E172).

Children under 12 - Isotard XL must not be given to children under 12 years.

What Isotard XL looks like and contents of the pack
Isotard 25 mg XL, 40 mg XL and 50 mg XL tablets are round and cream in colour with ‘IM25’, ‘IM40’
and ‘IM50’ respectively on one side.

If you take more Isotard XL than you should - You should only take what your doctor recommends. If you
take too many Isotard XL tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest
hospital casualty department immediately, taking the Isotard XL pack and remaining tablets with you.

Isotard 60 mg XL tablets are oval and cream in colour with a score line on both sides and ‘60’
on one side.
Isotard XL tablets are provided in packs of 28.

If you have taken more Isotard XL than you should, symptoms may include nausea, vomiting, restlessness,
confusion, warm flushed skin, blurred vision, headache, fainting, fast heart beats and palpitations.

Marketing Authorisation Holder:
ProStrakan Limited
Galabank Business Park
Galashiels
Scotland, TD1 1QH

If you forget to take Isotard XL - If you forget to take your tablet, take it as soon as possible and continue
to take the tablets as normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Isotard XL -Angina is a condition which may need treatment for life, always talk to your
doctor or pharmacist before stopping using Isotard XL.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Isotard XL can cause side effects, although not everybody gets them.
• Headaches may occur when treatment is first started but usually disappear after 1 to 2 eeks.
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• Low blood pressure may occasionally occur (you may experience this as dizziness, faintness on
standing, tiredness and feeling sick).
• More rarely, becoming flushed and allergic reactions (including rashes) can occur.
• Increased and decreased heart rate have also been reported.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Isotard XL







Keep out of the reach and sight of children.
Do not store above 25oC.
Store in the original package.
Do not use Isotard XL after the expiry date which is printed on the carton label has passed.
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.

Manufacturers:

Anderson Brecon (UK) Ltd.
Wye Valley Business Park
Hay-on-Wye
Hereford
United Kingdom, HR3 5PG
This leaflet was last revised in 08/2012

PG2367

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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