Skip to Content

ISOTARD 25 MG XL TABLETS

Active substance: ISOSORBIDE 5-MONONITRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the Patient

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 because it contains important
information for you
• 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 only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Isotard XL is and what it is used for
2. What you need to know before you take Isotard XL
3. How to take Isotard XL
4. Possible side effects
5. How to store Isotard XL
6. Contents of the pack and other information

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

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

2. What you need to know before you take Isotard XL

Do not take Isotard XL:
• if you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in section 6)
• 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 are taking riociguat e.g. Adempas for pulmonary hypertension
• 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

Warnings and precautions
Talk to your doctor or pharmacist before taking Isotard XL:
• if you suffer from malnutrition
• if you suffer from hypothermia (body temperature which is lower than normal)
• if you are pregnant, think you might be pregnant, considering becoming pregnant or are breast feeding
• if you have severe liver or kidney disease
• if your thyroid gland is underactive or you are taking thyroxine
• if you have recently suffered from a heart attack
• if 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.
Other medicines and Isotard XL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 riociguat, e.g. Adempas for pulmonary hypertension. When taken
together a fall in blood pressure can occur.
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.
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 with alcohol
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.
Pregnancy and breast-feeding
In pregnancy or when breast feeding, Isotard XL should only be used under medical supervision. If you are
pregnant or breast‑feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this 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.
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 this medicine exactly as your doctor has told you. 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 and the elderly - 1 or 2 tablets daily, ideally in the morning. Swallow Isotard XL tablets whole with
water. Do not crush or chew.
Children - Isotard XL must not be given to children.
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.
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.
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 medicine, 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 weeks.
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.

5. How to store Isotard XL





Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton label after EXP. The expiry
date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Isotard XL contains
- The active substance is isosorbide-5-mononitrate (each tablet contains 25, 40, 50 or 60 mg of the
active substance).
- The other ingredients are 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).
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.
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.
Marketing Authorisation Holder:
ProStrakan Limited
Galabank Business Park
Galashiels
Scotland, TD1 1QH
Manufacturers:
AndersonBrecon (UK) Ltd.
Wye Valley Business Park
Hay-on-Wye
Hereford
United Kingdom, HR3 5PG
This leaflet was last revised in 03/2015
LFT-ISO-GB-001

Expand view ⇕

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.

Hide