Isotard 60 mg XL Tablets

• 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.

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

• 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

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.

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.

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.

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.

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.

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.

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: Website: www.mhra.gov.uk/yellowcard.

• 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).

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.