The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: isosorbide mononitrateOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Isotard 60 mg XL Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Isosorbide mononitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Isosorbide mononitrate

Equivalent medicines (same active substance, strength and form)

→ Carmil XL 60 mg Tablets brand

→ Imdur Tablets 60mg brand

→ Monomax XL 60 mg Prolonged Release Tablets brand

→ Monomil XL 60mg Tablets brand

→ Monosorb XL 60mg Prolonged-Release Tablets brand

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

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.

What you need to know before you take it

e 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.

How to take it

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.

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: Website: www.mhra.gov.uk/yellowcard. 5.

How to store it

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.

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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: Kyowa Kirin 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 05/2016

Frequently asked questions about Isotard 60 mg XL Tablets

How do I take Isotard 60 mg XL Tablets?

Isotard 60 mg XL Tablets comes as tablet containing 60mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Isotard 60 mg XL Tablets?

The active substance in Isotard 60 mg XL Tablets is isosorbide mononitrate.

Are there equivalent medicines to Isotard 60 mg XL Tablets?

Medicines with the same active substance, strength and form include: Carmil XL 60 mg Tablets, Imdur Tablets 60mg, Monomax XL 60 mg Prolonged Release Tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Isotard 60 mg XL Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Isotard 60 mg XL Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: isosorbide mononitrate
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Isosorbide mononitrate (28 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Isotard XL is indicated in adults and the elderly for prophylactic treatment of angina pectoris.

4.2. Posology and method of administration

Adults:One tablet, once daily given in the morning. The dose may be increased to two tablets, the whole dose to be given together (dose range 25 to 120 mg).For Isotard 60 mg XL only, the dose can be titrated to minimise the possibility of headache by initiating treatment with half a tablet (30 mg) for the first two to four days. The tablets should not be chewed or crushed and should be swallowed with half a glass of fluid.Children:The safety and efficacy of Isotard XL ISMN prolonged release tablets has not been established.Elderly:No need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.The lowest effective dose should be used.Attenuation of effect (tolerance) has occurred in some patients being treated with prolonged release preparations. In such patients intermittent therapy may be more appropriate (see Section 4.4).Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see Section 4.4).The core of the tablet is insoluble in the digestive juices but disintegrates into small particles when all the active substance has been released. Very occasionally the matrix may pass through the gastrointestinal tract without disintegrating and be found inside the stool, but all active substance has been released.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, aortic/mitral valve stenosis, severe anaemia, closed-angle glaucoma, conditions associated with raised intracerebral pressure e.g. following head trauma, cerebral haemorrhage. Acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse) or very low blood pressure. Phosphodiesterase type-5 inhibitors e.g. sildenafil, tadalafil and vardenafil have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contra-indicated (see section 4.5). Isotard XL should not be given to patients with a known sensitivity to nitrates. Concomitant use with the soluble guanylate cyclase stimulator, riociguat, can cause hypotension and is contraindicated (see section 4.5).

4.4. Special warnings and precautions for use

Isotard XL ISMN prolonged release tablets are not indicated for relief of acute anginal attacks. In the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used. Isotard XL ISMN should be used with caution in patients who have a recent history of myocardial infarction, or who are suffering from hypothyroidism, hypothermia, malnutrition and severe liver or renal disease.The lowest effective dose should be used.Attenuation of effect (tolerance) has occurred in some patients being treated with prolonged release preparations. In such patients intermittent therapy may be more appropriate (see Section 4.2).Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see Section 4.2).Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.Severe postural hypotension with light-headedness and dizziness is frequently observed after the concomitant consumption of alcohol.Isotard XL tablets contain lactose and therefore should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

4.5. Interaction with other medicinal products and other forms of interaction

The hypotensive effect of Isotard XL may be potentiated by the concomitant administration of drugs with hypotensive effects e.g. beta-blockers, diuretics, ACE-inhibitors, calcium channel blockers, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonists and/or alcohol. The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiesterase type-5 inhibitors e.g. sildenafil (see section 4.3). Concomitant use with the soluble guanylate cyclase stimulator, riociguat, can cause hypotension and is contraindicated (see section 4.3).

4.6. Fertility, pregnancy and lactation

No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy. Safety in pregnancy, however, has not been established. It is not known whether nitrates are excreted in human milk and therefore caution should be exercised when administered to nursing women.Isosorbide mononitrate should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards.

4.7. Effects on ability to drive and use machines

The patient should be warned not to drive or operate machinery if hypotension, blurred vision or dizziness occurs.

4.8. Undesirable effects

Throbbing headache may occur when treatment is initiated, but usually disappears after 1–2 weeks of treatment. Hypotension, including postural hypotension, with symptoms such as dizziness, nausea and fatigue has occasionally been reported. Infrequently, flushing and allergic reactions (including rashes) can occur. These symptoms generally disappear during long-term treatment.Tachycardia and paroxysmal bradycardia have been reported. Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Symptoms: Nausea, vomiting, restlessness, warm flushed skin, blurred vision, headache, fainting, tachycardia, hypotension and palpitations. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur.Management: Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse. Correct hypotension by raising the foot of the bed and/or by expanding the intravascular volume. Other measures as indicated by the patient's clinical condition. If severe hypotension persists despite the above measures consider use of inotropes such as dopamine or dobutamine.

💬 Ask about this leaflet

Ask anything about Isotard 60 mg XL Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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