Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for Imdur contains a medicine called isosorbide mononitrate. This belongs to a group of medicines called 'nitrates'.
It is used to prevent chest pain (angina). It works by making the blood vessels relax and widen. This makes it easier for the heart to pump blood around the body.
The tablets are made so that they release the medicine slowly over a number of hours.
e Imdur Do not take Imdur: If you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in section 6). If you have ever had a stroke. If you have very low blood pressure. If you have severe anaemia. If you have a heart problem called 'cardiomyopathy' or 'pericarditis' or you have narrow heart valves. If you are taking sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, (used for male impotence). See the section "Other medicines and Imdur". Do not take Imdur if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Imdur. Warnings and precautions Talk to your doctor or pharmacist before taking Imdur if: You have ever had any serious damage to your heart, such as a heart attack or operation. If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Imdur. Other medicines and Imdur Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Imdur can affect the way some medicines work and some medicines can have an effect on Imdur. Page 1 of 4
Do not take Imdur if you are taking the following medicines: Sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, (used for male impotence). Do not take Imdur if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Imdur. Pregnancy, breast-feeding and fertility 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 You may feel dizzy after taking Imdur. If this happens, do not drive or use any tools or machines.
Imdur Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine Swallow the tablets whole or broken in half (if this is easier to swallow). Take the tablets with half a glass of water. Do not crush or chew the tablets. How much to take The recommended dose is one or two tablets a day. Take the medicine in the morning. Your doctor may ask you to start on a low dose so that you are less likely to have a reaction to starting Imdur. The blister strips are marked with the days of the week. If you are taking two tablets a day, make sure you take one tablet from each strip marked with the same day of the week. You must not take Imdur for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label). Very occasionally, some people see the remains of the tablet in their bowel motions. This is quite normal and does not mean that the medicine has not been released. Use in children Do not give these tablets to children. If you take more Imdur than you should If you take more Imdur than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the tablets can be identified. If you forget to take Imdur If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Headaches. Feeling sick (nausea). Feeling dizzy. The above problems usually disappear with time. Other possible side effects: Page 2 of 4
Common (may affect up to 1 in 10 people) Low blood pressure. This may make you feel faint or dizzy. Faster heartbeat Headache Feeling dizzy Feeling sick (nausea). Uncommon (may affect up to 1 in 100 people) Being sick (vomiting) Diarrhoea Rare (may affect up to 1 in 1,000 people) Fainting Rash Itchy skin Very rare (may affect up to 1 in 10,000 people)
Pain in muscles
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 directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5.
Imdur Keep this medicine out of the sight and reach of children. Do not store above 30°C. Do not use this medicine after the expiry date which is stated on the carton. 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.
What Imdur contains The active substance is isosorbide mononitrate. Each tablet contains 60 mg of the active substance. The other ingredients are aluminium silicate, paraffin special, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol, titanium dioxide and iron oxide. What Imdur looks like and contents of the pack Imdur Tablets 60 mg are yellow, and come in blister strips containing 7 tablets, which have the days of the week shown. A pack may contain either 7, 14, 28 or 98 tablets as multiples of the 7 tablet blister strip. Imdur Tablets 60 mg may also come in glass bottles of 100 tablets. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Imdur Tablets 60 mg is held by TopRidge Pharma (Ireland) Limited, 6-9 Trinity Street, Dublin 2, Ireland. Imdur Tablets 60 mg are manufactured by AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
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To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Reference number
Imdur Tablets 60 mg PL 46500/0002
This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in August 2017
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Imdur Tablets 60mg 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.
The active substance in Imdur Tablets 60mg is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: Carmil XL 60 mg Tablets, Isotard 60 mg XL Tablets, 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.
This leaflet reproduces the patient information leaflet approved for Imdur Tablets 60mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Prophylactic treatment of angina pectoris.
Posology
Adults
Imdur 60mg (one tablet) once daily given in the morning. The dose may be increased to 120mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated to minimise the possibility of headache, by initiating treatment with 30mg (half a tablet) for the first 2-4 days.
Paediatric population
The safety and efficacy of Imdur in children has not yet been established.
Older people
No evidence of a need for routine dosage adjustment in older people has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
The core of the tablet is insoluble in the digestive juices but disintegrates into small particles when all active substance has been released. Very occasionally the matrix may pass through the gastrointestinal tract without disintegrating and be found visible in the stool, but all active substance has been released.
Method of administration
Imdur Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Constrictive cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia.
Patients treated with Imdur must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil).
Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Imdur.
Imdur is not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
Concomitant administration of Imdur and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Imdur with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, Imdur and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.
The safety and efficacy of Imdur during pregnancy or lactation has not been established.
Patients may develop dizziness when first using Imdur. Patients should be advised to determine how they react to Imdur before they drive or operate machinery.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated, but usually disappears after 1-2 weeks of treatment. The dose can be titrated to minimise the possibility of headache, by initiating treatment with 30mg. Hypotension, with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
The following definitions of frequencies are used: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very Rare (<1/10,000).
Adverse drug reactions by frequency and system organ class (SOC)
System Organ Class
Frequency
Reaction
Nervous system disorders
Common
Headache, dizziness
Rare
Fainting
Cardiac and vascular disorders
Common
Hypotension, tachycardia
Gastrointestinal disorders
Common
Nausea
Uncommon
Vomiting, diarrhoea
Skin and subcutaneous tissue disorders
Rare
Rash, pruritus
Musculoskeletal and connective tissue disorders
Very rare
Myalgia
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.
Symptoms
Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.
Management
Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary fluids should be administered intravenously.
Ask anything about Imdur Tablets 60mg. 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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