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.
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Carmil XL contains a medicine called isosorbide mononitrate. This belongs to a group of medicines called 'nitrates'. ¢ tis used to prevent chest pain (angina). ¢ – Itworks by making the blood vessels relax and widen. This makes it easier for the heart to pump blood around the body.
e Carmil XL Tablets Do not take Carmil XL Tablets: « If you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients in the tablets (see Section 6 and end of Section 2). ¢ If you suffer from a condition called constrictive pericarditis (inflammation of the lining around the heart), or cardiac tamponade (where the fluid around the heart puts pressure on the heart). ¢ Ifyou are having a heart attack (acute myocardial infarction) ¢ Ifyou suffer from very low blood pressure (hypotension) ¢ If you suffer from a condition called aortic stenosis (narrowing of the main artery coming from the heart). ee you suffer from a condition called mitral stenosis (narrowing of the mitral valve on the left side the heart). ¢ If you suffer from a condition called hypertrophic cardiomyopathy (a heart disease which causes the heart muscle to become thick and can cause symptoms such as chest pain, dizziness and collapse). ¢ If you suffer from a condition which can increase the pressure on the brain e.g. a recent serious head injury and bleeding into the brain (cerebral haemorrhage). ¢ Ifyou suffer from severe anaemia (reduction in the number of red blood cells) if you suffer from closed angle glaucoma (a condition which can causes sudden attack of eye pain due to rapid increases in eye pressure, with symptoms such as blurred vision, painful red eye and headache)
Artwork Same Size Size : 280 x 180 mm
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lf you are taking any medicines for erectile problems, such as Viagra (Sildenafil), which belong to a group of medicines called phosphodiesterase type 5 inhibitors (see section 'Other Medicines and Carmil XL Tablets'). ¢ Ifyou are in the first three months of pregnancy Do not take Carmil XL Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carmil XL tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Carmil XL Tablets if you. e you ever had any serious damage to your heart, such as a heart attack or operation. suffer from liver or kidney disease suffer from hypothyroidism (underactive thyroid gland) suffer from hypothermia (very low body temperature) suffer from malnutrition (severe lack of food) ¢ drink alcohol – alcohol should be avoided during treatment with Carmil XL Tablets. If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Carmil XL Tablets. Reminder This medicine should not be used to treat a sudden angina attack. Your doctor should prescribe (GTN) glyceryl trinitrate (tablets or spray) if you have a sudden angina attack. Carmil XL Tablets is used to prevent attacks of angina, and should be used regularly, as prescribed by the doctor. Other Medicines and Carmil XL Tablets Tell you 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 Carmil XL tablets can affect the way some medicines work and some medicines can have an effect on Carmil XL tablets. Do not take Carmil XL tablets if you are taking the following medicines: * medicines which reduce blood pressure such as:
angiotensin II receptor antagonists, e.g. candesartan Sildenafil or similar medicines called phosphodiesterase Type 5 inhibitors, (used for male impotence).
intolerance to some sugars before taking these tablets. 3.
Howto take Carmil XL Tablets
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 easierto swallow). ¢ Take the tablets with half a glass of water. ¢ Donotcrush or chew the tablets. How much to take Adults: The recommended dose is one tablet taken once daily in the morning. This may be increased to two tablets on the advice of your doctor, in which case both tablets should be taken once daily in the morning. Treatment is sometimes started for the first 2-4 days, with 30mg tablet once daily in the morning in order to minimise the possibility of headache. The score line on the tablet is not intended to divide the tablet into equal halves. Elderly: The usual dose is the same as the adult dose. Children: Not recommended for use in children.
You must not take Carmil XL for a sudden attack of angina. If you have a sudden attack, take a glyceryI 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. If you take more Carmil XL Tablets than you should If you (or someone else) swallow a lot of tablets at the same time, or you think a child has swallowed any of these tablets, contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and your tablets with you. The symptoms of an overdose may be pulsing headache, reddening of the skin, cold perspiration, nausea, vomiting and a fast heart beat. If you forget to take Carmil XL Tablets ¢ If you forgot a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. ¢« Donottake a double dose to make up fora forgotten dose. If you stop taking Carmil XL Tablets Do not stop taking your tablets without first discussing this with your doctor as this may be armful. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
tke all medicines, this medicine can cause side effects, although not everybody gets em. The following side effects may happen with this medicine: e Headache * Feeling sick (nausea) ¢ Feeling dizzy The above problem usually disappear with time. Other possible side effects: Common (may affect up to 1 in 10 people)
Low blood pressure (this may make you feel faint or dizzy) Faster heartbeat (tachycardia) 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 e Rash ¢ – Itchy skin Very rare (may affect up to 1 in 10,000 people) e« Paininmuscles 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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
Howtostore Carmil XL Tablets
Keep this medicine out of the sight and reach of children. Store your tablets in the original package. Do not store above 25°C Do not use your medicine after the expiry date shown on the carton. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Carmil XL Tablets contain Each tablet contains 60mg of the active ingredient isosorbide-5-mononitrate. The other substances are lactose monohydrate, hypromellose, maize starch, glyceryl palmitostearate and magnesium stearate. What Carmil XL Tablets looks like and contents of the pack The tablets are white, capsule shaped,
biconvex and
uncoated
with scoring. They are
supplied in carton containing two strip of blister packs – each strip containing 14 tablets per carton) Marketing Authorization Holder and Manufacturer Milpharm Limited,
Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom This leaflet was last revised in 10/2023. Code: PB/Drugs/1802-OSP
tablets (28
Carmil XL 60 mg 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.
The active substance in Carmil XL 60 mg Tablets is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: Imdur Tablets 60mg, 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 Carmil XL 60 mg Tablets, 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: Monomil XL/Carmil XL tablets (one tablet) given once daily 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 the treatment with 30mg for the first 2 – 4 days.
The score line on the tablet is not intended to divide the tablet into equal halves.
Paediatric population:
The safety and efficacy of Monomil XL/Carmil XL tablets in children has not been established.
Elderly:
No evidence of a 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 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
Monomil XL/Carmil XL tablets must not be chewed or crushed. They should be swallowed whole with a small amount 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 Monomil XL/Carmil XL tablets must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil).
Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Monomil XL/Carmil XL tablets.
Monomil XL/Carmil XL tablets are not indicated for the relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
Monomil XL/Carmil XL tablets contains lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concomitant administration of Monomil XL/Carmil XL tablets and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Monomil XL/Carmil XL tablets with the potential result of serious side effects such as syncope or myocardial infarction. Therefore, Monomil XL/Carmil XL tablets and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.
The safety and efficacy of Monomil XL/Carmil XL tablets during pregnancy or lactation has not been established.
Patients may develop dizziness when first using Monomil XL/Carmil XL tablets. Patients should be advised to determine how they react to Monomil XL/Carmil XL tablets 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. 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 products 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in thr Google Play or Apple App Store.
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 the legs raised. If necessary fluids should be administered intravenously.
Ask anything about Carmil XL 60 mg 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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