Isosorbide Mononitrate 10Mg, 20Mg and 40Mg Tablets

Package leaflet: Information for the patient

Isosorbide Mononitrate 10mg, 20mg and 40mg tablets

Read all of this leaflet carefully before you - constrictive pericarditis (an inflammation of the heart sac) start taking this medicine because it contains - cardiac tamponade (accumulation of fluid around the heart) important information for you. - low cardiac filling pressures - aortic/mitral valve stenosis (narrowing of heart valves) • Keep this leaflet. You may need to read it again. • suffer from severe anaemia (low level of red blood cells) • If you have any further questions, ask your • suffer from closed angle glaucoma (high pressure in the doctor or pharmacist. eye) • This medicine has been prescribed for you • suffer from conditions associated with raised pressure only. Do not pass it on to others. It may harm on the brain (e.g. following head trauma and cerebral them, even if their signs of illness are the same haemorrhage) • suffer from severe hypovolaemia (decreased blood volume) as yours. • are taking sildenafil, vardenafil or tadalafil used in the • If you get any side effects, talk to your doctor treatment of male erectile dysfunction (when you cannot get or pharmacist. This includes any possible side an erection). effects not listed in this leaflet. See section 4. Warnings and precautions What is in this leaflet: Talk to your doctor or pharmacist before taking Isosorbide 1 What Isosorbide Mononitrate tablets Mononitrate tablets if you: • suffer from hypothyroidism (your thyroid gland does not are and what they are used for produce sufficient amounts of thyroid hormone) 2 What you need to know before you • suffer from malnutrition take Isosorbide Mononitrate tablets • have severe problems with your liver or kidneys • have low body temperature (hypothermia) 3 How to take Isosorbide Mononitrate • have recent history of myocardial infarction (heart attack) tablets • are already taking medicine to lower blood pressure 4 Possible side effects • are taking any other medication • are pregnant or breast-feeding 5 How to store Isosorbide Mononitrate tablets Isosorbide Mononitrate tablets are used to stop angina attacks 6 Contents of the pack and other from happening. It is not intended to treat a sudden attack of angina. The lowest effective dose should be used. Do not stop information taking Isosorbide Mononitrate tablets suddenly. It should be withdrawn gradually. 1 What Isosorbide Mononitrate tablets A low blood pressure caused by nitrates may occur with are and what they are used for paradoxical bradycardia (slowing of the heart rate) and Isosorbide Mononitrate belongs to a group of worsening of the symptoms of angina. medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the Taking Isosorbide Mononitrate tablets may cause transient strain on the heart making it easier to pump blood. hypoxaemia (an abnormally low level of oxygen in the blood). This Isosorbide Mononitrate tablets may be used to: happens because blood flow in your body is redistributed with an • relieve the pain and frequency of angina attacks. increase in perfusion of poorly ventilated areas of the lung. • help control certain types of heart failure. This may cause ischaemia (not enough blood going to your heart muscle) if you have coronary heart disease.

2 What you need to know before you Increasing doses and/or changes in intervals between doses take Isosorbide Mononitrate tablets can lead to this medicine not working with the effect that it Do not take Isosorbide Mononitrate should or not work at all. tablets if you: Other medicines and Isosorbide Mononitrate • are allergic to isosorbide-5-mononitrate, tablets isosorbide dinitrate or any of the other Tell your doctor or pharmacist if you are taking or have recently ingredients of this medicine (listed in section 6) taken or might take any other medicines: • have marked low blood pressure (systolic • other vasodilatators, blood pressure 90 mmHg) • antihypertensives (medicines to treat high blood pressure) • suffer from circulatory collapse or shock such as ACE-inhibitors, angiotensin- II-receptor antagonists, • suffer from cardiogenic shock beta-blockers, calcium antagonists and diuretics, • have had a heart attack • neuroleptics (used to treat psychiatric disorders) • have been diagnosed with any of the following: • sapropterin (used to lower phenylalanine levels in the blood - hypertrophic obstructive cardiomyopathy of patients with phenylketonuria) (a thickened heart muscle) • alprostadil (for male erection problems)

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148x210 Leaflet Reel Fed Profile (BST) Isosorbide Mononitrate Tablets 10, 20, 40mg x 56 (UK) Isosorbide mononitrate All strengths Tablet PIL - UK JDE No.: 50989937 approved for print/date Item number: BBBA8209 Colours Non Printing Colours 1. Black 1. profile Originator: G. Worth Dimensions: 148x210 Dimensions: 148x210 (Reel Fed) 2. 2. Origination Date: 14/05/2020 Min Body Text Size: 7.25pt Component: Leaflet for Blisters Revision Date: 23/06/2020 Supplier: Accord Barnstaple 3. 3. Revised By: G. Worth 4. Pharmacode: 5. 3220 Proof Round n/a Technical Date sent: 6. 3 Approval Date received: n/a Date Sent: 25/03/20 [email protected] Technologist: T. Hull Cartons and label leaflets only Technically Approved (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 • aldesleukin (for cancer treatment) • Significant drop in blood pressure may lead to an increase in • sildenafil , tadalafil and vardenafil, used to treat male erection chest pain (exacerbation of angina pectoris symptoms), states dysfunction. Treatments for erectile dysfunction can cause a of collapse, sometimes with bradyarrhythmias (slowing of the severe and dangerous fall in blood pressure when taken together heartbeat) with Isosorbide Mononitrate tablets. This can be fatal. Not known (frequency cannot be estimated from the available data) Isosorbide Mononitrate tablets and alcohol • Severe inflammatory skin disease (exfoliative dermatitis) Do not to drink alcohol with this medicine as it may increase the Tell your doctor if you notice any of the following side effects or blood pressure lowering effect of the tablets. notice any other effects not listed: Pregnancy and breast-feeding Very Common (may affect more than 1 in 10 people) If you are pregnant or breast-feeding, think you may be pregnant or • Particularly at the start of treatment, a temporary “nitrate headache” may are planning to have a baby, talk to your doctor or pharmacist before occur which normally subsides after some days of continued treatment. taking this medicine. Common (may affect up to 1 in 10 people) • Low blood pressure (hypotension) and/or drop in blood pressure when Driving and using machines standing up or move suddenly (postural hypotension), especially at Isosorbide mononitrate tablets may make you feel dizzy or light the beginning of treatment, which may be accompanied by a fast headed. You may experience blurred vision. If you experience such heartbeat (tachycardia), slight states of dizziness or feeling weak symptoms you should not drive or operate machinery. • Gastro-intestinal symptoms (feeling or being sick), especially when Isosorbide Mononitrate tablets contain lactose first taken If you have been told that you have an intolerance to some sugars, Uncommon (may affect up to 1 in 100 people) contact your doctor before taking this medicine. • Syncope (fainting), skin flushing 3 How to take Isosorbide Mononitrate tablets Not known (frequency cannot be estimated from the available data) Always take Isosorbide Mononitrate tablets exactly as your doctor has • Heartburn told you. Check with your doctor or pharmacist if you are not sure. • Formation of methaemoglobin, in particular in susceptible patients (e.g. those with methaemoglobin reductase deficiency, diaphorase Swallow the tablets with water after meals. deficiency or abnormal haemoglobin structure), which can cause The recommended doses are: bluish discolouration of the skin, shortness of breath and rapid Adults shallow breathing. • Angina: Initially 20mg two or three times a day, then a • Low blood pressure causing feeling or being sick, restlessness, pale maintenance dose of between 20-120mg a day. skin and excessive sweating • Congestive heart failure: 20mg two or three times a day Reporting of side effects depending on your condition. Your doctor may also be treating If you get any side effects, talk to your doctor, pharmacist or nurse. This you with other drugs. includes any possible side effects not listed in this leaflet. You can also Patients with kidney or liver disease: A lower dose may be given. report side effects directly via the Yellow Card Scheme at: Elderly: Dose should be reduced, especially in patients with kidney www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the or liver disease. Google Play or Apple App Store. Children: Not recommended By reporting side effects you can help provide more information on the safety of this medicine. If you take more Isosorbide Mononitrate tablets than you should 5 How to store Isosorbide Mononitrate tablets If you (or someone else) swallows a lot of tablets at the same time, Keep this medicine out of the sight and reach of children. or you think a child may have swallowed any, contact your nearest Store below 25oC in a dry place. hospital casualty department or tell your doctor immediately. Signs Do not use this medicine after the expiry date stated on the of an overdose include nausea, vomiting, restlessness, warm flushed carton. The expiry date refers to the last day of that month. skin, blurred vision, headache, fainting, tachycardia (a fast heartbeat), Do not throw away medicines via wastewater or low blood pressure, strong or irregular heartbeat, bluish discoloration household waste. Ask your pharmacist how to throw away of the skin, shortness of breath, rapid shallow breathing and increased medicines you no longer use. These measures will help pressure within the skull. protect the environment. If you forget to take Isosorbide Mononitrate tablets 6 Contents of the pack and other information Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then What Isosorbide Mononitrate tablets contain take the next dose at the right time. • The active substance is isosorbide mononitrate. Each tablet contains either 10mg, 20mg or 40mg of the If you stop taking Isosorbide Mononitrate tablets active ingredient. You may feel unwell if you suddenly stop taking isosorbide • The other ingredients are crospovidone, lactose, mononitrate tablets. Do not stop taking the tablets without talking magnesium stearate, maize starch, povidone and E460 to your doctor and follow their advice. (10mg and 40mg only). If you have any further questions on the use of this medicine, ask What Isosorbide Mononitrate tablets look like your doctor or pharmacist. and contents of the pack 4 Possible side effects Isosorbide Mononitrate tablets are white to off-white, circular, biconvex uncoated tablets impressed “C” on Like all medicines, this medicines can cause side effects, although one face and on the reverse, the identifying letters “IO” not everybody gets them. (10mg), “IS” (20mg, on either side of division line), “IV” Contact your doctor at once if you experience: (40mg). Uncommon (may affect up to 1 in 100 people) • Symptoms of an allergic reaction skin rash, swelling of the skin Pack sizes are 56 tablets of the extremities or face, swelling of lips, tongue, or the mucous Marketing Authorisation holder and membranes in mouth, throat, or airways, resulting in shortness of Manufacturer breath or difficulty to swallow. Accord, Barnstaple, EX32 8NS, UK Continued top of next column 50989937 BBBA8209 This leaflet was last revised in June 2020