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Nyzamac® SR 40 Mg & 60 Mg Capsules Isosorbide Mononitrate

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Nyzamac® SR 40 Mg & 60 Mg Capsules Isosorbide Mononitrate PACKAGE LEAFLET: INFORMATION FOR THE USER Nyzamac® SR 40 mg & 60 mg Capsules Isosorbide mononitrate Read all of this leaflet carefully before ▪ are at risk of having a stroke; you start taking this medicine because it • have liver or kidney problems, especially if contains important information for you. you are elderly; - Please keep this leaflet. You may need to • have cirrhosis of the liver; read it again. • have a poor diet; - If you have any further questions, ask your • have poor circulation; doctor or pharmacist. • have consumed alcohol as this may lead to - This medicine has been prescribed for you low blood pressure (hypotension); only. Do not pass it on to others. It may harm • feel that you are developing a tolerance to them, even if their symptoms are the same as Nyzamac SR Capsules; yours. • have a very low body temperature - If you get any side effects, talk to your doctor (hypothermia). or pharmacist. This includes any possible side effects not listed on this leaflet. See section 4. If you have an attack of angina whilst taking Nyzamac SR Capsules, do not stop taking your What is in this leaflet: Nyzamac SR Capsules. Your doctor will provide 1. What Nyzamac SR Capsules are and what another medicine to treat your condition. they are used for. 2. What you need to know before you take Children Nyzamac SR Capsules. Nyzamac SR Capsules are not suitable for use 3. How to take Nyzamac SR Capsules. in children. 4. Possible side effects. 5. How to store Nyzamac SR Capsules. Other medicines and Nyzamac SR Capsules 6. Contents of the pack and other information. Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines, including medicines obtained without 1. What Nyzamac SR Capsules are and a prescription. what they are used for It is especially important to tell your doctor if you The name of your medicine is Nyzamac SR are taking: Capsules. The active ingredient is isosorbide ▪ medicines used to treat high blood pressure mononitrate. Nyzamac SR Capsules belong to a (e.g. propranolol, furosemide); group of medicines called nitrates. ▪ medicines used to treat heart failure (e.g. nifedipine, ramipril); They are called prolonged-release capsules ▪ medicines used in the treatment of erectile because they are manufactured in a way that dysfunction (e.g. sildenafil); allows the isosorbide mononitrate to be released ▪ any medication which may cause a lowering and slowly absorbed by your body over a period of your blood pressure (e.g. causing dizziness of several hours. or light-headedness, especially on standing); ▪ medicines such as noradrenaline, which are Nyzamac SR Capsules are used in adults used to treat high blood pressure or a heart to prevent angina (chest pain) and work by attack; opening up blood vessels and reducing the pain. ▪ acetylcholine, which is used during some operations; 2. What you need to know before you take • medicines such as histamine, which is used Nyzamac SR Capsules to treat allergic reactions; • medicines used to treat migraines (e.g. Do not take Nyzamac SR Capsules if you: ergotamine). • are under 18 years of age; • are allergic to isosorbide mononitrate or any Nyzamac SR Capsules with food, drink and other medicines known as nitrates (glyceryl alcohol trinitrate, isosorbide dinitrate), or any of the Do not take Nyzamac SR Capsules at the same other ingredients of Nyzamac SR Capsules time as an alcoholic drink. listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. Pregnancy and breast-feeding More severe symptoms include swelling If you are pregnant or breast-feeding, think you of the face, lips, tongue and/or throat with may be pregnant or are planning to have a baby, difficulty in swallowing or breathing); ask your doctor or pharmacist for advice before • have any inflammation of the heart such as taking this medicine. The safety of Nyzamac SR pericarditis; Capsules during pregnancy or whilst breast- • have been diagnosed with any of the feeding has not been established. following heart conditions • Low cardiac filling pressure, Driving and using machines • Cardiac tamponade, You can drive while taking Nyzamac SR • Hypertrophic obstructive cardiomyopathy; Capsules but do not drive until you know how • have had any serious damage to your heart, the capsules affect you. They may give you low such as cardiomyopathy or have narrow heart blood pressure or make you feel dizzy, if they valves; affect you in this way, do not drive or operate • suffer from severe anaemia (low levels of red any machinery. blood cells in the blood); • have a low volume of blood in your body Nyzamac SR Capsules contain lactose, (hypovolaemia); sucrose and sodium. • have a head injury or bleeding of the brain; If you have been told by your doctor that you • have closed-angle glaucoma (high pressure have an intolerance to some sugars, contact in the eyes); your doctor before taking this medicinal product. • have low blood pressure (hypotension); This medicine contains less than 1 mmol • have decreased blood supply to the brain sodium (23 mg) per capsule, that is to say (cerebrovascular insufficiency); essentially ‘sodium-free’. • are taking a medicine called Viagra (sildenafil) used for male erectile dysfunction. 3. How to take Nyzamac SR Capsules Warnings and precautions Talk to your doctor or pharmacist before taking Always take Nyzamac SR Capsules exactly as Nyzamac SR Capsules if you: your doctor has told you. You should check with • have recently had a heart attack; your doctor or pharmacist if you are not sure. • have an underactive thyroid gland (hypothyroidism); The recommended dose for adults is 40mg or ▪ have angina due to other causes (such as 60mg a day, taken in the morning. Your doctor a large heart muscle), or have an increased may increase this dose to 120mg, to be taken circulatory volume; as a single dose. ▪ have a head injury or bleeding of the brain; ▪ develop low blood pressure (hypotension), a You can take your medicine with or without food. slow heart rate (bradycardia), or worsening your angina; Please read the back of this leaflet D50205-A A lower dose may be prescribed for the first 2-4 Reporting of side effects days. The capsules should be swallowed whole If you get any side effects, talk to your doctor with a glass of water. Do not crush or chew the or pharmacist. This includes any possible side capsules. effects not listed in this leaflet. You can also If Nyzamac SR Capsules are taken frequently report side effects directly via the Yellow Card and for long periods the effectiveness of the Scheme, website: www.mhra.gov.uk/yellowcard drug may decrease. If you notice that your or search for MHRA Yellow Card in the Google capsules are no longer working as well at Play or Apple App Store. By reporting side relieving the pain as they have done before, effects you can help provide more information consult your doctor. on the safety of this medicine. If you are elderly and suffer from low blood If Nyzamac SR Capsules are taken frequently pressure, liver or kidney disease, your doctor and for long periods the effectiveness of the may prescribe a lower dose for you to take. drug may decrease. If you notice that your capsules are no longer working as well at Use in children relieving the pain as they have done before, Nyzamac SR Capsules are NOT recommended consult your doctor. for children under 18 years of age. 5. How to store Nyzamac SR Capsules If you take more Nyzamac SR Capsules than you should Do not use this medicine after the expiry date If you take more Nyzamac SR Capsules than which is stated on the blister and carton. The you should, contact your doctor or nearest expiry date refers to the last day of that month. hospital emergency department immediately. Do not store above 25°C. Store in the original Take this leaflet and any remaining capsules package. with you. Symptoms of overdose include headache, KEEP THIS MEDICINE OUT OF THE SIGHT feeling over-excited, flushing, cold perspiration, AND REACH OF CHILDREN. feeling sick, being sick, feeling dizzy, fainting, a fast heart beat, low blood pressure, confusion, Do not throw away any medicines via shortness of breath and unconciousness. wastewater or household waste. Ask your pharmacist how to throw away medicines you If you forget to take Nyzamac SR Capsules no longer use. These measures will help protect If you remember within 8 hours take the the environment. forgotten dose immediately. If you remember after 8 hours take the dose at 6. Contents of the pack and other the usual time. information If you stop taking Nyzamac SR Capsules What Nyzamac SR Capsules contain Ask your doctor before stopping treatment with The active ingredient is isosorbide mononitrate. Nyzamac SR Capsules, as treatment should be Each 40mg prolonged-release capsule contains reduced gradually over several days and you 40 mg of isosorbide mononitrate. must be monitored carefully by your doctor. Each 60mg prolonged-release capsule contains 60 mg of isosorbide mononitrate. 4. Possible side effects The other ingredients are: lactose monohydrate, Like all medicines, Nyzamac SR Capsules can sugar spheres (containing sucrose and maize cause side effects, although not everyone gets starch), bleached dewaxed shellac, dewaxed them. shellac, talc, copolymer of methacrylic acid and methyl methacrylate (1:1) and copolymer If you experience the following side effects, of ethyl acrylate, methyl methacrylate and you should STOP taking your medicine and trimethylammonioethyl methacrylate chloride tell your doctor IMMEDIATELY or go to your (1:2:0:1) and the capsule shells are made of nearest casualty department.
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