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Home , Nicorandil, Riociguat

PACKAGE LEAFLET: INFORMATION FOR THE USER not take or any medicines for inflammation 10 mg Tablets (corticosteroids). Talk to your doctor or pharmacist before taking Nicorandil 20 mg Tablets Nicorandil: nicorandil - If you have low blood pressure. Read all of this leaflet carefully before you - If you have low blood potassium level and your start taking this medicine because it contains doctor has prescribed potassium supplements, important information for you. or if you are suffering from renal impairment or • Keep this leaflet. You may need to read it again. taking other medicinal products that may • If you have any further questions, ask your doctor increase potassium levels. or pharmacist. - If you have heart problems such as heart failure. • This medicine has been prescribed for you only. - If you have glucose 6 Phosphate Do not pass it on to others. It may harm them, Deshydrogenase deficiency. even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or Children pharmacist. This includes any possible side effects Nicorandil is not recommended in children. not listed in this leaflet. See section 4. Other medicines and Nicorandil: What is in this leaflet Tell your doctor or pharmacist if you are taking, have 1. What Nicorandil is and what it is used for recently taken or might take any other 2. What you need to know before you take medicines. This is because Nicorandil may affect Nicorandil the way some other medicines work. Also some 3. How to take Nicorandil medicines may affect the way nicorandil works. 4. Possible side effects Do not take this medicine and talk to your doctor 5. How to store Nicorandil if you are taking the following: 6. Contents of the pack and other information • Medicines for impotence such as , or vardenafil 1. WHAT NICORANDIL IS AND WHAT IT IS USED • Medicines to treat such FOR as . Nicorandil contains a medicine called nicorandil. This Tell your doctor, if you are taking any of the belongs to a group of medicines called following: “ activators”. It works by • Medicines to treat high blood pressure. increasing the blood flow through the blood • Medicines that widen the blood vessels. vessels of the heart. It improves the blood and • Medicines that increase blood potassium levels. oxygen supply of your heart muscle and reduces its • Dapoxetine, a medicine used to treat premature workload. Nicorandil is used to prevent or attenuate ejaculation. painful, straining symptoms ( pectoris) of your • Medicines for inflammation (corticosteroids, non- heart disease. It is used in adult patients who do not inflammatory steroidal such as tolerate or cannot take heart medicines called beta- ). blockers and/or antagonists. • Medicines for depression. • Aspirin (acetylsalicylic acid). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICORANDIL Nicorandil with Do not take Nicorandil: Nicorandil may lower your blood pressure. - If you are allergic to nicorandil or any of the other If you drink alcohol while you are treated with ingredients of this medicine (listed in section 6). Nicorandil, your blood pressure may be decreased - If you have low blood pressure (hypotension). even further. - If you have heart problems such as cardiogenic Pregnancy, breast-feeding and fertility shock, or left ventricular failure with low filling If you are pregnant or breast-feeding , think you may pressure or cardiac decompensation or shock. be pregnant or are planning to have a baby, ask your - If you are taking medicines to treat erectile doctor or pharmacist for advice before taking this dysfunction such as sildenafil, tadalfil, vardenafil medicine. (phosphodiesterase inhibitors) or medicines to You should avoid taking this medicine while you are treat pulmonary hypertension such as riociguat pregnant. ( stimulators). It is not known whether nicorandil passes in This may seriously affect your blood pressure. human milk. You should not breast-feed while you - If you have a low blood volume. are taking this medicine. - If you have a build-up of fluid in the lungs (pulmonary oedema). Driving and using machines Nicorandil may cause dizziness or weakness. Warnings and precautions If this happens, do not drive or use any tools or Talk to your doctor or pharmacist before taking machines. Nicorandil: Stop taking nicorandil straight away and talk to your 3. HOW TO TAKE NICORANDIL doctor if you experience any of the following: Always take this medicine exactly as your - Nicorandil may cause injuries to your doctor has told you. Check with your doctor or gastrointestinal tract such as ulcers. This can pharmacist if you are not sure. develop problems such as bleeding, fistula, holes, The recommended dose is: abscess, especially if you have - The usual starting dose is 10 mg twice daily. diverticular disease (a digestive condition - In case you are particularly prone to headache, affecting the large intestine). a lower dose of 5 mg twice daily might be - If your eyes become red, itchy or swollen. You prescribed by your doctor, for the first few days may have eye injuries, stop taking Nicorandil and (2 to 7 days). contact your doctor immediately. - Your doctor may increase the dose up to 20 mg These side effects can occur at the beginning of twice daily depending on your needs, response to treatment or latter in the treatment course. The treatment and tolerance. only possible treatment is to stop nicorandil. Do

Bozza no.: 1 / Recto Data: 09.05.2019 Colore: Nero Lineagrafica sa Codice: PIL-Nicorandil-10-20mg-PP.pdf Fto.: mm 130 x 480 6596 Gordola Preferably take one dose in the morning and one in • Red, itchy, swollen or watery eyes (conjunctivitis) the evening. • Eye injuries Swallow the tablet (oral use). • Cornea injuries Do not take out or separate tablet from the blister • Yellowing of the skin and eyes, light coloured strip until intake. bowel motions, dark coloured urine – This may be The 10 mg tablet can be divided into equal doses. signs of liver problems. For the 20 mg tablet, the score line is only there • Swelling of the face, lips, mouth, tongue or throat to help you break the tablet if you have difficulty which may cause difficulty in swallowing or swallowing it whole. breathing Do not swallow the drying agent which is the bigger • Stomach aches. tablet on one end of each blister strip. It is included in the pack to protect Nicorandil tablets from Not known (frequency cannot be estimated from moisture. On the blister, it is clearly indicated which the available data) tablet is the drying agent. If you do • Double vision (diplopia). accidentally take any of these drying agent tablets, Reporting of side effects they should not harm you but you should talk to If you get any side effects, talk to your doctor or your doctor straight away. pharmacist. This includes any possible side effects If you take more Nicorandil than you should: not listed in this leaflet. You can also report side If you take more tablets than you should, or if effects directly via the Yellow Card Scheme at: www. a child has swallowed any of your tablets, tell a mhra.gov.uk/yellowcard or search for MHRA Yellow doctor or go to a hospital casualty department Card in the Google Play or Apple App Store. By straight away. Take the medicine pack with you. reporting side effects you can help provide more You may feel blood pressure lowering effect such as information on the safety of this medicine. dizziness, feeling of weakness. You may also 5. HOW TO STORE NICORANDIL feel your heart is beating irregularly and faster. Keep this medicine out of the sight and reach of If you forget to take Nicorandil: children. If you forget to take a dose, take it as soon as you Do not use this medicine after the expiry date which remember, unless it is nearly time for your next dose. is stated on the carton and blister after EXP. The Do not take a double dose to make up for a expiry date refers to the last day of that month. forgotten dose. Do not store above 25°C. Store in the original If you have any further questions on the use of this package in order to protect from moisture. medicine, ask your doctor or pharmacist. Do not swallow the drying agent which is contained in the strip. 4. POSSIBLE SIDE EFFECTS Use the blister strip within 30 days of opening. Like all medicines, this medicine can cause side Do not throw away any medicines via wastewater or effects, although not everybody gets them. household waste. Ask your pharmacist how to throw Talk to your doctor straight away if you experience away medicines you no longer use. These measures any of the following: will help to protect the environment. Nicorandil may cause injuries to your gastrointestinal tract such as ulcers in the mouth, 6. CONTENT OF THE PACK AND OTHER tongue, stomach, guts (small and large), back INFORMATION passage. This can lead to developing problems such What Nicorandil contains: as bleeding (blood in your stools or vomit), fistula - The active substance is nicorandil. Two strengths (abnormal tube-like passage from one body cavity of tablets are available. The strengths are 10 mg to another or to the skin), holes, abscess, weight loss. and 20 mg. Ulcers can occur at other site such as: skin, genital - Other ingredients are maize starch, tract and nasal passages or around a stoma (in those croscarmellose sodium, stearic acid and with an artificial opening for waste mannitol (E421). removal such as a colostomy or ileostomy). What Nicorandil looks like and contents of the Other side effects include: pack: Very common (may affect more than 1 in 10 people) Nicorandil 10 mg tablets are white, round, scored on • Headache – This especially occurs during one side and embossed with ‘10’ on the other side. the first few days of treatment. Your doctor may Nicorandil 20 mg tablets are white, round, scored on progressively increase the dose to reduce the one side and embossed with ‘20’ on the other side. frequency of headaches. Nicorandil 10 mg tablets and 20 mg tablets are Common (may affect up to 1 in 10 people) available in blister packs. Each blister contains • Dizziness 10 tablets. The blisters are packed in cartons • Very fast, uneven or forceful heart-beat of 60 tablets. () • Flushing of the skin Marketing Authorisation Holder: Rivopharm UK Ltd. • Feeling sick (nausea) th • Being sick (vomiting) 30 Floor, 40 Bank Street, Canary Wharf, • Feeling of weakness. London E14 5NR Uncommon (may affect up to 1 in 100 people) Manufacturers: • Decrease in blood pressure. Laboratoires BTT ZI de Krafft - 67150 ERSTEIN- France. Rare (may affect up to 1 in 1,000 people) • Rash Rivopharm UK Ltd. • Itching 30th Floor, 40 Bank Street • Aching muscles not caused by exercise (myalgia). Canary Wharf London E14 5NR Very rare (may affect up to 1 in 10,000 people) • High potassium levels in the blood This leaflet was last approved in May 2019 (hyperkalaemia)

Bozza no.: 1 / Verso Data: 09.05.2019 Colore: Nero Lineagrafica sa Codice: PIL-Nicorandil-10-20mg-PP.pdf Fto.: mm 130 x 480 6596 Gordola