Nicorandil 10mg Tablets
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Dexrel
pharma
Nicorandil 10mg Tablets Nicorandil 20mg Tablets
Nicorandil
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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What is in this leaflet:
1. What Nicorandil Tablets are and what they are used for
2. What you need to know before you take Nicorandil Tablets
3. How to take Nicorandil Tablets
4. Possible side effects
5. How to store Nicorandil Tablets
6. Contents of the pack and other information
1. WHAT NICORANDIL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Nicorandil 10mg Tablets or Nicorandil 20mg Tablets (referred to as Nicorandil Tablets throughout this leaflet). These tablets contain a medicine called nicorandil. This belongs to a group of medicines called 'potassium-channel activators'.
Nicorandil Tablets work by increasing the blood flow through the blood vessels of the heart.
Nicorandil Tablets are used to prevent and treat long-term chest pain (angina).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICORANDIL TABLETS
Do not take Nicorandil Tablets and tell your doctor if:
• You are allergic (hypersensitive) to nicorandil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have low blood pressure (signs include feeling dizzy, light-headed or faint)
• You have a heart problem where the heart is damaged and cannot pump enough blood around the body
• You have heart failure (signs include shortness of breath, swollen ankles and legs, and feeling tired)
• You are taking medicines for erectile dysfunction (impotence) such as sildenafil, tadalafil or vardenafil.
Do not take this medicine if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nicorandil Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nicorandil Tablets if:
• You have been told by your doctor that you have low blood volume or low systolic blood pressure
• You have recently had a heart attack
• You have a build up of fluid in the lungs (pulmonary oedema)
• You have mouth ulcers
• You have bowel disease as it may get worse with Nicorandil.
When taking Nicorandil Tablets there is an increased risk that you may develop ulceration in different parts of your body, including your eyes and the gastro-intestinal track (gut). In some cases ulcers in the gut can rupture to cause serious bleeding. If you notice any signs of ulceration, you should seek immediate medical advice, as you will need to stop taking Nicorandil Tablets (see section 4).
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Nicorandil Tablets.
Other medicines and Nicorandil Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Nicorandil Tablets can affect the way some other medicines work. Also some medicines can affect the way Nicorandil Tablets work.
In particular, do not take Nicorandil Tablets, and tell your doctor if you are taking:
• Medicines for erectile dysfunction (impotence) such as sildenafil, tadalafil or vardenafil
Tell your doctor if you are taking any of the following:
• Medicines that widen the blood vessels such as hydralazine, minoxidil or nitroprusside (vasodilators)
• Medicines for high blood pressure
• Medicines for depression
• Medicines for inflammation (corticosteroids such as prednisolone)
• Aspirin (acetylsalicylic acid) used to treat minor aches and pains, to reduce fever or as an anti-platelet agent to reduce the risk of blood clots forming.
Nicorandil Tablets with food and drink
Do not drink alcohol while you are taking Nicorandil Tablets.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
You should not breast-feed if you are taking Nicorandil Tablets. This is because small amounts of this medicine may pass into mothers' milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE NICORANDIL TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water. Do not crush or chew the tablets
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• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
How much to take
• The usual dose is 10mg or 20mg taken twice a day, once in the morning and once in the evening.
• Your doctor might increase this to 30mg twice a day if necessary.
• If you have tendency to get headaches, your doctor may start you on a lower dose of 5mg (half of a 10mg tablet) twice a day.
Use in children
Nicorandil Tablets are not recommended for use in children.
If you take more Nicorandil Tablets than you should
If you take more tablets than you should, tell a doctor or go to a hospital casualty department immediately. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: you may feel dizzy or weak or have difficulty in breathing or wheezing.
If you forget to take Nicorandil Tablets
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for you to take your next dose, skip the dose you missed and continue to follow the dosing schedule as usual. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Nicorandil Tablets
Keep taking Nicorandil Tablets until your doctor tells you to stop. Do not stop taking Nicorandil Tablets because you feel better. If you stop, your illness may get worse or come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Nicorandil Tablets and see a doctor immediately or go to a hospital straight away if you have the following side effects:
Uncommon (affects less than 1 in 100 people)
• Red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching, difficulty breathing or swallowing. This could be an allergic reaction (angioedema).
Rare (affects less than 1 in 1,000 people)
• Burning pain in the middle or upper stomach between meals, bloating, heartburn, vomiting, these can be signs of ulcers in the stomach or gut. Severe ulcers can cause blood in your stools, vomiting, weight loss and severe abdominal pain.
Very rare (affects less than 1 in 10,000 people)
• Yellowing of your skin or eyes (which may be signs of liver problems).
• Red, itchy, swollen, watery eyes or painful eyes with blurred vision. This could be a symptom of eye ulceration.
Tell your doctor immediately if you have any of the following side effects:
Common (affects less than 1 in 10 people)
• Increased or fast heart-beat
Rare (affects less than 1 in 1,000 people)
• Blood in your stools or vomit, due to ulcers in the stomach or gut
• Ulcers in your mouth, or on your tongue
• Ulcers of the back passage, bleeding from the back passage
• Weight loss
Very rare (affects less than 1 in 10,000 people)
• Ulcers of the genital tract
• Skin ulcers, possibly on the hands, legs, or feet
• Ulcers in the nasal passages
• Ulcers around a stoma (in those with an artificial opening for waste removal such as a colostomy or ileostomy)
Tell your doctor as soon as possible if you have any of the following:
Very common (affects more than 1 in 10 people)
• Headache. These are more common when you first start taking Nicorandil Tablets.
Common (affects less than 1 in 10 people)
• Feeling dizzy or weak
• Feeling sick or being sick
• Flushing of the skin
Uncommon (affects less than 1 in 100 people)
• Feeling lightheaded or fainting (due to low blood pressure)
• Mouth ulcers
• Pain in your muscles
Rare (affects less than 1 in 1000 people)
• Skin rashes
Very rare (affects less than 1 in 10,000 people)
• Stomach pain
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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. HOW TO STORE NICORANDIL TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
Store below 25oC. Store in the original package to protect from moisture.
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nicorandil Tablets contain
• The active substance is nicorandil. Each 10mg tablet contains 10mg nicorandil. Each 20mg tablet contains 20mg nicorandil.
• The other ingredients are: cetyl alcohol, mannitol, croscarmellose sodium, povidone and sodium stearyl fumarate.
What Nicorandil Tablets look like and contents of the pack
The tablets are white to off-white, round, scored on one side and engraved with "10" or "20" on the other side.
The tablets can be divided into equal halves.
Nicorandil Tablets are available in packs of 10, 28, 30, 56 and 60 tablets in blister strips. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
This leaflet was last revised in November 2014.
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