Nicorandil 10 Mg Tablets
TEVA UK Ref: 231-30-12345-A LEA NICORANDIL 10mg & 20mg TABS TUK <BLU Version: 5 25 September 2014
TEVA UK Ref: 231-30-12345-A LEA NICORANDIL 10mg & 20mg TABS TUK <BLU Version: 5 25 September 2014
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.
NICORANDIL
10 mg AND 20 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
WHAT IS IN THIS LEAFLET
1. What Nicorandil is and what it is used for
2. What you need to know before you take Nicorandil
3. How to take Nicorandil
4. Possible side effects
5. How to store Nicorandil
6. Contents of the pack and other information
What Nicorandil is and what it is used for
Nicorandil Tablets contain the active substance nicorandil. This substance belongs to a group of medicines called "potassium channel activators". It works by relaxing blood vessels and increasing the blood flow and oxygen supply to the heart.
Nicorandil is used
to prevent chest pain (angina pectoris)
for long-term treatment of chest pain (stable angina
pectoris).
2 What you need to know before you take Nicorandil
Do not take Nicorandil
if you are allergic (hypersensitive) to nicorandil or any of the other ingredients of this medicine (listed in section 6)
if you have a condition called "cardiogenic shock". This is a severe drop in blood pressure, caused by the fact that the heart cannot pump enough blood around the body.
if you have a heart failure and your left side of the
heart fails to pump blood effectively (left ventricular
failure with low filling pressures)
if you have low blood pressure
together with medicines for impotence (see also
"Other medicines and Nicorandil").
Warnings and precautions
Talk to your doctor or pharmacist before taking
Nicorandil.
Take special care with Nicorandil if you have
• ulcers in the stomach or gut
• skin ulcers
• mouth ulcers
• been told by your doctor that you have a low blood volume or low systolic blood pressure
• an acute build up of fluid in the lungs (acute pulmonary oedema)
• recently had a heart attack (acute myocardial infarction).
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Other medicines and Nicorandil
Tell your doctor or pharmacist if you are taking, have recently taken or might any other medicines.
You must not take Nicorandil, and tell your doctor, if you are taking medicines for impotence such as sildenafil, tadalafil or vardenafil (phosphodiesterase 5 inhibitors). These medicines are also used for a rare progressive disease of the blood vessels in the lung (pulmonary arterial hypertension). The simultaneous use of these medicines and Nicorandil can lead to a serious drop in blood pressure.
Tell your doctor if you are taking any of the following:
• medicines that widen the blood vessels (vasodilators)
• medicines used to treat high blood pressure
• medicines used to treat depression (tricyclic antidepressants).
If you take one of these medicines together with Nicorandil your blood pressure could get too low.
If you take Nicorandil together with corticosteroids (medicines used to treat inflammation), perforations in the stomach or gut can occur.
Nicorandil with food, drink and alcohol
Do not drink alcohol while you are taking Nicorandil. This is because Nicorandil may increase the effect of alcohol.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. Nicorandil should not be used during pregnancy unless your doctor considers that it is clearly necessary.
You should not use Nicorandil if you are breast-feeding because it is not known whether nicorandil is excreted into human breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Since Nicorandil lowers your blood pressure, you may feel dizzy or light-headed while taking this medicine. If this happens, do not drive or use any tools or machines.
Nicorandil contains sodium starch glycolate (type A) and mannitol.
How to take Nicorandil
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Route and Method of administration
Take this medicine by mouth. Swallow the tablets whole with a sufficient amount of water (e.g. one glass of water). You can take the tablets with or without food. Do not crush or chew the tablets.
Dosage
The usual dose is 10 mg or 20 mg taken in the morning and in the evening (equivalent to a daily dose of 20 mg to 40 mg of Nicorandil). Your doctor might increase this to 30 mg twice a day, if necessary (equivalent to a daily dose of 60 mg of nicorandil).
If you have a tendency to get headaches, your doctor may start you on a lower dose of 5 mg twice a day (equivalent to 10 mg of nicorandil).
Use in children and adolescents
Nicorandil is not recommended for use in children and adolescents below 18 years due to insufficient data on its safety and efficacy.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package, in order to protect from moisture.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Nicorandil contains
The active substance is nicorandil. Each Nicorandil 10 mg Tablet contains 10 mg nicorandil and each Nicorandil 20 mg Tablet contains 20 mg nicorandil. The other ingredients are sodium starch glycolate (type A), stearic acid, mannitol.
What Nicorandil looks like and contents of the pack
Nicorandil 10 mg Tablets are white to off-white round, flat tablets with a break line on one side.
The tablets can be divided into equal halves.
Nicorandil 20 mg Tablets are white to off-white round and flat.
Nicorandil is available in blisters of 20, 30 or 60 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Bluepharma Industria Farmaceutica, S.A,
Cimo de Fala - S. Martinho do Bispo, 3045-016 Coimbra, Portugal
This leaflet was last revised in 09/2014
PL 00289/1746 PL 00289/1747
TEUZD
TEVA UK LIMITED
Elderly patients
Elderly patients should take the lowest possible dose that relieves the complaints.
Your doctor will decide how many tablets of Nicorandil you will have to take per day. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but talk to your doctor.
If you take more Nicorandil than you should
If you take more tablets than you should, or if a child has swallowed any of your tablets, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have or the child has taken. The following effects may happen: your blood pressure drops off and you may feel dizzy or weak, your heart may beat faster than normal or you have difficulty in breathing or wheezing.
If you forget to take Nicorandil
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Nicorandil
Keep taking Nicorandil until your doctor tells you to stop. Do not stop taking Nicorandil 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.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Nicorandil immediately and seek urgent medical advice immediately if you have any of the following side effects:
Rare: may affect up to 1 in 1,000 people
blood in your stools or vomit (due to ulcers in the stomach or gut), mouth ulcers, tongue ulcers, ulcers of the anus, or bleeding from the anus.
Very rare: may affect up to 1 in 10,000 people
yellowing of your skin or eyes (which may be signs of liver problems)
red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching, difficulty breathing or swallowing. This could be an allergic reaction (angioedema)
skin ulcers (possibly on the hands, legs, or feet), ulcers of the genital tract, in the nasal passages, or around a stoma (in those with an artificial opening for the bowels such as a colostomy or ileostomy).
In addition to the above, the following side effects have also been reported:
Very common: may affect more than 1 in 10 people
headache (this is more common when you first start taking Nicorandil).
Common: may affect up to 1 in 10 people
increased or fast heart-beat (palpitation) dizziness
increased heartbeat flushing of the skin feeling sick or being sick feeling weak.
Uncommon: may affect up to 1 in 100 people
decrease in blood pressure (feeling dizzy, lightheaded or faint).
Rare: may affect up to 1 in 1,000 people
skin rashes itching
pain in your muscles.
Very rare: may affect up to 1 in 10,000 people
• stomach ache.
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 at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Nicorandil
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