Nicorandil 20 Mg Tablets
Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nicorandil is and what it is used for
2. Before you take Nicorandil
3. How to take Nicorandil
4. Possible side effects
5. How to store Nicorandil
6. Further information
Nicorandil contains a substance called 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)
Do not take Nicorandil
- if you are allergic (hypersensitive) to nicorandil or any of the other ingredients of Nicorandil
- 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 "Taking other medicines")
Take special care with Nicorandil
- if you have ulcers in the stomach or gut
- if you have skin ulcers
- if you have mouth ulcers
- if you have been told by your doctor that you have a low blood volume or low systolic blood pressure
- if you have an acute build up of fluid in the lungs (acute pulmonary oedema)
- if you have recently had a heart attack (acute myocardial infarction )
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You must not take Nicornadil, 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 bloodvessels in the lung (pulmonary arterial hypertension). The simultaneous use of these medicines and Nicornadil 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 Nicornadil your blood pressure could get too low.
If you take Nicornadil together with corticosteroids (medicines used to treat inflammation), perforations in the stomach or gut can occur.
Taking Nicorandil with food and drink Do not drink alcohol while you are taking Nicorandil. This is because Nicorandil may increase the effect of alcohol.
Pregnancy and breast-feeding
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.
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.
Always take Nicorandil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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 10mg or 20mg taken in the morning and in the evening (equivalent to a daily dose of 20 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 nicorandil twice a day (equivalent to 10 mg of nicorandil). Therefore you can get Nicornadil 10 mg tablets, that can be divided into equal halves with 5 mg nicorandil each.
Use in children
Nicorandil is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
continued overleaf
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 ou to stop. Do not stop taking Nicorandil ecause you feel better. If you stop, your illness may get worse or come back.
Ifyou have any further questions on the use ofthis product, ask your doctor or pharmacist.
d) Tell your doctor as soon as possible if you nave any of the following side effects:
Very common
- Headache. These are more common when you first start taking Nicorandil.
Common
- Dizziness
- Increased heartbeat
- Flushing of the skin
- Feeling sick or being sick
- Feeling weak
Uncommon
- Decrease in blood pressure (feeling dizzy, lightheaded or fainting)
Rare
- Skin rashes
- Itching
- Pain in your muscles
e) Other side effects
Very rare
- Belly ache
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Nicorandil after the expiry date which is stated on the label carton and blister after EXP
Like all medicines, Nicorandil can cause side effects, although not everybody gets them.
Assessment of side effects is based on the following frequency rates:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in
10,000
very rare: affects less than 1 user in
10,000
a) Stop taking Nicorandil immediately and see a doctor or go to a hospital straight away if you have the following side effects:
Very rare
- 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).
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Nicorandil contains
- The active substance is nicorandil. Each 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 tablets are white to off-white round and flat
They are supplied in blisters of 20, 30 or 60 tablets.
Not all pack sizes may be marketed.
b) Stop taking Nicorandil and see your doctor if you develop ulcerations. These ulcers cannot medicinally be treated and they only respond if you discontinue the treatment with Nicorandil:
Rare
- 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
Marketing Authorisation Holder
Strandhaven Limited T/A Somex Pharma Ilford, Essex IG3 8BS, UK
Manufacturer
Bluepharma Industria Farmaceutica, S.A Cimo de Fala - S. Martinho do Bispo, 3045-016 Coimbra Portugal
This medicinal product is authorised in the Member States of the EEA under the following names
Very Rare
- 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)
c) Tell a doctor straight away if you have any of the following side effects
Common
- Increased or fast heart-beat (Palpitation)
United Kingdom: Nicorandil 20 mg tablets Spain: Nicorandil Petazone 20 mg comprimi-dos
Germany, Netherlands: Doranic 20 mg Tabletten
Italy: Doranic 20 mg compresse Portugal: Doranic 20 mg comprimidos Denmark:Nicozone 20 mg tabletter Ireland: Nicozone 20 mg tablets
This leaflet was last approved in 06/2011.