Nifedipine
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Nyefax.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking nifedipine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Nyefax is used for
Nyefax tablets are used for the treatment of hypertension (high blood pressure).
Nyefax tablets are a Schedule 4 medicine. They are only available on a doctor’s prescription.
How Nyefax works
Nifedipine tablets belong to a group of medicines called calcium channel blockers. They work by relaxing and opening up the blood vessels to lower blood pressure.
Your doctor may prescribe it for another purpose. Ask your doctor if you have any questions about why Nyefax tablets have been prescribed for you.
Before you take Nyefax
When you must not take it
Nyefax tablets should not be taken if you are allergic to nifedipine or to any of the other ingredients listed at the end of this leaflet.
Do not take Nyefax tablets if you are allergic to active substances which are similar to nifedipine. These include amlodipine, felodipine and isradipine. Symptoms of an allergic reaction may include skin rash, hay fever, difficulty in breathing or feeling faint.
Do not take Nyefax tabletsif you are pregnant or breast-feeding women. Tell your doctor if you become pregnant while you are taking Nyefax tablets.
Do not take Nyefax tablets if:
- you have had a heart attack in the last 8 days, or if you are in cardiogenic shock (very low blood pressure due to a failing heart)
- you are taking another medicine called rifampicin, an antibiotic used to treat various infections
Do not take Nyefax tablets after the expiry date which appears after the words “EXP” or “EXPIRY” printed on the pack.
Do not start taking Nyefax tablets if, when you start a new pack, the packaging is torn or shows signs of tampering.
Do not use Nyefax tablets to treat any other medical conditions unless your doctor says so.
Before you start to take it
You must tell your doctor if:
- you are allergic to any other medications or any foods, dyes or preservatives
- you have any other medical conditions (either now or in the past), especially heart failure, angina, narrowing of the aorta, diabetes, liver disease or kidney disease. Your should discuss these medical conditions with your doctor to check whether Nyefax tablets are suitable for you.
- you are taking any other medicines, including those that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Nifedipine tablets. These include:
- Cimetidine (Tagamet)
- Erythromycin (Erythrocin, EES, E-Mycin, Eryhexal)
- Warfarin (Coumadin, Marevan)
- Digoxin (Lanoxin PG, Lanoxin)
- Diltiazem (Cardizem, Cardizem-CD)
- Quinidine (Kinidin)
- Quinuproston and Dalfopristin (Synercid)
- Rifampicin (Rimycin)
- Phenytoin (Dilantin)
- Carbamazepine (Tegreto, Teril, Carbium)
- Cisapride (Prepulsid)
- Medicines used to treat HIV such as amprenavir, indinavir, nelfinavir, ritonavir or saquinavir
- Sodium valproate (Epilim, Valpro)
- Ketaconazole (Nizoral), itraconazole (Sporanox), fluconazole (Diflucan)
- Other medicines used to treat high blood pressure
- Tacrolimus (Prograf)
These medicines may be affected by Nyefax tablets or may affect how well they work. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Nyeax tablets.
You should not eat grapefruit or drink grapefruit juice while you are taking Nyefax tablets because this may cause your blood pressure to drop too low.
How to take Nyefax
How much to take
The correct dose of Nyefax tablets to take has been decided by your doctor. Make sure you follow the instructions given to you by your doctor. The usual dosage is 10 mg to 20 mg twice daily. If necessary the dose may be increased up to a maximum of 40mg twice daily. This dose should not be exceeded.
How to take it
The tablets should be swallowed with a little fluid. They may be taken with or without food.
When to take it
The tablets are usually taken every 12 hours. The tablets should generally be taken first thing in the morning followed by the second dose when retiring at night.
How long to take it
Your doctor will determine how long you should take Nyefax tablets. Do not stop taking the tablets unless you are told to by your doctor or you do not feel well while taking them (see SIDE EFFECTS).
If you forget to take it
If it is almost time for your next dose (within 6 hours of your next dose), skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you have missed several doses you should consult your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre for advice (Tel: Australia 13 11 26; NZ 0800 POISON or 0800 764766) or go to Accident and Emergency Department at the nearest hospital if you think you or anyone else may have taken too many Nyefax tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. The symptoms of overdose include dizziness, flushing and fainting, irregular or rapid heart beats, shortness of breath and even loss of consciousness.
While you are taking Nyefax
Things you must do
Take Nyefax tablets exactly as told by your doctor. If you do not follow your doctor’s instruction you may not get control of your blood pressure.
Tell all doctors, dentist and pharmacists who are treating you that you are taking Nyefax tablets.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem to be similar to yours.
Things to be careful of:
Be careful driving or operating machinery until you know how Nyefax tablets affect you. Nyefax tablets may cause dizziness or fainting in some patients, especially when they first start taking the medicine, when changing the dose or in some cases when taken in combination with alcohol. If affected, do not drive a vehicle, operate machinery or do anything else that could be dangerous
If you have been taking this medicine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may bring on your previous problem. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.
Side effects
All medicines have side effects. Sometimes they are serious, most of the time they are not. In serious cases you may need medical attention. The most common side effects are hypotension, dizziness, flushing, light-headedness, headache, nausea and vomiting, numbness in the hands and feet, swelling of the ankles or legs, bleeding, tender or swollen gums, tingling, tiredness, heartburn, an increase in the need to pass water and weakness.
Occaisionally, slight breast swelling may occur in older men. This side effect goes away when treatment is stopped.
Tell your doctor immediately or go to casualty at your nearest hospital if any of the following happen to you:
- fast or irregular heartbeat
- chest pain
- fainting
- skin reactions such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing, or trouble breathing, muscle pain, trembling, visual disturbances.
These side effects could be serious, you may need urgent medical attention. Serious side effects are rare.
As with all medicines, some people may be allergic to Nyefax tablets. Usually, if you are allergic to Nyefax tablets a reaction will occur shortly after you start taking it. Allergic reactions can affect the liver and appear as yellowing of the skin (jaundice) or cause symptoms such as a rash and fever.
Very rarely, some people experience a purple/brown discoloration of the skin, or redness, flaking and itching of the skin. Also, it has been reported for some people to develop a rash or blistering of the skin when they are exposed to sunlight.
In a small number of cases of in vitro fertilisation, medicines like nifedipine appeared to have interfered with the normal function of sperm. This effect went away after the medicine was stopped. In those men who are taking nifedipine tablets and are repeatedly unsuccessful in fathering a child by in vitro fertilisation, the medicine should be considered as one of the possible causes if no other explanation can be found.
If you experience any of these or any other side effects contact your Doctor.
After Using Nyefax
Storage
Protect your Nifedipine tablets from light and moisture. Keep them at a temperature below 25°C. Ensure that they are out of the reach of children.
Do not leave your tablets in the car on a hot day. Do not use a tablet if it is broken or the blister-foil seal has been broken.
Disposal
If your doctor or pharmacist tells you to stop taking Nifedipine tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Where to go for further information
Pharmaceutical companies are not in apposition to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What it looks like
Nyefax 20 mg tablets are available in blister strips, pack size 60 tablets. AUST R: 127280
Ingredients
Active ingredients:
- Nifedipine 20mg.
Other ingredients:
- Starch -pregelatinised maize
- Microcrystalline cellulose
- Lactose
- Polysorbate 80
- Magnesium stearate
- Purified water
- Hypromellose
- Macrogol
- Titanium dioxide
- Iron oxide red
- Iron oxide black
Sponsor
Douglas Pharmaceuticals Australia Limited
3/10 Inglewood Place
Norwest Business Park
Baulkham Hills NSW 2153
Date of leaflet preparation: May 2006
Published by MIMS August 2006