Nifedipine
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Nifehexal.
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 risk of you taking Nifehexal against the benefits it is expected to 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 want to read it again.
WHAT NIFEHEXAL IS USED FOR
The name of your medicine is Nifehexal. It contains the active ingredient nifedipine. Nifehexal is used to treat high blood pressure.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
Nifehexal belongs to a group of medicines called calcium channel blockers. They work by relaxing the blood vessels which in turn helps to reduce blood pressure.
There is no evidence that Nifehexal is addictive.
There is not enough information to recommend the use of this medicine for children under the age of 18 years.
BEFORE YOU TAKE NIFEHEXAL
When you must not take it
Do not take this medicine if you have an allergy to:
- nifedipine, active ingredient or any of the inactive ingredients listed at the end of this leaflet under Product Description
- any other similar medicines such as amlodipine, felodipine and israpidine.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin
Do not take this medicine if you have or have had any of the following medical conditions:
- a condition called cardiovascular shock (very low blood pressure due to a failing heart)
- a heart attack in the last eight days.
Do not take this medicine if you are taking another medicine containing the active substance rifampicin, an antibiotic used to treat tuberculosis and other serious infections.
Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine. The active ingredient in Nifehexal passes into breast milk and there is a possibility that your baby may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- congestive heart failure or any other heart or blood vessel conditions, such as low blood pressure
- narrowing of the aorta
- diabetes
- liver or kidney disease.
Nifehexal contains lactose. If you have been told by your doctor that you have intolerance to some sugars, tell your doctor before taking it.
If you have not told your doctor about any of the above, tell him/her before you start taking Nifehexal.
Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Nifehexal may interfere with each other. These include:
- beta-blockers, used to treat certain heart conditions and high blood pressure
- nitrates, used for angina pain
- cimetidine, used to treat ulcers in the gut
- phenytoin, used to treat epilepsy
- medicines used to treat asthma, such as terbutaline, theophylline and salbutamol
- digoxin, used to treat certain heart conditions
- quinidine, used to treat irregular heartbeat
- rifampicin, erythromycin, quinupristin and dalfopristin, used to treat infections
- warfarin, used to thin the blood
- diltiazem, used to treat high blood pressure and to prevent angina
- carbamazepine, used to control epilepsy, mania, bipolar mood disorder and sudden attacks of facial pain
- sodium valproate, used to control epilepsy
- cisapride, used to help control nausea and vomiting
- medicines used to treat HIV, such as amprenavir, indinavir, nelfinavir, ritonavir or saquinavir
- ketoconazole, itraconazole and fluconazole, used to treat fungal and yeast infections
- tacrolimus, used to stop rejection of a new transplanted kidney or liver
- fluoxetine, used to treat depression.
These medicines may be affected by Nifehexal or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
You should avoid eating grapefruit or drinking grapefruit juice while taking Nifehexal, as this can cause unwanted changes in the blood pressure lowering effect of the tablets.
HOW TO TAKE NIFEHEXAL
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
The usual adult dosage is 20mg twice daily. If required your doctor may increase this dose. However, the maximum adult dosage of 80mg per day should not be exceeded.
The dosage recommendation depends on your condition, and will be determined by your doctor.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions given to you. If you take the wrong dose, Nifehexal may not work as well and your problem may not improve.
How to take it
The tablets must be swallowed whole with a little fluid, with or without food. Do not crush, divide or chew the tablets.
When to take Nifehexal
Nifehexal is usually taken every twelve hours. The recommended time of administration is first thing in the morning, followed by the second dose before going to bed at night.
How long to take Nifehexal
Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose (i.e. within 6 hours), skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much
Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much Nifehexal.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include:
- feeling dizzy and fainting due to a drop in blood pressure
- irregular or rapid heart beats
- shortness of breath
- loss of consciousness.
WHILE YOU ARE TAKING NIFEHEXAL
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Nifehexal.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests or x-rays, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
Things you must not do
Do not use Nifehexal to treat any other complaint unless your doctor says so.
Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.
Things to be careful of
Be careful driving or operating machinery until you know how Nifehexal affects you. This medicine may cause dizziness or faintness in some patients, especially after the first few doses or when changing medication. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or faintness may be worse.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Nifehexal. All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- swelling of the feet and ankles
- dizziness or weakness
- numbness or tingling in the hands or feet
- nausea
- headache or flushing
- bleeding, tender or swollen gums
- skin reactions such as rash or itching
- muscle pain or trembling
- constipation
- need to urinate (pass water) more often.
These are the more common side effects of Nifehexal. Mostly, these are mild and short-lived.
Tell your doctor immediately if you notice any of the following:
- fast or irregular heartbeat
- chest pain
- breast size increase in men
- yellowing of the skin and/or eyes (jaundice)
- visual disturbances
- signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
Very rarely, some people experience a purple/brown discolouration 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.
Tell your doctor if you experience any of these symptoms.
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 Nifehexal tablets and are repeatedly unsuccessful in fathering a child by in vitro fertilisation, this medicine should be considered as one of the possible causes if no other explanation can be found.
If any of the following happen, stop taking Nifehexal, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
- swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
This is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
AFTER TAKING NIFEHEXAL
Storage
Keep your medicine in the original container. If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
The tablets should be stored protected from light, as they are highly light sensitive.
Do not store Nifehexal or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
PRODUCT DESCRIPTION
What Nifehexal looks like
Nifehexal 20mg – pink to light red round tablets. They are available in blisters of 60 tablets.
Ingredients
Active Ingredient:
- Nifehexal 20mg – 20mg nifedipine
Inactive Ingredients:
- polysorbate 80
- maize starch
- lactose
- microcrystalline cellulose
- magnesium stearate
- macrogol 4000
- hypromellose
- titanium dioxide
- iron oxide red.
Supplier
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335
This leaflet was revised in May 2012.
Australian Register Number
Nifehexal 20mg tablets: AUST R 68084
Published by MIMS September 2012