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 Nifehexal was 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.
Before you take Nifehexal
When you must not take it
Do not take Nifehexal if:
you are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description.
it is past its expiry date or the packaging appears to have been tampered with.
you are pregnant or breastfeeding, or if there is a possibility that pregnancy may occur.
you have a condition called cardiovascular shock (very low blood pressure due to a failing heart).
you have had a heart attack in the last eight days.
you are currently taking a medicine containing the active substance rifampicin.
Before you start to take it
Tell your doctor if you have allergies to:
any other medicines, especially if they are in the same drug class as nifedipine
any other substances, including foods, preservatives or dyes.
Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are using Nifehexal.
Tell your doctor if you have or have had any medical conditions, especially the following:
congestive heart failure or any other heart or blood vessel conditions, such as low blood pressure
liver or kidney disease.
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.
These medicines may be affected by Nifehexal, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Also avoid drinking grapefruit juice while taking Nifehexal, as it can interact with nifedipine.
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 you 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.
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 it
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 it
Your doctor will determine for how long you should take this medicine. Do not stop taking the tablets unless you are told to do so by your doctor or you do not feel well while you are taking them (see 'Side Effects' at the end of this leaflet).
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, 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 you missed.
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 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think 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
Always follow your doctor's instructions carefully.
Tell your doctor if you become pregnant while taking Nifehexal.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Nifehexal.
Things you must not do
Do not stop taking Nifehexal without your doctor's permission.
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.
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.
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. Do not be alarmed by this list of possible side effects. You may not experience any of them.
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
headache or flushing
bleeding, tender or swollen gums
skin reactions such as rash or itching
muscle pain or trembling
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
breast size increase in men
yellowing of the skin (jaundice)
These may be serious side effects of Nifehexal.
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.
Other side effects not listed above may also occur in some people.
Tell your doctor if you notice any other effects.
After taking Nifehexal
Keep Nifehexal in the original packaging until you need to take it. 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.
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.
What Nifehexal looks like
Nifehexal 20mg - pink to light red round tablets. They are available in blisters of 60 tablets.
Nifehexal 20mg - 20mg nifedipine
iron oxide red.
Nifehexal is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
This leaflet was revised in May 2008.
Australian Register Number
Nifehexal 20mg tablets: AUST R 68084
Published by MIMS/myDr September 2008
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