Adalat Retard Consumer Medicine Information

Nifedipine Retard 10mg and 20mg tablets

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about ADALAT RETARD.

This leaflet does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

This leaflet does NOT relate to other forms of ADALAT products.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ADALAT RETARD against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Please read this leaflet carefully and keep it handy so you can refer to it easily.

What ADALAT RETARD IS USED FOR

ADALAT RETARD tablets are used either to treat high blood pressure or to prevent chronic stable angina, one of a number of types of angina.

Please note ADALAT RETARD tablets are not used for the relief of a sudden attack of angina.

ADALAT RETARD tablets contain the active substance nifedipine which belongs to a group of medicines called calcium channel blockers. They work by opening up blood vessels in the body to lower blood pressure and improve the supply of blood and oxygen to the heart.

Your doctor, however, may prescribe ADALAT RETARD tablets for another purpose. Ask your doctor if you have any questions about why ADALAT RETARD tablets have been prescribed for you.

BEFORE YOU TAKE ADALAT RETARD

When you must not take it

Do not take ADALAT RETARD tablets if you are allergic to the active substance nifedipine or any of the tablet ingredients (see PRODUCT DESCRIPTION at the end of this leaflet).

Do not take ADALAT RETARD tablets if you are allergic to active substances which are similar to nifedipine. These include active ingredients such as amlodipine, felodipine and isradipine.

Do not take ADALAT RETARD tablets if you are pregnant or breastfeeding. Tell your doctor if you become pregnant while you are taking ADALAT RETARD tablets.

Do not take ADALAT RETARD tablets if you are taking another medicine containing the active substance rifampicin.

Do not take ADALAT RETARD tablets after the expiry date which appears after the words "EXP" or "EXPIRY" printed on the pack.

Do not start taking ADALAT RETARD tablets if, when you start a new pack, the packaging is torn or shows signs of tampering.

Do not use ADALAT RETARD tablets to treat any other medical conditions unless your doctor says so.

Before you start to use ADALAT RETARD tablets

You must tell your doctor if:

  • you are allergic to any other medicines or any foods, dyes or preservatives.
  • you have any other medical conditions (either now or in the past), especially those relating to heart failure, narrowing of the aorta, liver disease, diabetes or kidney disease. You should discuss these medical conditions with your doctor to check whether ADALAT RETARD 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 of the medicines in common use that may interfere with ADALAT RETARD tablets include:

  • Cimetidine (Tagamet™)
  • Erythromycin (Erythrocin™, EES™, E-Mycin™, Eryhexal™)
  • Warfarin (Coumadin™, Marevan™)
  • Digoxin (Lanoxin PG™, Lanoxin™)
  • Diltiazem (Cardizem™, Cardizem-CD™)
  • Quinidine (Kinidin™)
  • Quinupristin and dalfopristin (Synercid™)
  • Rifampicin (Rimycin™)
  • Phenytoin (Dilantin™)
  • Carbamazepine (Tegretol™, Teril™, Carbium™)
  • Cisapride (Prepulsid™)
  • Medicines used to treat HIV such as amprenavir, indinavir, nelfinavir, ritonavir or saquinavir
  • Sodium valproate (Epilim™, Valpro™)
  • Ketoconazole (Nizoral™), itraconazole (Sporanox™), fluconazole (Diflucan™)
  • Other medicines used to treat high blood pressure.
  • Tacrolimus (Prograf™)

(™ indicates trademark of the original manufacturer and/or supplier)

These medicines may be affected by ADALAT RETARD tablets or may affect how well ADALAT RETARD tablets 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 ADALAT RETARD tablets.

You should not eat grapefruit or drink grapefruit juice while you are taking ADALAT RETARD tablets because this can cause unwanted changes in the blood pressure lowering effect of the tablets.

HOW TO TAKE ADALAT RETARD

How much to take

The correct dose of ADALAT RETARD 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 required, your doctor may increase the dose up to 40 mg twice daily. The maximum dose of 80 mg (daily) should not be exceeded.

How to take it

The tablets are to be swallowed with some liquid, independently of meals.

Do not halve the tablets.

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 ADALAT RETARD tablets. 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 forgot to take it

If you have forgotten to take your ADALAT RETARD tablet(s) at the right time, take it as soon as you remember, then continue as normal for the next dose. If you do not remember until it is almost time to take your next dose [ie. within 6 (six) hours of your next dose], then skip the dose that you forgot but be sure to take the next dose when it is due.

Do NOT take a double dose to make up for the dose that you missed.

If you have missed several doses, consult your doctor.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre for advice (Telephone: Australia 13 11 26; New Zealand 0800 POISON or 0800 764 766), or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too many ADALAT RETARD tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Signs of an overdose include feeling dizzy and fainting due to drop in blood pressure, irregular or rapid heart beats, shortness of breath and even loss of consciousness.

WHILE YOU ARE TAKING ADALAT RETARD

Things you must do

Take ADALAT RETARD 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 or relief from your angina.

Tell your doctor if you continue to have angina attacks or if they become more frequent while you are taking ADALAT RETARD tablets.

Tell all doctors, dentists and pharmacists who are treating you that you are taking ADALAT RETARD tablets.

Things you must not do

Do not give this medicine 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 ADALAT RETARD tablets affect you.

ADALAT RETARD tablets may cause dizziness or fainting in some patients who have low blood pressure, especially when they first start taking the medicine. Make sure you know how you react to ADALAT RETARD tablets before driving a car, operating machinery, or doing anything else that could be dangerous if this happens to you.

If you have angina, be careful not to overdo physical activities when you first start taking ADALAT RETARD tablets. You may feel better when you start taking it, but you will need time to improve your physical fitness.

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.

ADALAT RETARD tablets help most people with high blood pressure or chronic stable angina, but like other medicines, they may have unwanted effects in a few people. Check with your doctor or pharmacist as soon as possible if you have any problems while taking ADALAT RETARD.

Some common side effects which have been reported for ADALAT RETARD tablets include:

  • headache
  • feeling dizzy
  • feeling sick (nausea)
  • flushing
  • fast or irregular heartbeats
  • loss of energy
  • numbness in the hands and feet swelling of the ankles or legs.
  • bleeding, tender or swollen gums
  • skin reactions such as rash, itching or hives, muscle pain, trembling, visual disturbances
  • an increase in the need to pass water.

Occasionally, slight breast swelling may occur in older men. This side effect goes away when treatment is stopped.

As with all medicines, some people may be allergic to ADALAT RETARD tablets. Usually, if you are allergic to ADALAT RETARD tablets, a reaction will occur shortly after you start taking the medicine. 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 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.

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 ADALAT RETARD 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.

Ask your doctor or pharmacist any questions you may have.

AFTER TAKING ADALAT RETARD

Storage

ADALAT RETARD tablets should be kept in a cool, dry place away from sunlight where the temperature is not likely to be greater than 25°C. Do not leave them in the car on hot days.

Keep the tablets where children cannot reach them.

Keep the tablets in their blister pack until it is time to take them. Do not use a tablet if the blister-foil seal has been broken.

Disposal

If your doctor tells you to stop taking ADALAT RETARD TABLETS, ask your pharmacist what to do with any tablets left over.

PRODUCT DESCRIPTION

What it looks like

ADALAT RETARD 10 tablets are round, film-coated tablets in pink-gray colour marked with "A 10" on one side and the Bayer cross on the reverse. The tablets are supplied in blister packs of 60's with each tablet containing 10 mg of nifedipine.

ADALAT RETARD 20 tablets are round, film-coated tablets, pink-grey in colour, marked with "1 U" on one side and the Bayer cross on the reverse. The tablets are supplied in blister packs of 60's with each tablet containing 20 mg of nifedipine.

Ingredients

Active Ingredients:

ADALAT RETARD 10 - nifedipine 10 mg
ADALAT RETARD 20 - nifedipine 20 mg

Inactive ingredient:

  • Cellulose
  • maize starch
  • lactose
  • polysorbate 80
  • hypromellose
  • macrogol 4000
  • magnesium stearate
  • iron oxide red
  • titanium dioxide.

Date of preparation:

Feb 2004