Adalat Oros Consumer Medicine Information

Nifedipine 30mg and 60mg tablets

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about ADALAT OROS. This leaflet does not relate to other forms of ADALAT products.

This leaflet 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 ADALAT OROS against the benefits they expect it will have for you.

As ADALAT OROS is a prescription medicine, it should only be used under medical supervision.

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 ADALAT OROS IS USED FOR

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

Please note ADALAT OROS is not used for the relief of a sudden attack of angina.

ADALAT OROS contains 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 OROS for another purpose. Ask your doctor if you have any questions about why ADALAT OROS has been prescribed for you.

ADALAT OROS is specially designed to allow the slow release of the active substance from the tablet after it is taken. It is composed of a strong outer shell which does not dissolve in the body and is excreted in the faeces. It is normal to find these "ghost-tablets" in the faeces. The active substance contained in them has been absorbed by the body before excretion.

BEFORE YOU TAKE ADALAT OROS

When you must not take it

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

Do not take ADALAT OROS 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).

Do not take ADALAT OROS if you have Kock Pouch or ileostomy.

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

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

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

Do not take tablets that show visible signs of deterioration (e.g. are broken or discoloured).

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

Before you start to take ADALAT OROS

Tell your doctor if you:

  • are allergic to any other medicines or any foods, dyes or preservatives.
  • have any other medical conditions (either now or in the past), especially those relating to heart failure, other heart or blood vessel disorders, low blood pressure, liver disease, diabetes, blockage of your oesophagus or intestine, prolonged diarrhoea, or surgical operations carried out on your bowel. You should discuss these medical conditions with your doctor to check whether ADALAT OROS is suitable for you.
  • experience symptoms of bowel blockage. The undissolved shell of the ADADALT OROS tablet or "ghost-tablets" may not be excreted in your faeces and may collect in your stomach. Surgical intervention may be necessary to remove the shells.

Taking other medicines

Tell your doctor or pharmacist if 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 OROS include:

  • Cimetidine (Tagamet™)
  • Erythromycin (Erythrocin™, EES™, E-Mycin™, Eryhexal™)
  • Warfarin (Coumadin™, Marevan™)
  • Digoxin (Lanoxin PG™, Lanoxin™)
  • Medicines used to treat irregular heartbeats such as Quinidine (Kinidin™) and some beta-blockers
  • Quinupristin and dalfopristin (Synercid™)
  • Rifampicin (Rimycin™)
  • Some medicines used to treat epilepsy
  • Cisapride (Prepulsid™)
  • Medicines used to treat HIV such as amprenavir, indinavir, nelfinavir, ritonavir or saquinavir
  • Oral medicines used to treat fungal infections
  • Other medicines used to treat high blood pressure or angina.
  • Tacrolimus (Prograf™)

(™ indicate trademarks of the original manufacturers/suppliers)

These medicines may be affected by ADALAT OROS or may affect how well ADALAT OROS works. 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 OROS.

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

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking ADALAT OROS.

HOW TO TAKE ADALAT OROS

How much to take

The correct dose of ADALAT OROS to take has been decided by your doctor. Make sure you follow the instructions given to you by your doctor. The dose range for the treatment of high blood pressure is between 20mg to 120 mg once daily, and for the treatment of chronic stable angina is between 30mg to 90mg once daily.

How to take it

The tablets must not be chewed or broken up. They are to be swallowed whole with some liquid. They can be taken either with or without a meal. Do not halve the tablets.

When to take it

The tablets should generally be taken in the morning.

How long to take it

Your doctor will determine how long you should take ADALAT OROS 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 forgot to take your daily dose of ADALAT OROS at the right time and remember in less than 12 hours, take it straight away, then continue as normal the next day. Otherwise, skip that day's dose but be sure to take the next day's dose when it is due.

Do NOT take a double dose to make up for the dose 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 in Australia 13 11 26; in 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 OROS. 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 OROS

Things you must do

Take ADALAT OROS 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 OROS.

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

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 OROS affects you.

ADALAT OROS may cause dizziness or fainting in some patients who have low blood pressure, especially when they first start taking the medicine, change dose, or drink alcohol.

Make sure you know how you react to ADALAT OROS before driving a car, operating machinery, or do 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 OROS. 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 OROS helps most people with high blood pressure or chronic stable angina, but like other medicines, it 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 OROS.

Some common side effects which have been reported for ADALAT OROS include headache, constipation, feeling dizzy, feeling sick (nausea), flushing, loss of energy, unusual tiredness or weakness, numbness in the hands and feet, and swelling of the ankles or legs. These effects often go away with time.

Bleeding, tender or swollen gums may occur some time after starting ADALAT OROS. Muscle pain, trembling, visual disturbances and an increase in the need to pass water may occur.

Occasionally, the treatment of high blood pressure may lead to slight breast swelling in older men. This side effect goes away when treatment is stopped.

Tell your doctor immediately if any of the following happen to you:

  • fast or irregular heartbeat
  • fainting
  • signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers.

These side effects could be serious. You may need medical attention. Serious side effects are rare.

If any of the following happen, stop taking ADALAT OROS and tell your doctor immediately or go to casualty at your nearest hospital:

  • chest pain
  • signs of allergy 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
  • signs of liver problems such as yellowing of the skin and/or eyes (jaundice).

These very serious side effects are rare. If you have these side effects you may need urgent medical attention.

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 that some people develop a rash or blistering of the skin when they are exposed to sunlight.

In very rare cases, the undissolved shell of the ADADALT OROS tablet or "ghost-tablets" may not be excreted in the faeces and may collect in the stomach. Tell your doctor if you experience symptoms of bowel blockage. Surgical intervention may be necessary to remove these shells.

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 OROS 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.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist any questions you may have.

AFTER USING ADALAT OROS

Storage

ADALAT OROS 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 it 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. Contact of ADALAT OROS with moisture can cause the release of the active ingredient from the tablet. To prevent this, the tablets must be kept in their original packaging until immediately before use. Do not use a tablet if the blister-foil seal has been broken.

Disposal

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

PRODUCT DESCRIPTION

What it looks like

ADATAT OROS 20 mg tablets (Available in Australia only) are round, biconvex film-coated tablets in rose-pink colour marked with "ADALAT 20" on one side. The tablets are supplied in blister packs of 30 tablets, with each tablet containing 20 mg of nifedipine.

ADALAT OROS 30 mg tablets are round, biconvex film-coated tablets in rose-pink colour marked with "ADALAT 30" on one side. The tablets are supplied in blister packs of 30 tablets, with each tablet containing 30 mg of nifedipine.

ADALAT OROS 60 mg tablets are round, biconvex film-coated tablets in rose-pink colour marked with "ADALAT 60" on one side. The tablets are supplied in blister packs of 30 tablets, with each tablet containing 60 mg of nifedipine.

Ingredients

Active Ingredients per tablet:

ADALAT OROS 20 - nifedipine 20mg
ADALAT OROS 30 - nifedipine 30mg
ADALAT OROS 60 - nifedipine 60mg

Inactive ingredients:

  • polyethylene oxide
  • magnesium stearate
  • sodium chloride
  • hypromellose
  • iron oxide red (CI 77491)
  • hydroxypropylcellulose
  • cellulose acetate
  • macrogol 4000
  • titanium dioxide
  • propylene glycol.

Date of preparation

September 2004