Consumer Medicine Information
ADALAT OROS™ (Add-a-lat Or-us)
nifedipine
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.
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.
Please note: Adalat Oros is not used for the relief of a sudden attack of angina.
BEFORE YOU TAKE ADALAT OROS
When you must not take it
Do not take Adalat Oros if you have an allergy to:
- nifedipine, the active ingredient in Adalat Oros
- any of the ingredients listed at the end of this leaflet
- active substances similar to nifedipine 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 are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
The active ingredient in Adalat Oros passes into breast milk and there is
a possibility that your baby may be affected.
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 this medicine after the expiry date printed on the pack and
blister.
The expiry date is printed on the carton and on each blister after "EXP"
(e.g. 11 09 refers to November 2009). The expiry date refers to the last day
of that month. If it has expired return it to your pharmacist for disposal.
Do not take this medicine if the packaging is torn or shows signs of
tampering.
If the packaging is damaged, return it to your pharmacist for disposal.
Do not take tablets that show visible signs of deterioration (e.g. are broken or discoloured).
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 experience symptoms of bowel blockage. The undissolved shell of the Adalat 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.
Tell your doctor if you have or have had any of the following medical conditions:
- heart failure
- other heart or blood vessel disorders
- low blood pressure
- narrowing of the aorta
- liver disease
- diabetes
- kidney disease
- blockage of your oesophagus or intestine
- prolonged diarrhoea
- 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.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Adalat Oros.
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 medicines and Adalat Oros may interfere with each other. These 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 it 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.
HOW TO TAKE ADALAT OROS
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 on the pharmacist label, ask your doctor or pharmacist for help.
How much to take
The correct dose of Adalat Oros to take has been decided by your doctor. The dose range for the treatment of high blood pressure is between 20 mg to 120 mg once daily, and for the treatment of chronic stable angina is between 30 mg to 90 mg 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 forget to take it
If you forget 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
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Adalat Oros.
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.
Do not use it to treat any other medical conditions unless your doctor says so.
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 Adalat Oros
affects you.
It 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
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking Adalat Oros.
All medicines can have side 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 the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
The list below includes the more common side effects of your medicine.
They are usually mild and short-lived.
- headache
- constipation
- feeling dizzy
- feeling sick (nausea),
- flushing
- loss of energy
- unusual tiredness
- weakness
- numbness in the hands and feet
- swelling of the ankles or legs
This list includes the less common side effects of your medicine.
- Bleeding
- tender or swollen gums may occur some time after starting Adalat Oros
- Muscle pain
- trembling
- visual disturbances
- an increase in the need to pass water may occur.
- 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 Adalat 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.
Tell your doctor or pharmacist if you notice anything that is making you
feel unwell.
Other side effects not listed above may also occur in some people.
Ask your doctor or pharmacist any questions you may have.
AFTER TAKING ADALAT OROS
Storage
Keep the tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep the medicine in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.
Do not leave it in the car.
Heat and damp can destroy some medicines.
Keep the tablets where children cannot reach them.
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.
Return any unused medicine to your pharmacist.
PRODUCT DESCRIPTION
What it looks like
Adalat 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 "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 "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 20 mg
- Adalat Oros 30 - nifedipine 30 mg
- Adalat Oros 60 - nifedipine 60 mg
Inactive ingredients:
- polyethylene oxide
- magnesium stearate
- sodium chloride
- hypromellose
- iron oxide red (CI 77491)
- hydroxypropylcellulose
- cellulose acetate
- macrogol 3350
- titanium dioxide
- propylene glycol
Supplier
Made in Germany for:
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
Bayer New Zealand Limited
3 Argus Place, Hillcrest,
North Shore, Auckland 0627
Australian Registration Numbers
ADALAT OROS 20 - AUST R 60101
ADALAT OROS 30 - AUST R 76041
ADALAT OROS 60 - AUST R 76040
Date of preparation
September 2009
See Bayer Australia website (www.bayer.com.au) for latest Australian Consumer Medicine Information.
See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.
™ Trademark of Bayer AG, Germany
© Bayer Australia Ltd. All rights reserved