Apo Trandolapril 1mg Capsules (Pack of 28)

ODRIK

trandolapril

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ODRIK.

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 risks of you taking ODRIK 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 ODRIK is used for

ODRIK is used to treat high blood pressure (hypertension) and also to treat some heart conditions.

There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can lead to serious health problems, including stroke, heart disease and kidney failure. ODRIK helps to lower your blood pressure.

ODRIK belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by relaxing your blood vessels, making it easier for blood to move around your body. This helps lower blood pressure and increase the supply of blood and oxygen to the heart.

Your doctor may prescribe ODRIK for another reason. Ask your doctor if you have any questions about why ODRIK has been prescribed for you.

ODRIK is only available with a doctor`s prescription.

ODRIK is not addictive.

ODRIK is not recommended for use in children as there have been no studies of its effects in children.

Before you take ODRIK

When you must not take it

Do not take ODRIK if you have had an allergic reaction to ODRIK or to any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath , swelling of the face, lips, tongue, throat, hands or feet.

Do not take ODRIK if you have taken any other ” ACE inhibitor” medicine before which caused your face, lips, tongue, throat, hands or feet to swell up, or made it hard for you to breathe.

If you have had an allergic reaction to an ACE inhibitor before, you may be allergic to ODRIK.

Do not take ODRIK if you have a history of swelling of the face, lips, mouth, tongue, throat, hands or feet for no apparent reason.

Taking ODRIK could cause this problem to happen again.

Do not take ODRIK if you are undergoing haemodialysis or having your blood treated outside your body.

Taking ODRIK could cause an allergic reaction.

Do not take ODRIK if you are pregnant or intend to become pregnant.

ODRIK may affect your developing baby if you take it during pregnancy.

Do not take ODRIK if you are breast-feeding or plan to breast-feed.

Like most ACE inhibitors, ODRIK is not recommended while you are breast-feeding.

Do not take ODRIK after the expiry date (EXP) printed on the pack.

Do not take ODRIK if the packaging is torn or shows signs of tampering or if the capsules don`t look quite right.

If you are not sure whether you should start taking ODRIK, contact your doctor.

Before you start to take it

Tell your doctor if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes
  • Tell your doctor if you have or have had any medical conditions, especially the following:

  • kidney or liver problems
  • regular dialysis, blood filtration or similar procedures
  • high levels of potassium in your blood
  • dizzy spells
  • diabetes
  • connective tissue disease
  • are about to have surgery or a general anaesthetic
  • any heart conditions
  • Tell your doctor if you have a family history of excessive swelling of the face, lips, mouth, tongue or throat.
    Tell your doctor if you are following a very low salt diet.

    Tell your doctor if you are about to receive desensitisation treatment for an allergy e.g. to insect stings

    Tell your doctor if you plan to become pregnant or breastfeed.

    ODRIK should not be used during pregnancy or while you are breast-feeding.

    If you have not told your doctor about any of the above, tell them before you start taking ODRIK

  • Taking other medicines

    Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

    Some medicines and ODRIK may interfere with each other.

    These include:

  • other high blood pressure medicines including diuretics (“fluid”) tablets
  • lithium – a medicine used to treat mood changes
  • some medicines used to treat arthritis, pain or fever
  • potassium supplements or large amounts of salt
  • potassium – containing salt substitutes in your food (check the label)
  • antacids
  • medicines which lower the body`s resistance to disease
  • general anaesthetics
  • These medicines may be affected by ODRIK or may affect how well it works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful of or to avoid while taking ODRIK.

    How to take ODRIK

    How much to take

    Your doctor will tell you how many capsules you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

    The usual dosage is one or two capsules taken once daily, up to a maximum of 4mg (two 2mg capsules) once daily.

    Dosage for older people over 65 years.

    The usual starting dose for older people is less than that for younger adults. Your doctor will adjust the dose of ODRIK, depending on how quickly your kidneys and liver can remove it from your body.

    Follow all directions given to you by your doctor and pharmacist carefully.

    These directions may differ from the information contained in this leaflet.

    If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

    How to take it

    Swallow ODRIK with water.

    When to take it

    Take ODRIK at about the same time each day.

    Taking your capsules at the same time each day will have the best effect. It will also help you remember when to take the capsules.

    It does not matter if you take ODRIK before, during or after food.

    If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of ODRIK.

    If you forget to take it

    If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

    Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

    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 to take your medicine, ask your pharmacist for some hints.

    How long to take it

    ODRIK helps control your condition, but does not cure it.

    Therefore you must take ODRIK every day. Continue taking the capsules for as long as your doctor tells you.

    If you take too much (overdose)

    Immediately telephone your doctor or pharmacist or the Poisons Information Centre (Australia telephone 13 11 26 or New Zealand 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much ODRIK. Do this even if there are no signs of discomfort or poisoning.

    You may need urgent medical attention.

    If you take too much ODRIK, you may feel dizzy, light-headed, weak, have palpitations or faint.

    While you are using ODRIK

    Things you must do

    Have your blood pressure checked when your doctor says, to make sure ODRIK is working.

    If you become pregnant while taking ODRIK tell your doctor immediately.

    If you feel light-headed or dizzy after taking your first dose of ODRIK, or when your
    dose is increased, tell your doctor immediately.

    Tell your doctor if you have excessive vomiting and/or diarrhoea while taking ODRIK.

    You may lose too much water and salt and your blood pressure may drop too much.

    Drink plenty of water when you are using ODRIK, especially if you sweat a lot (e.g. during hot weather or exercise).

    If you do not drink enough water while taking ODRIK, you may faint or feel light-headed or sick. This is because your blood pressure is dropping suddenly. If you continue to feel unwell, tell your doctor.

    Tell any other doctors, dentists, and pharmacists who are treating you that you are taking ODRIK.

    If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are taking ODRIK.
    If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking ODRIK.

    If you are about to have any blood tests, tell your doctor that you are taking ODRIK.

    ODRIK may interfere with the results of some tests.

    Go to your doctor regularly for a check-up.

    Your doctor may occasionally do a blood test to check your potassium level in the blood and to see how your kidneys are working.

    Things you must not do

    Do not give ODRIK to anyone else, even if they have the same condition as you.

    Do not take ODRIK to treat any other complaints unless your doctor tells you to.

    Do not stop taking ODRIK, or lower the dosage, without checking with your doctor.

    Things to be careful of

    If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up.

    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.

    Be careful driving or operating machinery until you know how ODRIK affects you.

    ODRIK may cause dizziness, light-headedness or tiredness in some people. Make sure you know how you react to ODRIK before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

    If this occurs, do not drive.

    If you drink alcohol, dizziness or light-headedness may be worse.

    Side effects

    Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ODRIK.

    ODRIK helps most people with hypertension and some heart conditions, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

    If you are over 65 years of age you may have an increased chance of getting side effects.

    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:

  • light-headedness or dizziness
  • nausea, vomiting, diarrhoea or stomach pains
  • indigestion
  • persistent dry cough
  • headache
  • unusual tiredness or weakness
  • aching, tender or weak muscles not caused by exercise
  • taste disturbance
  • These are the more common side effects of ODRIK.

  • Tell your doctor immediately if you notice any of the following:-

  • fast or irregular heart beat, also called palpitations
  • signs of worrying or frequent infections such as fever, severe chills, sore throat or mouth ulcers.
  • itchy skin rash or other skin problems
  • symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal.
  • These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

    If any of the following happen, stop taking ODRIK and tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

  • fainting within a couple of hours of taking ODRIK
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
  • severe dizziness and confusion with visual disturbances and speech problems
  • chest pain
  • rapid, shallow breathing, cold clammy skin, a rapid, weak pulse, dizziness, weakness and fainting.
  • These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

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

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

    After using ODRIK

    Storage

    Keep your capsules in the pack until it is time to take them.

    If you take the capsules out of the pack, they will not keep well.

    Keep your capsules in a cool dry place where the temperature stays below 25 degrees C.

    Do not store ODRIK or any other medicine in the bathroom or near a sink.

    Do not leave it in the car on hot days or on a window sill.

    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 ODRIK or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

    Product description

    What it looks like

    ODRIK capsules are available in three different strengths. Each strength has a separate colour to distinguish it from the others.

  • ODRIK 0.5mg:
  • red & yellow capsules
  • ODRIK 1.0mg:
  • red & orange capsules
  • ODRIK 2.0mg:
  • red capsules
  • Ingredients

    Active Ingredient:

  • ODRIK 0.5mg – 0.5 mg trandolapril per capsule
  • ODRIK 1mg – 1mg trandolapril per capsule
  • ODRIK 2mg – 2mg trandolapril per capsule
  • Inactive Ingredients:

  • maize starch
  • lactose
  • povidone
  • sodium stearylfumarate
  • gelatin
  • titanium dioxide (171)
  • erythrosine CI 45430 (127)
  • iron oxide yellow CI 77492 (172)
  • ODRIK does not contain gluten, sucrose or tartrazine or any other azo dyes.

    Supplier

    ODRIK is supplied in Australia by:

  • Knoll Australia, Division of Abbott Australasia Pty Ltd
  • 32-34 Lord Street
  • Botany NSW 2019
  • AUSTRALIA
  • (ABN 95 000 180 389)
  • ODRIK Australian Registration Numbers:
  • 0.5mg capsules:
  • AUST R 45486
  • 1.0mg capsules:
  • AUST R 45487
  • 2.0mg capsules:
  • AUST R 45488
  • Updated: 8 June 2006
  • ENQUIRE

    1800 200 736