Contains the active ingredient trandolapril
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
What is in this leaflet
Read this leaflet carefully before taking your medicine. This leaflet answers some common questions about trandolapril. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
- if there is anything you do not understand in this leaflet,
- if you are worried about taking your medicine, or
- to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with the medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Trandolapril. It contains the active ingredient trandolapril.
It is used to treat:
- hypertension (high blood pressure)
- heart problems (left ventricular dysfunction) following a heart attack.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
How it works
Trandolapril 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.
This medicine is not addictive.
Use in children
This medicine should not be used in children.
Before you take trandolapril
When you must not take it
Do not take this medicine if:
- You are undergoing haemodialysis or are having your blood treated outside of your body.
- You are taking aliskiren for the treatment of diabetes.
- You are pregnant.
Trandolapril may affect your developing baby if you take it during pregnancy. - You are breastfeeding.
Trandolapril may pass into human breast milk. - You or your family have a history of allergic reactions.
OR
You are hypersensitive to, or have had an allergic reaction to, trandolapril, any other ACE inhibitor or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital. - The expiry date (EXP) printed on the pack has passed.
- The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
- You have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes.
- You have or have had any medical conditions, especially the following:
- hypotension (low blood pressure)
- kidney or liver problems
- recent vomiting or diarrhoea
- dialysis, blood filtration or similar procedures
- high levels of potassium in your blood
- low levels of salt in your blood
- diabetes
- low white blood cell count
- connective tissue disease such as collagen vascular disease or are on an immunosuppressant therapy
- any heart conditions.
- You are following a low salt diet.
- You are about to receive desensitisation treatment for an allergy e.g. to insect stings.
- You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant.
- You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding.
- You are planning to have surgery or an anaesthetic.
- You are currently receiving or are planning to receive dental treatment.
- You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with trandolapril. These include:
- other high blood pressure medicines including other ACE inhibitors or beta-blockers
- diuretics used to treat fluid retention
- any anti-diabetic medicine including aliskiren
- lithium, neuroleptic or tricyclic antidepressants, used to treat mood changes
- anti-inflammatory pain medicines used to treat arthritis, pain or fever
- potassium supplements or large amounts of salt
- potassium-containing salt substitutes on your food (check the label)
- sympathomimetics – these may be found in some decongestants, cough/cold remedies and asthma medicines
- antacids
- allopurinol used for the treatment of gout
- medicines which lower the body’s resistance to disease such as immunosuppressive agents or systemic corticosteroids
- cytostatic medicines used to treat certain cancers
- procainamide used for abnormal heart rhythms
- general anaesthetics
- injectable gold (sodium aurothiomalate) used to treat rheumatoid arthritis.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with trandolapril.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Hypertension
The usual starting dose is 1mg once daily. Depending on how you respond this may be increased by your doctor.
Heart problems (left ventricular dysfunction) following a heart attack
The usual starting dose is 0.5mg once daily, followed by an increase to 1mg once daily, 2mg once daily and 4mg once daily, as directed by your doctor.
The maximum daily dose is 4mg daily.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Swallow this medicine with water.
When to take it
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take this medicine 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 this medicine.
How long to take it
This medicine helps control your condition, but does not cure it.
Therefore you must take this medicine every day. Continue taking the capsules for as long as your doctor tells you.
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 experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much of this medicine, you may feel dizzy, light-headed, weak, have palpitations or faint.
While you are taking this medicine
Things you must do
- you are about to be started on any new medicine
- you are pregnant or are planning to become pregnant
- you are breastfeeding or are planning to breast-feed
- you are about to have any blood tests
- you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Drink plenty of water when you are using this medicine, especially if you sweat a lot (e.g. during hot weather or exercise).
If you do not drink enough water while taking this medicine, 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.
Things you must not do
- Give this medicine to anyone else, even if their symptoms seem similar to yours.
- Take your medicine to treat any other condition unless your doctor tells you to.
- Stop taking your medicine, or change the dosage, without first 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.
Be careful driving or operating machinery until you know how this medicine affects you.
If you drink alcohol, dizziness or light-headedness may be worse.
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious, most of the time they are not.
Tell your doctor if you notice any of the following:
- 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.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
- 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.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects. You may need urgent medical attention.
- fainting within a couple of hours of taking this medicine
- 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.
Other side effects not listed above may occur in some patients.
Allergic reactions
If you think you are having an allergic reaction to trandolapril, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
- cough, shortness of breath, wheezing or difficulty breathing
- swelling of the face, lips, tongue, throat or other parts of the body
- rash, itching or hives on the skin
- fainting
- hay fever-like symptoms.
Storage and disposal
Storage
Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store this medicine 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 this medicine or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What APO-Trandolapril looks like
APO-Trandolapril Capsules are available in four different strengths.
- 0.5 mg
APO-Trandolapril Capsules 0.5 mg are orange coloured cap imprinted with ‘TR’ in black ink and ivory coloured body imprinted with ‘0.5’ in black ink. - 1 mg
APO-Trandolapril Capsules 1 mg are orange coloured cap imprinted with ‘TR’ in black ink and light orange coloured body imprinted with ‘1’ in black ink. - 2 mg
APO-Trandolapril Capsules 2 mg are orange coloured cap imprinted with ‘TR’ in black ink and orange coloured body imprinted with ‘2’ in black ink. - 4 mg
APO-Trandolapril Capsules 4 mg are flesh coloured cap imprinted with ‘TR’ in black ink and flesh coloured body imprinted with ‘4’ in black ink.
Ingredients
Active Ingredients:
Each tablet contains 0.5 mg, 1 mg, 2 mg or 4 mg of the active ingredient trandolapril.
It also contains the following inactive ingredients:
- Lactose
- Starch- maize
- Povidone
- Sodium stearylfumarate
- Gelatin
- Titanium dioxide (E171)
- Erythrosine – FD & C red 3 (E127)
(0.5 mg, 1 mg and 2 mg capsules) - Yellow iron oxide (E172)
(0.5 mg, 1 mg and 2 mg capsules) - Red iron oxide (E172)
(1 mg and 4 mg capsule) - Black ink (SW-9008)
(0.5 mg, 1 mg and 2 mg capsules) - Black ink (SW-9008 / SW-9009).
(4 mg capsule).
This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.
Australian Registration Numbers
- APO-Trandolapril Capsules 0.5 mg capsules: AUST R 135959
- APO-Trandolapril Capsules 1 mg capsules: AUST R 135968
- APO-Trandolapril Capsules 2 mg capsules: AUST R 135978
- APO-Trandolapril Capsules 4 mg capsules: AUST R 135985
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks, APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in March 2013.
Published by MIMS July 2013