Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using TARKA
TARKA contains the active ingredients trandolapril and verapamil hydrochloride. TARKA
is used to treat hypertension (high blood pressure).
For more information, see Section
1. Why am I using TARKA in the full CMI.
2. What should I know before I use TARKA
Do not use if you have ever had an allergic reaction to any medicine containing trandolapril
(or any other ACE inhibitor), any medicine containing verapamil or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use TARKA in the full CMI.
3. What if I am taking other medicines?
4. How do I use TARKA
The usual dosage for TARKA is one tablet daily. The maximum dose of TARKA is one 4/240
mg tablet once daily.
5. What should I know while using TARKA
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TARKA.
Have your blood pressure checked when your doctor says, to make sure TARKA is working
for you
If you feel light-headed or dizzy after taking your first dose of TARKA, or when your
dose is increased, tell your doctor immediately.
Tell your doctor if you have excessive vomiting and/or diarrhoea while taking TARKA.
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|
Things you should not do
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Do not take eat grapefruit or drink grapefruit juice whilst taking TARKA.
Do not use TARKA to treat any other complaints unless your doctor or pharmacist tells
you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not stop taking TARKA, or lower the dosage, without checking with your doctor.
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|
Driving or using machines
|
TARKA may cause dizziness, light-headedness, or tiredness, in some people. Make sure
you know how you react to TARKA; and if you have any of these symptoms, do not drive,
operate machinery or do anything else that could be dangerous.
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Drinking alcohol
|
Avoid drinking alcohol while you are taking this medicine. You may experience greater
blood pressure lowering effects than usual. You may experience worsening dizziness
or light-headedness.
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|
Looking after your medicine
|
Keep your tablets in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Tell your doctor if the following worry you: dizziness, nausea, vomiting, diarrhoea,
indigestion, persistent dry cough, headache, unusual tiredness, aching, tender or
weak muscles and taste disturbance.
Tell your doctor immediately or go to your nearest hospital if you experience any
serious side effects.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
trandolapril/verapamil hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TARKA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using TARKA.
Where to find information in this leaflet:
1. Why am I using TARKA
TARKA contains two different types of medicines: verapamil hydrochloride in a slow
release formulation, and trandolapril in an immediate release formulation.
Verapamil belongs to a group of medicines called calcium channel blockers.
Calcium channel blockers work by opening up blood vessels, which lets more blood and
oxygen reach the heart and at the same time lowers high blood pressure.
Trandolapril belongs to a group of medicines called Angiotensin Converting Enzyme
(ACE) Inhibitors.
ACE inhibitors work 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 your heart.
TARKA is used to treat hypertension (high blood pressure).
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.
Ask your doctor if you have any questions about why TARKA has been prescribed for
you.
Your doctor may have prescribed it for another reason.
There is no evidence that TARKA is addictive.
TARKA should not be given to children under the age of 18, as there have been no studies
of its effects in children.
2. What should I know before I use TARKA
Warnings
Do not use TARKA if:
you have an allergy to:
any medicine containing trandolapril (or any other ACE inhibitor)
any medicine containing verapamil.
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction include skin rash, itching, shortness
of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing
or breathing.
you have experienced symptoms such as wheezing, swelling of the face, lips, mouth,
tongue, throat, hands or feet, intense itching or severe skin rashes with previous
ACE inhibitor treatment or if you or a member of your family have had these symptoms
either spontaneously, or in response to another medicine in the past (a condition
called angioedema).
Taking TARKA could cause this problem to happen again.
you are pregnant or planning to become pregnant.
It may affect your developing baby if you take it during pregnancy.
you are breastfeeding
The active ingredients in TARKA may pass into breast milk and there is a possibility
that your baby may be affected.
you have severe kidney or liver problems
you have certain heart conditions (such as heart failure, a very slow heart rate,
heart conduction problems, some irregular heartbeats, or disease of the heart muscle)
you have low blood pressure, (hypotension)
you are currently being treated with intravenous β-adrenoreceptor antagonists (with
the exception of being treated in ICU
you undergo treatments where your blood is treated outside your body (extracorporeal
treatments), such as haemodialysis with certain membranes, or LDL-apheresis (removal
of LDL from your blood)
you have a history of angioedema (if you or a member of your family have had wheezing,
swelling of the face, lips, mouth, tongue, throat, hands or feet, intense itching
or severe skin rashes, either spontaneously, with previous ACE inhibitor treatment
or in response to another medicine in the past)
you are taking any of the following medications, or medications containing these ingredients:
aliskiren (under certain conditions)
ivabradine
Direct Oral Anticoagulants (DOACs) which thin the blood such as dabigatran (under
certain conditions)
neutral endopeptidase (NEP) inhibitors such as sacubitril or racecadotril.
sacubitril in combination with valsartan
Do not give this TARKA to a child under the age of 18 years.
TARKA's safety and effectiveness in children younger than 18 years have not been established.
Tell your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have or have had any of the following medical conditions:
any other heart problem, including aortic stenosis (narrowing of your aortic valve
or aorta - the main artery leaving your heart)
blood vessel (circulatory) disease or a stroke
liver problems
kidney problems, including narrowing of the arteries to your kidneys (called renal
artery stenosis) or need dialysis
high levels of potassium in your blood
recent vomiting or diarrhoea or if you are dehydrated
muscle conditions such as Duchenne muscular dystrophy, myasthenia gravis, Lambert-Eaton
syndrome
connective tissue disease
dizzy spells
diabetes
are of African origin, you may have a higher risk of angioedema.
In black patients, ACE inhibitors are less effective in lowering blood pressure than
in white patients.
are taking a diuretic ('fluid' tablets), potassium supplements, on a low-salt diet,
or use potassium-salt substitutes.
have or are about to have:
surgery or general anaesthetic
desensitisation treatment for an allergy e.g. to insect stings
regular dialysis, blood filtration or similar procedures
LDL removed from your blood (LDL-apheresis)
have an intolerance to some sugars. TARKA contains sugars (as lactose).
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with TARKA and affect how it works. Please tell your doctor if you are taking any of the following:
Medicines used to treat heart problems or high blood pressure:
Beta-blockers e.g. atenolol, propranolol, metoprolol, etc
Diuretics (also called fluid tablets)
Angiotensin II receptor blockers (also called ARBs, A2RAs, or sartans)
Aliskiren
Ivabradine
Digoxin
neutral endopeptidase (NEP) inhibitors such as sacubitril or racecadotril
Any other medicines used to control an irregular heartbeat e.g. quinidine, flecainide,
amiodarone, disopyramide, procainamide
Any other medicines used to control high blood pressure
Medicines used to treat or prevent blood clots (sometimes referred to as "blood thinners")
Direct Oral Anticoagulants (DOACs) which thin the blood such as dabigatran
aspirin, heparin
Medicines used to lower cholesterol
Statins such as atorvastatin, simvastatin or lovastatin
Medicines used to treat or prevent gout
Colchicine, sulfinpyrazone, allopurinol
Medicines used to lower blood glucose:
Anti-diabetic medicines such as insulin and any oral hypoglycaemic medicines, including
metformin, glibenclamide or vildagliptin
Medicines used to treat psychological problems
Any medicines used to treat depression, anxiety, or psychosis; such as imipramine,
buspirone, midazolam, lithium or tricyclic antidepressants.
Medicines used to treat epilepsy or seizures:
Phenytoin, carbamazepine, phenobarbital (phenobarbitone)
Medicines used to treat or prevent organ transplant rejection (immunosuppressants):
Such as ciclosporin, everolimus, sirolimus, tacrolimus and temsirolimus
Medicines used to treat infections or tuberculosis
Such as erythromycin, clarithromycin, telithromycin or rifampicin
Co-trimoxazole (trimethoprim and sulfamethoxazole)
Medicines used in the treatment of Human Immunodeficiency Virus (HIV):
Such as ritonavir
Medicines used in surgical procedures such as:
General anaesthetics used for inducing sleep
Muscle relaxants, including dantrolene
Medicines used to treat pain and inflammation (such as arthritis) or fever:
Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, diclofenac,
meloxicam, indometacin, celecoxib
Injectable gold
Other medicines that may react with TARKA:
Potassium supplements, or large amounts of salt
Potassium - containing salt substitutes in your food (check the label)
Sympathomimetics - these may be found in some decongestants, cough / cold remedies
and asthma medicines
Theophylline, a medicine used to treat asthma
Doxorubicin and cytostatic medicines, used to treat certain cancers
Cimetidine and other antacids, medicines commonly used to treat stomach ulcers and
reflux
Neuromuscular blocking agents such as vecuronium
Avoid grapefruit juice, as this may increase the blood levels of verapamil.
This is not a complete list of medicines which may interfere with TARKA.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking TARKA. You may need to use different amounts of your medicine
or take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TARKA.
4. How do I use TARKA
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet. Your doctor will tell
you how many tablets you will need to take each day and when to take them. This depends
on your condition, and whether or not you are taking any other medicines.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist
for help.
How much to take
The usual dosage for TARKA is one tablet daily.
The maximum dose of TARKA is one 4/240 mg tablet once daily.
When to take TARKA
Take TARKA at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
TARKA should ideally be taken in the morning with or after food.
If you need to take an antacid, take it at least 2 hours before or 2 hours after your
dose of TARKA.
Continue taking your medicine for as long as your doctor or pharmacist tells you.
TARKA helps control your blood pressure, but it does not cure it.
How to take TARKA
Swallow the tablets whole with a full glass of water.
Do not crush or chew TARKA tablets.
If you forget to use TARKA
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 you missed.
This may increase the chance of getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
advice.
If you use too much TARKA
If you think that you have used too much TARKA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include: a slow heartbeat, palpitations, chest pain, anxiety,
feeling faint, dizzy or light-headed, and collapsing.
5. What should I know while using TARKA
Things you should do
Have your blood pressure checked when your doctor says, to make sure TARKA is working
for you.
Drink plenty of water when you are using TARKA, especially if you sweat a lot (e.g.
during hot weather or exercise).
If you do not drink enough water while taking TARKA, you may feel faint or light-headed
or sick. This is because your blood pressure is dropping suddenly. If you continue
to feel unwell, tell your doctor.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking TARKA.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon that you are taking this medicine.
Visit your doctor regularly so that they can check on your progress.
Your doctor may ask you to have blood tests to check your liver from time to time
to make sure the medicine is working and to prevent unwanted side effects.
If you are about to receive any dialysis, desensitisation treatment for an allergy
e.g. to insect stings, or about to have LDL removed from your blood (LDL-apheresis),
tell your doctor that you are taking this medicine.
Call your doctor straight away if you:
feel light-headed or dizzy after taking your first dose of TARKA, or when your dose
is increased
have excessive vomiting and/or diarrhoea while taking TARKA.
The loss of water and salt from your body may cause your blood pressure to drop too
much.
become pregnant while you are taking this medicine
Remind any doctor, dentist or pharmacist you visit that you are using TARKA.
Things you should not do
Do not take eat grapefruit or drink grapefruit juice whilst taking TARKA.
Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not stop taking TARKA, or lower the dosage, without checking with your doctor.
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TARKA
affects you.
TARKA may cause dizziness, light-headedness, or tiredness, in some people. Make sure
you know how you react to TARKA; and if you have any of these symptoms, do not drive,
operate machinery or do anything else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Avoid drinking alcohol while you are taking this medicine.
You may experience greater blood pressure lowering effects than usual. You may experience
worsening dizziness or light-headedness.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the blister pack, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
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.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking TARKA.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
Report any side effects to your doctor promptly.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Less serious side effects
Very Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TARKA contains
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Active ingredient
(main ingredient)
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TARKA 2/180 contains 2 mg of trandolapril and 180 mg of slow release verapamil hydrochloride
as the active ingredients.
TARKA 4/240 contains 4 mg of trandolapril and 240 mg of slow release verapamil hydrochloride
as the active ingredients.
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
docusate sodium
hyprolose
hypromellose
iron oxide black
iron oxide red
iron oxide yellow
lactose monohydrate
macrogol 400
macrogol 6000
magnesium stearate
povidone
colloidal anhydrous silica
sodium alginate
sodium stearylfumarate
maize starch
purified talc
titanium dioxide
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Potential allergens
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TARKA contains sugars as lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What TARKA looks like
TARKA comes in two types of tablets:
TARKA 2/180 - pink, oval, film coated tablets, marked with the numbers "182" on one
side. The 2/180 mg strength is available in boxes of 28 tablets. (AUST R 104663)
TARKA 4/240 - red-brown, oval, film coated tablets, marked with the numbers "244"
on one side. The 4/240 mg strength is available in boxes of 28 tablets. (AUST R 104664)
Who distributes TARKA
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2023.
TARKA® is a Viatris company trade mark
TARKA_cmi\Oct23/00