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 taking Tambocor?
Tambocor contains the active ingredient flecainide acetate. Tambocor tablets and injection
are used to treat a heart condition called arrhythmia. Arrhythmia is an irregular
or abnormal heartbeat.
2. What should I know before I use Tambocor?
Do not use if you have ever had an allergic reaction to Tambocor 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.
3. What if I am taking other medicines?
Some medicines may interfere with Tambocor and affect how it works.
4. How do I use Tambocor?
The usual starting dose of Tambocor tablets is 50 mg to 100 mg every 12 hours. The
usual maximum dose is 300 mg a day. However, some patients may need up to 400 mg a
day. Follow your doctor's instructions exactly.
The dose for Tambocor IV injection is usually around 2 mg/kg body weight and is given
in a hospital. Your doctor may vary the dose to suit your condition.
5. What should I know while taking Tambocor?
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Things you should do
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If you are about to start on any new medicines, remind your doctor and pharmacist
that you are taking Tambocor tablets or are being given Tambocor injection
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Tambocor.
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Things you should not do
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Follow your doctor's instructions exactly. Do not stop taking Tambocor or lower the
dose without first checking with your doctor.
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Driving or using machines
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Tambocor can cause dizziness, light headedness, faintness and problems with your vision,
therefore do not drive or use any machines or tools.
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Looking after your medicine
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Tambocor tablets: keep in their blister pack and carton until it is time to take them.
Store in a cool dry place where the temperature stays below 30°C.
Keep out of reach of children.
Tambocor injection: will usually be stored in the hospital pharmacy and the pharmacist
will ensure that it is safely stored before use.
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6. Are there any side effects?
Common side effects include minor and temporary dizziness, blurred eyesight, double
vision and not able to stand bright lights, nausea, difficulty breathing, tiredness,
headache and chest pain.
Serious side effects include irregular or rapid heartbeat and dizziness.
Active ingredient:
Flecainide acetate (fleck-ain-ide-ass-e-tate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Tambocor tablets and injection.
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 Tambocor tablets and injections.
Where to find information in this leaflet:
1. Why am I taking Tambocor?
Tambocor contains the active ingredient flecainide acetate. Tambocor belongs to a group of drugs called antiarrhythmic medicines which slow down
the impulses that cause the heart to beat in an irregular or abnormal way.
Tambocor
is used to treat a heart condition called arrhythmia. Arrhythmia is an irregular or
abnormal heartbeat.
2. What should I know before I take Tambocor?
Warnings
Do not use Tambocor:
If you are allergic to flecainide acetate, or any of the ingredients listed at the
end of this leaflet. 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
Always check the ingredients to make sure you can use this medicine
If you have heart, liver, or kidney disease unless your doctor says it is suitable
for you
If the packaging is torn or shows signs of tampering.
Check with your doctor if you:
Have used Tambocor before and had any problems you think may have been caused by it
Have problems with your heart, liver or kidney
Take any medicines for any other condition.
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
Do not take Tambocor tablets or be given Tambocor injection if you are pregnant or
intend to become pregnant. Tambocor may affect your developing baby if you take it
during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. There is a possibility
that the active ingredient in Tambocor passes into breast milk and may affect your
baby.
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.
It is particularly important to tell your doctor or pharmacist if you are taking any
medicines to treat:
High blood pressure, angina or other heart conditions
Stomach ulcers.
Some medicines may interfere with Tambocor and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Tambocor.
4. How do I take Tambocor?
How much Tambocor to take
Tablets
In adults the usual starting dose of Tambocor tablets is 50 mg to 100 mg every 12
hours. Your doctor may gradually increase this dose. The usual maximum dose is 300
mg a day. However, some patients may need up to 400 mg a day
Follow your doctor's instructions exactly. Never change the dose yourself. Do not
stop taking Tambocor unless your doctor tells you to because if you suddenly stop
taking Tambocor it may make your condition worse.
Injection
The dose for Tambocor IV injection is usually around 2 mg/kg body weight and is given
in a hospital. Your doctor may vary the dose to suit your condition.
How to take Tambocor
Tablets
Swallow your tablets with plenty of water. You can take Tambocor tablets before or
after meals.
If you forget to take Tambocor
Tablets
Take Tambocor tablets regularly at the same time each day. If you miss your dose at
the usual time, take them as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Do not take a double dose to make up for the dose you
missed. If you miss two or more doses, talk to your doctor.
Injection
Your doctor will ensure that you are given the correct dose at the required time.
If you take too much Tambocor
Tablets
If you think that you have taken too many Tambocor tablets, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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.
Injection
The hospital doctor will ensure you are given the correct dose of Tambocor injection
but if you are worried about receiving too much Tambocor injection speak to the doctor.
5. What should I know while taking Tambocor?
Things you should do
If you are about to start on any new medicines, remind your doctor and pharmacist
that you are taking Tambocor tablets or are being given Tambocor injection.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Tambocor. It may affect other medicines used during surgery.
Call your doctor straight away if you:
Become pregnant while taking Tambocor tablets or are being given Tambocor injection.
Remind any doctor, dentist or pharmacist you visit that you are taking Tambocor.
Things you should not do
Do not stop taking Tambocor or lower the dose without first checking with your doctor.
Driving or using machines
Tambocor can cause dizziness light headedness, faintness and problems with your vision,
therefore do not drive or use any machines or tools.
Looking after your medicine
Tablets
Store below 30 0C.
Keep Tambocor tablets in their blister pack and carton until it is time to take them.
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.
Injection
Tambocor injection will usually be stored in the hospital pharmacy and the pharmacist
will ensure that it is safely stored before use
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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 Tambocor Tablets contain
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Active ingredient
(main ingredient)
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Flecainide acetate
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Other ingredients
(inactive ingredients)
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Starch
Croscarmellose sodium
Cellulose
Vegetable oil
Magnesium stearate
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Potential allergens
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None
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What Tambocor Injections contain
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Active ingredient
(main ingredient)
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Flecainide acetate
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Other ingredients
(inactive ingredients)
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Acetic acid
Sodium acetate
Water for injections
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Potential allergens
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None
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Do not take this medicine if you are allergic to any of these ingredients.
What Tambocor looks like
Tambocor 50 mg tablets are white, round tablets marked TR50 on one side and plain
on the other packed in blisters. Each pack contains 60 tablets (AUST R 41001).
Tambocor 100 mg tablets are white, round tablets marked TR100 on one side and plain
on the other packed in blisters. Each pack contains 60 tablets (AUST R 41002).
Tambocor IV injection is a clear, colourless solution in a clear glass ampoule. Each
pack contains 5 ampoules (AUST R 10592).
Who distributes Tambocor
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
This leaflet was prepared in November 2021.