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Amiodarone hydrochloride
Disclaimer
This document answers some common questions about Rithmik. 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 risk of you taking Rithmik against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this information with the medicine. You may want to read it again.
What Rithmik is used for
The name of your medicine is Rithmik. It contains the active ingredient amiodarone hydrochloride.
Rithmik is used to treat certain heart rhythm disorders.
Rithmik is used to control a fast or irregular heart beat.
Your doctor may have prescribed Rithmik for another reason. Ask your doctor if you have any questions about why Rithmik was prescribed for you.
How Rithmik works
Rithmik belongs to a group of medicines called antiarrhythmics.
Rithmik works by lengthening the period between one heart beat and the next, thus helping to bring the heart rate to a slower and more regular pace.
There is no evidence that Rithmik is addictive.
Before you take Rithmik
When you must not take Rithmik
Do not take Rithmik if:
• You are allergic to the active ingredient or iodine or any of the inactive ingredients mentioned at the end of this leaflet under Product Description. Symptoms of an allergic reaction include rash, asthma attack or hayfever.
• You have certain heart conditions.
• You have thyroid problems.
• You have severe respiratory (breathing) problems.
• You are pregnant or are thinking of getting pregnant. Rithmik is best avoided in the 3 months before getting pregnant and during pregnancy.
• You are breast feeding as it can be found in breast milk.
• It is past its expiry date or the packaging appears to have been tampered with.
Rithmik is not recommended for children.
Before you start to take Rithmik
Tell your doctor if you have allergies to:
• Any other medicines, especially if they are in the same drug class as amiodarone.
• Any other substances, including foods, preservatives or dyes.
Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are using Rithmik.
Tell your doctor if you have or have had any medical conditions, especially the following:
• Thyroid problems
• Other heart conditions
• Blood pressure problems
• Liver problems
• Respiratory (breathing) problems.
Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you take any of the following:
• Any medicines for your heart or blood pressure including:
• Calcium antagonists
• Beta blockers
• Digoxin
• Disopyramide
• Mexiletine
• Procainamide
• Quinidine
• Flecainide
• Sotalol
• MAO inhibitors, a type of drug used to treat depression
• Warfarin, a medicine which thins the blood
• Intravenous erythromycin, an antibiotic
• Intravenous pentamidine, an antibiotic
• Stimulating laxative agents, used to treat constipation
• Drugs which cause low potassium in your body e.g. fluid tablets
• Phenytoin, used to treat epilepsy
• Cyclosporin
• General anaesthesia
If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist.
These medicines may be affected by Rithmik, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
How to take Rithmik
Follow all directions given to you by your doctor and pharmacist carefully.
The usual dose is 200 mg three times a day for one week. The tablets should be taken consistently, at the same time with regards to food.
Therapy is then continued with 200 mg, two times a day for a further week.
The dose may then be reduced to 200 mg a day (or less if your doctor says so).
Swallow tablets whole with a little water or other liquid.
If you need to break Rithmik, hold tablet with both hands and snap along break line.
If you forget to take your dose
If you miss a dose, take it as soon as you remember, and continue to take it as you would normally.
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 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 some hints.
If you take too much
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much Rithmik. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are using Rithmik
Things you must do
• Always follow your doctor's instructions carefully.
• Tell all doctors, dentists and pharmacists that you are taking Rithmik.
• Tell your doctor if you become or intend to become pregnant while taking Rithmik.
• If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Rithmik.
• If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Amidoahexal.
Things you must not do
• Do not suddenly stop taking Rithmik without telling your doctor.
• Do not use Rithmik to treat any other complaint unless your doctor says so.
• Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
Be careful driving or operating machinery until you know how amiodarone affects you.
Rithmik may cause drowsiness, dizziness or blurred vision in some people, especially after the first dose.
Taking Rithmik tablets may make your skin more sensitive to the sun. This can range from an increased tendency to tan to intense redness and swelling.
Always use a 15+ sunscreen and wear a hat when outdoors.
Side effects
All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
• Nausea.
• Rithmik can cause small deposits to form on the eyeball. These usually go away after you stop the drug and rarely affect your sight.
• Bluish skin discolouration.
• Intense sunburn - always wear a sunscreen while taking Rithmik.
• Rash.
• Tremor, insomnia or vivid dreams
• Metallic taste.
These are all mild side effects of Rithmik. Tell your doctor immediately if you notice any of the following:
• Yellowing of the skin or eyes (called jaundice, a symptom of liver changes).
• Weight loss and restlessness (symptoms of an over active thyroid).
• Weight gain, constipation and reduced activity (symptoms of an under active thyroid).
• Muscle weakness or difficulty walking.
• Blurred or decreased vision.
These may be serious side effects of Rithmik. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, stop taking Rithmik, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
• Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
• Breathlessness or any difficulty breathing.
• Any disturbance in heart beat.
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
Your doctor will monitor you very carefully for side effects. This will involve blood tests to check how well your liver and thyroid are functioning. It will also involve regular chest x-rays, ECGs and eye tests. Your doctor will tell you how often you need to have these tests. This will depend on how long you are on Rithmik for and what dose you are on.
After using Rithmik
Storage
Keep Rithmik in the original packaging until you need to take it.
Store below 25°C in a dry place, out of the reach of children. Protect from light.
Do not store it in the bathroom or near a sink.
Disposal
Return any unused or out of date medicine to your pharmacist.
Product description
What Rithmik looks like
Rithmik 100 mg tablets: white, round tablets, scored on one side and convex on the other.
Rithmik 200 mg tablets: white, round tablets, biconvex with score on one side.
They are available in blister packs of 30 tablets.
Ingredients
As well as the active ingredient, Rithmik also contains some inactive ingredients. These are: maize starch, lactose, povidone, magnesium stearate and anhydrous colloidal silica.
Manufacturer
Hexal Australia Pty Ltd
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 0 HEXAL
www.hexal.com.au
Supplier
Rithmik is supplied in Australia by:
Arrow Pharmaceuticals Limited
24 Rothschild Avenue
Rosebery NSZ 2018
Australia
Australian Register Number
100 mg tablets: AUST R 98654
200 mg tablets: AUST R 98655
This information was prepared in November 2003.
RITHMIK/112003/CMI-1
Disclaimer
This document answers some common questions about Rithmik. 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 risk of you taking Rithmik against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this information with the medicine. You may want to read it again.
What Rithmik is used for
The name of your medicine is Rithmik. It contains the active ingredient amiodarone hydrochloride.
Rithmik is used to treat certain heart rhythm disorders.
Rithmik is used to control a fast or irregular heart beat.
Your doctor may have prescribed Rithmik for another reason. Ask your doctor if you have any questions about why Rithmik was prescribed for you.
How Rithmik works
Rithmik belongs to a group of medicines called antiarrhythmics.
Rithmik works by lengthening the period between one heart beat and the next, thus helping to bring the heart rate to a slower and more regular pace.
There is no evidence that Rithmik is addictive.
Before you take Rithmik
When you must not take Rithmik
Do not take Rithmik if:
• You are allergic to the active ingredient or iodine or any of the inactive ingredients mentioned at the end of this leaflet under Product Description. Symptoms of an allergic reaction include rash, asthma attack or hayfever.
• You have certain heart conditions.
• You have thyroid problems.
• You have severe respiratory (breathing) problems.
• You are pregnant or are thinking of getting pregnant. Rithmik is best avoided in the 3 months before getting pregnant and during pregnancy.
• You are breast feeding as it can be found in breast milk.
• It is past its expiry date or the packaging appears to have been tampered with.
Rithmik is not recommended for children.
Before you start to take Rithmik
Tell your doctor if you have allergies to:
• Any other medicines, especially if they are in the same drug class as amiodarone.
• Any other substances, including foods, preservatives or dyes.
Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are using Rithmik.
Tell your doctor if you have or have had any medical conditions, especially the following:
• Thyroid problems
• Other heart conditions
• Blood pressure problems
• Liver problems
• Respiratory (breathing) problems.
Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you take any of the following:
• Any medicines for your heart or blood pressure including:
• Calcium antagonists
• Beta blockers
• Digoxin
• Disopyramide
• Mexiletine
• Procainamide
• Quinidine
• Flecainide
• Sotalol
• MAO inhibitors, a type of drug used to treat depression
• Warfarin, a medicine which thins the blood
• Intravenous erythromycin, an antibiotic
• Intravenous pentamidine, an antibiotic
• Stimulating laxative agents, used to treat constipation
• Drugs which cause low potassium in your body e.g. fluid tablets
• Phenytoin, used to treat epilepsy
• Cyclosporin
• General anaesthesia
If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist.
These medicines may be affected by Rithmik, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
How to take Rithmik
Follow all directions given to you by your doctor and pharmacist carefully.
The usual dose is 200 mg three times a day for one week. The tablets should be taken consistently, at the same time with regards to food.
Therapy is then continued with 200 mg, two times a day for a further week.
The dose may then be reduced to 200 mg a day (or less if your doctor says so).
Swallow tablets whole with a little water or other liquid.
If you need to break Rithmik, hold tablet with both hands and snap along break line.
If you forget to take your dose
If you miss a dose, take it as soon as you remember, and continue to take it as you would normally.
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 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 some hints.
If you take too much
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much Rithmik. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are using Rithmik
Things you must do
• Always follow your doctor's instructions carefully.
• Tell all doctors, dentists and pharmacists that you are taking Rithmik.
• Tell your doctor if you become or intend to become pregnant while taking Rithmik.
• If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Rithmik.
• If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Amidoahexal.
Things you must not do
• Do not suddenly stop taking Rithmik without telling your doctor.
• Do not use Rithmik to treat any other complaint unless your doctor says so.
• Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
Be careful driving or operating machinery until you know how amiodarone affects you.
Rithmik may cause drowsiness, dizziness or blurred vision in some people, especially after the first dose.
Taking Rithmik tablets may make your skin more sensitive to the sun. This can range from an increased tendency to tan to intense redness and swelling.
Always use a 15+ sunscreen and wear a hat when outdoors.
Side effects
All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
• Nausea.
• Rithmik can cause small deposits to form on the eyeball. These usually go away after you stop the drug and rarely affect your sight.
• Bluish skin discolouration.
• Intense sunburn - always wear a sunscreen while taking Rithmik.
• Rash.
• Tremor, insomnia or vivid dreams
• Metallic taste.
These are all mild side effects of Rithmik. Tell your doctor immediately if you notice any of the following:
• Yellowing of the skin or eyes (called jaundice, a symptom of liver changes).
• Weight loss and restlessness (symptoms of an over active thyroid).
• Weight gain, constipation and reduced activity (symptoms of an under active thyroid).
• Muscle weakness or difficulty walking.
• Blurred or decreased vision.
These may be serious side effects of Rithmik. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, stop taking Rithmik, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
• Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
• Breathlessness or any difficulty breathing.
• Any disturbance in heart beat.
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
Your doctor will monitor you very carefully for side effects. This will involve blood tests to check how well your liver and thyroid are functioning. It will also involve regular chest x-rays, ECGs and eye tests. Your doctor will tell you how often you need to have these tests. This will depend on how long you are on Rithmik for and what dose you are on.
After using Rithmik
Storage
Keep Rithmik in the original packaging until you need to take it.
Store below 25°C in a dry place, out of the reach of children. Protect from light.
Do not store it in the bathroom or near a sink.
Disposal
Return any unused or out of date medicine to your pharmacist.
Product description
What Rithmik looks like
Rithmik 100 mg tablets: white, round tablets, scored on one side and convex on the other.
Rithmik 200 mg tablets: white, round tablets, biconvex with score on one side.
They are available in blister packs of 30 tablets.
Ingredients
As well as the active ingredient, Rithmik also contains some inactive ingredients. These are: maize starch, lactose, povidone, magnesium stearate and anhydrous colloidal silica.
Manufacturer
Hexal Australia Pty Ltd
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 0 HEXAL
www.hexal.com.au
Supplier
Rithmik is supplied in Australia by:
Arrow Pharmaceuticals Limited
24 Rothschild Avenue
Rosebery NSZ 2018
Australia
Australian Register Number
100 mg tablets: AUST R 98654
200 mg tablets: AUST R 98655
This information was prepared in November 2003.
RITHMIK/112003/CMI-1
