Tambocor XL 200 mg Capsules
Flecainide acetate
Read all of this leaflet carefully before you take this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Tambocor XL capsules are for
2. Before you take Tambocor XL capsules
3. How to take Tambocor XL capsules
4. Possible side effects
5. How to store Tambocor XL capsules
6. Further information.
What Tambocor XL capsules are for
Tambocor XL capsules belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart.
Tambocor XL capsules are used to treat:
- Irregular heart beat (arrhythmias)
- Heart beat too fast (tachycardia)
- Rapid contractions of muscles in the heart (atrial fibrillation).
Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control.
Before you take Tambocor XL capsules
Do not take Tambocor XL capsules and tell your doctor or nurse if:
- You are allergic to active substance flecainide acetate or any of the other ingredients of Tambocor XL capsules (See section 6)
- You have heart failure
- You have had a heart attack (myocardial infarction)
- Your heart misses beats (have heart block)
- You have long-standing rapid contractions of muscles in the heart (atrial fibrillation)
- You have or have ever had any heart problems including problems with the valves in your heart or conduction problems
- You have a specific condition where your heart beats abnormally (sinus node dysfunction)
- You are pregnant or breast-feeding.
Tambocor XL capsules are not recommended for use in children under 12 years of age.
If any of the above applies to you tell your doctor or nurse.
Before you take Tambocor XL capsules your doctor or nurse may check:
- Your fluid levels are correct
- Your liver and kidney functions.
This is to check that Tambocor XL capsules are right for you and to help the doctor calculate the dose you need.
Check with your doctor or nurse before taking Tambocor XL capsules if:
- You have high blood pressure
- You have chest pains (angina)
- You have heart disease
- You have kidney disease or kidney problems
- You have liver disease or liver problems
- You wear a pacemaker.
Tell your doctor or nurse if you are taking any of the following medicines:
- Any other medicine used to treat irregular heart beat (heart arrhythmias) or heart problems. Examples of such medicines include cardiac glycosides, beta-blockers, verapamil or amiodarone
- Medicines to treat high blood pressure
- Medicines used to treat depression (antidepressants), such as tricyclic antidepressants, Prozac, fluoxetine or reboxetine
- Medicines used to prevent epileptic fits (anticonvulsants) such as phenytoin, phenobarbital or carbamazepine
- Medicines to treat mental illness (antipsychotics) such as clozapine
- Medicines to treat allergic reactions (antihistamines) such as mizolastine or terfenadine
- Medicine to treat malaria (quinine)
- Medicine to treat HIV such as ritonavir, lopinavir or indinavir
- Water tablets (diuretics)
- Medicine to treat stomach ulcers (cimetidine)
- Medicine to help stop you smoking (bupropion)
- Any other medicine, including medicines obtained without a prescription.
These medicines may interfere with your treatment.
Pregnancy and breast-feeding
Do not take Tambocor XL capsules if you are pregnant, are trying to become pregnant, or are breast-feeding. If you are uncertain about anything, ask your nurse or doctor for advice.
How to take Tambocor XL capsules
Always take Tambocor XL capsules exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for your condition. Usually your treatment with Tambocor XL capsules will be started under hospital supervision.
Remember: Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control.
Tambocor XL capsules should be swallowed whole with some water. They should not be broken open or chewed.
Adults
- The usual dose is one 200 mg capsule per day.
- Occasionally your doctor may decide you need a higher or lower dose than this. If this is the case your doctor may prescribe Tambocor tablets.
The elderly and patients with kidney or heart problems
- For elderly patients, and patients with kidney or heart problems, the doctor may tell you to take a lower dose.
While you are taking this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.
Children
- Tambocor XL capsules are not recommended for children under 12 years of age.
If you take more Tambocor XL capsules than you should
If you accidentally take too much, immediately go to the nearest hospital casualty department.
If you forget to take Tambocor XL capsules
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you stop taking Tambocor XL capsules
Do not stop taking Tambocor XL capsules without first talking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines Tambocor XL capsules can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
Your heartbeat changes; it starts to pound, or it gets faster or slower
You have chest pain
You become breathless or have other breathing or lung problems
You faint or you feel faint
You have ringing in your ears
Your skin and eyes begin to go yellow (jaundice)
You have a fever, become flushed or sweat
You have fits (convulsions).
Other side effects:
- Feeling or being sick
- Constipation
- Feeling bloated
- Wind
- Diarrhoea
- Stomach pain or indigestion
- Loss of appetite
- Confusion and hallucinations
- Forgetfulness
- Difficulty sleeping
- Feeling anxious (worried)
- Depression
- Red, itchy or swollen skin rash
- Sensitivity of the skin to sunlight
- Hair loss
- Feeling weak or tired
- Headache
- Double or blurred vision
- Small cloudy spots on the eyeball
- Feeling giddy or lightheaded
- Dizziness or feeling that the room is spinning (vertigo)
- Shaking (tremors)
- Unsteady walking, uncontrolled movements or poor coordination
- Numb or tingling hands or feet
- Swelling.
If any of these side effects get serious, or you notice any side effects not listed in this leaflet, tell your doctor or nurse.
How to store Tambocor XL capsules
Keep out of the reach and sight of children.
Do not store above 25 °C.
Keep the container in the outer carton to protect the capsules from light and moisture.
Do not use Tambocor XL capsules after the expiry date on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
Further information
What Tambocor XL capsules contain
- The active substance in Tambocor XL capsules is flecainide acetate. Each 200 mg capsule contains 200 mg flecainide acetate.
- The other ingredients are microcrystalline cellulose (E 460i), methacrylic acid – methyl methacrylate copolymer, macrogol 400, talc (E 553b), gelatin, titanium dioxide (E 171), iron oxide black (E 172), and erythrosine (E 127), shellac (E 904) and propylene glycol (E 152).
What Tambocor XL capsules look like
Tambocor XL 200 mg capsules are light grey and pink with ‘3M 200’ printed in black ink.
Tambocor XL 200mg capsules come in packs containing 15, 30 or 60 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last updated 06/2010.
If this leaflet is difficult to see or read and you would like it in a different format, please contact
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK
M00072
562197M6410UK00
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a trademark of 3M and is used under license.
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