Tambocor 10 mg/ml Solution for Injection
Flecainide acetate
Read all of this leaflet carefully. This medicine is an injection and will only be given to you by a doctor in hospital.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 injection is for
- 2. Before you are given Tambocor injection
- 3. How you will be given Tambocor injection
- 4. Possible side effects
- 5. How to store Tambocor injection
- 6. Further information.
What Tambocor injection is for
Tambocor injection belongs to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart.
Tambocor injection is used to treat arrhythmias (irregular heart beat), tachycardia (heart beat too fast), and atrial fibrillation (rapid contractions of muscles in the heart). Tambocor injection is used by your doctor when a rapid response is required to control one or more of these conditions.
It is important for your doctor to treat these conditions quickly and effectively in order to prevent more serious heart problems from developing.
Before you are given Tambocor injection
Do not use Tambocor injection if:
- You are allergic to flecainide acetate or any of the other ingredients of Tambocor injection
- You have heart failure
- You have heart block (your heart misses beats)
- You have or have had any heart problems including problems with the valves in your heart or conduction problems
- You have sinus node dysfunction (a specific condition where your heart beats abnormally)
- You have had a myocardial infarction (heart attack)
- You are pregnant or breast-feeding.
Tambocor injection is 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 are given Tambocor injection your doctor or nurse may check
- Your fluid levels are correct
- Your liver and kidney functions.
This is to check that Tambocor injection is right for you and to help the doctor calculate the dose you need.
Check with the doctor or nurse before they give you Tambocor injection if:
- You have high blood pressure
- You have angina (chest pains)
- 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 if you are taking any of the following medicines:
- Any other medicine used to treat heart arrhythmias or heart problems such as cardiac glycosides, beta-blockers, verapamil or amiodarone
- Medicines to treat high blood pressure
- Antidepressants (medicines to treat depression), such as tricyclic antidepressants, Prozac or reboxetine
- Anticonvulsants (medicines used to prevent epileptic fits) such as phenytoin, phenobarbital or carbamazepine
- Antipsychotics (medicines to treat mental illness) such as clozapine
- Antihistamines (medicines to treat allergic reactions) such as mizolastine or terfenadine
- Quinine (medicine to treat malaria)
- Medicines to treat HIV such as ritonavir, lopinavar or indinavir
- Diuretics (water tablets)
- Cimetidine (medicine to treat stomach ulcers)
- Bupropion (a medicine to help you stop smoking)
- Any other medicine, including medicines obtained without a prescription.
These medicines may interfere with your treatment.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant, or breast-feeding, ask your doctor or nurse for advice before being given Tambocor.
How you will be given Tambocor injection
Tambocor injection will only be given to you by a doctor in hospital.
Important: Your doctor will choose the dose that is right for your condition. The doctor will also decide whether you receive Tambocor as an injection from the syringe, or in the form of an infusion (drip). The doctor or nurse will monitor the drip if this is chosen for you.
Adults
- The usual dose is 2 mg per kg body weight
- The doctor will give the injection slowly into your vein over at least 10 minutes by slow injection
- If the medicine is given via a drip, the maximum dose should not exceed 600 mg over 24 hours
- When given as a drip, Tambocor injection is diluted with a sterile solution containing 5% dextrose.
The elderly and patients with kidney/heart problems
- For elderly patients, and patients with kidney or heart problems, the doctor may give a lower dose and perform the injection or the infusion (drip) more
slowly.
During your treatment with Tambocor injection the doctor or nurse will monitor your heart with an electrocardiogram (ECG). This is to make sure that your medicine is working properly and that the dose you are taking is right for you.
If you are given more Tambocor injection than you should
This is unlikely as Tambocor will be injected slowly by a doctor who will monitor your heart continuously during treatment. If any problem occurs, Tambocor injection can be stopped and any symptoms of overdosage treated urgently.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines Tambocor injection can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
Your rapid or irregular heart beat seems to get worse
You have chest pain
You become breathless
You have ringing in your ears
Your skin and eyes begin to go yellow (jaundice)
You have a fever, become flushed or sweat.
Other side effects:
- Feeling sick
- Constipation
- Feeling bloated
- Wind
- Stomach pain
- Loss of appetite
- Confusion and hallucinations
- Difficulty sleeping
- Feeling anxious (worried)
- Red, itchy or swollen skin rash
- Feeling weak and tired
- Headache
- Double or blurred vision
- Dizziness or feeling that the room is spinning (vertigo)
- Swelling
- Depression.
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 injection
Keep out of the reach and sight of children.
Do not use Tambocor injection after the expiry date on the carton. The expiry date refers to the last day of that month.
Do not store above 30° C.
Do not freeze.
Protect from light.
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 injection contains
- The active ingredient is flecainide acetate. Each millilitre (ml) of solution contains 10 milligrams (mg) of flecainide acetate.
- The other ingredients are: sodium acetate, glacial acetic acid and water.
What Tambocor injection looks like
Tambocor injection comes in sealed 15 ml glass containers called ampoules.
Each box of Tambocor injection contains five 15 ml ampoules.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last updated December 2009
If this leaflet is difficult to see or read or you would like it in a different format, please contact
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
United Kingdom
562197M6110UK00
6204 1369 6
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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