100 mg tablets
flecainide acetate
What Tambocor is and what it is used for
Tambocor is used for the treatment and prevention of changes in the rhythm and speed of the heart.
What you need to know before you use Tambocor
Do not use Tambocor
- if you are hypersensitive to the active ingredient ( flecainide ) or any other ingredient in this medicine (listed in section 6)
- in heart diseases such as heart attack and heart failure
- in conduction disorders that are not treated with a pacemaker
- in case of medication with beta-blockers in connection with heart failure
- in some cases of persistent atrial fibrillation
- at certain types of flaps
- Brugada syndrome (disease of the conduction system of the heart)
Warnings and precautions
Talk to your doctor or pharmacist before using Tambocor:
- if you have any other heart disease
- if you have an abnormally low heart rate ( bradycardia ) or very low blood pressure
- if you have a pacemaker
- if you have impaired liver or kidney function
Elderly patients and patients with severely impaired renal function should exercise caution as the dose may need to be lowered.
The concentration of the drug in the blood may need to be checked in patients with severely impaired liver or kidney function and patients treated with high doses.
Before treatment is started, cardiac function should be carefully examined. Disturbances in the salt balance may need to be corrected.
If you have certain types of rhythm disorders, a specialist must start this treatment, and hospitalization may be necessary.
As with other medicines used to treat changes in the rhythm of the heart, Tambocor can cause rhythm disturbances or worsen an existing disturbance.
Children and young people
Tambocor is not recommended for children under 12 years of age due to a lack of treatment experience.
Other medicines and Tambocor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal remedies.
Tambocor can affect or be affected if it is taken at the same time as certain other medicinal substances against:
- diseases of the heart (eg, digoxin , amiodarone , quinidine , beta- blockers , or verapamil)
- depression (eg fluoxetine, paroxetine, moclobemide, and tricyclic antidepressants )
- epilepsy (eg phenytoin, phenobarbital, or carbamazepine)
- mental illnesses (eg clozapine)
- treatment of allergies (e.g. mizolastine or terfenadine)
- viral infections (eg, ritonavir)
- peptic ulcer (eg, cimetidine)
- smoking cessation (eg bupropion)
- fungal infections (eg, terbinafine)
- heart failure and fluid accumulation in the body’s tissues (e.g. diuretics )
- inflammatory conditions (eg corticosteroids )
- constipation (e.g. high doses or frequent intake of laxatives that can disturb the salt balance)
- malaria (eg quinine)
Some combinations should be completely avoided and others require dose adjustment, so you must consult your doctor before starting medication with Tambocor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The child may be affected during pregnancy. Tambocor should only be used during pregnancy if necessary.
Breast-feeding
Tambocor passes into breast milk. The child is not likely to be affected. Breastfeeding may only take place with the doctor’s permission during treatment with Tambocor. Consult your doctor or pharmacist before starting treatment.
Driving ability and use of machinery
The ability to drive and use machines may be affected in some patients who experience side effects such as dizziness and/or visual disturbances.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tambocor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Tambocor
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage for adults:
Treatment with Tambocor must be started in the hospital. A usual dose for adults is 100 mg 2 times daily. If the effect is unsatisfactory, the dose can be gradually increased by 50 mg every 4 days to a maximum of 200 mg twice daily.
When treating to stop a type of heart rhythm disorder called atrial fibrillation, the usual dose is 2 tablets of 100 mg (200 mg) Tambocor if you have a body weight of less than 70 kg. If you weigh 70 kg or more, the usual dose is 3 tablets of 100 mg (300 mg) of Tambocor. Treatment begins in the hospital.
Dosage for children and adolescents:
Tambocor is not recommended for children under 12 years of age due to a lack of treatment experience.
Dosage for elderly patients:
Elderly patients and patients with certain diseases may need a lower dose.
If you feel that the effect of Tambocor is too strong or too weak, contact your doctor or pharmacist.
If you have used too much Tambocor
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tambocor
Do not take a double dose to make up for a missed tablet.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Tambocor can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 users): Dizziness, a feeling of unsteadiness, and visual disturbances in the form of blurring and difficulty focusing. These side effects are usually transient and may disappear with continued treatment.
Common (may affect up to 1 in 10 people): Weakness, extreme tiredness, fever, and fluid accumulation in your tissues. As with other medicines used to treat changes in the rhythm of the heart, Tambocor can cause rhythm disturbances or worsen an existing disturbance. Respiratory distress.
Uncommon (may affect up to 1 in 100 people): Decrease in red and white blood cells and platelets. Nausea, vomiting, constipation, stomach pain, loss of appetite, diarrhea, digestive problems, tension. Arrhythmia in patients with a certain type of arrhythmia ( atrial flutter ). Allergic reactions such as skin rashes and hair loss.
Rare (may affect up to 1 in 1,000 people): Elevated levels of certain liver enzymes, sometimes with jaundice, which return to normal when treatment is stopped. Depression, anxiety, difficulty sleeping, confusion, hallucinations, and memory loss. Cramps, crawling/tingling, disturbances in the coordination of muscle movements, movement difficulties, reduced sensitivity to touch, fainting due to a sudden drop in blood pressure, tremors, nerve disease in the hands and feet, increased sweating, redness, sleepiness, headache. Dizziness and ringing in the ears ( tinnitus ). Pneumonia. Severe hives.
Very rare (may affect up to 1 in 10,000 users): Increase in certain antibodies. Deposit in the cornea of the eye. Photosensitivity (reaction with skin changes on light-exposed areas).
Frequency not known (cannot be estimated from the available data): Various types of changes in heart activity and heart rhythm including heart attack, cardiac arrest, heart failure, and chest pain have been reported. Impaired liver function. Impact on the lungs, for example, connective tissue growth, which causes the elasticity to decrease, which makes it difficult to breathe, and the absorption of oxygen deteriorates.
Different types of rhythm disturbances, some of which are dose-related.
How to store Tambocor
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
No special storage instructions.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacy how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is flecainide.
- Other ingredients are pregelatinized corn starch, croscarmellose sodium, microcrystalline cellulose, hydrogenated vegetable oil, and magnesium stearate.
Appearance and package sizes of the medicine
Tambocor tablets are white, round, and biconvex with a score. The diameter of the tablet is approximately 8.5 mm.
Tambocor is packed in blisters and each pack contains 20 or 100 tablets. Not all packages may be marketed.
Marketing Authorisation Holder:
Meda AB
Box 906
170 09 Solna
Telephone: 08-630 19 00
Email: info@medasverige.se
Manufacturer
Mylan Hungary Kft.
Mylan UTC 1
Come to room
H-2900
Hungary