100 mg, 200 mg hard
prolonged-release capsules flecainide acetate
What Tambocor Retard is and what it is used for
Tambocor Retard 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 Retard
Do not use Tambocor Retard
- 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 Retard:
- 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.
Like other medicines used to treat changes in the rhythm of the heart, Tambocor Retard can induce rhythm disturbances or worsen an existing disturbance.
Children and young people
Tambocor Retard is not recommended for children under 12 years of age because there is no experience with treatment.
Other medicines and Tambocor Retard
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 Retard can affect or be affected if it is taken simultaneously with 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 it is therefore very important that you consult your doctor before starting medication with Tambocor Retard.
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 Retard should only be used during pregnancy if necessary.
Breast-feeding
Tambocor Retard 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 Retard. 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 risky work. 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. A description of these effects and side effects can be found under other headings in the package insert. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Tambocor Retard
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage for adults:
A usual dose for adults is 200 mg and should be taken once a day at approximately the same time of day. To be swallowed whole.
Dosage for children and adolescents:
Tambocor Retard is not recommended for children under 12 years of age because there is no experience with treatment.
Dosage for elderly patients:
Elderly patients and patients with severely impaired kidney function or impaired liver function may need a lower dose.
If you feel that the effect of Tambocor Retard is too strong or too weak, contact your doctor or pharmacist.
If you have used too much Tambocor Retard
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 Retard
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Tambocor Retard 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. Like other medicines used to treat changes in the rhythm of the heart, Tambocor Retard can induce 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, memory loss. An ant crawls/tingles, disturbances in the coordination of muscle movements, movement difficulties, reduced sensitivity to touch, tremors. Increased sweating, and redness. Somnolence. Fainting due to a sudden drop in blood pressure. Headache. Nerve disease in hands and feet, cramp. 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 Retard
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.
Store at a maximum of 25 o C.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacy what to do with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Tambocor Retard 100 mg contains:
- The active substance is flecainide acetate.
- Other ingredients are microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer, macrogol 400, and talc. Capsule shell: Gelatin, titanium dioxide (E 171), and black iron oxide (E 172). Printing ink: Shellac, black iron oxide (E 172), propylene glycol, ammonium hydroxide, and potassium hydroxide.
Tambocor Retard 200 mg contains:
- The active substance is flecainide acetate.
- Other ingredients are microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer, macrogol 400, and talc. Capsule shell: Gelatin, titanium dioxide (E 171), black iron oxide (E 172), and erythrosine (E 127). Printing ink: Shellac, black iron oxide (E 172), propylene glycol, ammonium hydroxide, and potassium hydroxide.
Appearance and package sizes of the medicine
Tambocor Retard 100 mg prolonged-release capsule is a gray and white capsule marked with M and 100.
Tambocor Retard 200 mg prolonged-release capsule is a gray and pink capsule marked with M and 200.
Tambocor Retard is packed in blisters and each pack contains 30 or 60 prolonged-release capsules. Not all packages may be marketed.
Marketing Authorisation Holder
Viatris AB
Box 23033
104 35 Stockholm
Manufacturer
Meda Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg vd Höhe
Germany
Allphamed Pharbil Arzneimittel GmbH
Hildebrandstrasse 12
37081 Göttingen
Germany