TAVER Tablet (2014)

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Περιεχόμενα

1. Name of the medicinal product

TAVER, 200 mg, tablets.

2. Qualitative and quantitative composition

Each tablet contains 200 mg carbamazepine. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet. For oral administration. Each tablet is white, round, flat, scored. The tablet can be divided into equal halves.

4.1. Therapeutic indications

Epilepsy generalised tonic-clonic and partial seizures. Note: Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure ...

4.2. Posology and method of administration

Posology Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated ...

4.3. Contraindications

Hypersensitivity to the active substance or structurally related drugs (e.g. tricyclic antidepressants) or any of the excipients listed in section 6.1. Patients with atrioventricular block, a history of ...

4.4. Special warnings and precautions for use

Warnings Agranulocytosis and aplastic anaemia have been associated with Taver; however, due to the very low incidence of these conditions, meaningful risk estimates for Taver are difficult to obtain. The ...

4.5. Interaction with other medicinal products and other forms of interaction

Cytochrome P450 3A4 (CYP 3A4) is the main enzyme catalysing formation of the active metabolite carbamazepine 10, 11-epoxide. Co-administration of inhibitors of CYP 3A4 may result in increased carbamazepine ...

4.6. Fertility, pregnancy and lactation

Pregnancy Offspring of epileptic mothers with untreated epilepsy are known to be more prone to developmental disorders, including malformations. Developmental disorders and malformations, including spina ...

4.7. Effects on ability to drive and use machines

The patients ability to react may be impaired by the medical condition resulting in seizures and adverse reactions including dizziness, drowsiness, ataxia, diplopia, impaired accommodation and blurred ...

4.8. Undesirable effects

Summary of the safety profile Particularly at the start of treatment with Taver, or if the initial dosage is too high, or when treating elderly patients, certain types of adverse reaction occur very commonly ...

4.9. Overdose

Symptoms The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular, respiratory systems and the adverse drug reactions mentioned under section 4.8. Central nervous ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anti-epileptic, neurotropic and psychotropic agent ATC Code: N03AX1 Dibenzazepine derivative As an antiepileptic agent its spectrum of activity embraces: partial ...

5.2. Pharmacokinetic properties

Absorption Carbamazepine is absorbed almost completely but relatively slowly from the tablets. The conventional tablets yield mean peak plasma concentrations of the unchanged substance within 12 hours ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, local tolerance, genotoxicity and carcinogenic potential. Reproductive toxicity ...

6.1. List of excipients

Starch maize, povidone, sodium lauryl sulfate, sodium starch glycollate, powdered cellulose and magnesium stearate.

6.2. Incompatibilities

None known.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

PVC-Alu blisters in carton packs of 50 tablets.

6.6. Special precautions for disposal and other handling

None. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

7169

9. Date of first authorization / renewal of the authorization

20/10/1979

10. Date of revision of the text

10/2014

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