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SPC, UK: Tegretol Tablets 100mg, 200mg, 400mg (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Novartis Pharmaceuticals UK Ltd
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Name of the medicinal product

Tegretol 100mg, 200mg and 400mg Tablets.

Qualitative and quantitative composition

The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide. Each tablet contains 100mg / 200mg / 400mg carbamazepine Ph.Eur.

Pharmaceutical form

100mg Tablets: The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side impressed GEIGY, the other B/W and a score. 200mg Tablets: The tablets are white, round, flat, uncoated ...

Therapeutic indications

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

Posology and method of administration

Tegretol is given orally, usually in two or three divided doses. Tegretol may be taken during, after or between meals, with a little liquid e.g. a glass of water. Before deciding to initiate treatment, ...

Contraindications

Known hypersensitivity to carbamazepine or structurally related drugs (e.g. tricyclic antidepressants) or any other component of the formulation. Patients with atrioventricular block, a history of bone ...

Special warnings and precautions for use

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

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 ...

Pregnancy and lactation

Pregnancy In animals (mice, rats and rabbits) oral administration of carbamazepine during organogenesis led to increased embryo mortality at a daily doses which caused maternal toxicity (above 200mg/kg ...

Effects on ability to drive and use machines

The patients ability to react may be impaired by dizziness and drowsiness caused by Tegretol, especially at the start of treatment or in connection with dose adjustments; patients should therefore exercise ...

Undesirable effects

Particularly at the start of treatment with Tegretol, or if the initial dosage is too high, or when treating elderly patients, certain types of adverse reaction occur very commonly or commonly, e.g. CNS ...

Overdose

Signs and symptoms The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular or respiratory systems. Central nervous system: CNS depression; disorientation, somnolence, ...

Pharmacodynamic properties

Therapeutic class: Anti-epileptic, neurotropic and psychotropic agent; Dibenzazepine derivative. ATC Code: N03AF01 As an antiepileptic agent its spectrum of activity embraces: partial seizures (simple ...

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 ...

Preclinical safety data

In rats treated with carbamazepine for two years, the incidence of tumours of the liver was found to be increased. The significance of these findings relative to the use of carbamazepine in humans is, ...

List of excipients

Tegretol Tablets: Each uncoated tablet contains aerosil 200 standard Microcrystalline cellulose Nymcel ZSB-10 Magnesium stearate

Incompatibilities

None known.

Shelf life

36 months.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Tegretol 100mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets. Tegretol 200mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets. Tegretol 400mg come in PVC/PE/PVDC blister packs of 56. ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Trading as Geigy Pharmaceuticals Frimley Business Park Frimley Camberley Surrey GU16 7SR England

Marketing authorization number(s)

Tegretol 100mg Tablets: PL 00101/0461 Tegretol 200mg Tablets: PL 00101/0462 Tegretol 400mg Tablets: PL 00101/0463

Date of first authorization / renewal of the authorization

4 July 1997 / 8 December 2008

Date of revision of the text

22 November 2012