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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Περιεχόμενα

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 ...

Pharmaceutical form

100mg Tablets: The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side ...

Therapeutic indications

Epilepsy generalised tonic-clonic and partial seizures. Note: Tegretol is not usually effective in absences ...

Posology and method of administration

Tegretol is given orally, usually in two or three divided doses. Tegretol may be taken during, after ...

Contraindications

Known hypersensitivity to carbamazepine or structurally related drugs (e.g. tricyclic antidepressants) ...

Special warnings and precautions for use

Warnings Agranulocytosis and aplastic anaemia have been associated with Tegretol; however, due to the ...

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 ...

Pregnancy and lactation

Pregnancy In animals (mice, rats and rabbits) oral administration of carbamazepine during organogenesis ...

Effects on ability to drive and use machines

The patients ability to react may be impaired by dizziness and drowsiness caused by Tegretol, especially ...

Undesirable effects

Particularly at the start of treatment with Tegretol, or if the initial dosage is too high, or when treating ...

Overdose

Signs and symptoms The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular ...

Pharmacodynamic properties

Therapeutic class: Anti-epileptic, neurotropic and psychotropic agent; Dibenzazepine derivative. ATC ...

Pharmacokinetic properties

Absorption Carbamazepine is absorbed almost completely but relatively slowly from the tablets. The conventional ...

Preclinical safety data

In rats treated with carbamazepine for two years, the incidence of tumours of the liver was found to ...

List of excipients

Tegretol Tablets: Each uncoated tablet contains aerosil 200 standard Microcrystalline cellulose Nymcel ...

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 ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Trading as Geigy Pharmaceuticals Frimley Business Park Frimley Camberley ...

Marketing authorization number(s)

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

Date of first authorization / renewal of the authorization

4 July 1997 / 8 December 2008

Date of revision of the text

22 November 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.