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SPC, UK: GABITRIL Film-coated tablets (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Gabitril 10 mg film-coated tablets.

Qualitative and quantitative composition

Each Gabitril 10 mg tablet contains: Tiagabine anhydrous, INN 10 mg (as hydrochloride monohydrate). For the full list of excipients, see section 6.1.

Pharmaceutical form

10 mg: Tablet. White, oval biconvex film-coated tablet embossed on one side with 252.

Therapeutic indications

Gabitril is an anti-epileptic drug indicated as add-on therapy for partial seizures with or without secondary generalisation where control is not achieved by optimal doses of at least one other anti-epileptic ...

Posology and method of administration

Gabitril should be taken orally with meals. Dosing schemes may need to be individualised based upon a patients particular characteristics such as age and concomitant medications. Concomitant use with drugs ...

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Severely impaired liver function. Gabitril in combination with St Johns Wort (Hypericum perforatum) (see section ...

Special warnings and precautions for use

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs ...

Interaction with other medicinal products and other forms of interaction

Anti-epileptic agents that induce hepatic enzymes (such as phenytoin, carbamazepine, phenobarbital and primidone) enhance the metabolism of tiagabine. The plasma concentration of tiagabine may be reduced ...

Fertility, pregnancy and lactation

Pregnancy Animal experiments have not shown a teratogenic effect of tiagabine. Studies in animals have however, revealed peri- and post-natal toxicity of tiagabine at very high doses. Clinical experience ...

Effects on ability to drive and use machines

Gabitril may cause dizziness or other CNS related symptoms, especially during initial treatment. Therefore caution should be shown by patients driving vehicles or operating machinery.

Undesirable effects

Adverse events are mainly CNS related. A full list of adverse reactions reported with Gabitril during clinical studies and post marketing experience is shown in the table below. Adverse reactions are listed ...

Overdose

Symptoms most often accompanying Gabitril overdose, alone or in combination with other drugs, have included seizures, including status epilepticus, in patients with and without underlying seizure disorders, ...

Pharmacodynamic properties

Gabitril is an anti-epileptic drug. Tiagabine is a potent and selective inhibitor of both neuronal and glial GABA uptake, which results in an increase in GABAergic medicated inhibition in the brain. Tiagabine ...

Pharmacokinetic properties

Tiagabine is rapidly and virtually completely absorbed from Gabitril tablets, with an absolute bioavailability of 89%. Administration with food results in a decreased rate and not extent of absorption. ...

Preclinical safety data

Animal safety data carried out in the rat, mouse and dog gave no clear evidence of specific organ toxicity nor any findings of concern for the therapeutic use of tiagabine. The dog appears to be particularly ...

List of excipients

Tablet Core: Cellulose, microcrystalline (E460) Ascorbic acid (E300) Lactose, anhydrous Starch, pregelatinised (maize) Crospovidone Silica, colloidal anhydrous (E551) Hydrogenated vegetable oil (Type 1) ...

Incompatibilities

None.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not refrigerate or freeze. Store in the original package.

Nature and contents of container

Child resistant, white polyethylene bottles with white polypropylene screw closures. Each bottle contains a high density polyethylene canister of activated clay desiccant. Packs containing 50 and 100 tablets. ...

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Marketing authorization number(s)

Gabitril 10 mg PL 16260/0010

Date of first authorization / renewal of the authorization

30<sup>th</sup> September 2002

Date of revision of the text

07/2016

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