GABITRIL Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Gabitril 10 mg film-coated tablets.
Qualitative and quantitative composition
<u>Each Gabitril 10 mg tablet contains:</u> Tiagabine anhydrous, INN 10 mg (as hydrochloride monohydrate). <u>Excipient(s) with known effect:</u> For the full list of excipients, see section 6.1.
Pharmaceutical form
<u>10 mg:</u> 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 (<em>Hypericum perforatum</em> ...
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
<u>Tablet Core:</u> Cellulose, microcrystalline (E460) Ascorbic acid (E300) Lactose Starch, pregelatinised (maize) Crospovidone Silica, colloidal anhydrous (E551) Hydrogenated vegetable oil (Type 1) Stearic ...
Incompatibilities
None.
Shelf life
4 years.
Special precautions for storage
Do not store above 25°C. Store in the original package.
Nature and contents of container
Child resistant, white polyethylene bottles with white polypropylene screw closures with an embedded desiccant agent. Packs containing 50 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom
Marketing authorization number(s)
PL 16260/0010
Date of first authorization / renewal of the authorization
Date of first authorisation: 30<sup>th</sup> September 2002 Date of latest renewal: 31<sup>th</sup> August 2006
Date of revision of the text
22/07/2022
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