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MOTETIS Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Motetis 25 mg tablet.

Qualitative and quantitative composition

Each Motetis 25 mg tablets contains 25 mg of tetrabenazine. Excipient(s) with known effect: Contains lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Yellow, round, flat tablet with a score line on one side.

Therapeutic indications

Movement disorders associated with organic central nervous system conditions, e.g. Huntingtons chorea, hemiballismus and senile chorea. Tetrabenazine is also indicated for the treatment of moderate to ...

Posology and method of administration

Dose Adults Dosage and administration are variable and only a guide is given. An initial starting dose of 25 mg three times a day is recommended. This can be increased by 25 mg a day every three or four ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients Tetrabenazine can block the action of reserpine. Thus, these substances should not be taken concomitantly Use of monoamine oxidase inhibitor ...

Special warnings and precautions for use

Tardive Dyskinesia The condition should be persistent despite withdrawal of antipsychotic therapy, or in cases where withdrawal of antipsychotic medication is not a realistic option; also, where the condition ...

Interaction with other medicinal products and other forms of interaction

Levodopa should be administered with caution in the presence of tetrabenazine. Tetrabenazine should not be administered in the presence of MAOIs because of the risk of possible severe adverse effects. ...

Pregnancy and lactation

Pregnancy Category B2. There is inadequate evidence of safety of the drug in human pregnancy and no evidence from animal work, but it has been in wide use for many years without apparent ill consequence. ...

Effects on ability to drive and use machines

Patients should be advised that tetrabenazine may cause drowsiness and therefore may modify their performance at skilled tasks (driving ability, operation of machinery, etc.) to a varying degree, depending ...

Undesirable effects

Adverse effects are usually mild with little hypotensive action and few digestive disorders. The main unwanted effect reported to date has been drowsiness, which occurs with higher doses. If depression ...

Overdose

Signs and symptoms of overdosage may include nausea, vomiting, diarrhoea, drowsiness, sweating, hypotension, confusion, hallucinations, hypothermia and sedation. Treatment is symptomatic. For advice on ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nervous system drugs ATC code: N07XX06 Actions Tetrabenazine is a synthetic derivative of benzylquinolizine that causes depletion of dopamine and other monoamines in the central ...

Pharmacokinetic properties

Tetrabenazine is quickly and mostly absorbed after oral administration. Its absorption is not affected by the taking of food. After administration of single doses from 12.5 to 50 mg of tetrabenazine, the ...

Preclinical safety data

In repeated dose toxicity studies orally administered tetrabenazine is generally well tolerated across all animal species tested. Most effects observed are related to the pharmacological parameters of ...

List of excipients

Motetis tablet contains iron oxide yellow, lactose monohydrate, magnesium stearate, pregelatinised maize starch and purified talc.

Incompatibilities

Not applicable.

Shelf life

36 months.

Special precautions for storage

Store at or below 25°C.

Nature and contents of container

HDPE bottle pack with child-resistant caps, containing 112 tablets.

Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660

Date of first authorization / renewal of the authorization

29 November 2011

Date of revision of the text

08 February 2019

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