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TARDIBEN Tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tardiben 25 mg tablets.

Qualitative and quantitative composition

Each tablet contains 25 mg Tetrabenazine. Excipient with known effect: Each tablet contains 64.05 mg lactose monohydrate corresponding to 60.8 mg lactose (see section 4.4). For the full list of excipients, ...

Pharmaceutical form

Tablet. Yellow, 7.0 2.8 mm round, with one-side break notch. The tablet can be divided into equal halves.

Therapeutic indications

Tardiben is indicated for hyperkinetic motor disorders with Huntingtons chorea. Tardiben is also indicated for the treatment of moderate to severe tardive dyskinesia, which is disabling and/or socially ...

Posology and method of administration

The tablets are for oral use. The therapy should be supervised by a doctor experienced in treating hyperkinetic disorders. Posology Adults Huntingtons chorea Dosage and administration are individual in ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Tetrabenazine can block the action of reserpine. Thus these substances should not be taken concomitantly. Use ...

Special warnings and precautions for use

The dose of tetrabenazine should be titrated to determine the most appropriate dose for each patient. In vitro and in vivo studies indicate that the tetrabenazine metabolites α-HTBZ and β-HTBZ are substrates ...

Interaction with other medicinal products and other forms of interaction

Tetrabenazine should not be used concomitantly with reserpine, MAO inhibitors. Levodopa should be administered with caution in the presence of Tardiben. The possibility of additive sedative effects should ...

Fertility, pregnancy and lactation

Pregnancy Animal studies are insufficient with respect to effects on pregnancy, embryofetal development, birth, or development postpartum (see section 5.3). There are no adequate data from the use of tetrabenazine ...

Effects on ability to drive and use machines

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

Undesirable effects

The following undesirable effects are ranked according to system organ class and to their frequency: Very common (≥ 1/10) Common (≥1/100 to < 1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥ 1/10,000 to < ...

Overdose

Signs and symptoms of overdosage may include acute dystonia, oculogyric crisis, nausea, vomiting, diarrhoea, confusion, hallucinations, somnolence, sweating, hypotension, hypothermia, rubor and tremor. ...

Pharmacodynamic properties

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

Pharmacokinetic properties

Absorption/Distribution Tetrabenazine is quickly and completely absorbed after oral administration. Its absorption is not affected by the intake of food. Clinical testing has shown that a single dose of ...

Preclinical safety data

In repeat-dose toxicity studies, the effects observed with orally administered tetrabenazine were related to depletion of central stores of monoamines. Common symptoms were hypoactivity, lethargy, strabismus, ...

List of excipients

Maize starch (Cornstarch) pre-gelatinised Lactose monohydrate Talc Ferric oxide yellow E172 Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

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

Nature and contents of container

White round high-density polyethylene (HDPE) tablet container with a child-resistant, tamper-evident polypropylene (PP) screw cap with mounted desiccant. Tardiben is available in pack sizes of 42 and112 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

AOP Orphan Pharmaceuticals AG, Wilhelminenstrasse 91/II f, 1160 Vienna, Austria

Marketing authorization number(s)

PL 21344/0016

Date of first authorization / renewal of the authorization

07/07/2016

Date of revision of the text

16/05/2018

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