TARDIBEN Tablet (2018)
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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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