Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: AOP Orphan Pharmaceuticals AG, Wilhelminenstrasse 91/II f, 1160 Vienna, Austria
Tardiben is indicated for hyperkinetic motor disorders with Huntington’s chorea.
Tardiben is also indicated for the treatment of moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing, if
The tablets are for oral use. The therapy should be supervised by a doctor experienced in treating hyperkinetic disorders.
Dosage and administration are individual in each patient and therefore only a guide is given.
An initial starting dose of 12.5 mg one to three times a day is recommended. This can be increased every three or four days by 12.5 mg until the optimal effect is observed or up to the occurrence of intolerance effects (sedation, Parkinsonism, depression).
The maximum daily dose is 200 mg a day.
If there is no improvement at the maximum dose in seven days, it is unlikely that the compound will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.
Recommended starting dose of 12.5 mg a day, subsequently titrated according to response. Medication should be discontinued if there is no clear benefit or if the side-effects cannot be tolerated.
No specific studies have been performed in the elderly, but tetrabenazine has been administered to elderly patients in standard dosage without apparent ill effect. Parkinson-like adverse reactions are quite common in these patients and could be dose-limiting.
The safety and efficacy in children have not yet been established. No data are available.
The treatment is not recommended in children.
In patients with mild and moderate hepatic impairment half the initial dose and a slower up-titration of the dose is recommended. Patients with severe hepatic impairment have not been studied, therefore additional caution is advised in these patients (see also section 4.4 and 5.2).
No studies have been performed in patients with renal impairment. Caution is advised in the treatment of these patients.
Signs and symptoms of overdosage may include acute dystonia, oculogyric crisis, nausea, vomiting, diarrhoea, confusion, hallucinations, somnolence, sweating, hypotension, hypothermia, rubor and tremor. Treatment is symptomatic.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control centre on the treatment of any overdose.
Shelf life: 3 years.
Store in the original package in order to protect from light.
Do not store above 25°C.
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 tablets.
Not all pack-sizes may be marketed.
No special requirements.
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