Tetrabenazine 25 mg Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Tetrabenazine

Dostupné z:

Aop Orphan Pharmaceuticals GmbH

ATC kód:

N07XX; N07XX06

INN (Medzinárodný Name):

Tetrabenazine

Dávkovanie:

25 milligram(s)

Forma lieku:

Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Other nervous system drugs; tetrabenazine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2010-09-24

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TETRABENAZINE 25 MG TABLETS
tetrabenazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effect not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Tetrabenazine is and what it is used for
2. What you need to know before you take Tetrabenazine
3. How to take Tetrabenazine
4. Possible side effects
5.
How to store Tetrabenazine
6. Contents of the pack and other information
1.
WHAT TETRABENAZINE IS AND WHAT IT IS USED FOR
Tetrabenazine is a medicine belonging to the group treating disorders
of the nervous system.
Tetrabenazine is used for the treatment of diseases causing jerky,
irregular, uncontrollable movements
(hyperkinetic motor disorders with Huntington’s chorea).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TETRABENAZINE
DO NOT TAKE TETRABENAZINE
-
if you are allergic to tetrabenazine or any of the other ingredients
of Tetrabenazine 25 mg tablets
(listed in section 6).
-
if you use reserpine (medicine to control high blood pressure and
treat psychotic states).
-
if you use a medicine which belongs to the group of drugs called
monoamine oxidase (MAO)
inhibitors (medicine to treat depression)
-
if you have liver impairment
-
if you suffer from Parkinson-like symptoms
-
if you have a depression
-
if you are having thoughts of harming or killing yourself
-
if you are breast-feeding
-
if you suffer from pheochromocytoma (tumour of the adrenal gland)
-
if you suffer from pro-lactin-dependent tumours, e.g. pituitary or
breast cancer
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tetrabenaz

Súhrn charakteristických

Health Products Regulatory Authority
14 February 2024
CRN00DVGF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tetrabenazine 25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg Tetrabenazine.
Excipient with known effects:
Each tablet contains 60.8 mg lactose (see section 4.4)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet Yellow, round, with a break line on one-side and `TE25`
engraved on the reverse side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tetrabenazine is indicated for hyperkinetic motor disorders with
Huntington’s chorea.
4.2 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
_ _
_Huntington's chorea_
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 occurence 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.
Elderly population
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.
Paediatric population
The safety and efficacy in children have not yet been established. The
treatment is not recommended in children.
Patients with renal impairment
No studies have been performed in patients with renal impairment.
Caution is advised in the treatment of these pati