Tetrabenazine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tetrabenazine

Available from:

AOP Orphan Ltd

ATC code:

N07XX06

INN (International Name):

Tetrabenazine

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090300; GTIN: 9007653000617

Patient Information leaflet

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
Tetrabenazin

Summary of Product characteristics

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 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.
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 patients.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to