Tardiben 25mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Tetrabenazine

Saatavilla:

AOP Orphan Ltd

ATC-koodi:

N07XX06

INN (Kansainvälinen yleisnimi):

Tetrabenazine

Annos:

25mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04090300; GTIN: 9007653000907

Pakkausseloste

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TARDIBEN 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
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tardiben is and what it is used for
2.
What you need to know before you take Tardiben
3.
How to take Tardiben
4.
Possible side effects
5.
How to store Tardiben
6.
Contents of the pack and other information
1.
WHAT TARDIBEN IS AND WHAT IT IS USED FOR
Tardiben contains a substance called tetrabenazine. This is a medicine
belonging to the group that
treats disorders of the nervous system.
Tardiben is used for the treatment of diseases causing jerky,
irregular, uncontrollable movements
(hyperkinetic motor disorders with Huntington’s chorea).
Tardiben is also indicated for the treatment of moderate to severe
Tardive Dyskinesia:
-
Tardive dyskinesia is a condition characterised by uncontrollable
movements such as facial
spasm, grimacing, or peculiar tongue movements.
-
Some medicines used to treat certain mental health conditions
(antipsychotics) can cause tardive
dyskinesia.
-
Tardiben should only be given to you for the treatment of tardive
dyskinesia when symptoms
are moderate to severe, disabling, and/or embarrassing in social
situations.
-
Tardiben should only be given to you when symptoms persist, even after
your doctor has
stopped, changed, or reduced the dose of your antipsychotic
medication.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARDIBEN
DO NOT TAKE TARDIBEN:
-
if you are allergic (hypersensitive) to tetrabenazine or any of the
other ingredients of Tardiben
(

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tardiben 25 mg tablets
2
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, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Yellow, 7.0 x 2.8 mm round, with one-side break notch.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 condition persists despite withdrawal of antipsychotic therapy
-
withdrawal of antipsychotic medication is not a realistic option
-
the condition persists despite a reduction in dosage of antipsychotic
medication or
-
the condition persists despite switching to atypical antipsychotic
medication
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.
_TARDIVE DYSKINESIA _
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 sid