Benzhexol Tablets 2mg

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

TRIHEXYPHENIDYL HYDROCHLORIDE

Предлага се от:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

АТС код:

N04AA01

INN (Международно Name):

TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg

Лекарствена форма:

TABLET

Композиция:

TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg

Вид предписание :

POM

Терапевтична област:

ANTI-PARKINSON DRUGS

Статус Оторизация:

Authorised

Дата Оторизация:

2007-02-15

Листовка

page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BENZHEXOL 2 MG TABLETS
Trihexyphenidyl Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE
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.
-
Ιf 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 Benzhexol is and what it is used for
2. What you need to know before you take Benzhexol
3. How to take Benzhexol
4. Possible side effects
5. How to store Benzhexol
6. Contents of the pack and other information
1.
WHAT BENZHEXOL IS AND WHAT IT IS USED FOR
Benzhexol is an antispasmodic (muscle relaxing) drug. Benzhexol is
used for the treatment of
Parkinson’s disease. Benzhexol helps patients with Parkinson’s
disease by improving muscle
control and reducing stiffness so that they can move more naturally.
Benzhexol can also be
used to treat movement disorders (extreme restlessness, involuntary
movements or muscle
spasms) which may be caused by certain drugs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENZHEXOL
DO NOT TAKE BENZHEXOL
-
if you are allergic (hypersensitive) to trihexyphenidyl hydrochloride
or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Benzhexol
•
if you have glaucoma.
•
if you have heart, liver or kidney disease or suffer from high blood
pressure.
•
if you have prostate problems.
•
if you have trouble passing urine.
•
if you have a stomach ulcer or suffer from severe heartburn or acid
indigestion or any other
digestive disorders.
•
if you suffer from a condition called myasthenia gravis.
•
if you suffer from tardive dy

Данни за продукта

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benzhexol 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg trihexyphenidyl hydrochloride.
Excipient(s) with known effect
This product contains 62,5 mg lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat, scored tablets.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benzhexol
is
an
antispasmodic
drug
which
exerts
a
direct
inhibitory
effect
on
the
parasympathetic nervous system. It also has a relaxing effect on
smooth muscle.
It is indicated in all forms of Parkinsonism (postencephalitic,
arteriosclerotic and idiopathic). It is
often useful as adjuvant therapy when treating these forms of
Parkinsonism with Levodopa.
Benzhexol is effective in reducing the rigidity of muscle spasm,
tremor and excessive salivation
associated with Parkinsonism. Benzhexol is also indicated to control
extrapyramidal disorders
(e.g. akathisia manifested by extreme restlessness and dyskinesia
characterised by spastic
contractions and involuntary movements) due to central nervous system
drugs such as Reserpine
and the phenothiazines.
Page 2 of 7
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults only _
Optimal dosage should always be determined empirically, usually by
initiating therapy at a
relatively low level and by subsequent graduated increments.
The usual dosage for Parkinsonism is 6-10 mg per day although some
patients chiefly in the
post-encephalitic group may require an average total dose of 12-15 mg
daily. It should be given
orally either three or four times a day at mealtimes.
Normal dosage for drug-induced Parkinsonism is usually between 5 mg
and 15 mg per day,
although some cases have been controlled by 1 mg daily.
In all cases, Benzhexol dosage should be increased or decreased only
by small increments over a
period of several days. In initial therapy the dose should be 1 mg the
first day, 2