Trihexyphenidyl 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trihexyphenidyl hydrochloride

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

N04AA01

INN (International Name):

Trihexyphenidyl hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090200

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
121218/2
Ennogen
Trihexyphenidy 2 /5 mg Leaflet
UK
English
160 x 300 mm
9 pt
1 of 1
3
03-01-19
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
Trihexyphenidyl 2mg and 5mg Tablets
[trihexyphenidyl hydrochloride]
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, pharmacist or nurse.
!
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET
1.
What Trihexyphenidyl Tablets are and what
they are used for
2.
What you need to know before you take
Trihexyphenidyl Tablets
3.
How to take Trihexyphenidyl Tablets
4.
Possible side effects
5.
How to store Trihexyphenidyl Tablets
6.
Contents of the pack and other information
1. WHAT TRIHEXYPHENIDYL TABLETS ARE
AND WHAT THEY ARE USED FOR
Trihexyphenidyl Tablets contain the active
substance trihexyphenidyl hydrochloride. This
belongs to a group of medicines known as
anticholinergics which are used in the treatment of
Parkinson's disease. This particular medicine is
used for treating Parkinson's disease and also to
prevent and control side effects which are similar
to Parkinson's disease and are caused by certain
medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TRIHEXYPHENIDYL TABLETS
DO NOT TAKE TRIHEXYPHENIDYL TABLETS:
!
If you are allergic to trihexyphenidyl
hydrochloride or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Tal

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trihexyphenidyl 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trihexyphenidyl hydrochloride 5mg
Excipient with known effect: Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White flat bevelled tablets, marked MP21 on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trihexyphenidyl 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. Trihexyphenidyl is effective in reducing
the rigidity of
muscle
spasm,
tremor
and
excessive
salivation
associated
with
Parkinsonism.
Trihexyphenidyl is also indicated to control extrapyramidal disorders
(eg 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.
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 6-10mg per day although some
patients chiefly
in the post-encephalitic group may require an average total dose of
12-15mg daily. It
should be given orally either three or four times a day at mealtimes.
Normal dosage for drug-induced Parkinsonism is usually between 5mg and
15mg per
day, although some cases have been controlled by 1mg daily.
In all cases, trihexyphenidyl dosage should be increased or decreased
only be by
small increments over a period of several days. In initial therapy the
dose should be
1mg the first day, 2mg the second day with further increase of 2mg per
day at 3-5 day
intervals