Trihexyphenidyl 2mg 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:

2mg

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

PROPOSED
PATIENT
INFORMATION
LEAFLET
INFORMATION FOR THE USER
AGITANE / TRIHEXYPHENIDYL
HYDROCHLORIDE 2 MG & 5 MG
TABLETS
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 Agitane is and what it is used for
2. What you need to know before you take Agitane
3. How to take Agitane
4. Possible side effects
5. How to store Agitane
6. Contents of the pack and other information
_ _
_1.WHAT AGITANE IS AND WHAT IT IS USED FOR _
The
name
of
this
medicine
is
Agitane.
It
contains
a
substance called Trihexyphenidyl Hydrochloride BP.
Agitane belongs to a group of medicines known as the
anti-spasmodics (muscle relaxing) drug
that act on the
central
nervous
system
to
control
certain
muscular
movement
disorders
such
as
spasms,
abnormal
movements and troublesome restlessness. Agitane also
reduces muscular stiffness and saliva production.
Agitane is used in the management of Parkinson’s disease
or Parkinsonism caused by encephalitis or hardening of the
arteries. It is also used to control certain types of disorder
such as muscular rigidity, stiffness, tremor (fine shaking of
the hands), spasm which may be caused by certain drugs
acting
on
the
central
nervous
system
of
which
the
phenothiazine
drugs
(used
to
treat
mental
disorders,
nausea and vomiting) are examples.
If you are not sure why you have been prescribed Agitane
then please ask your doctor.
_2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGITANE _
DO NOT TAKE AGITANE:
If you are allergic to trihexyphenidyl or any of the other
ingredients of this medicine (listed i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trihexyphenidyl 2mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg of trihexyphenidyl hydrochloride
Excipient(s) with known effect
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White, flat bevel edged tablets with a breakline.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1. Treatment of parkinsonism
2. Prevention and control of drug-induced extrapyramidal symptoms
(excluding tardive dyskinesia)
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, trihexyphenidyl dosage should be increased or decreased
only 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 increases
of
2mg per day at three to five-day intervals until the optimum dose is
reached.
If patients are already being treated with other parasympathetic
inhibitors,
trihexyphenidyl should be substituted as part of the therapy. When
trihexyphenidyl is used concomitantly with levodopa the usual dose of
each
may need to be reduced. Careful adjustment is necessary, depending on
side
effects and the degree of symptom control. Trihexyphenidyl dosage of
3-6mg
daily in divided doses, is usually adequate.
Trihexyphenidyl may be taken before or after meals according to the
way the
patient reacts. If trihexyphenidyl tends to dry the mouth excessively,
it may
be better to take it before mea