Trihexyphenidyl 2mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Trihexyphenidyl hydrochloride

Հասանելի է:

A A H Pharmaceuticals Ltd

ATC կոդը:

N04AA01

INN (Միջազգային անվանումը):

Trihexyphenidyl hydrochloride

Դոզան:

2mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 04090200; GTIN: 5016418085237

Տեղեկատվական թերթիկ

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

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Agitane
Trihexyphenidyl 2 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trihexyphenidyl Hydrochloride – 2.00 mg
Excipient with known effect: Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White flat bevelled edge plain tablets, odourless.
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 characterized 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 6-10 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 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 da