Trihexyphenidyl 2mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Trihexyphenidyl hydrochloride

Dostopno od:

Genus Pharmaceuticals Holdings Ltd

Koda artikla:

N04AA01

INN (mednarodno ime):

Trihexyphenidyl hydrochloride

Odmerek:

2mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04090200; GTIN: 5030451001108

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trihexyphenidyl Tablets 2mg
Artane Tablets 2mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trihexyphenidyl 2mg contains 2mg trihexyphenidyl hydrochloride BP.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Route of administration: _
_ _
Trihexyphenidyl Tablets are for oral administration.
Each white scored tablet coded ‘GP 4434’ contains trihexyphenidyl
hydrochloride 2mg.
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
_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 by
small increments over a period of several days. In initial therapy the
dose
should be