Trihexyphenidyl 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TRIHEXYPHENIDYL HYDROCHLORIDE

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

N04AA01

INN (International Name):

TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg

Pharmaceutical form:

TABLET

Composition:

TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-01-31

Patient Information leaflet

PATIENT INFORMATION LEAFLET
TRIHEXYPHENIDYL 2MG & 5 MG TABLETS
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
KEEP THE LEAFLET; YOU MAY NEED TO READ IT AGAIN. IF YOU HAVE ANY
QUESTIONS OR ARE NOT SURE ABOUT
ANYTHING, ASK YOUR DOCTOR OR PHARMACIST.
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO
OTHERS. IT MAY HARM THEM, EVEN
IF THEIR SYMPTOMS 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 LEASFLET. SEE SECTION 4.
IN THIS LEAFLET:
1.
What Trihexyphenidyl Tablets are and what they are used for
2.
Before you take Trihexyphenidyl Tablets
3.
How to take Trihexyphenidyl Tablets
4.
Possible side effects
5.
How to store Trihexyphenidyl Tablets
6.
Further information
1.
WHAT TRIHEXYPHENIDYL TABLETS ARE AND WHAT THEY ARE USED FOR
Trihexyphenidyl belongs to a group of medicines called antimuscarinics
(sometimes called
anticholinergics). It works by correcting a chemical imbalance in the
brain that affects the
transmission of nerve impulses. It is used to treat Parkinson's
disease by improving muscle control and
reducing stiffness so patients can move more naturally. It is also
used to treat abnormal face and body
movements, muscle spasms and restlessness caused by certain drugs.
2.
BEFORE YOU TAKE TRIHEXYPHENIDYL TABLETS
DO NOT TAKE THESE TABLETS IF:
•
you are allergic to Trihexyphenidyl or any of the other ingredients
(see section 6). (An allergic
reaction may be recognised as shortness of breath, blocked nose, rash,
itching, swollen face or
lips).
CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF:
•
you have hardening of the arteries
•
you have ever had a reaction to any other medicine
•
you have high blood pressure
•
you have heart, liver or kidney problems
•
you have an enlarged prostate gland, have bladder problems or have
difficulty in passing urine
you have glaucoma (increased pressure in the eye)
•
you have a blockage in your stomach or bowel yo

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trihexyphenidyl 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of trihexyphenidyl hydrochloride
For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
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
Route of administration: Oral
Dosage
Adults (only)
All forms of parkinsonism
Initial dose:
1 – 2 mg gradually increased by 1 – 2 mg increment to 6 – 10 mg
daily according to the patient’s response. Some patients may require
12 – 15 mg daily or more. The maximum daily dose is 20 mg.
Postencephalitic patients tolerate and require larger doses.
Drug-induced parkinsonism
Usual dose:
5 – 10 mg daily
Some cases may be controlled with 1 mg daily.
Elderly:
Patients over 65 years of age may require a reduced dosage.
The above dosage should be administered in 3 – 4 divided doses daily
before or with
meals.
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Antimuscarinic treatment of parkinsonism should never be terminated
suddenly.
When changing from one drug to another, withdraw the one in small
amounts while
gradually increasing the dose of the other.
Trihexyphenidyl tablets may be given with other drugs employed for the
relief of
parkinsonism e.g. other antimuscarinic drugs, levodopa and amantadine.
Dose
reduction may be required.
4.3
CONTRAINDICATIONS
Known hypersensitivity to trihexyphenidyl hydrochloride or any of the
ingredients.
Incipient glaucoma may be precipitated.
The following are not absolute contraindications, nevertheless caution
must be
observed in patients with hypertension,cardiac, liver or kidney
dysfunction,
obstructive disease of the gastrointestinal or genitourinary tracts,
glaucoma, and in
males with a prostatic hypertrophy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Anticholinergic medicati