Trihexyphenidyl 5mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Trihexyphenidyl hydrochloride

Հասանելի է:

Crescent Pharma Ltd

ATC կոդը:

N04AA01

INN (Միջազգային անվանումը):

Trihexyphenidyl hydrochloride

Դոզան:

5mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 04090200; GTIN: 5017123285158

Տեղեկատվական թերթիկ

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

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trihexyphenidyl 5mg Tablets BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of trihexyphenidyl hydrochloride BP.
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.
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
CONTRA-INDICATIONS
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 medication