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BENZHEXOL 5MG TABLETS

Active substance(s): TRIHEXYPHENIDYL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Benzhexol 2mg and 5mg Tablets
[trihexyphenidyl hydrochloride]
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 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,
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Benzhexol Tablets are and what they are
used for
2. What you need to know before you take
Benzhexol Tablets
3. How to take Benzhexol Tablets
4. Possible side effects
5. How to store Benzhexol Tablets
6. Contents of the pack and other information
1. WHAT BENZHEXOL TABLETS ARE AND
WHAT THEY ARE USED FOR
Benzhexol Tablets contain the active ingredient
trihexyphenidyl. This belongs to a group of
medicines known as anti-muscarinics 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 BENZHEXOL TABLETS
Do not take Benzhexol Tablets:
If you are hypersensitive (allergic) to
trihexyphenidyl or any of the other ingredients
of Benzhexol Tablets.

!

Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Benzhexol Tablets if you:
! Have glaucoma (increased pressure in the eye)
! Suffer from high blood pressure
! Suffer from kidney, heart, liver or prostate
problems
! Suffer from stomach or bowel blockage
! Are elderly - these tablets should be used with
caution and may cause confusion, delusions
and hallucinations
! Suffer from bladder problems or have difficulty
passing urine
! Suffer from a condition called myasthenia
gravis (a rare muscle weakness disorder)

!
!

Experience unusual movements of the face
and tongue as this may be a sign of a serious
condition known as tardive dyskinesia
Have arteriosclerosis (hardening of the
arteries).

Other medicines and Benzhexol Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. In particular:
! Other medicines that have an anti-muscarinic
effect such as atropine, hyposcine, oxybutynin
and tolterodine used to treat bowel or bladder
problems
! Monoamine oxidase inhibitors (MAOIs) used to
treat depression e.g phenelzine, isocarboxzid
! Antihistamines used to treat allergic reactions
e.g diphenhydramine
! Disopyramide used to treat an irregular heart
beat
! Phenothiazines used to treat mental disorders
or nausea and vomiting e.g chlorpromazine,
thioridazine and fluphenazine
! Metoclopramide or domperidone used to treat
the symptoms of nausea
! Tricyclic antidepressants e.g. amitriptyline
! Nefopam used to treat pain
! Ketoconazole used to treat fungal infections
! Other medicines used in the treatment of
Parkinson's disease e.g amantidine and
levodopa
! Medicines used to stimulate the nervous
system.
If you use nitrate tablets under your tongue to treat
angina attacks, you may find that trihexyphenidyl
makes your mouth too dry to dissolve them.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice if you are
pregnant or planning on becoming pregnant.
These tablets should not be used during breastfeeding.
Driving and using machines
These tablets can cause some people to have
blurred vision, feel confused or feel dizzy. If you
are affected do not drive or operate machinery.
Benzhexol Tablets contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
3. HOW TO TAKE BENZHEXOL TABLETS
Always take Benzhexol Tablets exactly as your
doctor has instructed you. You should check with
your doctor or pharmacist if you are unsure.

The tablets are taken orally. The dose should be
taken in 3 to 4 divided doses daily, before or with
meals.

!

Adults:
The starting dose is 1mg daily. This will be
gradually increased until a maintenance dose of 515mg daily, in 3-4 divided doses is achieved. The
maximum daily dose is 20mg. The dose will be
determined for you by your doctor.

!
!
!
!

Elderly:
Patients over 65 years may require a reduced adult
dose.
When these tablets are used with other drugs to
relieve Parkinson's disease, such as levodopa and
amantadine, the dose may need to be reduced.
Your doctor will decide the dose that is best for
you. The pharmacist's label will also tell you how
many tablets to take and how often.
If you take more Benzhexol Tablets than you
should
This medicine is to be taken at regular intervals, as
determined by the physician. If you take too many
tablets by mistake contact your nearest hospital
casualty department or tell your doctor
immediately. Take your tablet pack with you.
Symptoms of an overdose include flushing and
dryness of the skin, dilated pupils, dry mouth and
tongue, irregular heartbeat, increased breathing
rate, fever, feeling sick and being sick.
If you stop taking Benzhexol Tablets
This medicine is not to be stopped abruptly, keep
taking your medicine until your doctor tells you how
to reduce the dose slowly.
If you forget to take Benzhexol Tablets
If you miss a dose of this medicine, take it as soon
as possible. However, if it is almost time for your
next dose, skip the missed dose and continue with
the regular dosing schedule.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everyone gets them.
Allergic reactions may occur rarely, with symptoms
such as rash, itching, swelling of the face,
wheeziness, shortness of breath, tightness in the
chest, fever, low blood pressure and feeling dizzy
particularly when standing up. If any of these
occur STOP taking the medicine and contact a
doctor immediately.
Other side effects that may occur:! Dry mouth, difficulty swallowing
! Constipation, feeling sick and being sick
! Large pupils, lack of near vision, eye
discomfort, increased sensitivity to light and
painful increased pressure in the eye
! Agitation
! Confusion
! Hallucinations
! Feeling optimistic
! Inability to sleep or restlessness
! Forgetfulness
! Paranoid delusions (being worried that
something bad is happening without any
reason)

!

Redness and dryness of the skin or
skin rashes
Difficulty passing urine or unable to
pass urine
Thirst
Fever
Faster heartbeat
Worsening of myasthenia gravis (very
tired or weak muscles).

These side effects are more likely to
occur in patients receiving higher than the
recommended dose.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE BENZHEXOL TABLETS
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date stated
on the label.
Store in the original package.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Benzhexol Tablets contain:
Benzhexol 2mg and 5mg Tablets contain 2mg and
5mg of the active ingredient trihexyphenidyl
hydrochloride respectively.
The other ingredients are: magnesium stearate,
maize starch, pregelatinised maize starch and
lactose.
What Benzhexol Tablets look like and contents
of the pack
Benzhexol Tablets are white, flat bevel edged
tablets with a breakline.
Pack sizes for 2mg and 5mg tablets are 28, 30, 42,
50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 in
plastic containers.
Blister packs in cartons contain 28, 30, 42, 56, 60,
84, 90 and 112 tablets.
Marketing Authorisation Holder
Ennogen Pharma Limited, Unit G4 Riverside
Industrial Estate, Riverside Way, Dartford, DA1
5BS
Manufacturer
Regent GM Laboratories Limited
Cunard Road, North Acton, London NW10 6PN
This leaflet was last revised in November 2014.

SIZE : 160 X 270 (mm) Back

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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