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TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLETS

Active substance(s): TRIHEXYPHENIDYL HYDROCHLORIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

TRIHEXYPHENIDYL HYDROCHLORIDE 5mg TABLETS
Patient Information Leaflet

1. What Trihexyphenidyl hydrochloride 5mg Tablets are and what they are used for
The name of your medicine is Trihexyphenidyl hydrochloride 5mg Tablets. Trihexyphenidyl is an
antispasmodic (muscle relaxing) drug. Trihexyphenidyl is used to treat Parkinson’s disease.
Trihexyphenidyl helps patients with Parkinson’s disease by improving muscle control and reducing
stiffness so that they can move more naturally. Trihexyphenidyl can also be used to treat movement
disorders (extreme restlessness, involuntary movements or muscle spasms) which may be caused by
certain drugs.

Take special care if you are taking any of the following:
• monoamine oxidase inhibitors (e.g. moclobemide, tranylcypromine) or tricyclic antidepressants
(e.g. amitriptyline) for the treatment of depression
• phenothiazines (e.g. chlorpromazine, thioridazine) or clozapine for the treatment of mental illness
• antihistamines for the treatment of allergies
• disopyramide for the treatment of an irregular heartbeat
• levodopa for the treatment of Parkinson’s disease
• amantidine for viral infections
• nefopam, a painkiller
• metoclopramide or domperidone
• parasympathomimetics (e.g. neostigmine, bethanechol) for the treatment of urinary retention.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, planning to become pregnant, or breast-feeding without
consulting your doctor first.

WARNING!

Driving and using machines
Trihexyphenidyl can cause blurred vision or dizziness. Do not drive or operate machinery if this happens
to you.

UK PIL DATED JUNE 2009
REPORTING OF SIDE EFFECTS

CODE:

06464/2702A

Important information about the ingredients of Trihexyphenidyl hydrochloride 5mg Tablets
This medicine contains starch. This is suitable for people with coelic disease. Patients with wheat allergy
(different from coelic disease) should not take this medicine.
3. How to take Trihexyphenidyl hydrochloride 5mg Tablets
Always take Trihexyphenidyl hydrochloride 5mg Tablets exactly as your doctor has told you to. The label
on your medicine should also tell you. You should check with your doctor or pharmacist if you are not
sure.
The dose of trihexyphenidyl varies from person to person depending on the symptoms. You will normally
start on a low dose and this may be increased gradually by your doctor. The usual dose is between
5 - 15 mg per day (each tablet contains 5mg). Some people may need less, especially if they are also
taking other medicines. Also, if you are over 65 years of age, you may need less than the usual dose.
Trihexyphenidyl hydrochloride 5mg Tablets should be taken at meal times (just before or just after a
meal).
If you are not sure how many tablets to take or when to take them, ask your pharmacist.
Trihexyphenidyl hydrochloride 5mg Tablets should be swallowed whole with a glass of water.
If you take more Trihexyphenidyl hydrochloride 5mg Tablets than you should
If you have taken an overdose of Trihexyphenidyl hydrochloride 5mg Tablets (that is more than the doctor
has told you to) get medical help immediately, either by calling your doctor or going to the nearest hospital
casualty department. Remember to take the labelled medicine bottle with you, whether there are any
Trihexyphenidyl hydrochloride 5mg Tablets left or not.

Colour
Swatch

Black

WARNING!

DATE:
DATE:

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription (like aspirin).

06/01/13

DT
ARTWORKER:

Take special care with Trihexyphenidyl hydrochloride 5mg Tablets if you:
• have glaucoma
• have heart, liver or kidney disease or suffer from high blood pressure
• have prostate problems
• have trouble passing urine
• have a stomach ulcer or suffer from severe heartburn or acid indigestion or any other digestive
disorders
• suffer from a condition called myasthenia gravis
• suffer from tardive dyskinesia (unusual movements of the face and tongue)
• are elderly or under the age of 21.

DATE OF PROOF:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0440
PRE-PRESS NO.:

CUSTOMER: Waymade
PRODUCT:
Trihexyphenidyl Hydrochloride 5mg tabs

2. Before you take Trihexyphenidyl hydrochloride 5mg Tablets
Do not take Trihexyphenidyl hydrochloride 5mg Tablets if you:
• are allergic (hypersensitive) to trihexyphenidyl or any other ingredient in the tablets (see
section 6 – Further information for details)

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

In this leaflet
1. What Trihexyphenidyl hydrochloride 5mg Tablets are and what they are used for
2. Before you take Trihexyphenidyl hydrochloride 5mg Tablets
3. How to take Trihexyphenidyl hydrochloride 5mg Tablets
4. Possible side-effects
5. How to store Trihexyphenidyl hydrochloride 5mg Tablets
6. Further information

PROOF HISTORY:
v.2 - waymade - 06/01/13

Leaflet Flat Size = 148 x 317

27mm

Read all of this leaflet carefully before you start taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell
your doctor or pharmacist.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If you forget to take Trihexyphenidyl hydrochloride 5mg Tablets
If you forget to take a tablet you should take it as soon as you remember. However, if this is within 2 hours
of your next dose you should skip the missed tablet and carry on taking the rest of your tablets as usual.
Do not take a double dose to make up for the forgotten tablet.

WARNING!

If you experience any of the following rare side effects you should tell your doctor as soon as possible:
• restlessness or agitation
• feelings of confusion or delusion (loss of the sense of reality)
• hallucinations
• difficulty in sleeping
• false sense of well-being
• immediate or short-term memory loss
• worsening of myasthenia gravis (very tired or weak muscles)
• large pupils and lack of near vision
• eye discomfort and increased sensitivity to light
• painful increased pressure in the eye
• faster heart beat
• being sick
• reddening and dryness of skin or skin rashes
• inability to pass urine or difficulty passing urine
• thirst
• fever (raised body temperature)

If any of the side-effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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.

DATE:

DT

06/01/14
DATE OF PROOF:





5. How to store Trihexyphenidyl hydrochloride 5mg Tablets
Keep your tablets in the original container until you need to take one. This protects the tablets
from moisture which may spoil them.
Do not use after the expiry date printed on the carton, or tablet blister strip. The expiry date refers
to the last day of the month.
Keep your tablets in a safe, dry place where children cannot reach them.
Your tablets should be kept at room temperature (15-30°C).
If your doctor decides to stop your medicine you should return any tablets that are left to your
pharmacist (chemist) for disposal. Medicines should not be put down the sink, the toilet or in
the waste bin.
If you have any queries please ask your pharmacist (chemist).
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

UK PIL DATED JUNE 2009
REPORTING OF SIDE EFFECTS

06464/2702A

6. Further information
What is in Trihexyphenidyl hydrochloride 5mg Tablets?
Trihexyphenidyl hydrochloride Tablets contain 5mg of the active ingredient Trihexyphenidyl hydrochloride
in a white, round tablet marked with a breakline on one side.

CODE:

Trihexyphenidyl Hydrochloride 5mg tabs





ARTWORKER:




PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

By reporting side effects you can help provide more information on the safety of this medicine.

The other ingredients in Trihexyphenidyl hydrochloride 5mg Tablets are calcium hydrogen phosphate
(used to bind the ingredients of the tablet together), maize starch (used to add bulk to the tablet) and
magnesium stearate.
Trihexyphenidyl hydrochloride 5mg Tablets are available in packs of 100 tablets.
POM

PL No: 06464/2702 Trihexyphenidyl Hydrochloride 5mg Tablets

This product is manufactured by Teopharma S.r.l., Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV), Italy
and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 06.01.2014

Colour
Swatch

Black

WARNING!

DATE:

However you should tell your doctor if any of the following common side effects are severe or become
troublesome:
• dryness of mouth (this can be improved by sucking pastilles)
• constipation
• blurring of vision or dizziness
• feeling sick or nervous

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 317

CUSTOMER
APPROVED:

If you stop taking Trihexyphenidyl hydrochloride 5mg Tablets
Do not stop taking this medicine suddenly as your symptoms may get worse. If your dose needs to be
lowered, your doctor will reduce the amount you should take gradually.
4. Possible side-effects
Like all medicines, Trihexyphenidyl hydrochloride 5mg Tablets can cause side effects, although not
everybody gets them. If you experience any of the following very rare side effects you should tell your
doctor or go to your nearest casualty department immediately:
• allergic reaction such as swelling of the eyelids, face or lips or skin rash
• difficulty breathing or tightness in the chest
• difficulty swallowing

PROOF HISTORY:
v.2 - waymade - 06/01/14

Notes:

27mm

Expand view ⇕

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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