ARTANE TABLETS 2MG

Active substance: TRIHEXYPHENIDYL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Artane Tablets 2mg and 5mg
Read all of this leaflet carefully before you start taking this medicine
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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.

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

1. WHAT ARTANE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Artane 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.

2. BEFORE YOU TAKE ARTANE TABLETS
Do not take Artane Tablets if you:


are allergic (hypersensitive) to trihexyphenidyl or any other ingredient in the tablets (see section 6
– Further information for details)

Take special care with Artane 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

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).
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

amantadine 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.

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

Important Information about the ingredients of Artane 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 ARTANE TABLETS
Always take Artane 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 either 2mg or 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.
Artane 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. Artane tablets should be swallowed whole with a
glass of water.

If you take more Artane Tablets than you should
If you have taken an overdose of Artane 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 Artane Tablets left or not.

If you forget to take Artane 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.
If you stop taking Artane 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 can cause side-effects although not everybody gets them.
If you experience any of the following very rare side-effects, you should contact your doctor immediately or go
to your nearest casualty department:

allergic reactions such as swelling of the eyelids, face or lips, skin rash

difficulty breathing or tightness in the chest

difficulty swallowing
If you experience any of the following rare side-effects, you should contact your doctor as soon as possible:

restlessness or agitation

feelings of confusion or delusion (loss 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 heartbeat

being sick

reddening and dryness of skin or skin rashes

inability to pass urine or difficulty passing urine

thirst

fever( raised body temperature)
However you should tell your doctor if any of the common side effects are severe or become troublesome

dryness of mouth (this can be approved by sucking pastilles)

constipation

blurring of vision or dizziness

feeling sick or nervous
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

5. HOW TO STORE ARTANE TABLETS
Keep out of the reach and sight of children.
Do not take Artane Tablets after the expiry date which is printed on the pack. The expiry date refers to the last
day of the month.
Artane Tablets should be kept at room temperature (15- 30 C). Keep your tablets in the original bottle until
you need to take one. This protects the tablets from moisture which may spoil them. If your doctor decides to
stop your medicine, you should return any unused tablets to your pharmacist.
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.

6. FURTHER INFORMATION
What Artane Tablets contain
The active substance in the Artane Tablets is trihexyphenidyl hydrochloride.
Other ingredients are: calcium hydrogen phosphate, starch and starch pregelatinised, magnesium stearate
and purified water.

What Artane Tablets look like and the contents of the pack
Artane Tablets 2mg and 5mg are white tablets with either GP 4434 (2mg) or GP4434 (5mg) on the side. Each

bottle contains 84 tablets
POM
PL 17225/0001
PL 17225/0002

Artane Tablets 2mg
Artane Tablets 5mg

Marketing Authorisation Holder
Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN. UK

Manufacturer
Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex, BN3 3LW, UK
This leaflet was last approved in May 2011.

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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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