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AGITANE

Active substance(s): TRIHEXYPHENIDYL HYDROCHLORIDE

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PROPOSED AT COA
acting on the central nervous system of which the
phenothiazine drugs (used to treat mental disorders,
nausea and vomiting) are examples.
AGITANE / TRIHEXYPHENIDYL
If you are not sure why you have been prescribed Agitane
HYDROCHLORIDE 2 mg & 5 mg
then please ask your doctor.
PATIENT INFORMATION LEAFLET

TABLETS

PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL
THE PRESCRIBED COURSE OF AGITANE.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION.
What is in your medicine?
The name of this medicine is Agitane. It contains a
substance called Trihexyphenidyl Hydrochloride BP.
The active ingredient in this medicine is Trihexyphenidyl
Hydrochloride. This is the new name for Benzhexol
Hydrochloride. The ingredient itself has not changed.
Agitane is available in two strengths 2 mg and 5 mg
Trihexyphenidyl Hydrochloride together with the ingredients
lactose, maize starch, pre-gelatinised maize starch, sodium
starch glycollate, magnesium stearate.
The tablets are round, white, flat, bevel edged and both
strengths are available in containers of 28, 30, 50, 56, 60,
84, 100, 250, 500 and 1000 tablets. The 5 mg tablets are
scored. The 2 mg tablets are unscored.
The name and address of the product licence holder of
Agitane is: Chelonia Healthcare Limited, 11 Boumpoulinas,
3rd Floor, Nicosia, P.C. 1060, Cyprus
Agitane is manufactured by either: DDSA Pharmaceuticals
Ltd., Chatfield Road, off York Road, London SW11 3SE or
Meridian Healthcare (UK) Ltd., Rich Industrial Estate,
Chatfield Road, off York Road, Battersea, London SW11
3SE.
How does Agitane work?
Agitane belongs to a group of medicines known as the antimuscarinics that act on the central nervous system to
control certain muscular movement disorders such as
spasms, abnormal movements and troublesome
restlessness. Agitane also reduces muscular stiffness and
saliva production.
Why have you been prescribed Agitane?
Agitane is used in the management of Parkinson’s disease
or Parkinsonism caused by encephalitis or hardening of the
arteries. It is also used to control certain types of disorder
such as muscular rigidity, stiffness, tremor (fine shaking of
the hands), spasm which may be caused by certain drugs

Before taking this medicine
Tell your doctor if you are pregnant, planning a
pregnancy, or are breast-feeding.
Do not use Agitane if you have ever had any unusual or
allergic reactions to trihexyphenidyl or any of the other
ingredients of these tablets. Tell your doctor or pharmacist
if you are allergic to any other substances such as food,
preservatives or dyes.
Also tell your doctor if you suffer from high blood pressure
or disorders of the heart, liver or kidneys.
Do not use Agitane if you have suffered or suffer from:
• glaucoma (increased eyeball pressure)
• obstructive disease of the urinary tract, prostate
problems or difficulty passing urine
• obstructive disease of the gastro-intestinal tract or
constipation.
Use while driving or operating machinery
Agitane may cause blurred vision or dizziness. If affected
do not attempt to drive or operate dangerous machinery.
Can you take Agitane with other medicine?
It is important that your doctor is aware of any other
medication you are taking, whether it is prescribed or
bought without a prescription. Your doctor will be able to
identify medicines which you should not take with Agitane.
Tell your doctor if you are or have been taking any of the
following:
• phenothiazine drugs such as chlorpromazine used to
treat mental disorders
• tricyclic antidepressants such as imipramine
• monoamine oxidase inhibitors (MAOIs) for depression
• ketoconazole (to treat certain fungal infections)
• antihistamines (for allergies)
• parasympathomimetic medicines (for urine retention)
• nefopam (for pain relief)
• disopyramide (for irregular heart beat)
• nitrates (for angina)
• metoclopramide or domperidone used to prevent
nausea, vomiting and to help treat heartburn
• Amantadine (for Parkinson’s disease or flu)
• Any other treatment for Parkinson’s disease.
Proper use of this medicine
Take this medicine only in the doses prescribed by your
doctor. Do not take more of it and do not take it more often
or for a longer time than your doctor ordered.
Common Dosage

PROPOSED AT COA
This medicine is to be taken by mouth.
Common side effects are dryness of mouth, blurring of
Treatment should always be started at a low dose and
vision, dizziness, mild feeling of sickness (nausea),
gradually increased until the right dose for you has been
constipation or nervousness. These reactions tend to
determined.
become less troublesome as treatment continues.
Tell your doctor immediately if you develop mental
Adults: The usual dosage for Parkinson’s disease is 6-10
confusion, agitation or sickness and vomiting. You may be
mg per day, however some patients may need more. This
advised to take smaller doses with gradual increases to an
should be given at mealtimes either three or four times a
acceptable level.
day.
Less common side effects include difficulty urinating,
For drug-induced Parkinsonism the normal dose is 5 mg increased heartbeat and hypersensitivity (allergic
15 mg per day. Some patients may be controlled by as little
reactions).
as 1 mg daily.
Some patients taking high doses may experience
At the beginning of therapy the dose should be 1 mg on the
confusion, excitement, agitation, hallucinations, insomnia
first day, 2 mg on the second day and thereafter increases
(difficulty sleeping), memory loss and psychiatric
of 2 mg per day at 3-5 day intervals, continued until the
disturbances. If you experience any of these symptoms
right dose for you is reached. The maximum daily dose is
contact your doctor immediately.
20 mg.
If you notice any of the above reactions or side effects, or if
you notice other unusual or worrying changes contact your
Children: Agitane is not recommended for children.
doctor.
Elderly: If you are over 60 years of age you may require
smaller amounts of Agitane.
In all patients changes in dosage either upward or
downwards should only be in small steps over a period of
days.
Do not stop taking this medicine suddenly as your
symptoms may get worse. Your doctor will reduce the dose
gradually if it needs to be lowered.
Should I take my tablets before or after meals?
If you take Agitane before meals you may feel sick. Taking
Agitane after meals may make you thirsty. You may find
that chewing gum, peppermints or drinking water will help
but if you have a very dry mouth, taking your tablets before
meals may be preferable.
What to do if too many tablets are taken at the same
time?
If you think you may have taken too many of your tablets,
either call your doctor straight away, or go to the nearest
hospital casualty department. Always keep any remaining
tablets in the container in which they were given to you so
that the medicine can be identified by the doctor or
pharmacist at the hospital.
Also tell them whether you have taken any other
medicines.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to
your regular dosing schedule. Do not take two doses at
once.
If you feel this medicine is not working well after you have
taken it for a short time (1-2 weeks) do not increase the
dose, instead check with your doctor.
What side effects can occur when taking Agitane?

Storing your medicine
You must keep this medicine in a safe place where children
cannot get it. Your medicine could harm them.
Keep your medicine in a dry place and store below 25°C.
Keep container tightly closed and protect from light.
If your doctor tells you to stop the treatment, return any
remaining tablets to the doctor or pharmacist. On the label
you will find the words “expiry date” followed by numbers
indicating the day, month and year. This is the date when
the medicine is no longer fit for use. Do not use the
medicine after this date, but return it to your doctor or
pharmacist.
A reminder
Remember this medicine is for you. Never give it to
someone else, even if their condition is the same as yours.
This leaflet does not contain the complete information
about your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist who
have access to additional information.
This leaflet was revised in 02/2013

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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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