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Agitane (Trihexyphenidyl 5mg)

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PROPOSED AT COA

PATIENT INFORMATION LEAFLET

AGITANE / TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg & 5 mg TABLETS

acting on the central nervous system of which the phenothiazine drugs (used to treat mental disorders, nausea and vomiting) are examples.

If you are not sure why you have been prescribed Agitane then please ask your doctor.

The active ingredient in this medicine is Trihexyphenidyl Hydrochloride. This is the new name for Benzhexol Hydrochloride. The ingredient itself has not changed.


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.

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 anti-muscarinics 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.

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.

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


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


This medicine is to be taken by mouth.

Treatment should always be started at a low dose and gradually increased until the right dose for you has been determined.

Adults: The usual dosage for Parkinson's disease is 6-10 mg per day, however some patients may need more. This should be given at mealtimes either three or four times a day.

For drug-induced Parkinsonism the normal dose is 5 mg -15 mg per day. Some patients may be controlled by as little as 1 mg daily.

At the beginning of therapy the dose should be 1 mg on the first day, 2 mg on the second day and thereafter increases of 2 mg per day at 3-5 day intervals, continued until the right dose for you is reached. The maximum daily dose is 20 mg.

Children: Agitane is not recommended for children.

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.

AT COA

Common side effects are dryness of mouth, blurring of vision, dizziness, mild feeling of sickness (nausea), constipation or nervousness. These reactions tend to become less troublesome as treatment continues.

Tell your doctor immediately if you develop mental confusion, agitation or sickness and vomiting. You may be advised to take smaller doses with gradual increases to an acceptable level.

Less common side effects include difficulty urinating, increased heartbeat and hypersensitivity (allergic reactions).

Some patients taking high doses may experience confusion, excitement, agitation, hallucinations, insomnia (difficulty sleeping), memory loss and psychiatric disturbances. If you experience any of these symptoms contact your doctor immediately.

If you notice any of the above reactions or side effects, or if you notice other unusual or worrying changes contact your doctor.

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

What side effects can occur when taking Agitane?