Patient leaflet - Agitane (Trihexyphenidyl 5 mg)
1.What Agitane is and what it is used for
The name of this medicine is Agitane. It contains a substance called Trihexyphenidyl Hydrochloride BP.
Agitane belongs to a group of medicines known as the anti-spasmodics (muscle relaxing) drug 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.
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 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.
2.What you need to know before you take Agitane
Do not take Agitane:
If you are allergic to trihexyphenidyl or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking this medicine if you have :
- high blood pressure or disorders of the heart, liver or kidneys.
- 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
suffer from a condition called muscle weakness
(myasthenia gravis)
- suffer from tardive dyskinesia (unusual movements of the face and toungue)
- have mental health problems
- are elderly.
Children
These tablets are not recommended for use in children.
Other medicine and Agitane
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is important that your doctor is aware of any other medication you are taking, whether it is prescribed or bought without a prescription (like aspirin). 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, thioridazine ) or clozapine used to treat mental disorders
- tricyclic antidepressants such as imipramine, amitriptyline
monoamine oxidase inhibitors (MAOIs) e.g.
moclobemide, trancylcypromine for depression
- antihistamines (for allergies)
- parasympathomimetic medicines (e.g. neostigmine bethanechol) for the treatment of urine retention
- nefopam (for pain relief)
- disopyramide (for irregular heart beat)
- 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.
Agitane with food and drink
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Agitane may cause blurred vision or dizziness. If affected do not attempt to drive or operate dangerous machinery.
Agitane contains Lactose
If you know you have an intolerance to lactose or other sugars contact your doctor before taking Agitane.
3.How to take Agitane
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure .
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.
The recommended dose is:
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.
Use in Children: Agitane is not recommended for children.
Elderly: If you are over 65 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.
If you take more Agitane than you should
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.
Symptoms of overdoses with antimuscarinic agents including flushing and dryness of the skin, dilated pupils, dry mouth and tongue, fast heart rate , rapid respiration, high fever, hypertensions, nausea, vomiting. A rash may appear on the face or upper trunk. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsion. In severe overdose, CNS depression may occur with coma, circulatory and respiratory failure and death.
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.
If you forget to take Agitane
If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not take double dose to make up for a forgotten dose.
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.
If you stop taking Agitane
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following 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
If you experience any of the following 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 weak muscles)
- large pupils and lack of near vision
- eye discomfort and increased sensitive 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 following side effects are severe or become troublesome:
- dryness of mouth(this can be improved by sucking pastilles)
- constipation
- blurring vision or dizziness
- feeling sick or nervous
If you notice any of the above reactions or side effects, or if you notice other unusual or worrying changes contact your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme [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 Agitane
Keep this medicine out of the sight and reach of children.
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. Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use . These measures will help to protect the environment.
6. Contents of the pack and other information
What Agitane contains
Agitane is available in two strengths 2 mg and 5 mg. The active ingredient in this medicine is Trihexyphenidyl Hydrochloride. This is the new name for Benzhexol Hydrochloride. The ingredient itself has not changed. The other ingredients are lactose, maize starch, pre-gelatinised maize starch, sodium starch glycollate, magnesium stearate.
What Agitane looks like and contents of the pack
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.
Marketing Authorisation Holder
Chelonia Healthcare Limited, 11 Boumpoulinas, 3rd Floor, Nicosia, P.C. 1060, Cyprus
Manufacturer
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.
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was revised in 02/2017