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AGITANE (TRIHEXYPHENIDYL 5MG)

Active substance(s): TRIHEXYPHENIDYL HYDROCHLORIDE / TRIHEXYPHENIDYL HYDROCHLORIDE / TRIHEXYPHENIDYL HYDROCHLORIDE

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PROPOSED
PATIENT INFORMATION LEAFLET
INFORMATION FOR THE USER

AGITANE / TRIHEXYPHENIDYL
HYDROCHLORIDE 2 mg & 5 mg
TABLETS
Read all of this leaflet carefully before you start taking
this medicine because it contains important
information for you.
- 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 only.
Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet .See section 4.
What is in this leaflet
1. What Agitane is and what it is used for
2. What you need to know before you take Agitane
3. How to take Agitane
4. Possible side effects
5. How to store Agitane
6. Contents of the pack and other information
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

PROPOSED
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

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

Battersea, London SW11 3SE.
For more information about this product, please contact the
Marketing Authorisation Holder.

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, pregelatinised 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,

This leaflet was revised in 02/2017

Expand Transcript

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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