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Trihexyphenidyl 5mg Tablets Bp

Document: leaflet MAH GENERIC_PL 20416-0030 change

PATIENT INFORMATION LEAFLET

* TRIHEXYPHENIDYL

2mg&5mg Tablets


Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet, you may need to read it again. If you have any questions or are not sure about anything, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Trihexyphenidyl Tablets are and what they are used for

2.    Before you take Trihexyphenidyl Tablets

3.    How to take Trihexyphenidyl Tablets

4.    Possible side effects

5.    How to store Trihexyphenidyl Tablets

6.    Further information

1.    What Trihexyphenidyl Tablets are and what they are used for

Trihexyphenidyl belongs to a group of medicines called antimuscarinics (sometimes called anticholinergics). It works by correcting a chemical imbalance in the brain that affects the transmission of nerve impulses. It is used to treat Parkinson’s disease by improving muscle control and reducing stiffness so patients can move more naturally. It is also used to treat abnormal face and body movements, muscle spasms and restlessness caused by certain drugs.

2.    Before you take Trihexyphenidyl Tablets

Do not take these tablets if:

•    you are allergic to Trihexyphenidyl or any of the other ingredients (see section 6). (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips).

Check with your doctor before taking these tablets if:

•    you have hardening of the arteries

•    you have ever had a reaction to any other medicine

•    you have high blood pressure

•    you have heart, liver or kidney problems

•    you have an enlarged prostate gland, have bladder problems or have difficulty in passing urine

•    you have glaucoma (increased pressure in the eye)

•    you have a blockage in your stomach or bowel

•    you are elderly

•    you have a condition called myasthenia gravis (a rare muscle weakness disorder)

•    you experience unusual movements of the face, tongue, arms and legs as this may be a sign of a serious condition known as tardive dyskinesia

•    you are pregnant or breast feeding. This medicine should NOT be taken during breast feeding.

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

•    nefopam (used for pain relief)

•    ketoconazole (used to treat fungal infections)

•    disopyramide (used to treat irregular heart beat)

•    metoclopramide or domperidone (used to stop you feeling or being sick)

•    amantadine or levodopa (used to treat Parkinson’s disease)

•    monoamine oxidase inhibitors (MAOIs) e.g. isocarboxacid or moclobemide or tri-cyclic antidepressants e.g. amitriptyline (for treating depression)

•    antihistamines (used to treat allergies)

•    phenothiazines e.g. chlorpromazine (used to treat mental illness)

•    any other medicines to help your muscles to contract and which are being used to avoid problems following an operation, such as difficulty passing urine or to treat a condition known as myasthenia gravis (e.g. neostigmine, distigmine)

•    any medicine you have to dissolve under your tongue e.g. glyceryl trinitrate (used to treat angina)

•    any other anti-muscarinic medicines such as those being used to treat irritable bowel syndrome, stomach or bowel conditions (e.g. atropine, hyoscine), bladder problems (e.g. darifenacin, oxybutynin) or Parkinson’s disease (e.g. benzatropine, procyclidine). Taking these medicines at the same time may increase the risk of side effects such as dry mouth, difficulty in passing urine and constipation. If you are elderly you may also become confused.

Other special warnings:

Driving or using machinery:

Some people may experience blurred vision or feel dizzy or less alert than usual when they are taking these tablets. Do not drive or operate machinery if this happens to you.


Important information about one of the ingredients of this medicine:

Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Trihexyphenidyl Tablets

Swallow the tablets with a drink of water just before or with a meal.

The dose will be different for different medical conditions and patients. Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions. The pharmacist’s label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

The usual dose starts at 1 - 2mg (half to one 2mg tablet) per day. This may be increased by your doctor gradually to a maximum dose of 20mg (four 5mg tablets) per day.

Do not stop taking this medicine suddenly as your symptoms may get worse. If your dose needs to be reduced your doctor will reduce the amount you should take gradually.

Remember, this medicine is for YOU. Do not give it to someone else, even if their symptoms are the same as yours. This medicine may harm them.

If you take too many Trihexyphenidyl Tablets:

If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

If you forget to take Trihexyphenidyl Tablets:

If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME.

4.    Possible side effects

Like all medicines, Trihexyphenidyl can cause side effects, although not everybody gets them. 30 - 50% of patients may experience dry mouth, constipation, blurred vision, dizziness and stomach upset.

If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as they may be signs of an allergic reaction:

•    shortness of breath, blocked nose, rash, itching, swollen face or lips (could happen to more than 1 in 100 people, but less than 1 in 10)

The following other side-effects have been reported with trihexyphenidyl:

Uncommon effects (that could happen to more than 1 in 100 people, but less than 1 in 10):

•    difficulty in passing urine

•    faster heart beat

•    nervousness

•    high doses of this medicine may cause excitement, feeling of great happiness, agitation or confusion, hallucinations, restlessness, difficulty sleeping, change in your mental well-being or you may have paranoid delusions (worry that something bad is happening without any reason). Your memory may also be affected.

Do not be concerned by this list of side effects, you may not get any of them. If any of the effects get serious, or if you notice any other unusual or unexpected symptoms please tell your doctor or pharmacist.

5.    How to store Trihexyphenidyl Tablets

Keep this medicine in the original package and store in a cool, dry place.

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

6.    Further information

Ingredients:

Each Trihexyphenidyl Tablet 2mg contains 2mg of trihexyphenidyl hydrochloride.

Each Trihexyphenidyl Tablet 5mg contains 5mg of trihexyphenidyl hydrochloride.

Other ingredients are magnesium stearate, maize starch, pregelatinised maize starch and lactose.

What the medicine looks like:

The tablets are round and white with a breakline on one side.

They are available in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

The Product Licence Holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED and the Manufacturer is Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.


Date leaflet revised: June 2010

If you would like this leaflet in a different format please contact the licence holder at the above address.