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Ref: 1370/0210131/F

Orphenadrine Hydrochloride 50mg Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

*    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. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Orphenadrine 50mg Tablets and will be referred to as Orphenadrine Hydrochloride Tablets throughout the rest of this leaflet.

In this leaflet:

M What Orphenadrine Hydrochloride Tablets are and what they are used for

3 Before you take Orphenadrine Hydrochloride Tablets How to take Orphenadrine Hydrochloride Tablets [A Possible side effects

How to store Orphenadrine Hydrochloride Tablets Further information

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking other anticholinergic agents at the same time as Orphenadrine Hydrochloride Tablets, this can lead to an increase in dry mouth and difficulties in passing water. Your doctor or pharmacist will be able to advise you whether any of the medicines you are taking fall into this category.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Do not use Orphenadrine Hydrochloride Tablets during pregnancy or if you are breast-feeding, unless clearly necessary.

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or have blurred vision whilst taking Orphenadrine Hydrochloride Tablets.

Important information about some of the ingredients of Orphenadrine Hydrochloride Tablets

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

^ What Orphenadrine Hydrochloride Tablets are and what they are used for

The active ingredient in Orphenadrine Hydrochloride Tablets belongs to the group of medicines called anticholinergic agents. Orphenadrine Hydrochloride Tablets are used in the treatment of all forms of Parkinson's disease, a condition which can cause uncontrollable trembling of the hands, and other difficulties of movement, for example in standing or walking. Anticholinergic agents are also used when other medicines have caused these problems.

^ Before you take Orphenadrine Hydrochloride Tablets

Do not take Orphenadrine Hydrochloride Tablets. Tell your doctor if you:

*    are allergic (hypersensitive) to orphenadrine or any of the other ingredients of Orphenadrine Hydrochloride Tablets. (see list in section 6 ‘Further information')

*    have increased pressure in the eye (glaucoma).

*    have an enlarged prostate.

*    are unable to pass water for any reason.

*    have a blockage in your digestive system or any stomach disorders.

*    suffer from a rare inherited disease where the breakdown of

haemoglobin (a pigment in the red blood cells) is affected (porphyria).

*    suffer from involuntary movements of the face or body (tardive dyskinesia). Your doctor will take this into consideration before prescribing the tablets for you.

_*    suffer from a rare hereditary problem of fructose and galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Orphenadrine Hydrochloride Tablets should not be given to children.

Take special care with Orphenadrine Hydrochloride Tablets Tell your doctor if you:

_*    suffer from heart disease

_*    suffer from liver disorders

_*    suffer from kidney disorders

_*    have difficulties passing water

^ How to take Orphenadrine Hydrochloride Tablets

Always take Orphenadrine Hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose for adults and the elderly is three tablets daily in divided doses. Your doctor may increase this dose, if necessary, by one tablet every two to three days up to a maximum of eight tablets in a day. Usually you will need long term treatment with Orphenadrine Hydrochloride Tablets.

Use in children

Orphenadrine Hydrochloride Tablets should not be given to children.

If you take more Orphenadrine Hydrochloride Tablets than you should

Taking more Orphenadrine Hydrochloride Tablets than have been prescribed could be dangerous.

If you, or anyone else, should accidentally take more tablets than prescribed, you must phone your doctor or go to a hospital casualty department immediately.

If you forget to take Orphenadrine Hydrochloride Tablets

Take the forgotten dose as soon as you remember. If it is time for your next dose skip the dose you missed and just continue to follow the dosing schedule as usual. Do not take a double dose to make up for a forgotten one.

If you stop taking Orphenadrine Hydrochloride Tablets

If you are to stop taking Orphenadrine Hydrochloride Tablets then your doctor will make sure that the dose is gradually reduced over a number of days. You should not stop taking the tablets unless you have been told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Orphenadrine Hydrochloride 50mg Tablets

Patient Information Leaflet (continued)

Possible side effects

Like all medicines, Orphenadrine Hydrochloride Tablets can cause side effects, although not everybody gets them. If you are elderly you may be more likely to get side effects

Uncommon (fewer than 1 in 100 patients)

allergic reactions may occur while on treatment with Orphenadrine Hydrochloride Tablets. Signs of allergy include: rash - wheezing -breathlessness - swollen eyelids, face or lips and in extreme cases collapse. If you get any of these symptoms soon after taking Orphenadrine Hydrochloride Tablets, do not take any more. Tell a doctor immediately and take the packaging and this leaflet with you.

Other possible side effects:

Common (fewer than 1 in 10 patients)

_*    dry mouth, stomach upsets

_*    dizziness

_*    difficulty in seeing clearly

Uncommon (fewer than 1 in 100 patients)

_*    rapid heart beat

_*    changes of mood such as highly elevated mood, confusion, sleepiness, hallucinations, difficulty in sleeping, nervousness, seizure (fits)

_*    difficulty in passing water

Rare (fewer than 1 in 1000 patients)

_*    memory disturbance

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.

Revision date: 02/10/13

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[5 How to store Orphenadrine Hydrochloride Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store at room temperature (15°C-25°C)

Do not take this medicine after the expiry date which is printed on the blister label or carton. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

If your medicine becomes discoloured or shows any other signs of deterioration, ask your pharmacist who will advise you what to do.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

^ Further information

What Orphenadrine Hydrochloride Tablets contains:

The active ingredient is orphenadrine hydrochloride. Each tablet contains 50mg orphenadrine hydrochloride.

The other ingredients are microcrystalline cellulose, microgranular corn starch, stearic acid, magnesium stearate, amorphous silica, shellac, acacia, talc, sucrose, beta-carotene.

What Orphenadrine Hydrochloride Tablets look like and contents of the pack

Orphenadrine Hydrochloride Tablets are yellow, round and sugar coated with no markings.

Each pack contains 100 tablets.