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PACKAGE LEAFLET: INFORMATION FOR THE USER

Procyclidine Tablets 5mg

Procyclidine hydrochloride

Read all ofthis leaflet carefullybeforeyoustarttakingthis medicinebecauseitcontains importantinformationforyou.

•    Keepthis leaflet. You may need to read itagain.

•    Ifyouhaveanyfurtherquestions, askyourdoctororpharmacistornurse.

•    Thismedicinehasbeenprescribedforyouonly.Donotpassitontoothers. Itmayharmthem,eveniftheirsignsofillnessarethesameas

•    Ifyougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanysideeffectsnotlisted inthisleaflet.Seesection4. Whatisinthisleaflet:

1.    WhatProcyclidineTabletsareandwhattheyareusedfor

2.    WhatyouneedtoknowbeforeyoutakeProcyclidineTablets

3.    HowtotakeProcyclidineTablets

4.    Possiblesideeffects

5.    HowtostoreProcyclidineTablets

6.    Contentsofthepackand otherinformation

1.    WhatyouneedtoknowbeforeyoutakeProcyclidineTablets

Procyclidine belongs to a group of medicines called antimuscarinics (anticholinergics). It is most commonly used for Parkinson's disease or symptoms(parkinsonism)duetoothercauses, including drug induced parkinsonism.

2.    WhatyouneedtoknowbeforeyoutakeProcyclidineTablets DonottakeProcyclidineTabletsifyou:

•    Arehypersensitive(allergic)toprocyclidineoranyoftheotheringredientsinProcyclidineTablets(listedinsection6).

•    Havean obstruction oftheintestineand/orstomach

•    Havedifficultyurinating

•    Sufferfromglaucoma(eyediseasecausedbytoomuchpressurewithintheeye).

Warningsandprecautions:

Ifyouhavehadanyofthefollowingyoushouldtellyourdoctorbeforetakingthismedicine:

•    Pregnantormaybecomepregnant, orbreast-feeding

•    Chronickidneyorliverdisease

•    Difficultypassingwater,whichinsomemenmaybeduetoanenlargedprostate.

•    Suffer from a movement disorder called tardive dyskinesia, in which movements (especially of the limbs) are slow or difficult, or uncontrolledandjerky. Thisconditionmay bemadeworse ifyouaregivenprocyclidinewhilstbeingtreatedwithneurolepticdrugs

•    Ifyouareelderly,yourdosemayneedtobecarefullymonitoredtopreventanysideeffects.

OthermedicinesandProcyclidineTablets:

Tellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyothermedicines.

Iftaken with some other medicines the effects of ProcyclidineTablets orthe effects ofother medicines may be changed. Please check with your doctorifyouaretakinganyofthefollowing:

•    Antihistamines

•    Antidepressants

•    Phenothiazines (formental illness)

•    Amantadineorlevodopa(usedinParkinson'sdiseaseorsomeviralinfections)

•    Ketoconazole(usedforfungalinfectionssuchasathlete'sfootorthrush)

•    Quinidineordisopyramide(usedforconditionsoftheheart)

•    Tacrine(fortreatingsymptomsofAlzheimer'sdisease).

ProcyclidineTabletswithfoodanddrink:

Swallowthetabletswithalittlewateraftermeals.

Pregnancyandbreast-feeding:

Askyourdoctororpharmacistforadvicebeforetakinganymedicineifyouarepregnant,planningonbecomingpregnantorarebreast-feeding.

Drivingandusingmachinery:

DonotdriveoroperatemachineryasProcyclidineTabletsmaymakeyoufeeldizzy,confused,disorientatedoraffectyoureyesight.

ProcyclidineTabletscontainlactose:

Ifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,contactyourdoctorbeforetakingthismedicinalproduct.

3.    HowtotakeProcyclidineTablets

AlwaystakeProcyclidineTabletsexactly asyourdoctorhastoldyouto.Youshouldcheckwith yourdoctororpharmacistifyouarenotsure.

Adults:

The usual dose is between 2and6 tablets a day, depending on yourcondition and howyou respond.Thetablets should betaken in3or4 divided doses, after meals with a little water. Your doctorwill usually startyou on a low dose and increase it slowly (every day or every few days) to the bestdoseforyou.

Children:

ProcyclidineTabletsarenotrecommendedforuseinchildren.

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IfyoutakemoreProcyclidineTabletsthanyoushould:

An overdose of this medicine may be harmful. If you or someone else, have taken too much of your medicine tell your doctor or pharmacist, orgotothenearesthospital casualtydepartmentimmediately.

Ifyou forgettotakeProcyclidineTablets:

Ifyou forget to take a dose at the right time, take it as soon as you remember, then go on as before. Do not take a double dose to make up for theforgottendose.

IfyoustoptakingProcyclidineTablets:

You should finish all the tablets your doctor has prescribed even if you feel better. You should still take all the tablets you have been given, itmaybedangeroustostoptakingthemedicinewithoutyourdoctor'sadvice.

4.    Possiblesideeffects

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.

If you are also taking medicines for schizophrenia, mania or mental conditions, you may experience uncontrolled jerky movements of your limbs when you first start to take procyclidine tablets. If this happens talk to your doctor immediately - it may be necessary for your doctor toreducethedoseofyourothermedicine.

Otherunwantedsideeffectsmayincludethefollowing:

Commonlyoccurringsideeffectsinclude:

•    Dry mouth

•    Blurred vision

•    Constipation

•    Urinaryretention.

Other side effects which occur less frequently include:

•    Nausea

•    Vomiting

•    Gingivitis (inflammation of the gums)

•    Skin rashes

•    Feeling nervous

•    Stomachupsets.

Sideeffectsthathavebeenreportedon rareoccasions:

•    Psychotic-like symptoms (eg. hallucinations or personality changes).

Higher doses of procyclidine may cause disorientation, anxiety, agitation, dizziness, confusion or hallucinations and may affect your mental processesormemory.

Reportingofsideeffects

Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.

5.    HowtostoreProcyclidineTablets Keep out of the sight and reach of children.

Do not store these tablets above25°C.

DonotuseProcyclidineTablets after the expiry date which is stated on the carton. The expiry date refers to the last day of the month. Storethemintheoriginalcontainertoprotectfromlight.

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

6. Contents ofthepackand otherinformation

What Procyclidine Tablets contain:

These tablets contain 5mg of the active ingredient Procyclidine Hydrochloride. Thetabletsalsocontainmaizestarch, magnesiumstearateandanhydrouslactose.

WhatProcyclidineTabletslooklikeandthecontentsofthepack:

The tablets are white, with'PR5'on one side and a breakline on the other. Procyclidine Tablets are available in packs of 28,84,100 and 500 tablets. Notallpacksizesmaybemarketed.

MarketingAuthorisationHolder:

Co-Pharma Limited Unit4, MetroCentre,

TolpitisLane,Watford,

Herts.

UK, WD189SS Tel:01923255580 Fax: 0192 3 255581

I POM I

This leafletwas last revised in 06/2015.

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