TEVA UK Ref: 231-30-70131-A LEA PROCYCLIDINE 5mg TAB TUK <KRA Version: 2    09 November 2015

PROCYCLIDINE 5 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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.

IN THIS LEAFLET

1 What Procyclidine is and what it is used for

2. Before you take Procyclidine

3. How to take Procyclidine

4. Possible side effects

5. How to store Procyclidine

6. Further information

Ol WHAT PROCYCLIDINE IS AND WHAT IT IS USED FOR

• Procyclidine 5 mg tablets are part of a group of drugs known as anti-cholinergics. These drugs block the action of a particular chemical called acetylcholine, which allows nerve impulses to be sent • Procyclidine is used to treat:

• the symptoms of Parkinson's disease (Parkinsonism). These symptoms include tremor, shaky movements and rigid limbs • symptoms such as restlessness caused by drugs such as antipsychotics (neuroleptics).

©I BEFORE YOU TAKE PROCYCLIDINE

DO NOT take Procyclidine if you:

• are allergic (hypersensitive) to procyclidine or any of the other ingredients of this medicine • have ever suffered from “closed angle glaucoma" (loss of vision due to abnormally high pressure in the eye)

• have an obstructive disease of the stomach or intestines • (in men) have trouble passing urine because of an enlarged prostate gland • suffer from urinary retention (have difficulty in passing urine), that is untreated

• have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Take special care with Procyclidine Tell your doctor before you start to take this medicine if you:

• are elderly. Your dose may need to be carefully monitored to prevent any side effects

• you have an enlarged prostate gland • suffer from cardiac disorders or from cardiovascular disease (disease of the heart)

• have ever had any problems with your liver or kidneys

• suffer from stomach cramps, abdominal pains or constipation • have ever suffered from glaucoma or may be predisposed to glaucoma or obstructive disease of the stomach or intestines (e.g. you may have been told in the past that you are more at risk of these conditions, or have a family history of them)

• suffer from psychotic episodes (experience delusions, hallucinations, speech difficulty or unusual behaviour)

•    suffer from tardive dyskinesia, which are uncontrollable movements particularly of the face, mouth and tongue

•    have a history of alcohol or drug abuse.

Taking other medicines

Talk to your doctor if you are taking any

of the following:

•    antidepressants (e.g. amitriptyline, paroxetine) or monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide)

•    antipsychotics (neuroleptics) such as the phenothiazines group (e.g. thioridazine - for severe anxiety of schizophrenia)

•    clozapine, to treat schizophrenia

•    amantadine or levodopa (for Parkinson's disease)

•    disopyramide (to control heart rhythm)

•    quinidine (to treat irregular heartbeat)

•    ketoconazole (for fungal infection)

•    antihistamines, to relieve allergies such as hay fever (e.g. cetirizine, loratadine)

•    cisapride, metoclopramide or domperidone (to treat feeling sick or being sick)

•    sublingual nitrates for angina (e.g. glyceryl trinitrate, isosorbide dinitrate)

•    tacrine, memantine (to treat the symptoms of Alzheimer's disease)

•    nefopam, used to treat pain.

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

Important information about some of the ingredients of Procyclidine

•    Patients who are intolerant to lactose should note that Procyclidine tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy and breast-feeding

•    If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any medicine.

Driving and using machines

•    Procyclidine may cause blurred vision, dizziness, mental confusion, impaired thinking and memory, disorientation and hallucinations. If you are affected, DO NOT drive or operate machinery.

HOW TO TAKE PROCYCLIDINE

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

The tablets should be swallowed whole with a drink of water after meals. The usual dose is:

•    Adults

Initially 2.5 mg three times a day after meals. Your doctor will increase this dose by 2.5 mg to 5 mg a day every 2 to 3 days until he or she finds a dose which works best for you.

The maximum dose is usually 20 mg a day if you are taking your tablets to control symptoms caused by other drugs. The maximum dose may be higher, 30 to 60 mg a day if your Parkinsonism is not caused by drugs.

•    Elderly

A reduced dose may be required.

•    Children

Procyclidine is not recommended for use in children.

If you take more Procyclidine than you should

If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause mood disturbance, mental confusion, restlessness, agitation, hallucinations and sleeplessness lasting up to twenty-four hours.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Procyclidine

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking Procyclidine

DO NOT stop taking your medicine without talking to your doctor first even if you feel better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Procyclidine can cause side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

If you are taking a medicine for mental illness (called a neuroleptic) at the same time as Procyclidine:

•    you can develop uncontrolled movements of your face and tongue (tardive dyskinesia). The dose of either of the medicines may need to be adjusted

•    unusual body movements, particularly of your hands, arms and legs which may have previously been occurring with the medicine for your mental illness can be made worse by addition of Procyclidine.

If either of these happen, tell your doctor straight away.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown:

Common (affecting less than one person in 10 but more than one person in 100)

•    blurred vision

•    a dry mouth

•    constipation

•    difficulty in passing water.

Uncommon (affecting less than one person in 100 but more than one person in 1,000)

•    agitation (feeling irritable)

•    anxiety

•    nervousness

•    feeling confused

•    disorientation

•    you lose touch with what's real and what's not, seeing, hearing or feeling things that aren't there (Hallucinations)

•    dizziness

•    impaired thinking or memory

•    nausea (feeling sick) or vomiting (being sick)

•    gingivitis (inflammation of the gum)

•    skin rash.

Rare (affecting less than one person in 1,000 but more than one person in 10,000)

•    psychotic symptoms occurring together such as dizziness, mental confusion, excitement, reduced concentration or memory, disorientation, you lose touch with what's real and what's not, seeing, hearing or feeling things that aren't there (Hallucinations), anxiety, agitation (feeling irritable insomnia (difficulty sleeping).

Other side effects

•    rapid heart beats (tachycardia).

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE PROCYCLIDINE

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use Procyclidine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater 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 Procyclidine Tablets contain(s):

•    The active ingredient is procyclidine hydrochloride 5 mg

•    The other ingredients are lactose, microcrystalline cellulose, pregelatinised starch, magnesium stearate, talc and sodium starch glycolate.

What Procyclidine Tablets look like and contents of the pack:

•    Procyclidine 5 mg Tablets are white, round biconvex tablets engraved with "PDE" and "5" on each side of a scoreline on one side, and twin triangle logo on the reverse

•    The tablets are available in packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company responsible for manufacture: Teva Operations Poland Sp. z o.o. Ul. Mogilska 80, 31-546 Krakow, Poland.

This leaflet was last revised:

November 2015

PL 00289/1645

^ET7W71

TEVA UK LIMITED

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