Patient leaflet - Procyclidine Hydrochloride 5 mg tablets

1. WHAT PROCYCLIDINE IS AND WHAT IT IS USED FOR

Procyclidine hydrochloride Tablets contains the active substance Procyclidine hydrochloride. Procyclidine belongs to a group of medicines called anticholinergics, which stop a substance called acetylcholine working in your body.

Procyclidine is used to:

Treat and relieve the signs of Parkinson’s disease such as:
- Stiff muscles, paralysis, and tremor (shaking of hands)
- Problems talking, writing and walking
- Producing too much saliva and dribbling
- Sweating and uncontrolled eye movements
- Depression
Stop side effects called ‘extrapyramidal effects’, which are caused by some medicines. These may include signs similar to Parkinson’s disease or restlessness and unusual head and body movements.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCYCLIDINE

Do not take procyclidine

if you are allergic to procyclidine or any of the other ingredients of this medicine (listed in section 6)
if you have problems passing water (urinary retention)
if you suffer from a problem caused by too much pressure in your eye called ‘closed angle glaucoma’
if you have stomach cramps and pains or constipation.

Do not take if the above applies to you. If you are not sure, talk to your doctor or pharmacist or nurse before taking procyclidine.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking procyclidine:

If you are elderly. Your dose may need to be carefully monitored to prevent any side effects
If you suffer from a problem caused by too much pressure in your eye called ‘narrow angle glaucoma’ or if you have a higher chance to get glaucoma
If you have an enlarged prostate gland
If you have a mental illness and are taking procyclidine to control the
side-effects of your medicines. Occasionally people who take this medicine may have a psychotic episode.
- If you have kidney or liver problems
- If you have an obstructive disease of your bowel
- In some patients who use procyclidine to control side effects of other medicines, involuntary repetitive body movements may occur. If this happens to you, your doctor may decide to give you lower doses. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or nurse before taking procyclidine.

Children

Do not give this medicine to children.

Other medicines and procyclidine

Tell your doctor or pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because procyclidine can affect the way some other medicines work. Also, some other medicines can affect the way procyclidine works. In particular tell your doctor or pharmacist or nurse if you are taking any of the following:

Medicines used to treat mental health problems (including Alzheimer’s disease and dementia)
Levodopa and amantadine, used in Parkinson’s disease
Disopyramide, quinidine and nitrate tablets (including tablets that dissolve under the tongue), used to treat heart problems
Cisapride, domperidone and metoclopramide, used to treat sickness, indigestion and feeling sick (nausea)
Antihistamines, used to treat hay fever and allergies
Nefopam, used to treat pain
Paroxetine, used to treat depression and/or anxiety disorders in adults
Ketoconazole, used to treat fungal infections

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or nurse before taking procyclidine.

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 or nurse for advice before taking this medicine.

Driving and using machines

You may have blurred vision, dizziness, confusion or disorientation while taking procyclidine. If this happens do not drive or use any tools or machines.

Procyclidine hydrochloride Tablets contains lactose

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

Procyclidine hydrochloride Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE PROCYCLIDINE

Always take this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

Swallow the tablets with a drink of water
You can take procyclidine at any time of day, with or without food. Some people find they feel less sick if they take it at meal times
The score line is not intended for breaking tablet.

To treat Parkinson’s disease

The recommended starting dose is 2.5mg, three times a day.
This can be increased by 2.5mg to 5mg each day, every two or three
CONSILIENT CODE : P1688

PLEASE NOTE : PAPER COPIES ARE SUPPLIED AS A VISUAL REFERENCE ONLY. DO NOT MATCH FOR COLOUR

Item(s): Procyclidine Hydrochloride 2.5, 5, 10 mg Tablets

Size: 320 x 180 mm

Software:

Fonts

Helvetica Neue 9pt (min)

Number: 11

Date: 03 March 2026 days until an effect is seen. This is known as the ‘maintenance dose’. The daily maintenance dose is usually 15mg to 30mg.

The maximum daily dose your doctor may decide to prescribe is 60 mg.
Although the dose is usually taken three times a day, your doctor may ask you to take a fourth dose before bedtime.

To treat uncontrolled body movements (extrapyramidal symptoms) caused by taking other medicines

Procyclidine can be used to control side-effects caused by other medicines.

The recommended starting dose is 2.5mg, three times a day.
This can be increased by 2.5mg each day until an effect is seen.
The daily maintenance dose is usually 10mg to 30mg.
Your doctor may decide to stop your procyclidine after three or four months to see if your side effects return.
If you need procyclidine for a longer period of time, your doctor may decide to stop every now and then.

Elderly

If you are elderly, your dose may need to be carefully monitored to prevent any side effects.

Use in children

Procyclidine is not usually recommended for use in children.

If you take more procyclidine than you should

If you take more procyclidine tablets than you should, talk to a doctor or go to a hospital straight away.

Take the medicine pack with you.

If you forget to take procyclidine

Take a dose as soon as you remember it and then go on as before. Do not take a double dose to make up for a forgotten tablet.

If you stop taking procyclidine

You should not stop taking procyclidine without talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

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

The following side effects may happen with this medicine:

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 your 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 the addition of procyclidine.

If either of these happen, tell your doctor straight away. Common (may affect up to 1 in 10 people)

Problems passing water (urinary retention)
Blurred vision
Dry mouth
Constipation

Uncommon (may affect up to 1 in 100 people)

Feeling sick (nausea) or being sick (vomiting)
Inflamed gums (gingivitis)
Dizziness, nervousness, feeling confused, not knowing where you are (feeling disoriented), reduced concentration or memory, hearing unexpected noises or seeing unexpected sights (hallucinations), anxiety, agitation (feeling irritable)
Skin rash

Rare (may affect up to 1 in 1,000 people)

‘Psychotic disorder’, which includes symptoms occurring together such as dizziness, confusion, reduced concentration or memory,
disorientation, hearing unexpected noises or seeing unexpected sights (hallucinations), anxiety, agitation (feeling irritable)
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 or nurse.
Reporting of side effects
If you 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 Yellow Card Scheme website: www.mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PROCYCLIDINE

Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the outer carton and blister. 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 protect the environment

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Procyclidine hydrochloride Tablets contains

The active substance is procyclidine hydrochloride.

Each 2.5 mg tablet contains 2.5 mg of procyclidine hydrochloride
Each 5 mg tablet contains 5 mg of procyclidine hydrochloride
Each 10 mg tablet contains 10 mg of procyclidine hydrochloride The other ingredients are: Lactose monohydrate, Povidone, Sodium starch glycolate & Magnesium stearate.

See section 2 for further information on lactose & sodium content.

What Procyclidine hydrochloride Tablets look like and contents of the pack

Procyclidine hydrochloride 2.5 mg tablets are white colour, bioconvex, round shaped, debossed with ‘2.5’ on one side and plain on other side.
Procyclidine hydrochloride 5 mg tablets are white, round, biconvex tablets, one side with deep break line with notches, debossed with 05 below break line and plain above the break line, deep break line on the other side. The score line is not intended for breaking the tablet.
Procyclidine hydrochloride 10 mg tablets are white, round, biconvex tablets, one side with deep break line with notches, debossed with 10 below break line and plain above the break line, deep break line on the other side. The score line is not intended for breaking the tablet.

Pack sizes: 14 or 28 tablets packed in Aluminium foil blister packs. Not all the sizes may be marketed.

Marketing Authorisation Holder

Consilient Health Ltd.

Floor 3, Block 3, Miesian Plaza,

Dublin 2, D02Y754, Ireland.

Manufacturer

Key Pharmaceuticals Ltd.

Galen House, 83 High Street, Somersham,

Cambridgeshire, PE28 3JB, UK

This leaflet was last revised in March 2026.

Other formats:

To request a copy of this leaflet in braille, large print or audio, please email drugsafety@consilienthealth.com.

Please provide them with the following information:

Procyclidine Hydrochloride 2.5 mg Tablets - PL 24837/0174 Procyclidine Hydrochloride 5 mg Tablets - PL 24837/0175 Procyclidine Hydrochloride 10 mg Tablets - PL 24837/0176

P1688

CONSILIENT CODE : P1688