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PROCYCLIDINE HYDROCHLORIDE 5 MG TABLETS

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

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Transcript
(Procyclidine
Hydrochloride)

PROCYCLIDINE
HYDROCHLORIDE
5 mg TABLETS

Package leaflet:
Information for the patient

Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
• 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 only. Do not
pass it on to others. It may harm them, even if their signs
of illness 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.
What is in this leaflet:
1. What Procyclidine is and what it is used for
2. What you need to know before you take Procyclidine
3. How to take Procyclidine
4. Possible side effects
5. How to store Procyclidine
6. Contents of the pack and other information
1. What Procyclidine is and what it is used for
Procyclidine belongs to a group of medicines called
anticholinergics, which stop a substance called acetylcholine
working in your body. Procyclidine is used to:
• reduce the symptoms of Parkinson's disease by helping
muscle control and reducing stiffness
• control Parkinson-like side effects caused by certain
medicines used to treat mental health conditions.
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 glaucoma (increased pressure in the eye)
• if you have been told you have a blockage in your
intestine (gut)
• if you are unable to, or have difficulty, passing urine and are
not currently receiving any form of treatment for this from
your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Procyclidine:
• if you have liver or kidney disease
• if you have high blood pressure or a heart condition
• if you have difficulty passing urine due to an enlarged
prostate gland
• if you have a history of blockages in your intestine (gut)
• if you have a family history of glaucoma (increased pressure
in the eye), or you have been told that you may be at risk of
developing glaucoma
• if you suffer from repetitive movements of the hands,
mouth, tongue, lips and eyes, which you are unable
to control and may be caused by certain medicines.
Procyclidine can make these symptoms worse. If this occurs,
talk to your doctor who may advise that you change the
amount of medicine that you take
• if you have a mental health condition
• if you are taking a phenothiazine medicine and are in, or
travelling to, an area with high temperatures and/or high
humidity (this medicine may make it more likely that your
body is unable to regulate body temperature normally and
your body temperature may become higher than normal).

Description Procyclidine Hydrochloride 5mg 100/500 tablets
Component Type Leaflet

Pharma Code 279

Affiliate Item Code 656699

SAP No. N/A

Superceded Affiliate Item Code 509228
TrackWise PR No. 656699
MA No. 4569/0110
Packing Site/Printer N/A
Supplier Code LT1308AE

Vendor Job No. 256765
Trackwise Proof No. 2
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

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Other medicines and Procyclidine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription, including the
following:
• medicines for mental health conditions (such as Alzheimer's
disease, dementia, depression, schizophrenia), e.g. tacrine,
memantine, monoamine oxidase inhibitors, paroxetine,
tricyclic and related antidepressants (such as amitriptyline),
clozapine and phenothiazines
• medicines which may be known as parasympathomimetics
e.g. nicotine (used to help stop smoking), pilocarpine
(used to treat dry mouth or certain types of glaucoma),
bethanechol (used to help pass urine)
• medicines used to treat nausea, sickness and indigestion
such as cisapride, domperidone and metoclopramide
• medicines often used to treat Parkinson's disease such as
amantadine and levodopa
• medicines for heart complaints e.g. disopyramide,
quinidine and buccal (dissolved on the gum in the mouth)
or sublingual (placed under the tongue to dissolve) nitrate
tablets (usually used to help treat chest pain (angina))
• medicines for treating pain, in particular, nefopam
• ketoconazole used to treat a fungal infection
• antihistamines.
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 for advice before taking this medicine.
Driving and using machines
Do not drive or operate machines if you feel dizzy,
confused, disorientated or suffer blurred vision whilst
taking Procyclidine.
Procyclidine 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 Procyclidine
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
• Take your dose with a glass of water
• Taking your dose after a meal may mean that you notice
less side effects as a result of taking this medicine
Your doctor may start you on a low dose of procyclidine and
gradually increase it until you have reached the correct dose
to control your symptoms. If you feel your symptoms are
getting worse, tell your doctor.
Adults:
Treatment of Parkinson's disease – The recommended
starting dose is half a tablet (2.5 mg of procyclidine) three
times a day. If symptoms are not controlled, every two or
three days your doctor may recommend that you increase
the amount you are taking by 2.5 mg or 5 mg (additional half
tablet or one tablet per day) until symptoms are controlled.
The recommended maximum dose is 30 mg (6 tablets) of
procyclidine, but if necessary your doctor may recommend
that you take up to 60 mg (12 tablets) of procyclidine a day.
Although the dose is usually taken three times a day, your
doctor may also recommend that you take a fourth dose
before bedtime if needed.
Treatment of Parkinson-like symptoms caused by
medicine - The recommended starting dose is half a tablet
(2.5 mg of procyclidine) three times a day. If symptoms
are not controlled, your doctor may recommend that you
increase the amount you are taking by 2.5 mg (additional
half tablet) each day until symptoms are controlled.
The recommended maximum dose is 30 mg (6 tablets) of
procyclidine a day.
656699

Date: 25 Jun 2015

Page Count

No. of colours 1
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Time: 12:40
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Body Text Size 9 pt

Dimensions 168 x 252mm

Min Text Size used 9 pt

It is recommended that your doctor withdraws treatment
with procyclidine every 3 or 4 months to see if the symptoms
have gone away. If the symptoms return, your doctor will
normally recommend that you continue with treatment
with procyclidine.
Older people: Smaller doses than those stated above may be
given. This is because older people may be more sensitive to
the effects of procyclidine.
Use in children and adolescents: Procyclidine is not suitable
for children and adolescents.
If you take more Procyclidine than you should
If you take more Procyclidine than you should, contact
your doctor or nearest hospital emergency department
immediately. Take the container and any remaining tablets
with you. Symptoms of overdose include: fast heartbeat,
agitation, restlessness, confusion, severe inability to sleep,
excitement (although occasionally people may feel anxious
and aggressive) and disorientation. The pupils in the eye
may not open or close when light is shined on them and
hallucinations (seeing or hearing things that are not real) may
also occur. In severe cases, you may feel very sleepy, fall into
unconsciousness or into a coma.
If you forget to take Procyclidine
If you forget to take your dose of Procyclidine, take it as
soon as you remember unless it is almost time for your next
dose. Do not take a double dose to make up for the dose
you missed.
If you stop taking Procyclidine
Do not suddenly stop taking Procyclidine unless your doctor
advises you to do so. If you stop taking the tablets too quickly,
your original symptoms may return.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking this medicine and tell your doctor immediately
if you:
• suffer symptoms of an allergic reaction such as skin rash,
swelling of the face, lips, tongue or throat or difficulty
breathing. These are signs of a serious allergic reaction
(frequency not known: cannot be estimated from the
available data).
• experience a mental health condition, which can cause
unusual thoughts and perceptions such as hallucinations
(seeing or hearing things that are not real) or delusions
(a belief or strong feeling which is not based on real
information or experiences). This side effect is rare (may
affect up to 1 in 1,000 people).
Tell your doctor straight away if you suffer from any of the
following side effects:
• nervousness
• fast heart beat
• dizziness
• confusion, or reduced ability to understand what is
going on
• reduced memory, disorientation
• feeling anxious or agitated
• hallucinations.
These effects are uncommon (may affect up to 1 in
100 people) but you may need medical attention or your
doctor may need to reduce your dose.
Common side effects (may affect up to 1 in 10 people) are:
• dry mouth
• blurred vision
• constipation
• difficulty urinating (passing water).

Uncommon side effects (may affect up to 1 in 100 people)
are:
• inflammation of the gums in the mouth
• feeling sick, being sick
• rash.
If you are taking Procyclidine to help control side effects of
medicines being used to treat mental health conditions, you
may notice an apparent worsening of symptoms.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any 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.
5. How to store Procyclidine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton or bottle label after 'EXP'. The expiry date refers
to the last day of that month.
Store below 25°C.
For blister packs, store in the original package in order to
protect from light and moisture.
For bottles, keep the bottle tightly closed in order to protect
from light and moisture.
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 to
protect the environment.
6. Contents of the pack and other information
What Procyclidine contains
The active substance is procyclidine. Each tablet contains
5 mg of procyclidine hydrochloride. The other ingredients
are lactose anhydrous, microcrystalline cellulose and
magnesium stearate.
What Procyclidine looks like and contents of the pack
The tablets are white, marked 'PE' above the breakline and
'5' below the breakline on one side and 'G' on the reverse.
Procyclidine is available in containers (which may contain a
plastic spacer at the top of the container) and blister packs
of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100,
112, 120, 168, 180, 250 and 500 tablets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
Manufacturer
Gerard Laboratories, 35-36 Baldoyle Industrial Estate, Grange
Road, Dublin 13.
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire,
EN6 1TL.
This leaflet was last revised in June 2015

LT1308AE
656699

Description Procyclidine Hydrochloride 5mg 100/500 tablets
Component Type Leaflet

Pharma Code 279

Affiliate Item Code 656699

SAP No. N/A

Superceded Affiliate Item Code 509228
TrackWise PR No. 656699
MA No. 4569/0110
Packing Site/Printer N/A
Supplier Code LT1308AE

Vendor Job No. 256765
Trackwise Proof No. 2
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Sign-offs

Date: 25 Jun 2015

Page Count

No. of colours 1
Colours
Non-Print
Colours

Time: 12:40
2/2

Black

Keyline

Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 168 x 252mm

Min Text Size used 9 pt

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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