Skip to Content

UK Edition. Click here for US version.

PROCYCLIDINE HYDROCHLORIDE 5 MG TABLETS

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PEEL HERE BUT DO NOT REMOVE

procyclidine
#5 mg
tablets
5
mg

Procyclidine Hydrochloride
5 mg tablets

5
mg

100 tablets

Procyclidine Hydrochloride
5 mg tablets

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.

6. Contents of the pack and other
information

100 tablets

Marketing Authorisation Holder

The active substance is procyclidine. Each tablet
contains 5 mg of procyclidine hydrochloride.
The other ingredients are lactose anhydrous,
microcrystalline cellulose and magnesium stearate.

Each tablet contains: Procyclidine Hydrochloride 5 mg.
Also contains: lactose
Dosage: For oral use as directed by a doctor.
Read the package leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C. Keep the bottle tightly closed in order
to protect from light and moisture.

PL 04569/0110

PL 04569/0110

POM

121212

• 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. W
 hat Procyclidine is and what it is used for
2. W
 hat you need to know before you take
Procyclidine
3. H
 ow to take Procyclidine
4. P
 ossible side effects
5. H
 ow to store Procyclidine
6. C
 ontents 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

1

health conditions, you may notice an apparent
worsening of symptoms.

Store below 25°C.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet.






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.

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.

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.

5. How to store Procyclidine
Keep this medicine out of the sight and reach of
children.

19
20

3

Tell your doctor straight away if you suffer from
any of the following side effects:

Reporting side effects

For bottles, keep the bottle tightly closed in order to
protect from light and moisture.

• 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

17

Gerard Laboratories, 35-36 Baldoyle Industrial Estate,
Grange Road, Dublin 13.
Generics [UK] Ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL.

121212

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.
For blister packs, store in the original package in
order to protect from light and moisture.

Manufacturer

Do not drive or operate machines if you feel dizzy,
confused, disorientated or suffer blurred vision
whilst taking Procyclidine.

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.

Procyclidine contains lactose

If you forget to take Procyclidine

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

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

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

2
• 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.

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.

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)

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)

Common side effects (may affect up to 1 in
10 people) are:





d
 ry 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

18

Stop taking this medicine and tell your doctor
immediately if you:

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.

• 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).

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.




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.

16 15

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
13
14

21

4 5

body temperature may become higher than
normal).

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.

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.

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,

22

6 7

Pregnancy and breast-feeding

(procyclidine hydrochloride)

What Procyclidine looks like and contents of
the pack

This leaflet was last revised in July 2017

POM

LL0543AA
1226869
Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

Package leaflet: Information for the patient

Procyclidine Hydrochloride 5 mg Tablets

What Procyclidine contains

Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Each tablet contains: Procyclidine Hydrochloride 5 mg.
Also contains: lactose
Dosage: For oral use as directed by a doctor.
Read the package leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C. Keep the bottle tightly closed in order
to protect from light and moisture.
LL0543AA
1226869
Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

9

procyclidine
#5 mg
tablets

If you take more Procyclidine than you should,
contact your doctor or nearest hospital emergency
department immediately. Take the container

3. How to take Procyclidine

8

Adults:

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

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.

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.

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.

10

11

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.

12

PEEL HERE BUT DO NOT REMOVE

procyclidine
#5 mg
tablets
5
mg

Procyclidine Hydrochloride
5 mg tablets

5
mg

500 tablets

Each tablet contains: Procyclidine Hydrochloride 5 mg.
Also contains: lactose
Dosage: For oral use as directed by a doctor.
Read the package leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C. Keep the bottle tightly closed in order
to protect from light and moisture.
PL 04569/0110

PL 04569/0110

What is in this leaflet:

1. W
 hat Procyclidine is and what it is used for
2. W
 hat you need to know before you take
Procyclidine
3. H
 ow to take Procyclidine
4. P
 ossible side effects
5. H
 ow to store Procyclidine
6. C
 ontents 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






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.

500 tablets

Marketing Authorisation Holder

The active substance is procyclidine. Each tablet
contains 5 mg of procyclidine hydrochloride.
The other ingredients are lactose anhydrous,
microcrystalline cellulose and magnesium stearate.

Store below 25°C.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet.

Reporting side effects

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.

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.

5. How to store Procyclidine
Keep this medicine out of the sight and reach of
children.

19
20
• 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

Gerard Laboratories, 35-36 Baldoyle Industrial Estate,
Grange Road, Dublin 13.
Generics [UK] Ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL.

12121

health conditions, you may notice an apparent
worsening of symptoms.

For blister packs, store in the original package in
order to protect from light and moisture.

Manufacturer

Do not drive or operate machines if you feel dizzy,
confused, disorientated or suffer blurred vision
whilst taking Procyclidine.

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.

Procyclidine contains lactose

If you forget to take Procyclidine

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

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

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

2
• 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.

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.

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)

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)

Common side effects (may affect up to 1 in
10 people) are:





d
 ry 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

18

Stop taking this medicine and tell your doctor
immediately if you:

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.

• 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).

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.




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.

16 15

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
13
14

21

4 5

body temperature may become higher than
normal).

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.

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.

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,

22

6 7

Pregnancy and breast-feeding

(procyclidine hydrochloride)

What Procyclidine looks like and contents of
the pack

This leaflet was last revised in July 2017

POM

Package leaflet: Information for the patient

Procyclidine Hydrochloride 5 mg Tablets

What Procyclidine contains

Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

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.

17

9

6. Contents of the pack and other
information

1

3

Tell your doctor straight away if you suffer from
any of the following side effects:

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.

LL0542AA
1227828
Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

12121

• 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.

Procyclidine Hydrochloride
5 mg tablets

Each tablet contains: Procyclidine Hydrochloride 5 mg.
Also contains: lactose
Dosage: For oral use as directed by a doctor.
Read the package leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C. Keep the bottle tightly closed in order
to protect from light and moisture.

POM

LL0542AA
1227828
Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

procyclidine
#5 mg
tablets

If you take more Procyclidine than you should,
contact your doctor or nearest hospital emergency
department immediately. Take the container

3. How to take Procyclidine

8

Adults:

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

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.

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.

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.

10

11

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.

12

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide