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PILOCARPINE EYE DROPS BP 2.0% W/V

Active substance(s): PILOCARPINE HYDROCHLORIDE

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D03226

Pilocarpine Eye Drops 1%, 2% and 4% w/v
Pilocarpine Hydrochloride

(Referred to as Pilocarpine Eye Drops in this leaflet)
Read all of this leaflet carefully before you start using this medicines because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any of the 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 Pilocarpine Eye Drops are and what are
they used for
2. What you need to know before you use
Pilocarpine Eye Drops
3. How to use Pilocarpine Eye Drops
4. Possible side effects
5. How to store Pilocarpine Eye Drops
6. Contents of the pack and other information

1. What Pilocarpine Eye Drops are
and what are they used for

• medicines used to make the pupil larger
and dry up the saliva in your mouth, such as
atropine and phenylephrine.
• medicines used to treat Parkinson’s disease,
anticholinergic drugs such as orphenadrine,
procyclidine and trihexyphenidyl.
• antidepressants including tricyclic
antidepressants (such as amitriptyline) and
monoamine oxidase inhibitors (MAOI’s),
a type of medicine used to treat severe
depression.
• phenothiazines (medicines used to
treat serious mental disorders) e.g.
chlorpromazine.
• medicines used to treat high blood pressure
(adrenergic blockers) such as guanethidine.

Pilocarpine Hydrochloride belongs to a group of
medicines called miotics, these medicines affect If you have any doubts about whether you
muscles in the eye causing the pupil of the eye
should use this medicine talk to your doctor
to get smaller.
or pharmacist.
Pilocarpine Eye Drops are used to treat certain
forms of glaucoma (an increase in the pressure
within the eye) and to reverse the effect of drugs
that cause the pupil of the eye to get bigger.

Pilocarpine Eye Drops with food,drink and
alcohol
You are advised not to drink alcohol during
your treatment with Pilocarpine Eye Drops.

2. What you need to know before
you use Pilocarpine Eye Drops

Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine.

Do not use Pilocarpine Eye Drops if:
• you are allergic (hypersensitive) to Pilocarpine
or any of the other ingredients in this
medicine, which are listed in section 6 of this
leaflet
• you are suffering from inflammation of the
coloured part of the eye (acute iritis or anterior
uveitis)
• you are suffering from eye disorders such
as narrow angle glaucoma or secondary
glaucoma.
• you are wearing soft contact lenses.
Warnings and precautions:
Talk to your doctor or pharmacists before taking
Pilocarpine eye drops if
• you are suffering from any heart problems.
• you have asthma.
• you have Parkinson’s disease.
• you have problems in passing urine.
• you have high blood pressure.
• you have a stomach ulcer.
• you are pregnant or are breast-feeding.
If you are unsure about how to use Pilocarpine
Eye Drops talk to your doctor or pharmacist.
Children
Pilocarpine should be given at the lowest
available dose at the start of the treatment for
children under 18 years of age.

Driving and using machines
Pilocarpine Eye Drops can cause difficulty in
adapting to the dark. You should not drive or
use machinery in poor light. The eye drops may
also cause blurred vision. If this happens, you
should not drive or operate machinery until
you can see clearly.
Pilocarpine eye drops contains
benzalkonium
This medicine contains benzalkonium chloride
which may cause eye irritation and is known to
discolour soft contact lenses.
Soft contact lenses must not be worn during
treatment with Pilocarpine Eye Drops.

3. How to use Pilocarpine Eye
Drops
Always use Pilocarpine Eye Drops exactly as
your doctor has told you. Always complete a
course of treatment. Do not stop because you
feel better.
Pilocarpine Eye Drops are for external use only.

Instructions for use
1. Before opening a new bottle of Pilocarpine
Eye Drops, please check that the safety strip
Eye tests
on the front of the bottle is unbroken.
Your doctor may want to check your eyes before
and during your therapy particularly if you have 2. Tear off the safety strip to break the seal.
had any eye disorders. If you have not had your 3. Wash your hands well before use.
4. Remove the outer cap. If you are putting
eyes checked recently, tell your doctor.
in the eye drops yourself, you should use a
mirror.
Other medicines and Pilocarpine
5. Tilt your head back and look up at the
Please tell your doctor or pharmacist if you
ceiling.
are taking or have recently taken any other
6. Pull the lower lid of the eye out to form a
medicines, including medicines obtained
small pocket between your eyelid and your
without a prescription.
eye.
7. Hold the container between the thumb and
Some medicines can interfere with your
middle finger of the other hand, turn the
treatment. Tell your doctor if you are taking any
bottle upside down near to the eye, try not
of the following:
to touch the eye with the nozzle.
8. Apply enough pressure to the bottle to
• antihistamines (medicines used to treat
release one to two drops, as directed by
allergies).
your doctor.
• anticholinesterases, (such as neostigmine)
9. Blink your eye a few times.
which are medicines that affect the muscles
10. If you think that you have missed your eye,
and are used to treat diseases like myasthenia
then insert another drop.
gravis.

11. Repeat steps 5-10 above for your other eye
if you have been told to use Pilocarpine Eye
Drops in both eyes.
12. Replace the outer cap on the bottle,
trying not to touch the applicator tip with
anything, including the eye or your fingers.
13. Wash your hands.

With long term use it is possible that the lens of
your eye may change shape resulting in changes
to your vision.
You may not know if you have some of the side
effects. Your doctor will detect them during
examinations.

Always use this medicine exactly as described in
this leaflet or as your doctor has told you. Check
with your doctor or pharmacist if you are not
sure.

Reporting of side effects
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
Your doctor will decide how much you need
Healthcare professionals are asked to report
based on the severity of your condition and your any suspected adverse reactions via the Yellow
response to treatment.
Card Scheme Website: http://www.mhra.gov.uk/
yellowcard.
Adults (including the elderly)
The usual dose is two drops three times daily.
Use in children
Lowest available dose and concentration
should be used at the start of the treatment
for children under 18 years of age. Your
doctor might increase the dose up to the
maximum recommended adult dosage of the
2 % Pilocarpine eye drops depending on the
response and tolerability.

5. How to store Pilocarpine Eye
Drops

Keep this medicine out of the sight and reach of
children.
Make sure the container is properly closed after
each use. Store Pilocarpine Eye Drops in their
original container to protect from moisture and
away from direct light. Store below 25°C.

If you use more Pilocarpine Eye Drops than
you should
If you are at all concerned that you have used or
been given too much of this medicine please tell
your doctor.

Do not use Pilocarpine Eye Drops after the expiry
date which is printed on the label. The expiry
date refers to the last day of that month.

If you swallow any Pilocarpine Eye Drops
Pilocarpine Eye Drops are for external use only.
If you have swallowed or you suspect someone
else has swallowed any Pilocarpine Eye Drops,
contact your doctor or go to the accident and
emergency department of your local hospital at
once. Always take the container and this leaflet
with you if possible, even if empty.

Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

Dispose of this medicine 28 days after opening.

6. Contents of the pack and other
information

If you forget to take Pilocarpine Eye Drops
If you miss a dose of Pilocarpine Eye Drops,
use them as soon as you remember unless it
is nearly time for the next dose, then carry on
using it as before. Do not take a double dose to
make up for one you have missed.

What Pilocarpine Eye Drops contain
The active substance is Pilocarpine
hydrochloride 1%, 2% or 4% w/v

If you stop using Pilocarpine Eye Drops
You should keep using Pilocarpine Eye Drops for
as long as your doctor has asked. Your treatment
is helping your condition, even if you have not
noticed a difference in how you feel. Should you
need to stop your treatment, your doctor will
advise you how to do this.

What Pilocarpine Eye Drops look like and
contents of the pack
Pilocarpine Eye Drops are a clear, colourless and
sterile solution supplied in a plastic dropper
bottle. Each bottle contains 10ml of the solution.

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

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everyone gets them.
Common side effects (may affect 1 and 10 in
every 100 patients):
• itching, smarting and a burning sensation
around the eye
• a red skin rash with itching (urticaria)
• swelling, redness or soreness of the eyelid
• swelling of the front of the eye (conjunctiva)
• temporarily blurred vision
• temporary short sightedness
• difficulty in seeing in poor light
• enlargement of the veins in the eye
• headache and brow ache (especially in young
patients at the beginning of treatment)
• bleeding within the front of the eye
• detachment of the retina (the inner surface of
the eye)
Rare may affect up to 1 in 1,000 people:
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• increase in saliva
• increased flow of tears
• trembling or shaking
• wheezing and breathing difficulties
• change in blood pressure or changes in the
way your heart beats

The other ingredients are benzalkonium chloride
and purified water.

Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd
T/a Martindale Pharma
Bampton Road
Harold Hill
Romford Essex RM3 8UG UK
Manufacturers:
Martindale Pharmaceuticals Ltd Bampton Road
Harold Hill
Romford Essex RM3 8UG UK
Marketing Authorisation numbers:
Pilocarpine Eye Drops 1% w/v PL 00156/0079
Pilocarpine Eye Drops 2% w/v PL 00156/0080
Pilocarpine Eye Drops 4% w/v PL 00156/0078
This leaflet was last revised in: 04/2016

D03226

PACKAGE LEAFLET: INFORMATION FOR THE USER

Continued overleaf

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3226-C

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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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