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PILOCARPINE EYE DROPS BP 3.0% W/V

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D01633

Pilocarpine Eye Drops 0.5%, 1%, 2%, 3% and 4% w/v
Pilocarpine Hydrochloride
Read all of this leaflet carefully before you start to use Pilocarpine Eye Drops. It contains
important information
• 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 symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

In this leaflet:
1. What Pilocarpine Eye Drops are and what are
they used for
2. Before using Pilocarpine Eye Drops
3. How to use Pilocarpine Eye Drops
4. Possible side effects
5. Storing Pilocarpine Eye Drops
6. Further information

1. What Pilocarpine Eye Drops are
and what are they used for
Pilocarpine Hydrochloride belongs to a group of
medicines called miotics, these medicines affect
muscles in the eye causing the pupil of the eye to
get smaller.
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.

2. Before using Pilocarpine Eye
Drops
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 secondary glaucoma
• you are wearing soft contact lenses.
Take special care with 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 any of the above apply to you please consult
your doctor before using Pilocarpine Eye Drops.
If you are unsure about how to use Pilocarpine Eye
Drops talk to your doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Some medicines can interfere with your treatment.
Tell your doctor if you are taking any of the
following:
• antihistamines (medicines used to treat
allergies)
• anticholinesterases, (such as neostigmine)
which are medicines that affect the muscles and
are used to treat diseases like myasthenia gravis
• medicines used to make the pupil larger and dry
up the saliva in your mouth, such as atropine
• medicines used to treat Parkinson’s disease,
such as benzatropine

• antidepressents 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 treatserious
mental disorders) e.g. chlorpromazine
• medicines used to treat high blood pressure
(adrenergic blockers) such as guanethidine.
If you have any doubts about whether you
should use this medicine talk to your doctor or
pharmacist.
Using Pilocarpine Eye Drops with food and
drink
You are advised not to drink alcohol during your
treatment with Pilocarpine Eye Drops.
Pregnancy & breast-feeding
Pilocarpine Eye Drops should not be used if you
are pregnant, trying to become pregnant or
breast-feeding unless your doctor considers it
essential.
Ask your doctor for advice before taking any
medicine.
Effects on the ability to drive and use 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.
Important information about some of the
ingredients of Pilocarpine Eye Drops
This medicine contains benzalkonium chloride
which may cause eye irritation and is known to
discolour soft contact lenses.

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.
Soft contact lenses must not be worn during
treatment with Pilocarpine Eye Drops.
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
on the bottom of the outer cap is unbroken.
2. Twist the outer cap to break the seal
3. Wash your hands well before use.
4. Remove the outer cap. If you are putting in the
eye drops yourself, you should use a mirror.
5. Tilt your head back and look up at the ceiling.
6. Pull the lower lid of the eye out to form a small
pocket between your eyelid and your eye.
7. Hold the container between the thumb and
middle finger of the other hand, turn the
bottle upside down near to the eye, try not to
touch the eye with the nozzle.
8. Apply enough pressure to the bottle to release
one to two drops, as directed by your doctor.
Continued overleaf

9. Blink your eye a few times.
10. If you think that you have missed your eye,
then insert another drop.
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.

• diarrhoea
• increase in saliva
• increased flow of tears
• trembling or shaking
Common side effects are:
• itching, smarting and a burning sensation
around the eye
• a red skin rash with itching (urticaria)
• 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)

If you are unsure on how to use Pilocarpine Eye
Drops talk to your doctor or pharmacist.
How much to use
Adults and the elderly
Your doctor will decide how much you need
based on the severity of your condition and your
response to treatment.

You may not know if you have some of the side
effects. Your doctor will detect them during
examinations.

To treat glaucoma:
The usual dose is one or two drops every six hours
or as prescribed by your doctor.

If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

When used before eye surgery:
The usual dose is one drop every five minutes or as
directed by your doctor.

5. Storing Pilocarpine Eye Drops

To reverse the effect of drugs that make the pupil
of the eye get larger:
The usual dose is one drop every 5 minutes until
the pupil is normal or as directed by your doctor.
Children
Use in children will only be considered if the child’s
doctor considers it essential.
If you use too many Pilocarpine Eye Drops
If you are at all concerned that you have used or
been given too much of this medicine please tell
your doctor.
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.
If you miss a dose of 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.
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.

Make sure the container is properly closed after
each use.

4. Possible side effects
Like all medicines, Pilocarpine Eye Drops are
suitable for most people, but they can sometimes
cause side effects, although not everyone gets
them.
Some side effects can be serious
Stop treatment with the eye drops and tell your
doctor immediately if you notice any of the
following rare symptoms:
• bleeding within the front of the eye
• detachment of the retina (the inner surface of
the eye)
• wheezing and breathing difficulties
• change in blood pressure or changes in the way
your heart beats
Rare but less serious side-effects are:
• feeling sick (nausea)
• being sick (vomiting)

Keep out of the reach and sight of children

Store Pilocarpine Eye Drops in their original
container to protect from moisture and away from
direct light. Store below 25°C.
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.
Dispose of this medicine four weeks after
opening.
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.

6. Further Information
What Pilocarpine Eye Drops contain
The active substance is Pilocarpine hydrochloride
0.5, 1, 2, 3 or 4% w/v
The other ingredients are benzalkonium chloride
and purified water.
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.

Product Licence Holder:
Martindale Pharmaceuticals Ltd. Bampton
Road, Harold Hill, Romford Essex RM3 8UG.UK
Manufacturers:
Martindale Pharmaceuticals Ltd. Bampton Road,
Harold Hill, Romford Essex RM3 8UG.UK
Farmigea S.p.A. Via G.B. Oliva 6/8, 56121 Pisa, Italy
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at the above
address.
Product licence numbers:
Pilocarpine Eye Drops 0.5% w/v PL 0156/0076
Pilocarpine Eye Drops 1% w/v PL 0156/0079
Pilocarpine Eye Drops 2% w/v PL 0156/0080
Pilocarpine Eye Drops 3% w/v PL 0156/0077
Pilocarpine Eye Drops 4% w/v PL 0156/0078
This leaflet was last updated March 2011
D01633

Package leaflet: information for the user

Expand Transcript

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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