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MINIMS PILOCARPINE NITRATE 2.0%

Active substance: PILOCARPINE NITRATE

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Minims® Pilocarpine Nitrate 2% w/v
Eye Drops, solution
Pilocarpine nitrate

Read all this leaflet carefully before you start using your
medicine. It contains a summary of the information available on
your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone
else.
In this leaflet:
1. What Minims® Pilocarpine Nitrate eye drops are and what
they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information

1. What Pilocarpine Nitrate eye drops are and what they
are used for
Minims® Pilocarpine Nitrate contains a miotic agent. It is used to
make the pupil of the eye smaller. Your doctor or eye specialist
may use it to:
reverse the effects of eye drops which cause the pupil to
enlarge
treat high pressure of liquid inside the eye (glaucoma) in
emergency situation
This medicine is indicated for children, adults and the elderly.

2. Before you use your eye drops
Do not use these drops if
you are allergic to the active substance (pilocarpine nitrate).
you have had an allergy to other miotic agents in the past
you have some particular eye conditions where the
constriction of the pupil should be avoided (e.g. inflammation
of the iris, some forms of glaucoma...)
you wear soft contact lenses.
Take special care
Ask yourself the following questions:
Do you have a heart disease (heart failure)?
Do you have asthma?
Do you have stomach ulcers?
Do you have high blood pressure?
Do you have problems with passing urine?
Do you have Parkinson's disease?
Do you have any other eye conditions?
If the answer to any of these questions is yes, tell your doctor
or eye specialist.
Do you use any of these medicines?
creams or pills containing corticosteroids
medicines belonging to a family called anticholinergics
medicines used to treat allergic reactions (e.g. hayfever,
hives...) called antihistamines
a pain killer called pethidine
medicines used to treat depression
any other medicine used to make the pupil of the eye smaller
If the answer to any of these questions is yes, tell your doctor or
eye specialist.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use
these drops or to prescribe you an alternative.
Contact lenses
Do not use these eye drops if you wear soft contact lenses.
Your doctor will ask you to remove your contact lenses prior to
the administration of the drops. There is no information on the
effect of this product on contact lenses. Therefore, do not wear
your contact lenses until the effects of the drops have
completely worn off.
Driving and using machines
These eye drops may affect your ability to focus and/or see in
the dark.
As with all eye drops, your vision may be blurred after putting
the drops in. Wait until your vision is clear before driving or
using machines.

3. How to use your eye drops
The drops are in special single use “Minims” units, to treat both
eyes if necessary. Once opened, use immediately. Discard any
unused portion.

Dosage
Your doctor or eye specialist will decide the appropriate dosage
of Minims® Pilocarpine depending on the reason for which it has
been prescribed. He/she will give you more detailed
instructions. Make sure you follow these instructions carefully.
Method of administration
Make sure you follow these instructions carefully:
1. Wash your hands.
2. Use a mirror, this will help you to see what you are doing.
3. Carefully dry your eyes using a tissue, and twist off the cap
from the Minims body of the unit.
4. Pull your lower eyelid down gently, and then carefully place 1
or 2 drops inside your lower eyelid.
5. Close your eye and blink a few times to make sure your eye
is covered by the liquid.
6. Close the eyelids. It is advisable to press gently on the inner
corner of your eyelid for 3 minutes. This will help stop the
solution draining into your nose and throat. This is especially
advisable in children, the elderly and population at risk.
7. Repeat steps 4, 5 and 6 for the other eye if necessary, then
throw away the Minims unit, even if some solution remains.
If you use more Minims® Pilocarpine Nitrate than you
should, an overdose is very unlikely to occur. If you suddenly
feel unwell after receiving the drops, tell your doctor or eye
specialist or contact your nearest emergency department
immediately.

4. Possible side effects
Reactions in and around the eyes can occur: sensations of
burning, itching, stinging, blurring of vision, discomfort in the
eyes and red eyes.
You may have difficulty to focus and/or adjust your eyes to
the dark and experience bleeding in the main part of the eye.
You may experience changes to your eyes when you use the
product for a long period.
Browache or headache may occasionally occur, especially in
younger patients who have just started using this medicine.
Other reactions have been rarely reported: low blood
pressure, abnormally slow heart beat, wheezing and
shortness of breath, salivation, sweating, sickness, diarrhoea
and watering of the eyes.
If any of the side effects gets serious, please seek immediate
medical attention. If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. How to store your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated
on the overwrap of each unit and on the carton after the letters
“EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Store in the original
package in order to protect from light.
The drops are in special single use “Minims” units, to treat both
eyes if necessary. Once opened, use immediately. Discard any
unused portion.
Medicines should not be disposed of via wastewater 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 do your eye drops contain
The active ingredient is pilocarpine nitrate. Each Minims unit
contains approximately 0.5 ml eye drops solution of
pilocarpine nitrate 2% w/v (10 mg).
The other ingredient is purified water.
This medicine does not contain a preservative as it is a sterile
single use unit.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Chauvin Pharmaceuticals Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN – UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Numbers:
Minims® Pilocarpine Nitrate 2% w/v :
PL 0033/5014R (UK) ; PA 118/17/2 (Ireland)
DATE OF PREPARATION: August 2008
Art. 76423 GB252E01-05.07

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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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