Minims Pilocarpine Nitrate 2% w/v eye drops solution – patient leaflet, side effects, dosage

1. What Minims® Pilocarpine Nitrate eye drops are and w

hat they are used for e the pupil of the eye smaller.

ncy situation arpine Nitrate nts of this medicine (listed in section 6).

f the pupil should be avoided (e.g. inflammation of the iris, some

Minims® Pilocarpine Nitrate contains a miotic agent. It is used to mak 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 emerge This medicine is indicated for children, adults and the elderly.

2. What you need to know before you use Minims® Piloc

Do not use Minims® Pilocarpine Nitrate if:

• you are allergic to pilocarpine nitrate or any of the other ingredie
• you have had an allergy to other miotic agents in the past
• you have some particular eye conditions where the constriction o forms of glaucoma)
• you wear soft contact lenses.

Warnings and precautions

Talk to your doctor or pharmacist before taking medication for:

• Heart disease (heart failure)
• Bronchial asthma
• Stomach ulcers
• High blood pressure
• Urinary tract obstruction
• Parkinson’s disease
• Any other eye conditions

If the answer to any of these questions is yes, tell your doctor or eye s Other medicines and Minims® Pilocarpine Nitrate

Tell your doctor or eye specialist if you are taking, have recently taken

• Creams or pills containing corticosteroids
• Medicines belonging to a family called anticholinergics
• Medicines used to treat allergic reactions (e.g. hayfever, hives) ca
• A pain killer called pethidine
• Medicines used to treat depression

• Any other medicine used to make the pupil of the eye smaller Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or a advice before taking this medicine as he/ she may decide to use thes Contact lenses

Do not use these eye drops if you wear soft contact lenses. Your docto administration of the drops. There is no information on the effect of th 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 dar As with all eye drops, your vision may be blurred after putting the dro

pecialist.

or might take any other medicines.

lled antihistamines re planning to have a baby, ask your doctor or eye specialist for e drops or to prescribe you an alternative.

r will ask you to remove your contact lenses prior to the is product on contact lenses. Therefore, do not wear your contact k.

ps in. Wait until your vision is clear before driving or using machines

A P

3. How to use Minims® Pilocarpine Nitrate

The drops are for single use only and provided in single use Minims uni Discard any unused portion.

Dosage

Your doctor or eye specialist will decide the appropriate dosage of Mi prescribed. He/she will give you more detailed instructions. Make sur Use in children and adolescents

Your child’s doctor will start the treatment with Minims® Pilocarpine on the doctor may decide to increase the dose to the maximum recommen Method of administration

Make sure you follow these instructions carefully:

1. 1. Wash your hands.
2. 2. Use a mirror, this will help you to see what you are doing.
3. 3. Carefully dry your eyes using a tissue. Twist and pull cap to separ
4. 4. Pull your lower eyelid down gently, and then carefully place 1 or
5. 5. Close your eye and blink a few times to make sure your eye is co
6. 6. Close the eyelids. It is advisable to press gently on the inner corn help stop the solution draining into your nose and throat. This is elderly and population at risk.
7. 7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw solution remains.

If you use more Minims® Pilocarpine Nitrate than you should, an Art. 77112

P1UKIE04

ts, to treat both eyes if necessary. Once opened, use immediately.

nims® Pilocarpine depending on the reason for which it has been e you follow these instructions carefully.

the lowest available dose. Depending upon response and tolerance, ded adult dosage of the 2% pilocarpine eye drop solution.

ate from the Minims body (Diagram 1).

2 drops inside your lower eyelid.

vered by the liquid.

er of your eyelid for 1 minute. This will especially advisable in children, the away the Minims unit, even if some overdose is very unlikely to occur. If Diagram 1 you suddenly feel unwell after receiving the drops, tell your doctor or immediately.

4. Possible side effects

• Like all medicines, this medicine can cause side effects, although no
• Reactions in and around the eyes can occur: sensations of burning,
• You may have difficulty to focus and/or adjust your eyes to the d
• You may experience changes to your eyes when you use the prod
• Browache or headache may occasionally occur, especially in youn
• Other reactions have been rarely reported: low blood pressure, a salivation, sweating, sickness, diarrhoea and watering of the eye If any of the side effects gets serious, please seek immediate medical please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. Th You can also report side effects directly via:

United Kingdom

Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; E By reporting side effects you can help provide more information on th

5. How to store Minims® Pilocarpine Nitrate

eye specialist or contact your nearest emergency department t everybody gets them.

itching, stinging, blurring of vision, discomfort in the eyes and red eyes. ark and experience bleeding in the main part of the eye. uct for a long period.

ger patients who have just started using this medicine. bnormally slow heart beat, wheezing and shortness of breath, s.

attention. If you notice any side effects not listed in this leaflet, is includes any possible side effects not listed in this leaflet.

-mail: medsafety@hpra.ie.

e safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use the eye drops after the expiry date which is stated on 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 The drops are for single use only and provided in single use Minims uni Discard any unused portion.

Medicines should not be disposed of via wastewater or household wast required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Minims® Pilocarpine Nitrate contains

• The active ingredient is pilocarpine nitrate. Each Minims unit contains ap
• The other ingredient is purified water.

This medicine does not contain a preservative as it is a sterile single u What Minims® Pilocarpine Nitrate looks like and contents of the

Minims® Pilocarpine Nitrate is a clear colorless solution. Each carton c

Marketing Authorisation Holders:

Bausch & Lomb UK Ltd

106 London Road - Kingston-upon-Thames - KT2 6TN - UK Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901

Bausch H Lake Driv Campus, Marketing Authorisation Numbers:

Minims® Pilocarpine Nitrate 2% w/v :

PL 03468/0078 (UK) ; PA22698/014/001 (Ireland)

This leaflet was last revised in: March 2019

overwrap of each unit and on the carton after the letters “EXP”. The in order to protect from light.

ts, to treat both eyes if necessary. Once opened, use immediately.

e. Ask your pharmacist how to dispose of medicines no longer proximately 0.5 ml eye drops solution of pilocarpine nitrate 2% w/v (10 mg).

se unit.

pack ontains 20 units.

ealth Ireland Ltd., 3013 e, Citywest Business

Dublin 24 Ireland

Manufacturer:

Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France