Minims Pilocarpine Nitrate 2% w/v, Eye Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pilocarpine nitrate

Available from:

Bausch Health Ireland Limited

ATC code:

S01EB; S01EB01

INN (International Name):

Pilocarpine nitrate

Dosage:

2.0 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Parasympathomimetics; pilocarpine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

Bausch & Lomb
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINIMS® PILOCARPINE NITRATE 2% W/V
EYE DROPS, SOLUTION
PILOCARPINE NITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-- 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. What Minims® Pilocarpine Nitrate eye drops are and what they are
used for
2. What you need to know before you use Minims® Pilocarpine Nitrate
3. How to use Minims® Pilocarpine Nitrate
4. Possible side effects
5. How to store Minims® Pilocarpine Nitrate
6. Contents of the pack and other information
1. WHAT MINIMS® 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. WHAT YOU NEED TO KNOW BEFORE YOU USE MINIMS® PILOCARPINE NITRATE
DO NOT USE MINIMS® PILOCARPINE NITRATE IF:
• you are allergic to pilocarpine nitrate or any of the other
ingredients of this medicine (listed in section 6).
• 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking medication for:
• Heart disease (heart f

Summary of Product characteristics

Health Products Regulatory Authority
07 May 2019
CRN008VPS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Pilocarpine Nitrate 2% w/v, Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pilocarpine nitrate 2.0% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pilocarpine is used as a miotic, for reversing the action of weaker
mydriatics and in the emergency treatment of glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly):_
Simple glaucoma: 1 to 2 drops of solution three times daily.
Closed angle glaucoma: 1 to 2 drops of solution administered as
required.
To reverse mydriasis: 1 to 2 drops of solution.
Miosis: 1 to 2 drops of solution.
During the treatment of acute narrow-angle glaucoma, occasionally the
anterior chamber may be flattened, which may
contribute to a worsening of this condition. If the patient’s IOP
(intraocular pressure) is not at a satisfactory level on this
regimen, concomitant glaucoma therapy can be instituted. Patients with
dark irisies may need higher concentrated pilocarpine
eye drops.
Paediatric population
Based on the infrequency of reports of adverse events in children, and
the extensive experience of use of pilocarpine in
childhood glaucoma, concentrations of up to 2% may be safely used in
children. Currently available data are described in
section 5.1 but no recommendation on a posology can be made.
Treatment should be started with the lowest available dose and
concentration in patients under 18 years of age. Depending on
clinical response and tolerability, the dose may be increased up to
the maximum recommended adult dosage of the 2%
pilocarpine eye drop solution. Directly after administration of any
dose, the lacrimal punctum should be occluded for one
minute with a finger to limit systemic exposure.
4.3 CONTRAINDICATIONS
Conditions where pupillary constriction is undesi