Pilocarpine Eye Drops 4.0% w/v

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PILOCARPINE HYDROCHLORIDE

Available from:

Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC code:

S01EB01

INN (International Name):

PILOCARPINE HYDROCHLORIDE 4 % (W/V)

Pharmaceutical form:

EYE DROPS

Composition:

PILOCARPINE HYDROCHLORIDE 4 % (W/V)

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2006-10-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
C99927
Pilocarpine Hydrochloride
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)
�

Summary of Product characteristics

Page 1 of 4 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Pilocarpine Eye Drops BP 4.0% w/v 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Pilocarpine Hydrochloride BP                          4.0% w/v 

3. 
PHARMACEUTICAL FORM 

Eye Drops. 

CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Pilocarpine is a direct acting miotic indicated for:  

•

chronic simple glaucoma.  
•

acute  (closed  angle)  glaucoma  alone,  or  in  conjunction  with  other  agents  to  decrease 
intra-ocular pressure prior to surgical treatment. 
•

miosis - to counteract the effects of cycloplegic or mydriatic eye drops. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Dosage schedule: 

_Adults and the elderly _

a)  
In  the  treatment  of  open  angle  glaucoma,  the  dosage  is  one  or  two  drops  every  six 
hours or as prescribed by the physician. 

 The  strength  of  the  preparation  and  the  frequency  of  use  are  determined  by  the 
severity of the condition and the response to treatment. 

b)  
When used prior to surgery for acute attacks of closed-angle glaucoma, the dosage is 
one drop every five minutes until miosis is obtained or as directed by the physician. 

c) 
To  overcome  weaker  mydriatics,  the  normal  dosage  is  one  drop  every  five  minutes 
until the effect is counteracted or as directed by the physician. 

 _Children _

The safety and efficacy of the product have not been established for use in children. It 
should only be used when considered essential by the physician._ _

Route of administration 
Page 2 of 4 

For topical ocular use. 

4.3