Pilocarpine Eye Drops 2.0% w/v

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

PILOCARPINE HYDROCHLORIDE

Dostupno od:

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

ATC koda:

S01EB01

INN (International ime):

PILOCARPINE HYDROCHLORIDE 20 mg/ml

Farmaceutski oblik:

EYE DROPS

Sastav:

PILOCARPINE HYDROCHLORIDE 20 mg/ml

Tip recepta:

POM

Područje terapije:

OPHTHALMOLOGICALS

Status autorizacije:

Withdrawn

Datum autorizacije:

2007-08-02

Uputa o lijeku

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)
�

Svojstava lijeka

Page 1 of 5 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Pilocarpine Eye Drops BP 2.0% w/v 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Pilocarpine Hydrochloride BP 20mg/ml  

3. 
PHARMACEUTICAL FORM 

Eye Drops. 

4. 
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 drops 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

For topical use only 

Adults and the elderly._ _

a)  
In the treatment of open angle, 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 has not been established for use in children. It should 
only be used when considered essential by the physician._ _
Page 2 of 5 

4.3. 
CONTRA-INDICATIONS 

•

Hypersensitivity to any component. 
•

Acute iritis 
•

Anterior uveitis 
•

Some forms of secondary glaucoma 
•

Soft contact lenses. 

4.4