COMAREST Ophthalmic solution

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

iPharma (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

Ophthalmic solution

Composition:

Each 1 ml solution contains LATANOPROST 50,0 mcg

Authorization status:

Registered

Authorization date:

2022-12-07

Patient Information leaflet

COMAREST
PATIENT INFORMATION LEAFLET
LATANOPROST 50 ΜG
49/15.4/0154 (REGISTERED)
VERSION: 0000 OF 12 JULY 2022
PAGE | 1
SUBMITTED 20/05/2022 ECTD0001
REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022
SCHEDULING STATUS:
S4
COMAREST
LATANOPROST 50 MICROGRAM/ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE COMAREST
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
Comarest has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What Comarest is and what it is used for
2. What you need to know before you use Comarest
3. How to use Comarest
4. Possible side effects
5. How to store Comarest
6. Contents of the pack and other information
1.
WHAT COMAREST IS AND WHAT IT IS USED FOR
Comarest belongs to a group of medicines known as prostaglandin
analogues. It works by increasing the natural
outflow of fluid from inside the eye into the bloodstream. It lowers
the pressure inside your eye.
Comarest is used to treat conditions known as glaucoma and ocular
hypertension in adults. Both of these
conditions are linked with an increase in the pressure within your
eye, eventually affecting your eye sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COMAREST
DO NOT USE COMAREST:
•
you are hypersensitive (allergic) to latanoprost, benzalkonium
chloride or to any of the other
ingredients of Comarest (listed in section 6).
•
If you are pregnant or breastfeeding your baby.
COMAREST
PATIENT INFORMATION LEAFLET
LATANOPROST 50 ΜG
49/15.4/0154 (REGISTERED)
VERSION: 0000 OF 12 JULY 2022
PAGE | 1
SUBMITTED 20/05/2022 ECTD0001
REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022
WARNINGS AND PRECAUTIONS
Take special care with Comarest:
•
If you are about to have or have had eye surgery (including cataract
surgery)
•
If you have suffered or are currently suffering from a viral infection
of t

Summary of Product characteristics

COMAREST
PROFESSIONAL INFORMATION
LATANOPROST 50 ΜG
49/15.4/0154 (REGISTERED)
VERSION: 0000 OF 12 JULY 2022
PAGE | 1
SUBMITTED 20/05/2022 ECTD0001
REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022
SCHEDULING STATUS
S4
1 NAME OF THE MEDICINE
Comarest, 50 microgram/ ml, Ophthalmic Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains latanoprost 50 microgram.
One drop contains approximately 1,5 microgram latanoprost.
_Excipients with known effect: _
Each millilitre contains benzalkonium chloride 0,02 % m/v as
preservative.
Sodium dihydrogen phosphate monohydrate (E339i) 7,70 mg/ml.
Disodium phosphate anhydrous (E339ii) 1,55 mg/ml.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ophthalmic Solution
Sterile, colourless or pale yellow, clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma, chronic angle closure
glaucoma and ocular hypertension.
In children less than 3 years of age, Comarest can be initiated prior
to other corrective procedures and may be
continued if therapeutic response is adequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Use in adults (including the elderly) _
One drop in the affected eye(s) once daily. Optimal effect is obtained
if Comarest is administered in the
evening.
The dosage of Comarest should not exceed once daily since it has been
shown that more frequent
administration decreases the intra-ocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
COMAREST
PROFESSIONAL INFORMATION
LATANOPROST 50 ΜG
49/15.4/0154 (REGISTERED)
VERSION: 0000 OF 12 JULY 2022
PAGE | 2
SUBMITTED 20/05/2022 ECTD0001
REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022
Reduction of the intraocular pressure starts about three to four hours
after administration and maximum
effect is reached after 8 to 12 hours. Pressure reduction is
maintained for at least 24 hours. Comarest may be
used concomitantly with other clas