COSOPT SOLUTION

Pays: Afrique du Sud

Langue: anglais

Source: South African Health Products Regulatory Authority (SAHPRA)

Disponible depuis:

Mundipharma (Pty) Ltd

Dosage:

See ingredients

forme pharmaceutique:

SOLUTION

Composition:

EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 22,26 mg TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 6,83 mg

Statut de autorisation:

Registered

Date de l'autorisation:

2000-02-10

Notice patient

Mundipharma (Pty) Ltd
Cosopt
20 mg Dorzolamide / 5 mg Timolol
Page 1 of 14
NOVEMBER 2021
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
COSOPT
®
Ophthalmic Solution
ACTIVE SUBSTANCE(S)
Dorzolamide and timolol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING COSOPT
®
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
COSOPT
®
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 COSOPT
®
is and what it is used for
2.
What you need to know before you use COSOPT
®
3.
How to use COSOPT
®
4.
Possible side effects
5.
How to store COSOPT
®
6.
Contents of the pack and other information
1.
WHAT COSOPT
® IS AND WHAT IT IS USED FOR
COSOPT contains two medicines: dorzolamide and timolol.
•
Dorzolamide belongs to a group of medicines called “carbonic
anhydrase inhibitors”.
•
Timolol belongs to a group of medicines called “beta blockers”.
Mundipharma (Pty) Ltd
Cosopt
20 mg Dorzolamide / 5 mg Timolol
Page 2 of 14
NOVEMBER 2021
COSOPT
®
is prescribed to lower raised pressure in the eye in the treatment of
glaucoma
and ocular hypertension.
Elevated pressure in the eye may damage the optic nerve resulting in
deterioration of vision
and possible blindness. There generally are few symptoms that you can
feel to tell you
whether you have elevated pressure within your eye. Your doctor's
examination is needed
to determine this. If you have raised pressure in your eye, regular
eye examinations and
measurements of the pressure within your eyes will be necessary.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COSOPT
®
DO NOT USE COSOPT
®
:
•
if you are hypersensitive (allergic) to dorzolamide and/or timolol or
any of
the other
ingredients of COSOPT
®
(listed in section 6).
•
if you have asthma or have ever had asthma,
•
if you have chronic obstructive lung

Résumé des caractéristiques du produit

Mundipharma (Pty) Ltd
Cosopt
20 mg Dorzolamide / 5 mg Timolol
Page 1 of 23
November 2021
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S3
1
NAME OF THE MEDICINE
Cosopt
®
Ophthalmic Solution
STRENGTH
20 mg dorzolamide base and 5 mg timolol base
PHARMACEUTICAL FORM
Ophthalmic solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE DECLARATION
Dorzolamide hydrochloride
Timolol maleate
QUANTITATIVE DECLARATION
Each ml of COSOPT
®
contains 22,26 mg dorzolamide hydrochloride equivalent to 20 mg
dorzolamide base and 6,83 mg timolol maleate equivalent to 5,0 mg
timolol base and 0,0075
% _m/v_ benzalkonium chloride as preservative.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ophthalmic solution
Clear, colourless to nearly colourless, slightly viscous solution,
with a pH between 5.5, and
5.8, and an osmolarity of 242-323 mOsM.
Mundipharma (Pty) Ltd
Cosopt
20 mg Dorzolamide / 5 mg Timolol
Page 2 of 23
November 2021
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COSOPT
®
is indicated in the treatment of elevated intra-ocular pressure (IOP)
in patients
with ocular hypertension, open-angle glaucoma, pseudoexfoliative
glaucoma or other
secondary open-angle glaucomas when concomitant therapy is
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose is one drop of COSOPT
®
in the affected eye(s) two times daily.
When substituting COSOPT
®
for another ophthalmic antiglaucoma agent(s), discontinue the
other agent(s) after proper dosing on one day, and start COSOPT
®
on the next day.
If another topical ophthalmic agent is being used, COSOPT
®
and the other agent should be
administered at least ten minutes apart.
PAEDIATRIC POPULATION
Safety and efficacy in paediatric patients below the age of 2 years
have not been
established. Although COSOPT
®
has been used in children 2 to 6 years of age, however
data on safety and efficacy are insufficient to recommend a safe and
effective dose (see
Paediatric Use Section 5.1).
4.3
CONTRAINDICATIONS
COSOPT
®
is contraindicated in pat