COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Santen Oy Niittyhaankatu 20, 33720 Tampere, Finland

ATC code:

S01ED51

INN (International Name):

DORZOLAMIDE 20 mg/ml TIMOLOL 5 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

DORZOLAMIDE 20 mg/ml TIMOLOL 5 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2023-11-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COSOPT PRESERVATIVE-FREE 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION IN
SINGLE-DOSE CONTAINER
(dorzolamide / timolol)
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 side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What COSOPT Preservative-Free is and what it is used for
2.
What you need to know before you use COSOPT Preservative-Free
3.
How to use COSOPT Preservative-Free
4.
Possible side effects
5.
How to store COSOPT Preservative-Free
6.
Contents of the pack and other information
1.
WHAT COSOPT PRESERVATIVE-FREE IS AND WHAT IT IS USED FOR
COSOPT Preservative-Free 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”.
These medicines lower the pressure in the eye in different ways.
COSOPT Preservative-Free is prescribed to lower raised pressure in the
eye in the treatment of glaucoma
when beta-blocker eyedrop medicine used alone is not adequate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COSOPT PRESERVATIVE-FREE
DO NOT USE COSOPT PRESERVATIVE-FREE
•
if you are allergic to dorzolamide hydrochloride, timolol maleate or
any of the other ingredients of
this medicine (listed in section 6).
•
if you have now or had in the past respiratory problems, such as
asthma, or severe chronic
obstructive bronchitis (severe lung disease which may cause
wheeziness, dificulty in breathing
and/or long-standing cough).
•
if you have a slow heart beat, heart failure or disorders of he

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in
single-dose container
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding
to 20 mg dorzolamide
and 6.83 mg of timolol maleate corresponding to 5 mg timolol.
One drop (about 0.03-0.05 mL) contains on average 0.8 mg of
dorzolamide and 0.2 mg of timolol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution in single-dose container
Clear, colourless to nearly colourless, slightly viscous solution,
with a pH between 5.5 and 5.8, and an
osmolality of 242 -323 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COSOPT Preservative-Free is indicated in the treatment of elevated
intraocular pressure (IOP) in
patients with open-angle glaucoma or pseudoexfoliative glaucoma when
topical beta-blocker
monotherapy is not sufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of Cosopt Preservative-Free in the (conjunctival
sac of the) affected eye(s)
two times daily.
If another topical ophthalmic agent is being used, Cosopt
Preservative-Free and the other agent
should be administered at least ten minutes apart.
This medicinal product is a sterile solution that does not contain a
preservative. The solution from
one individual single dose container is to be used immediately after
opening for administration to
the affected eye(s). Since sterility cannot be
maintained after the individual single dose container
is opened, any remaining contents must be discarded immediately after
administration.
Patients should be instructed to wash their hands before use and avoid
allowing the container to
come into contact with the eye or surrounding structures as this could
cause injury to the eye (see
instructions for use).
Patients should also be instructed that ocular solutions, if handled
improperly, can become
contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye
and