Cosopt Multi preservative-free 20mg/ml+5mg/ml eye drops, solution

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Dorzolamide hydrochloride; TIMOLOL MALEATE

Inapatikana kutoka:

Santen OY

ATC kanuni:

S01ED; S01ED51

INN (Jina la Kimataifa):

Dorzolamide hydrochloride; TIMOLOL MALEATE

Kipimo:

20/5 milligram(s)/millilitre

Dawa fomu:

Eye drops, solution

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Beta blocking agents1); timolol, combinations

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2018-06-01

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
COSOPT MULTI PRESERVATIVE-FREE 20MG/ML+5MG/ML EYE DROPS, SOLUTION
(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 Multi preservative-free is and what it is used for
2.
What you need to know before you use COSOPT Multi preservative-free
3.
How to use COSOPT Multi preservative-free
4.
Possible side effects
5.
How to store COSOPT Multi preservative-free
6.
Contents of the pack and other information
1.
WHAT COSOPT MULTI PRESERVATIVE-FREE IS AND WHAT IT IS USED FOR
COSOPT Multi 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 Multi preservative-free is prescribed to lower raised pressure
in the eye in the treatment of
glaucoma when beta-blocker eye drop medicine used alone is not
adequate.
COSOPT Multi preservative-free eye drops solution is a sterile
solution that does not contain a
preservative.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COSOPT MULTI PRESERVATIVE-FREE
DO NOT USE COSOPT MULTI 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

Tabia za bidhaa

Health Products Regulatory Authority
13 February 2020
CRN009H6K
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cosopt Multi preservative-free 20mg/ml+5mg/ml eye drops, solution
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 0.03mL) contains about 0.6 mg of dorzolamide and 0.15
mg of timolol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless to nearly colourless, slightly viscous solution,
practically free from visible particles with a pH between 5.5 and
5.9, and an osmolality of 240 - 325 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 Multi preservative-free in the
(conjunctival sac of the) affected eye(s) two times daily.
If another topical ophthalmic agent is being used, Cosopt Multi
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.
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
subsequent loss of vision may result from using
contaminated solutions.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption is reduced. This may result in a
decrease in systemic side ef