COSOPT 20 mg/ml + 5 mg/ml eye drops, solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Dorzolamide; Timolol

Tilgjengelig fra:

PCO Manufacturing Ltd.

ATC-kode:

S01ED; S01ED51

INN (International Name):

Dorzolamide; Timolol

Dosering :

20 mg/ml + 5 milligram(s)/millilitre

Legemiddelform:

Eye drops, solution

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Beta blocking agents1); timolol, combinations

Autorisasjon status:

Authorised

Autorisasjon dato:

2012-10-05

Informasjon til brukeren

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSOPT
® 20 MG/ML + 5 MG/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 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”.
These medicines lower the pressure in the eye in different ways.
COSOPT 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
DO NOT USE COSOPT
•
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, difficulty in
breathing and/or long-standing cough).
•
if you have a slow heart beat, heart failure or disorders of heart
rhythm (irregular heart
beats).
•
if you have severe kidney disease or problems, or a prior history of
kidney stones.
•
if you have excess acidity of the blood caused by a build u

Preparatomtale

Health Products Regulatory Authority
09 January 2024
CRN00F16Y
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
COSOPT 20 mg/ml + 5 mg/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.
Excipient(s) with known effect: benzalkonium chloride
For the full list of the excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from France, Italy, Greece and Romania:_
Clear, colourless or nearly colourless, slightly viscous solution with
a pH between 5.5 and 5.8 and an osmolarity of 242‒323
mOsM
4 CLINICAL PARTICULARS
As per PA0879/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0879/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Hydroxyethyl cellulose
Mannitol (E 421)
Sodium citrate (E 331)
Sodium hydroxide for pH adjustment
Water for injections
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Cosopt should be used no longer than 28 days after first opening the
container.
Health Products Regulatory Authority
09 January 2024
CRN00F16Y
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special temperature
storage conditions.
Keep the container in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Two alternate containers may be marketed.
White translucent plastic container, a dropper and a white screw cap.
One container contains 5 ml of solution.
or
The OCUMETER Plus Ophthalmic Dispenser consists of a translucent
container with a sealed dropper tip, a flexible fluted side
area which is depressed to dispense the drops, and a 2-piece cap
assembly. One dispenser unit containing 5 ml in a cardboard
carton.
Tamper evidence is provided