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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Timolol; Dorzolamide

Tillgänglig från:

IMED Healthcare Ltd.

ATC-kod:

S01ED51

INN (International namn):

Timolol; Dorzolamide

Dos:

20/5 milligram(s)

Läkemedelsform:

Eye drops, solution

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

timolol, combinations

Bemyndigande status:

Authorised

Tillstånd datum:

2012-04-20

Bipacksedel

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 heartbeat, heart failure
or disorders of heart rhythm (irregular
heartbeats).
•
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 up of chlori

Produktens egenskaper

Health Products Regulatory Authority
30 March 2023
CRN00DHHS
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 with known effect: benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from Greece_
Clear, colourless to 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 (E421)
Sodium citrate (E331)
Sodium hydroxide (E524) for pH adjustment
Water for injections
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton 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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special temperature
storage conditions.
Keep the bottle in the outer carton, in order to protect from light.
Health Products Regulatory Authority
30 March 2023
CRN00DHHS
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
The COSOPT container contains 5 ml of solution.
White translucent low-density polyethylene container, a transparent
dropper and a white cap.
Tamper evidence is provided by a safety strip on the container label.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest