COSOPT 20/5 Mg/Ml Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE

Available from:

B & S Healthcare

ATC code:

S01ED51

INN (International Name):

DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE

Dosage:

20/5 Mg/Ml

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents

Authorization status:

Authorised

Authorization date:

2011-04-01

Patient Information leaflet

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. 

The name of your medicine is Cosopt 20mg/ml + 5mg/ml eye
drops, solution but 
will be referred to as Cosopt throughout this leaflet.  

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 bronchiti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
COSOPT 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.
Excipients: Benzalkonium chloride 0.075 mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
_Product imported from UK and Italy:_
Clear, colourless to nearly colourless, slightly viscous solution.
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
The dose is one drop of COSOPT in the (conjunctival sac of the) affected eye(s) two times daily.
If another topical ophthalmic agent is being used, COSOPT and the other agent should be administered at least ten
minutes apart.
Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into
contact with the eye or surrounding structures.
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.
Patients should be informed of the correct handling of the OCUMETER PLUS bottles.
_Usage Instructions_
1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A
gap between the bottle and the cap is normal for an unopened bottle.
2. Tear off the Safety Str