TRUSOPT 20mg/ml Eye drops, solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DORZOLAMIDE

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

S01EC03

INN (International Name):

DORZOLAMIDE 20 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

DORZOLAMIDE 20 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2006-02-27

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

TRUSOPT 20 MG/ML EYE DROPS, SOLUTION 
(dorzolamide) 

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 possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 
1. 
What TRUSOPT is and what it is used for 
2. 
What you need to know before you use TRUSOPT 
3. 
How to use TRUSOPT 
4. 
Possible side effects 
5. 
How to store TRUSOPT 
6. 
Contents of the pack and other information 

1. 
WHAT TRUSOPT IS AND WHAT IT IS USED FOR 

TRUSOPT contains dorzolamide which belongs to a group
of medicines called "carbonic anhydrase 
inhibitors." 

This medicine is prescribed to lower raised pressure in the eye
and to treat glaucoma. This medicine 
can be used alone or in addition to other medicines which
lower the pressure in the eye (so-called beta-
blockers). 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE TRUSOPT 

DO NOT USE TRUSOPT: 

- 
if you are allergic to dorzolamide hydrochloride or any of the
other ingredients of this medicine 
(listed in section 6). 
- 
 if you have severe kidney impairment or problems, or a
prior history of kidney stones. 

WARNINGS AND PRECAUTIONS 

Talk to your doctor or pharmacists before using TRUSOPT. 

Tell your doctor or pharmacist about any medical problems you
have now or have had in the past, 
including eye problems and eye surgeries, and about any aller

Summary of Product characteristics

 
1. 
NAME OF THE MEDICINAL PRODUCT 

TRUSOPT 20 mg/ml eye drops, solution. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains 22.26 mg of dorzolamide
hydrochloride equivalent with 20 mg of dorzolamide. 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Eye drops, solution. 

Clear, colourless to
nearly colourless, slightly viscous solution. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

TRUSOPT is indicated: 


as adjunctive therapy to beta-blockers, 


as monotherapy in patients unresponsive to beta-blockers or in
whom beta-blockers are 
contraindicated, 
in the treatment of elevated intra-ocular pressure in: 


ocular hypertension, 


open-angle glaucoma, 


pseudoexfoliative glaucoma. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 
When used as monotherapy, the dose is one drop of dorzolamide in
the conjunctival sac of the affected 
eye(s), three times daily. 

When used as adjunctive therapy with an ophthalmic beta-blocker,
the dose is one drop of 
dorzolamide in the conjunctival sac of the affected eye(s) two
times daily. 

When substituting dorzolamide for another ophthalmic anti-glaucoma
agent, discontinue the other 
agent after proper dosing on one day, and start dorzolamide on
the next day. 

If more than one topical ophthalmic drug is being used, the drugs
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 c