DORZOLAMIDE

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

DORZOLAMIDE HYDROCHLORIDE

Disponibil de la:

Actavis Group PTC ehf

Codul ATC:

S01EC03

INN (nume internaţional):

DORZOLAMIDE HYDROCHLORIDE

Dozare:

20 Mg/Ml

Forma farmaceutică:

Eye Drops Solution

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

dorzolamide

Statutul autorizaţiei:

Marketed

Data de autorizare:

2011-01-14

Prospect

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 DORZOLAMIDE IS AND WHAT IT IS USED
FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU USE
DORZOLAMIDE
3 HOW TO USE DORZOLAMIDE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE DORZOLAMIDE
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT DORZOLAMIDE IS AND WHAT IT IS USED
FOR
Dorzolamide is a sterile eye drop solution.
Dorzolamide contains dorzolamide, a sulphonamide-
related compound, as the active ingredient.
Dorzolamide is an ophthalmic carbonic anhydrase
inhibitor which reduces high pressure in the eye.
It is indicated in the treatment of elevated intra-ocular
pressure in conditions such as ocular hypertension and
glaucoma (open-angle glaucoma, pseudo-exfoliative
glaucoma). Dorzolamide can be used alone or in
addition to other medicines which lower the pressure
in the eye (so-called beta-blockers).
2 BEFORE YOU USE DORZOLAMIDE
DO NOT USE DORZOLAMIDE:
• if you are allergic to dorzolamide or any of the other
ingredients of this medicine (listed in section 6).
•
if you have severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Dorzolamide
• if you have or have had liver problems in the past
•
if you have been told you have a corneal defect
•
if you have had any allergies to any medicines
•
if you have had, or are about to have eye surgery
•
if you have suffered an eye injury or have an eye
infection
•
if you have a prior history of kidney stones
•
if you are taking orally another carbonic anhydrase
inhibitor
•
if

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dorzolamide 20mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg dorzolamide (as 22.3 mg of dorzolamide
hydrochloride).
Excipients with known effect: Each ml of eye drops solution contains
0.075mg Benzalkonium Chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Isotonic, buffered, slightly viscous, clear, colorless aqueous
solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dorzolamide 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,
•
pseudo-exfoliative 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 dispensing container to
contact 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.
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