TRUSOPT Preservative-Free 20 mg/ml eye drops, solution in single-dose container

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Dorzolamide

Beschikbaar vanaf:

Santen OY

ATC-code:

S01EC; S01EC03

INN (Algemene Internationale Benaming):

Dorzolamide

Dosering:

20 milligram(s)/millilitre

farmaceutische vorm:

Eye drops, solution in single-dose container

Toedieningsweg:

via the ocular route

Eenheden in pakket:

30 x 0.2ml (2 sachets with 15 single dose containers); 60 x 0.2ml (4 sachets with 15 single dose containers)

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutische categorie:

Antiglaucoma preparations and miotics, Carbonic Anhydrase Inhibitors, dorzolamide

Therapeutisch gebied:

Carbonic anhydrase inhibitors; dorzolamide

therapeutische indicaties:

It l 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.

Autorisatie-status:

Marketed

Autorisatie datum:

2006-06-02

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRUSOPT® PRESERVATIVE-FREE 20 MG/ML EYE DROPS, SOLUTION IN
SINGLE-DOSE CONTAINER
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 Preservative-Free is and what it is used for
2.
What you need to know before you use TRUSOPT Preservative-Free
3.
How to use TRUSOPT Preservative-Free
4.
Possible side effects
5.
How to store TRUSOPT Preservative-Free
6.
Contents of the pack and other information
1.
WHAT TRUSOPT
PRESERVATIVE-FREE IS AND WHAT IT IS USED FOR
TRUSOPT Preservative-Free 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 PRESERVATIVE-FREE
DO NOT USE TRUSOPT PRESERVATIVE-FREE
-
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.
If you are not sure whether you should use this medicine, contact your
doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using TRUSOPT
Preservative-Free.
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 all

Productkenmerken

Health Products Regulatory Authority
01 March 2023
CRN00DDHK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TRUSOPT Preservative-Free 20 mg/ml eye drops, solution in single-dose
container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to
20 mg of dorzolamide and one drop contains
approximately 0.8 mg of dorzolamide hydrochloride equivalent to 0.7 mg
of dorzolamide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container
Clear, colourless to nearly colourless, slightly viscous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRUSOPT Preservative-Free 20 mg/ml 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