Dorzolamide 20mg/ml eye drops

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Dorzolamide hydrochloride

Verfügbar ab:

Accord-UK Ltd

ATC-Code:

S01EC03

INN (Internationale Bezeichnung):

Dorzolamide hydrochloride

Dosierung:

20mg/1ml

Darreichungsform:

Eye drops

Verabreichungsweg:

Ocular

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 11060000; GTIN: 5012617021762

Gebrauchsinformation

DORZOLAMIDE 20MG/ML
EYE DROPS SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE USER
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BBBA0482
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.
• The full name of this medicine is Dorzolamide
20mg/ml Eye Drops Solution but within the leaflet
it will be referred to as Dorzolamide eye drops.
WHAT IS IN THIS LEAFLET:
1 WHAT DORZOLAMIDE EYE DROPS ARE AND WHAT
THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU USE
DORZOLAMIDE EYE DROPS
3 HOW TO USE DORZOLAMIDE EYE DROPS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE DORZOLAMIDE EYE DROPS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT DORZOLAMIDE EYE DROPS ARE AND WHAT
THEY ARE USED FOR
Dorzolamide eye drops are a sterile eye drop solution.
Dorzolamide eye drops contain 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 eye drops 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
DORZOLAMIDE EYE DROPS
DO NOT USE DORZOLAMIDE EYE DROPS IF YOU
• are ALLERGIC to dorzolamide or any of the other
ingredients of this medicine (listed in section 6).
•
have SEVERE KIDNEY problems
WARNING AND PRECAUTIONS
Talk to your doctor before usin

Fachinformation

OBJECT 1
DORZOLAMIDE 20MG/ML EYE DROPS SOLUTION
Summary of Product Characteristics Updated 09-Oct-2017 | Accord-UK Ltd
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, colourless aqueous
solution.
4. Clinical particulars
4.1 Therapeutic indications
Dorzolamide 20mg/ml Eye Drops Solution 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.
Patients should