Dorzolamide 20mg/ml eye drops, solution

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Dorzolamide hydrochloride

Доступна з:

Accord Healthcare Ireland Ltd.

Код атс:

S01EC; S01EC03

ІПН (Міжнародна Ім'я):

Dorzolamide hydrochloride

Дозування:

20 milligram(s)/millilitre

Фармацевтична форма:

Eye drops, solution

Терапевтична области:

Carbonic anhydrase inhibitors; dorzolamide

Статус Авторизація:

Not marketed

Дата Авторизація:

2011-01-14

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOLAMIDE 20MG/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 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 st

Характеристики продукта

Health Products Regulatory Authority
23 March 2020
CRN009JS7
Page 1 of 8
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.
Health Products Regulatory Authority
23 March 2020
CRN009J