Itoco 20 mg/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dorzolamide hydrochloride

Available from:

Farmaprojects S.A.

ATC code:

S01EC03

INN (International Name):

Dorzolamide hydrochloride

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

dorzolamide

Authorization status:

Not marketed

Authorization date:

2022-08-12

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ITOCO
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 Itoco is and what it is used for
2.
What you need to know before you use Itoco
3.
How to use Itoco
4.
Possible side effects
5.
How to store Itoco
6.
Contents of the pack and other information
1.
WHAT ITOCO IS AND WHAT IT IS USED FOR
Itoco contains dorzolamide which belongs to a group of medicines
called "carbonic anhydrase
inhibitors". Itoco is in the form of eye drops without preservatives.
Itoco is used in order to reduce elevated pressure in the eye (eyes)
and in therapy of glaucoma.
Itoco can be used as the only eye medicine, or with other medicines
lowering the pressure in the eyes
(called beta-adrenolytics).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ITOCO
DO NOT USE ITOCO
-
If you are allergic to dorzolamide or any of the other ingredients of
this medicine (listed in
section 6).
-
If you have abnormal blood pH (hyperchloraemic acidosis), severe
kidney impairment or
problems, or a prior history of kidney stones.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Itoco.
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 allergies to
any medications.
If you develop any eye irritation or any new eye problems such as
redness of the eye or swellin

Summary of Product characteristics

Health Products Regulatory Authority
21 June 2023
CRN00DDK0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Itoco 20 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains dorzolamide hydrochloride equivalent to 20 mg
dorzolamide.
Each drop (about 35 µl) contains 0.70 mg of dorzolamide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops)
Clear, colourless, viscous solution.
pH: 5.0 - 6.0
Osmolality: 260 - 310 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Itoco 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
In monotherapy, the dose is 1 drop of dorzolamide in to the
conjunctival sac of the affected eye(s), three times daily.
As adjunctive therapy with an ophthalmic beta-adrenolytic, the dose is
1 drop of dorzolamide in the conjunctival sac of the
affected eye (eyes) 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 administrated at least 10‑minute apart. Eye
ointment should be used as the last.
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.
Health Products Regulatory Authority
21 June 2023
CRN00DDK0
Page 2 of 8
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