Eyzeetan 0.3 mg/ml + 5 mg/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bimatoprost; Timolol Maleate

Available from:

Morningside Healthcare (Malta) Limited

ATC code:

S01ED51

INN (International Name):

Bimatoprost; Timolol Maleate

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

timolol, combinations

Authorization status:

Not marketed

Authorization date:

2019-11-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EYZEETAN 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION
bimatoprost/timolol
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IMPORTANT INFORMATION ABOUT THE ADMINISTRATION OF THIS PRODUCT
Eyzeetan Eye Drops are contained within a novel multi-dose eye drop
bottle, which allows for the
solution not to contain any preservatives. Due to the design of the
container, administration with these
eye drops is not the same as standard eye drop bottles.
•
Prior to first use, practice using the drops away from the eye. Slowly
squeeze the bottle to
deliver one drop in the air to get used to the pressure and time
required to deliver one drop.
•
Please note that there might be a few seconds delay between squeezing
and the drop coming
out. Do not squeeze too hard, or more than one drop may come out.
•
After use and prior to recapping, the bottle should be shaken once in
a downwards direction,
without touching the dropper tip, in order to remove any residual
liquid on the tip. This is
necessary in order to ensure delivery of subsequent drops.
•
If more than one type of eye drop is used, leave at least 5 minutes
between administration of
each eye drop solution.
Please read the full instructions on the correct use of this product
in
SECTION 3
of the leaflet (“how to
use Eyzeetan”), before using these eye drops.
WHAT IS IN THIS LEAFLET
1.
What Eyzeetan is and what it is used for
2.
What you need to know before you use Eyzeetan
3.
How to use Eyzeetan
4.
Possible side effects
5.
How to sto

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2024
CRN00F3FT
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eyzeetan 0.3 mg/ml + 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol
(as 6.8 mg of timolol maleate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless aqueous solution. Osmolality: 261-319 mOsm/Kg
pH: 6.8 – 7.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular hypertension who are
insufficiently responsive to topical beta-blockers or prostaglandin
analogues.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage in adults (including older people)_
The recommended dose is one drop of Eyzeetan in the affected eye(s)
once daily, administered either in the morning or in the
evening. It should be administered at the same time each day.
Existing literature data for bimatoprost/timolol 0.3mg/ml + 5mg/ml eye
drops, solution (preserved formulation) suggest that
evening dosing may be more effective in IOP lowering than morning
dosing. However, consideration should be given to the
likelihood of compliance when considering either morning or evening
dosing (see section 5.1).
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not exceed one drop in the
affected eye(s) daily.
Eyzeetan eye drops solution is a sterile solution that does not
contain a preservative.
_Renal and hepatic impairment_
Eyzeetan has not been studied in patients with hepatic or renal
impairment. Therefore caution should be used in treating such
patients.
_Paediatric population_
The safety and efficacy of Eyzeetan in children aged less than 18
years has not been established. No data are available.
Method of administration
If more than one topical ophthalmic medicinal product is to be used,
each one should be in