Eyreida 0.3 mg/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bimatoprost

Available from:

European Regulatory Affairs t/a Ivowen

ATC code:

S01EE03

INN (International Name):

Bimatoprost

Dosage:

0.3 milligram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

bimatoprost

Authorization status:

Not marketed

Authorization date:

2019-11-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EYREIDA 0.3MG/ML EYE DROPS, SOLUTION
Bimatoprost
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.
IMPORTANT INFORMATION ABOUT THE ADMINISTRATION OF THIS PRODUCT
Eyreida Eye Drops are contained within a novel multidose 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 Eyreida”), before using these eye drops.
WHAT IS IN THIS LEAFLET
1.
What Eyreida is and what it is used for
2.
What you need to know before you use Eyreida
3.
How to use Eyreida
4.
Possible side effects
5.
How to store Eyreida
6.
Contents of the pack and o

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2022
CRN00CR4S
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eyreida 0.3 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 0.3 mg of bimatoprost.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless, eye drops. Osmolality: 261-319 mOsm/Kg
pH: 6.8 – 7.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in chronic open-angle
glaucoma and ocular hypertension in adults (as monotherapy
or as adjunctive therapy to beta-blockers).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop in the affected eye(s) once daily,
administered in the evening. The dose should not exceed
once daily as more frequent administration may lessen the intraocular
pressure lowering effect.
Eyreida eye drops solution is a sterile solution that does not contain
a preservative.
_Paediatricpopulation:_
The safety and efficacy of Eyreida in children aged 0 to 18 years has
not yet been established. No data are currently available.
_Hepatic or renal impairment_
_ _
Eyreida has not been studied in patients with renal or moderate to
severe hepatic impairment and should therefore be used
with caution in such patients. In patients with a history of mild
liver disease or abnormal alanine aminotransferase (ALT),
aspartate aminotransferase (AST) and/or bilirubin at baseline,
bimatoprost 0.3 mg/ml eye drops (preserved formulation),
solution had no adverse effect on liver function over 24 months.
Method of administration
If more than one topical ophthalmic medicinal product is being used,
each one should be administered at least 5 minutes apart.
_Before instillation of the eye drops_
- Users should be instructed to wash their hands before opening the
bottle.
- Users should also be instructed to not use this medicine if they
notice that the tamper-proof seal on the bottle neck is broken
before they fir