Elymbus 0.1 mg/g eye gel in single-dose container

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Bimatoprost

Διαθέσιμο από:

Laboratoires Thea

Φαρμακολογική κατηγορία (ATC):

S01EE03

INN (Διεθνής Όνομα):

Bimatoprost

Φαρμακοτεχνική μορφή:

Eye gel in single-dose container

Θεραπευτική περιοχή:

bimatoprost

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2023-06-23

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ELYMBUS 0.1 MG/G EYE GEL IN SINGLE-DOSE CONTAINER
_ _
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.
WHAT IS IN THIS LEAFLET
1.
What Elymbus is and what it is used for
2.
What you need to know before you use Elymbus
3.
How to use Elymbus
4.
Possible side effects
5.
How to store Elymbus
6.
Contents of the pack and other information
1.
WHAT ELYMBUS IS AND WHAT IT IS USED FOR
Elymbus is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
Elymbus eye gel is used to reduce high pressure in the eye in adults.
This medicine may be used on its
own or with other drops called beta-blockers which also reduce
pressure.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly being
drained out of the eye and new liquid is made to replace this. If the
liquid cannot drain out quickly
enough, the pressure inside the eye builds up. This medicine works by
increasing the amount of liquid
that is drained. This reduces the pressure inside the eye. If the high
pressure is not reduced, it could
lead to a disease called glaucoma and eventually damage your sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELYMBUS
DO NOT USE ELYMBUS
-
if you are allergic to bimatoprost or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Elymbus.
Talk to your doctor, if:
-
You have any breathing problems
-
You have liver or kidney proble

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
23 June 2023
CRN00CTJL
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elymbus 0.1 mg/g eye gel in single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One g of eye gel contains 0.1 mg bimatoprost.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye gel.
Colourless opalescent gel.
pH: 6.9 – 7.9.
Osmolality: 250 – 350 mosmol/kg.
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.
_SPECIAL POPULATIONS_
_Patients with hepatic impairment_
Elymbus has not been studied in patients with 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, solution (preserved formulation) had no
adverse effect on liver function over 24 months.
_Patients with renal impairment_
Elymbus has not been studied in patients with renal impairment and
should therefore be used with caution in such patients.
_Paediatric population_
The safety and efficacy of Elymbus in children aged 0 to 18 years has
not yet been established.
_ _
Method of administration
Ocular use.
The use of bimatoprost in contact lens wearers has not been studied.
Therefore, contact lenses should be removed before
instillation of the eye gel and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicinal product is being used,
they should be administered at least 15 minutes before
Elymbus. El