Oxybuprocaine Agepha 4 mg/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxybuprocaine hydrochloride

Available from:

AGEPHA Pharma s.r.o.

ATC code:

S01HA02

INN (International Name):

Oxybuprocaine hydrochloride

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

oxybuprocaine

Authorization status:

Marketed

Authorization date:

2023-01-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYBUPROCAINE AGEPHA 4 MG/ML EYE DROPS, SOLUTION
oxybuprocaine hydrochloride
_ _
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.
-
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 Oxybuprocaine Agepha is and what it is used for
2.
What you need to know before you use Oxybuprocaine Agepha
3.
How to use Oxybuprocaine Agepha
4.
Possible side effects
5.
How to store Oxybuprocaine Agepha
6.
Contents of the pack and other information
1.
WHAT OXYBUPROCAINE AGEPHA IS AND WHAT IT IS USED FOR
This medicine is an anaesthetic for external use in adults.
It is intended to locally anaesthetise the surface of the eye for
short ophthalmological procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXYBUPROCAINE AGEPHA
DO NOT USE OXYBUPROCAINE AGEPHA
-
if you are hypersensitive (allergic) to oxybuprocaine or to any of the
ingredients of Oxybuprocaine
Agepha (listed in section 6);
-
if you are hypersensitive (allergic) to other local anaesthetics which
belong to the same group of
active substances (p-aminobenzoic acid).
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH OXYBUPROCAINE AGEPHA
If you wear contact lenses; remove your contact lenses prior to
instillation and wait until the anaesthetic
effect has fully subsided before putting them back on the eye (also
see
3. HOW TO USE OXYBUPROCAINE
AGEPHA
).
In patients with a history of allergies, heart diseases, asthma,
overactive thyroid gland (hyperthyroidism)
and liver diseases as well as in elderly patients.
If you have an inflamed eye, as red eyes greatly increase the passage
into the blood stream through the
surface of the eyes.
LONG-TERM AND REPEATED USE
Oxybuprocaine Agepha is
only intended for short-term use by a physi

Summary of Product characteristics

Health Products Regulatory Authority
30 January 2023
CRN00CRR0
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxybuprocaine Agepha 4 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 4 mg oxybuprocaine hydrochloride.
Each drop contains approximately 0.133 mg of oxybuprocaine
hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To produce local anaesthesia in the eye for short opthalmological
procedures.
Oxybuprocaine Agepha 4 mg/ml eye drops, solution is indicated in
adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 drop before the procedure, repeated as needed.
Since Oxybuprocaine hydrochloride is a fast-acting local anaesthetic,
the envisaged intervention should be performed within
10 to 15 minutes following the last application of Oxybuprocaine
Agepha 4 mg/ml.
_Paediatric population_
The safety and efficacy of Oxybuprocaine Agepha in children and
adolescents has not been established.
Method of administration
For use on the eye.
Instil dropwise into the eye to be examined.
Avoid touching the tip of the dropper insert with the fingers as well
as direct contact with the eye.
Lacrimal sac at the medial canthus should be compressed for 1-2
minutes in order to avoid a potential systemic effect.
For other applicable measures, see section 4.4.
People wearing contact lenses (see section 4.4)
DURATION OF USE
The duration of use must be limited to the intervention.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1

Known hypersensitivity to topical anaesthetics which belong to the
group of active substances of p-aminobenzoic
acid
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
30 January 2023
CRN00CRR0
Page 2 of 5
Not intended for long-term use as this may result in the risk of
severe corneal damage.
For externa