Minims Oxybuprocaine Hydrochloride 0.4% w/v Eye Drops Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OXYBUPROCAINE HYDROCHLORIDE

Available from:

Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

ATC code:

S01HA02

INN (International Name):

OXYBUPROCAINE HYDROCHLORIDE

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

OXYBUPROCAINE HYDROCHLORIDE 0.4 percent weight/volume

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-10-04

Patient Information leaflet

76850
P1UKIE01_76850_Minims-Oxybuprocaine_Hydrochloride04_SOL20SDU_UK_IE_v1.indd
1
2014-09-02 11:07:56
BAUSCH&LOMB
MINIMS® OXYBUPROCAINE HYDROCHLORIDE 0.4% W/V
EYE DROPS, SOLUTION
OXYBUPROCAINE HYDROCHLORIDE
Read all this leaflet carefully BEFORE you start using your medicine.
It contains a summary of the information available
on your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. Remember
this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1.
What Minims® Oxybuprocaine Hydrochloride eye drops are and what they
are used for
2.
Before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Further information
1.
WHAT MINIMS® OXYBUPROCAINE HYDROCHLORIDE EYE DROPS ARE AND WHAT THEY
ARE USED
FOR
Minims® Oxybuprocaine Hydrochloride contains an anaesthetic. It is
used to numb the surface of the eye temporarily.
Your doctor or eye specialist will use it:
•
to examine your eye without it being painful,
•
to measure the pressure inside your eye,
•
to perform minor operations such as the removal of stitches and
foreign bodies,
•
for the fitting of contact lenses.
This medicine is indicated for children, adults and the elderly.
2.
BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
•
you are allergic to the active substance (oxybuprocaine hydrochloride)
or any of the other ingredients (refer to the end
of this leaflet).
•
you are using at the same time as Minims® Oxybuprocaine Hydrochloride
other eye drops containing chlorhexidine
acetate as a preservative.
TAKE SPECIAL CARE
•
If you have had an allergic reaction to other local anaesthetics in
the past. Inform your doctor or eye specialist.
•
When your eye has been numbed it is important not to rub it and to
keep it free of dust and bacterial contamination.
Your doctor or eye specialist will make sure that your eye is properly
protected.
•
If you have an inflamed eye, as red eyes greatly increase the passage
into the bl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minims Oxybuprocaine Hydrochloride 0.4% w/v Eye Drops Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Oxybuprocaine Hydrochloride Ph. Eur. 0.4 % w/v. Each unit
(0.5ml) contains
Oxybuprocaine Hydrochloride 2mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, aqueous, sterile single use eye drop solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a sterile, single use eye drop for use as an anaesthetic prior to
tonometry, contact lens fitting,
foreign body removal and
meibomian cyst incision. The drops should be instilled topically into
the conjunctival sac.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children:
One drop is sufficient to anaesthetise the surface of the eye to allow
tonometry after one minute. A
further drop after 90
seconds will provide adequate anaesthesia for the fitting of contact
lenses.
Three drops at 90 second intervals provides sufficient anaesthesia for
a foreign body to be
removed from the corneal epithelium or for incision of a meibomian
cyst
through the conjunctiva.
Corneal sensitivity is normal again after about one hour.
Each Minims unit should be discarded after use.
4.3
CONTRAINDICATIONS
Known hypersensitivity to oxybuprocaine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Transient stinging and blurring of vision may occur on instillation.
The anaesthetised eye should be protected from dust and bacterial
contamination.
The cornea
may be damaged by prolonged application of anaesthetic eye drops.
Systemic absorption may be reduced by compressing the lacrimal sac at
the medial canthus for a
minute during and
following the instillation of the drops. (This blocks the passage of
the drops
via the naso lacrimal duct to the wide
absorptive area of the nasal and pharyngeal mucosa. It is
especially advisable in children).
Use with caution on an inflamed eye, as hyperaemia greatly increases
the rate of systemic
absorption through the
con