Minims Oxybuprocaine Hydrochloride 0.4%w/v

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxybuprocaine hydrochloride 0.4%{relative}

Available from:

Bausch & Lomb (NZ) Ltd

INN (International Name):

Oxybuprocaine hydrochloride 0.4% w/v

Dosage:

0.4% w/v

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Oxybuprocaine hydrochloride 0.4%{relative} Excipient: Hydrochloric acid Purified water

Units in package:

Single use dropper, 0.5ml, 20 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

BASF Pharma (Evionnaz) SA

Product summary:

Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1988-12-01

Patient Information leaflet

MINIMS
® OXYBUPROCAINE
EYE DROPS
_Oxybuprocaine hydrochloride Eye Drops _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Oxybuprocaine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Minims
Oxybuprocaine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT MINIMS
OXYBUPROCAINE IS USED
FOR
Minims Oxybuprocaine belongs to a
group of medicines called local
anaesthetics.
It is used to numb or block the
feeling of pain in your eye(s) during
short-term medical procedures.
These procedures may include,
measuring the pressure in your eye,
inserting contact lenses, removing
foreign bodies from your eye(s) and
other minor operations on your
eye(s).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
MINIMS OXYBUPROCAINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE MINIMS OXYBUPROCAINE
IF YOU HAVE AN ALLERGY TO:
*
Any medicine containing
Oxybuprocaine
*
Any other local anaesthetic
*
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
*
Shortness of breath
*
Wheezing or difficulty breathing
*
Swelling of the face, lips, tongue
or other parts of the body
*
Rash, itching or hives on the skin
DO NOT USE THIS MEDICINE IF YOU
HAVE AN INFECTION IN YOUR EYE.
DO NOT USE THIS MEDICINE IF YOU ARE
PREGNANT OR BREAST-FEEDING.
Your doctor will discuss the risks
and benefits involved.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
THIS MEDICINE HAS BEEN DEV

Summary of Product characteristics

1/4
NEW ZEALAND DATA SHEET
1
MINIMS Oxybuprocaine Hydrochloride, eye drops solution 0.4% w/v
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL unit contains 2 mg Oxybuprocaine hydrochloride.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Clear, colourless, single-use, sterile eye drops.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
As a topical ocular anaesthetic.
4.2
Dose and method of administration
Adults (including the Elderly) and Children
One drop is sufficient when dropped into the conjunctival sac to
anaesthetise the
surface of the eye to allow tonometry after one minute. A further drop
after 90
seconds provides adequate anaesthesia for the fitting of contact
lenses. Three drops
at 90 second intervals provide 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.
Instil dropwise into the eye according to the recommended dosage.
Each Minims unit should be discarded after use.
4.3
Contraindications
Not to be used in patients with a known hypersensitivity to the
product.
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.
When applied to the conjunctiva, benoxinate is less irritant than
amethocaine in
normal concentrations.
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
2/4
NEW ZEALAND DATA SHEET
and pharyngeal mucosa. It is especially advisable in children).
4.5
Interaction with other medicaments and other forms of interaction
None stated.
4.6
Fertility, pregnancy and lactation
This product should not be use