MINIMS PROXYMETACAINE HYDROCHLORIDE W/V, EYE DROPS 0.5 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROXYMETACAINE HYDROCHLORIDE

Available from:

Chauvin Pharmaceuticals Limited

INN (International Name):

PROXYMETACAINE HYDROCHLORIDE

Dosage:

0.5 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

Minims P
ro
xymet
acaine Hy
dr
ochlor
ide Inser
t - UK & Ir
eland (A
ubenas)
R
enee C
ondon  - e:
 r
enee
[e-mail] - t:
 585.338.8252 - f:
 585.338.8959
9335200
5336
BLACK
CY
AN
MAGENT
A
YELLOW
PMS

320
PMS

2985
PMS

346
BLACK
1
2
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SPECIAL INSTRUCTIONS  / PLACED IMAGES: N/A
TYPE SIZE: 
16pt/6.5pt
(MAX/MIN)
MINIMS
®
PROXYMETACAINE
HYDROCHLORIDE  
0.5% EYE DROPS 
0.5% W/V PROXYMETACAINE 
HYDROCHLORIDE BP
ABOUT MINIMS PROXYMETACAINE 
HYDROCHLORIDE 0.5%
The name of this medicine is Minims 
Proxymetacaine hydrochloride 0.5%.
Each Minims unit is a sterile, single-use 
eye drops container which contains 
0.5% w/v proxymetacaine hydrochloride 
solution. The solution also contains 
purified water and small amounts of 
hydrochloric acid and sodium hydroxide. 
Each Minims unit contains approximately 
0.5ml of solution. Each carton contains 
20 Minims units. Proxymetacaine 
hydrochloride is used as a local 
anaesthetic.
WHO MAKES MINIMS 
PROXYMETACAINE HYDROCHLORIDE 
0.5%?
Minims Proxymetacaine hydrochloride 
0.5% is manufactured by Laboratoire 
Chauvin S.A. Z.I. Ripotier, 07200/Aubenas, 
France. The Marketing Authorisations for 
Minims Proxymetacaine hydrochloride 
0.5% (PL 0033/0151 & PA 118/46/1) are 
held by Chauvin Pharmaceuticals Ltd,  
106 London Road, Kingston-Upon- 
Thames KT2 6TN, England.
WHAT IS IT FOR ?
Minims Proxymetacaine hydrochloride 
0.5% is used to numb the eye 
temporarily. This could be necssary for a 
number of reasons. Most often, Minims 
Proxymetacaine hydrochloride 0.5% is 
used to allow your doctor or eye specialist 
to measure the pressure inside your eye 
or perform minor operations such as the 
removal of stitches and foreign bodies. 
This product is not intended to be used 
as a long term treatment for painful eye 
conditions.
BEFORE USING MINIMS 
PROXYMETACAINE HYDROCHLORIDE 
0.5%
•  Are you allergic to Proxymetacaine 
hydrochloride?
•  Do you suffer from heart disease?
•  Do you have an over

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Proxymetacaine hydrochloride 0.5% w/v, Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Proxymetacaine hydrochloride 0.5 % w/v.
_For excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To be used as a topical ocular anaesthetic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly) and children:_
Deep anaesthesia: Instil 1 drop every 5 - 10 minutes for 5 - 7 applications.
Removal of sutures: Instil 1 or 2 drops 2 to 3 minutes before removal of stitches.
Removal of foreign bodies: Instil 1 or 2 drops prior to operating.
Tonometry: Instil 1 or 2 drops immediately before measurement.
Do not use if the solution is more than pale yellow in colour.
Each Minims unit should be discarded after a single use
A period of at least one minute should be allowed after administration of Minims Proxymetacaine hydrochloride 0.5%,
before subsequent administration of other topical agents.
4.3 CONTRAINDICATIONS
Do not use in patients with a known hypersensitivity to any component of the preparation.
In view of the immaturity of the enzyme system which metabolises the ester type local anaesthetics in premature
babies, this product should be avoided in these patients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/01/2014_
_CRN 2042320_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used cautiously and sparingly in patients with known allergies, cardiac disease or
hyperthyroidism because of the increased risk of sensitivity reactions.
This product is not