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MINIMS LIDOCAINE & FLUORESCEIN

Active substance(s): FLUORESCEIN SODIUM / LIDOCAINE HYDROCHLORIDE

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76862 P1UKIE01
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Nazwa produktu
Product Name

Minims Lidocaine
hydrochloride 4% w/v
and Fluorescein sodium
0.25%
DRP SOL

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76862

Kod farmaceutyczny
Pharmacode

-

P1UK01

Inny kod
Other code

76862 (Data Matrix)

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Opracowane przez
Designed by
Nr korekty
Proof No
Kod wersji
Valeant version code
Rozmiar czcionki
Font size
Krój czcionki
Font used

5

Data
Date

09.04.2015

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Black

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd
PMR_ICN-14-0806-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

- g/m2

Minims® Lidocaine Hydrochloride 4% w/v
and Fluorescein Sodium 0.25% w/v
Eye Drops, solution
Lidocaine Hydrochloride and Fluorescein Sodium

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® Lidocaine Hydrochloride and Fluorescein Sodium 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® Lidocaine Hydrochloride and Fluorescein Sodium eye drops are and what they are used for
Minims® Lidocaine Hydrochloride and Fluorescein Sodium contains a local anaesthetic (lidocaine) and a diagnostic agent (fluorescein).
Lidocaine Hydrochloride is a local anaesthetic which temporarily numbs the surface of the eye.
Fluorescein sodium is a temporary dye which helps the doctor or eye specialist to examine your eye.
Your eye drops are used to:
• numb and stain the surface of the eye, for a short time only, to help the doctor or eye specialist to examine your eye .
• help your doctor or eye specialist to measure the pressure inside your eye by a test called tonometry.
Scratches on the conjunctiva (the lining of the inside of the eyelids and part of the eye) are stained yellow or orange by fluorescein.
Damage to the cornea (the transparent membrane covering the surface of the eye) is stained green.
Any foreign bodies which are stuck in your eye are surrounded by a green ring.
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 one of the active substances (lidocaine or fluorescein) or any of the other ingredients (refer to the end of this leaflet).
• you are allergic to other similar types of local anaesthetic.
Take special care
You should tell your doctor if:
• your eyes are red or inflamed
Your eye drops are not intended for long term use. Frequent use of local anaesthetic in the eye over long periods of time may severely
affect your eyesight.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative.
Contact lenses
The doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this
product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off.
Driving and using machines
As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.

3. How to use your eye drops
A doctor or eye specialist will use these eye drops to examine your eye.
The drops are for single use only and provided in single use Minims units, to examine both eyes if necessary. Once opened, use
immediately. Discard any unused portion.
Dosage
• The normal adult dose is 1 or more drops in one or both eyes.
• The dose for children will be decided by the doctor or eye specialist.

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2015-04-09 09:44:34

76862 P1UKIE01
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Nazwa produktu
Product Name

Minims Lidocaine
hydrochloride 4% w/v
and Fluorescein sodium
0.25%
DRP SOL

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Method of administration
The doctor or eye specialist will put the drops in your eye for you. A sterile eyewash may be used to wash away any excess solution.
Your eye will remain numb for up to 30 minutes. Avoid touching the eye until the anaesthetic has worn off. Your doctor or eye
specialist will make sure that your eye is properly protected.
If you use more Minims® Lidocaine Hydrochloride and Fluorescein Sodium than you should, an overdose is very unlikely to occur.
If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department
immediately.

Kod Wytwórcy
Manufacturer code

76862

4. Possible side effects

Kod farmaceutyczny
Pharmacode

-

P1UK01

Inny kod
Other code

76862 (Data Matrix)

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Opracowane przez
Designed by
Nr korekty
Proof No
Kod wersji
Valeant version code
Rozmiar czcionki
Font size
Krój czcionki
Font used

5

Data
Date

09.04.2015

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Black

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd
PMR_ICN-14-0806-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

- g/m2

The following side-effects have been reported very rarely (can occur in less than 1 in 10.000 patients treated):
• allergic reactions with redness and irritation of the eye, swelling around the eye,
• severe allergic reaction with difficulty in breathing and symptoms of shock,
• itchy skin rash with raised red blotches.
If you do experience any effects after using these drops, which appear to be an allergic reaction, seek immediate medical attention.
If any of the side effects gets serious, please seek immediate medical attention. If you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated on the overwrap of each unit and on the carton after the letters “EXP”. The expiry
date refers to the last day of that month. Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light.
The drops are for single use only and provided in single use Minims units, to examine both eyes if necessary. Once opened, use
immediately. Discard any unused portion.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further information
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

What do your eye drops contain
• The active ingredients are lidocaine hydrochloride and fluorescein sodium. Each unit contains approximately 0.5 ml eye drops solution
of lidocaine hydrochloride 4% w/v (20 mg) and fluorescein sodium 0.25% w/v (1.25 mg).
• The other ingredients are povidone, hydrochloric acid (for pH adjustment) and purified water.
This medicine does not contain a preservative as it is a sterile single use unit.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Bausch & Lomb UK Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Numbers:
Minims® Lidocaine Hydrochloride 4% w/v and Fluorescein Sodium 0.25% w/v :
PL 03468/0075 (UK) ; PA 555/12/1 (Ireland)
DATE OF PREPARATION: April 2015
Art.76862

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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