MINIMS ARTIFICIAL TEARS

Active substance: SODIUM CHLORIDE

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P1UKIE01 76815

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

ULOTKA PIL

Nazwa produktu
Product Name

Minims Artificial Tears
0.35% w/w & 0.44% w/w
DRP SOL

Kraj
Country (ISO)

United Kingdom (UK),
Irleand (IE)

Kolor nadruku Colours

0.35% w/w Sodium Chloride + 0.44%w/w Hyetellose Eye Drops, Solution

Black

Nr korekty
Proof No

4

Data
Date

16.07.2014

5336

Kod Wytwórcy
Manufacturer code

Opracowane przez
Designed by

Nr wykrojnika
Spec No

76815

Kod farmaceutyczny
Pharmacode

76815 Data Matrix
-

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 6 pt

Wymiar ulotki
PIL size

80 x 140 mm

Krój czcionki
Font used

Baush&Lomb Bold
Baush&Lomb Regular

Gramatura papieru
Paper weight

- g/m2

Komentarze Comments (Reason for the change)
Leaflet carton and overwrap label should state 0.5g instead of 0.5ml
PMR_ICN-14-0143-A

Akceptacja Techniczna Technical Approval

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® Artificial Tears eye drops is and what it is 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® Artificial Tears eye drops is and what it is used for

Minims® Artificial Tears contains a lubricant. It is used as a substitute for natural tears.
This medicine is indicated for children, adults and the elderly.
2.

Before you use your eye drops

There are no special precautions which should be taken before using this product.
If you are pregnant, may be pregnant, or are breastfeeding
You can use Minims® Artificial Tears as it will not harm your baby, and it is safe
to use during breastfeeding.
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

The drops are in special single use “Minims” units, to treat both eyes if necessary.
Once used, they must be thrown away.
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

Dosage
The amount of solution used should be enough to irrigate the eye properly.
Method of administration
If you are putting the eye drops in yourself, then follow these instructions
carefully:
1. Wash your hands.
2. Use a mirror, this will help you to see what you are doing.
3. Twist off the cap from the Minims body of the unit.
4. Pull your lower eyelid down gently, and then gently squeeze until some
liquid falls inside your lower eyelid.

P1UKIE01_76815_Minims_Artificial_Tears035_044_05DRP20_UK_IE_v1.indd 1

2014-07-16 10:41:55

P1UKIE01 76815

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

ULOTKA PIL

Minims Artificial Tears
0.35% w/w & 0.44% w/w
DRP SOL

5.
6.

Kolor nadruku Colours

Black

Kraj
Country (ISO)

United Kingdom (UK),
Irleand (IE)

Nr korekty
Proof No

4

Data
Date

16.07.2014

5336

Kod Wytwórcy
Manufacturer code

Opracowane przez
Designed by

Nr wykrojnika
Spec No

76815

Kod farmaceutyczny
Pharmacode

76815 Data Matrix
-

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 6 pt

Wymiar ulotki
PIL size

80 x 140 mm

Krój czcionki
Font used

Baush&Lomb Bold
Baush&Lomb Regular

Gramatura papieru
Paper weight

- g/m2

Komentarze Comments (Reason for the change)
Leaflet carton and overwrap label should state 0.5g instead of 0.5ml
PMR_ICN-14-0143-A

Akceptacja Techniczna Technical Approval

Make sure the dropper does not touch any parts of your eye.
Close the eyelids.
Repeat steps 4 and 5 for the other eye, then throw away the Minims unit
even if some solution remains.

4.

Nazwa produktu
Product Name

Possible side effects

No side effects are expected to occur following the use of these eye drops.
If you notice any side effects whilst using this medicine, 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 to protect
from light.
The drops are in special single use “Minims” units, to treat both eyes if necessary.
Once used, they must be thrown away.
6.

Further information

What do your eye drops contain

The active ingredients are hyetellose and sodium chloride. Each Minims
unit contains approximately 0.5 ml eye drops solution of hyetellose
0.44% (2.2 mg) and sodium chloride 0.35% (1.75 mg).

The other ingredients are borax, boric acid and purified water.
This medicine does not contain a preservative as it is a sterile single use unit.
One of the active ingredients in this medicine is hyetellose.
This is the new name for hydroxyethylcellulose. The ingredient itself has
not changed.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Chauvin Pharmaceuticals Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
A copy of this Patient Information Leaflet is available in large print and audio format at
www.xpil.medicines.org.uk
DATE OF PREPARATION: July 2014
Art. 76815

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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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