MINIMS ARTIFICIAL TEARS
Active substance(s): HYDROXYETHYLCELLULOSE / SODIUM CHLORIDE
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P1UKIE03 76893
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
Black
Nr wykrojnika
Spec No
5338
Kod Wytwórcy
Manufacturer code
76893
Kod farmaceutyczny
Pharmacode
76893 Data Matrix
P1UKIE03
Inny kod
Other code
-
Rozmiar czcionki
Font size
minimum 9 pt
Wymiar ulotki
PIL size
160 x 240 mm
Krój czcionki
Font used
Baush&Lomb Bold
Baush&Lomb Regular
Gramatura papieru
Paper weight
60 g/m2
Opracowane przez
Designed by
Nr korekty
Proof No
Kod wersji
Valeant version code
4
Data
Date
27.10.2015
Komentarze Comments (Reason for the change)
QRD update
PMR_ICN-15-0654-A
Packing Site: Laboratoire Chauvin, Aubenas, France
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
0.35% w/w Sodium Chloride + 0.44%w/w Hyetellose Eye Drops, Solution
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-- Keep this leaflet. You may need to read it again.
-- Ask your pharmacist if you need more information or advice.
-- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
-- You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Minims® Artificial Tears eye drops is and what it is used for
2. What you need to know 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. Contents of the pack and other 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. What you need to know before you use your eye drops
There are no special precautions which should be taken before using this product.
Pregnancy, breast-feeding and fertility
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.
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 and pull cap to separate from the Minims body (Diagram 1).
4. Pull your lower eyelid down gently, and then gently squeeze until some liquid falls inside your
lower eyelid.
Make sure the dropper does not touch any parts of your eye.
5. Close the eyelids.
6. Repeat steps 4 and 5 for the other eye, then throw away the Minims unit even if some solution
remains.
P1UKIE03_76893_Minims_Artificial_Tears035_044_05DRP20_UK_IE_v2.indd 1
Diagram 1
2015-10-27 08:26:32
P1UKIE03 76893
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
4. Possible side effects
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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may briefly have blurred vision or a slight stinging feeling after using your drops.
Black
Opracowane przez
Designed by
Nr korekty
Proof No
4
Data
Date
27.10.2015
Nr wykrojnika
Spec No
5338
Kod Wytwórcy
Manufacturer code
76893
Kod farmaceutyczny
Pharmacode
76893 Data Matrix
Kod wersji
Valeant version code
P1UKIE03
Inny kod
Other code
-
Rozmiar czcionki
Font size
minimum 9 pt
Wymiar ulotki
PIL size
160 x 240 mm
Krój czcionki
Font used
Baush&Lomb Bold
Baush&Lomb Regular
Gramatura papieru
Paper weight
60 g/m2
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via:
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
United Kingdom
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Komentarze Comments (Reason for the change)
QRD update
PMR_ICN-15-0654-A
Packing Site: Laboratoire Chauvin, Aubenas, France
Akceptacja Techniczna Technical Approval
5. How to store your eye drops
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
6. Contents of the pack and other information
What 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.
What your eye drops look like and contents of the pack
It is a clear, colourless solution.
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
A copy of this Patient Information Leaflet is available in large print and audio format at www.xpil.medicines.org.uk
This leaflet was last revised in: October 2015
P1UKIE03_76893_Minims_Artificial_Tears035_044_05DRP20_UK_IE_v2.indd 2
2015-10-27 08:26:32
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
Black
Nr wykrojnika
Spec No
5338
Kod Wytwórcy
Manufacturer code
76893
Kod farmaceutyczny
Pharmacode
76893 Data Matrix
P1UKIE03
Inny kod
Other code
-
Rozmiar czcionki
Font size
minimum 9 pt
Wymiar ulotki
PIL size
160 x 240 mm
Krój czcionki
Font used
Baush&Lomb Bold
Baush&Lomb Regular
Gramatura papieru
Paper weight
60 g/m2
Opracowane przez
Designed by
Nr korekty
Proof No
Kod wersji
Valeant version code
4
Data
Date
27.10.2015
Komentarze Comments (Reason for the change)
QRD update
PMR_ICN-15-0654-A
Packing Site: Laboratoire Chauvin, Aubenas, France
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
0.35% w/w Sodium Chloride + 0.44%w/w Hyetellose Eye Drops, Solution
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-- Keep this leaflet. You may need to read it again.
-- Ask your pharmacist if you need more information or advice.
-- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
-- You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Minims® Artificial Tears eye drops is and what it is used for
2. What you need to know 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. Contents of the pack and other 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. What you need to know before you use your eye drops
There are no special precautions which should be taken before using this product.
Pregnancy, breast-feeding and fertility
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.
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 and pull cap to separate from the Minims body (Diagram 1).
4. Pull your lower eyelid down gently, and then gently squeeze until some liquid falls inside your
lower eyelid.
Make sure the dropper does not touch any parts of your eye.
5. Close the eyelids.
6. Repeat steps 4 and 5 for the other eye, then throw away the Minims unit even if some solution
remains.
P1UKIE03_76893_Minims_Artificial_Tears035_044_05DRP20_UK_IE_v2.indd 1
Diagram 1
2015-10-27 08:26:32
P1UKIE03 76893
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
4. Possible side effects
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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may briefly have blurred vision or a slight stinging feeling after using your drops.
Black
Opracowane przez
Designed by
Nr korekty
Proof No
4
Data
Date
27.10.2015
Nr wykrojnika
Spec No
5338
Kod Wytwórcy
Manufacturer code
76893
Kod farmaceutyczny
Pharmacode
76893 Data Matrix
Kod wersji
Valeant version code
P1UKIE03
Inny kod
Other code
-
Rozmiar czcionki
Font size
minimum 9 pt
Wymiar ulotki
PIL size
160 x 240 mm
Krój czcionki
Font used
Baush&Lomb Bold
Baush&Lomb Regular
Gramatura papieru
Paper weight
60 g/m2
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via:
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
United Kingdom
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Komentarze Comments (Reason for the change)
QRD update
PMR_ICN-15-0654-A
Packing Site: Laboratoire Chauvin, Aubenas, France
Akceptacja Techniczna Technical Approval
5. How to store your eye drops
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
6. Contents of the pack and other information
What 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.
What your eye drops look like and contents of the pack
It is a clear, colourless solution.
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
A copy of this Patient Information Leaflet is available in large print and audio format at www.xpil.medicines.org.uk
This leaflet was last revised in: October 2015
P1UKIE03_76893_Minims_Artificial_Tears035_044_05DRP20_UK_IE_v2.indd 2
2015-10-27 08:26:32
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.
