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MINIMS CHLORAMPHENICOL 0.5%

Active substance(s): CHLORAMPHENICOL

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Art.76955
P1UK02

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

ULOTKA PIL

Nazwa produktu
Product Name

Minims Chloramphenicol
0.5% w/v
DRP

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Opracowane przez
Designed by

5511

Kod Wytwórcy
Manufacturer code

76955

Kod farmaceutyczny
Pharmacode

-

Black

Nr korekty
Proof No

6

Data
Date

15.06.2016

Kod wersji
Valeant version code

P1UK02

Inny kod
Other code

76955 (Data Matrix)

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
Art 45
PMR_ICN-16-0554-A
Packing Site: Laboratoire Chauvin, Aubenas, France -

60 g/m2

Minims® Chloramphenicol 0.5%
Eye Drops, solution
Chloramphenicol

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® Chloramphenicol 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

Akceptacja Techniczna Technical Approval

1. What Minims® Chloramphenicol eye drops are and what are they used for

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

Minims® Chloramphenicol contains an antibiotic. It is used to treat infections of your eyes.
Sometimes parts of the outer surface of the eye, such as the cornea (the transparent membrane covering the surface of the eye) or the
conjunctiva (the lining of the inside of the eyelids and part of the eye), may become infected with bacteria. These eye drops can be used
to treat this infection and are effective against many different types of bacteria.
If the eye infection is very severe, your doctor may give you antibiotic tablets as well as this antibiotic eye drops. 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 the active substance (chloramphenicol) or any of the ingredients (refer to the end of this leaflet).
Take special care
If you use these eye drops over a long period of time they could possibly become less effective or produce allergic reactions.
In order to prevent this, make sure that you stop using this medicine as soon as your doctor tells you to.
Do you use any of these medicines?
Chymotrypsin (solution used during cataract surgery) may not work properly when used at the same time as Minims® Chloramphenicol.
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
Your doctor will ask you to remove your contact lenses prior to the administration of the drops.
Do not wear your contact lenses throughout the entire treatment course.
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
Do not use this product for longer than the time frame stated by your doctor or eye specialist, as it may become less effective at
treating your eye infection.
The drops are for single use only and provided in single use Minims units, to treat both eyes if both eyes are infected. Once opened, use immediately.
Discard any unused portion.
Dosage
The normal dose is 1 to 2 drops to each infected eye up to six times a day.
If you have a severe infection your doctor or eye specialist may ask you to use this medicine more frequently at first, until the infection
starts to get better. The frequency of treatment can then be gradually reduced.
If your eyes get worse or are not better after a few days of using these eye drops, see your doctor or eye specialist or pharmacist.
Use in newborn infants:
Your child’s doctor may prescribe a lower dose to reduce the risk of side effects. The maximum duration of treatment is 10-14 days.

P1UK02_76955_Minims_Chloramphenicol_05_w-v_DRP20SDU_UK_IE_06.indd 1

2016-06-15 11:27:02

Art.76955
P1UK02

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

ULOTKA PIL

Nazwa produktu
Product Name

Minims Chloramphenicol
0.5% w/v
DRP

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Opracowane przez
Designed by

5511

Kod Wytwórcy
Manufacturer code

76955

Kod farmaceutyczny
Pharmacode

-

Black

Nr korekty
Proof No

6

Data
Date

15.06.2016

Kod wersji
Valeant version code

P1UK02

Inny kod
Other code

76955 (Data Matrix)

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
Art 45
PMR_ICN-16-0554-A
Packing Site: Laboratoire Chauvin, Aubenas, France -

Akceptacja Techniczna Technical Approval

60 g/m2

Method of administration
Make sure you follow these instructions carefully:
1. Wash your hands.
2. Use a mirror, this will help you to see what you are doing.
3. Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit.
4. Pull your lower eyelid down gently, and then carefully place 1 or 2 drops inside your lower eyelid.
Make sure the dropper does not touch any parts of your eye.
5. Close your eye and blink a few times to make sure your eye is covered by the liquid.
6. Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining
into your nose and throat. This is especially advisable in children, the elderly and population at risk.
7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains.
If you use more Minims® Chloramphenicol 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.
If you forget to use Minims® Chloramphenicol, you should take the missed dose as soon as you remember, unless it is nearly time for the
next dose, but you should not take a double dose to make up for a missed dose.

4. Possible side effects
• Minims® Chloramphenicol may cause burning, stinging, itching and skin irritation (including dermatitis) around the area it has been
used on. These effects are not permanent.
• Aplastic anaemia (condition in which the bone marrow is unable to produce blood cells) and bone marrow depression can occur but these
are extremely rare and your doctor will have taken your medical history into account when deciding to prescribe Minims® Chloramphenicol.
Pale skin, weakness, increased heart rate, out of breath, headache, pain, fever, infection, bruises may be a sign a severe blood disorder.
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

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

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.
Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the original package in order to protect from light.
If necessary, the product may be stored at temperature not exceeding 25°C for up to 1 month only and then thrown away.
In that case, affix a label bearing the relevant expiry date to the carton label.
The drops are for single use only and provided in single use Minims units, to treat both eyes if both eyes are infected. 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
What do your eye drops contain
• The active ingredient is chloramphenicol. Each Minims unit contains approximately 0.5 ml eye drops solution of chloramphenicol
0.5% w/v (2.5 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.
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® Chloramphenicol 0.5% w/v :
PL 03468/0069 (UK); PA 555/13/1 (Ireland)
Minims is a trademark of Bausch & Lomb Incorporated or its affiliates. ©Bausch & Lomb Incorporated
DATE OF PREPARATION: June 2016
Art.76955 P1UK02

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2016-06-15 11:27:02

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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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