MINIMS POVIDONE IODINE 5% W/V EYE DROPS SOLUTION

Active substance: POVIDONE-IODINE

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Art.76686 9199501
GB306E01-07.10

Minims® Povidone Iodine 5% w/v
Eye Drops, Solution
Iodinated Povidone
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
In this leaflet:
1. What Minims® Povidone Iodine is and what it is used for
2. Before you use Minims® Povidone Iodine
3. How to use Minims® Povidone Iodine
4. Possible side effects
5. How to store Minims® Povidone Iodine
6. Further information
1. WHAT MINIMS® POVIDONE IODINE IS AND WHAT IT IS USED FOR
Minims® Povidone Iodine is a solution that contains an antiseptic known as Iodinated Povidone 5% in an eye wash solution.
It is used for cleaning the surface of your eye before eye surgery.
2. BEFORE YOU USE MINIMS® POVIDONE IODINE
Do not use Minims® Povidone Iodine
• if you are allergic to Iodinated Povidone, iodine or any of the other ingredients (listed in section 6)
• for injecting into the eye
• for any purpose other than cleaning the surface of your eye before eye surgery
• at the same time as using medicines for use on the eye that contain mercury-based preservatives
• in premature babies
Take special care with Minims® Povidone Iodine
This product is strictly only for use to clean the eyes before surgery and should not be used for any other purpose.
Using other medicines
Talk to your doctor or pharmacist if you are:
• using other medicines on your eyes, particularly if they contain mercury-based preservatives, as these may affect the Minims® Povidone
Iodine treatment
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Pregnancy and breast-feeding
You can use this product if you are pregnant or if you are breast-feeding.
Driving and using machines
Minims® Povidone Iodine is not meant for use outside the hospital or clinic and does not affect your ability to drive or use machines.
3. HOW TO USE MINIMS® POVIDONE IODINE
The drops are supplied in single-dose units that are meant to treat both eyes if both eyes are affected.
Use in children and adolescents
This product can be used in babies, infants, children and adolescents.
Instruction for proper use
In the operating room and after the anesthetic has been applied to your eyes, the nurse or doctor will clean your eyes with Minims®
Povidone Iodine as follows:
1. The area around your eyes will be carefully cleaned with an antiseptic sterile cotton swab.
2. The nurse / doctor will then twist off the cap of the Minims® unit to open it.
3. 2 to 3 drops of the solution will be gently dropped onto your eye/eyes.
4. You will be asked to close your eyes and roll your eyes around to spread the solution over the surface of the eyes.
5. Your eyes will then be rinsed thoroughly with a sterile saline solution until the characteristic colour of the Iodinated Povidone
disappears.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
This medicine can cause serious allergic reactions. Although such reactions are very rare, if you experience itching, swelling and red
blotches on your skin and you feel unwell, you must ask for help immediately from a doctor or other healthcare provider, such as your nurse.
Use in children
If this medicine has been given to your baby and your baby is not responding or seems unwell, you must ask your doctor
to check that your baby is not suffering from a thyroid problem.

Art.76686 9199501
GB306E01-07.10

The following are other side effects that have been reported after using either iodine or povidone and could appear following use of Minims
Povidone Iodine.
Rare (may affect up to 1 in 1,000 people)
• Eyes that are red, or with inflammation of the cornea (the transparent membrane of the eye).
Not known (frequency cannot be estimated from the available data)
• A yellow stain on the eyes; reversible staining of moist skin in the eyes or mouth, which may cause irritation. The stain can be removed
with water.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available
from your local pharmacy.
5. HOW TO STORE MINIMS® POVIDONE IODINE
Keep this medicine out of the reach and sight of children.
For single use only. Discard immediately after first use.
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.
Store between 2˚C and 8˚C.
Store in the original package to protect from light.
This medicine can be stored unrefrigerated below 25°C for up to one month. After this period the product should be discarded. When you
take it out of the refrigerator, write the current date on the carton, as well as the date for a month later, so that you know when to discard the
medicine.
Do not use Minims® Povidone Iodine if you notice that the container is damaged.
Any unused product or waste material should be disposed of in accordance with local requirements.
6. FURTHER INFORMATION
What Minims® Povidone Iodine contains
• The active substance is Iodinated Povidone. Each single-dose container contains 25 mg of Iodinated Povidone in 0.5 ml of solution. One
ml solution contains 50 mg Iodinated Povidone.
• The other ingredients are glycerol, nonoxinol 9, disodium phosphate anhydrous, citric acid monohydrate, sodium chloride, sodium
hydroxide and purified water.
What Minims® Povidone Iodine looks like and contents of the pack
This medicinal product is presented as an eye drop solution in a single-dose container marked with “PVI 5.0".
This solution is a deep brown-red coloured solution.
Each single-dose container is overwrapped in a plastic sachet
Each carton contains 20 single-dose containers.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bausch & Lomb U.K. Limited
106 London Road
Kingston-Upon-Thames
Surrey
KT2 6TN
United Kingdom
Tel: +44 (0) 1748 828864
Fax: +44 (0) 1748 828801
Manufacturer:
Laboratoire Chauvin
Z.I.Ripotier Haut
07200 Aubenas
France
Information to healthcare professionals
The product may be stored without refrigeration at not more than 25˚C for up to one month. Where needed, the adhesive label provided in
the carton may be completed and affixed over the bar code by a pharmacist, indicating an expiry date of one month from the date of supply.
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 01/2013
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.

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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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