Minims Povidone Iodine 5% W/V Eye Drops Solution
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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 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.
Instructions for proper use
In the operating room and after the anaesthetic 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 a 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, Minims® Povidone Iodine can cause side effects, although not everybody gets them.
The following side effects have been reported with either iodine or povidone in published literature and could be associated with the use of Minims Povidone Iodine.
Rare (may affect up to 1 in 1,000 people)
• Eyes that are red, superficial inflammation of the cornea (transparent membrane of the eye).
Very rare (may affect up to 1 in 10,000 people)
• allergic reactions to iodinated povidone such as itching, swelling and red blotches on the skin or severe (possibly life-threatening) shock.
Not known (frequency cannot be estimated from the available data)
• yellowing of the eyes; reversible staining of moist skin in the eyes or mouth, with an irritant effect (the stain can be removed with water).
Use in children
Not known (frequency cannot be estimated from the available data)
Minims® Povidone Iodine may have an effect on the thyroid in very small babies.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 20 mg of Iodinated Povidone in 0.4 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 a presented as eye drop solution in single-dose container marked with “PVI 5.0”.
This solution is 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 25C 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.
This leaflet was last revised in September 2013