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1. Minims Povidone Iodine 5% W/V Eye Drops Solution
2. Minims Povidone Iodine 5% W/V Eye Drops Solution

Art. 76920 P1UKIE01

BAUSCH+LOMB

Minims® Povidone Iodine 5% w/v Eye Drops, Solution

lodinated Povidone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    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.

What is in this leaflet

1.    What Minims Povidone Iodine is and what it is used for

2.    What you need to know 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.    Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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

Warnings and precautions

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:

-    applying any other medicines to your eyes especially antimicrobial eye drops and eye drops containing mercury-based preservatives, as these may affect the way Minims Povidone Iodine works.

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.

Minims Povidone Iodine contains disodium phosphate anhydrous

3. HOW TO USE MINIMS POVIDONE IODINE

Use in Adults

The drops are supplied in single-dose units that are meant to treat both eyes if both eyes are affected.

The recommended dose is two to three drops of the solution instilled onto the eye/eyes and leave for two minutes.

Use in children and adolescents

This product can be used in babies, infants, children and adolescents. The recommended dose is the same as for adults.

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    ound your eyes will be carefully cleaned with a sterile cotton swab.

2.    The nurse / doctor will then twist off the cap of the Minims Povidone Iodine unit to open it.

3.    Two to three 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.    The drops will be left on the eye / eyes for two minutes before rinsing. Your eyes will then be rinsed thoroughly with a sterile saline solution until the characteristic colour of the Iodinated Povidone disappears.

Art. 76920 P1UKIE01

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 and pseudo-allergic reactions, such as red and itchy rash, swelling of the face, hands and feet, eyes, lips and/ or tongue, difficulties in breathing or swallowing, low blood pressure; some of them may be life-threatening.

-    In very rare cases, some patients with severe damage to the clear layer at the front of the eye(the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Not known (frequency cannot be estimated from the available data)

-    yellowing of the eyes; irritant effect on mucosa (membrane that lines various cavities in the body) and deep tissue; reversible, transient brown coloration (which can the removed with water).

Use in children

Not known (frequency cannot be estimated from the available data)

In neonates Minims Povidone Iodine may have an effect on the thyroid, causing the thyroid gland to not make enough thyroid hormones to meet the body's needs.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom    Ireland

Yellow Card Scheme    HPRA Pharmacovigilance

Website: www.mhra.gov.uk/yellowcard    Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971; Fax: +353 1 6762517

Website: www.hpra.ie; e-mail: medsafety@hpra.ie By reporting side effects you can help provide more information on the safety of this medicine.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER 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 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:    Manufacturer:

Bausch & Lomb U.K. Ltd    Laboratoire Chauvin

106 London Road    Z.I.Ripotier Haut

Kingston-Upon-Thames    07200 Aubenas

Surrey, KT2 6TN    France

This leaflet was last revised in April 2016.

Minims is a trademark of Bausch & Lomb Incorporated or its affiliates. © Bausch & Lomb Incorporated

The following information is intended for healthcare professionals only:

Posology

Adults (including the elderly)

Instill two to three drops of the solution onto the eye / eyes and leave for two minutes.

Paediatric population

The adult dose may be used in neonates, infants, children and adolescents

Method of administration:

-    Wash hands thoroughly before use

-    Clean the area around the eyes with a sterile cotton swab

-    Twist off the cap of the container to open it

-    Do not touch the eye with the single-dose container nozzle

-    Gently instill 2 to 3 drops of the solution onto the eye / eyes

-    Allow the solution to spread, by asking the patient to close their eyes and roll their eyes around

-    Leave the drops on the eye / eyes for two minutes before rinsing:

-------------------------------------------------_>.?

Using a suitable syringe, irrigate the eye / eyes thoroughly with sterile saline 09% w/v solution until the characteristic colour of the iodine solution disappears Contraindications

-    Hypersensitivity to iodinated povidone, to iodine or to any of the medicinal product's excipients

-    Minims Povidone Iodine 5% w/v eye drops, solution is contraindicated for intra-ocular or peri-ocular injection

-    Concomitant use with topical ophthalmic formulations containing mercury-based preservatives

-    Pre-term neonates Special precautions for storage

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 in the area provided on the carton by a pharmacist, indicating an expiry date of one month from the date of supply, date of removal from refrigerator, new expiry date and discard immediately after first use.

P1UKIE01_76920_Minims_Povidone_Iodine_5DRP_20SDU_UK_IE_v1.indd 2 2016-05-19 14:17:20