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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iodinated povidone

Available from:

Bausch Health Ireland Limited

ATC code:

S01AX; S01AX18

INN (International Name):

Iodinated povidone

Dosage:

5 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Other antiinfectives; povidone-iodine

Authorization status:

Marketed

Authorization date:

2012-12-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MINIMS® POVIDONE 5% W/V EYE DROPS, SOLUTION
Iodinated 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 drops solution.
It is used for cleaning the surface of your eye before eye surgery or
eye injection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MINIMS POVIDONE IODINE
DO NOT USE MINIMS POVIDONE IODINE
-
If you are allergic to povidone iodine, or any product containing
povidone iodine or
_ _
any of the
other ingredients of the medicine listed in section 6.
-
In pre-term infants.
-
For injecting into the eye and the eye surroundings.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Minims Povidone
Iodine:
-
If you have a thyroid disorder. Monitoring of thyroid function is
should be considered, particularly
in the elderly, during regular repeated use of this medicine.
-
If you have dry eyes syndrome.
Special warnings
Minims Povidone Iodine 5% w/v eye drops, solution is strictly only for
use to clean the eyes before
surgery or eye injection and should not be used for any other purpose.
Precautions for use
After

Summary of Product characteristics

Health Products Regulatory Authority
13 September 2019
CRN008P87
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Povidone Iodine 5% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose container provides 20 mg of Iodinated Povidone in 0.4
ml of solution. One milliliter of solution contains 50
mg Iodinated Povidone
Excipient with known effect:
Disodium phosphate anhydrous 0.75 mg/ml (0.03 mg in each drop) ( see
section 4.8).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Drops, Solution
Deep brown-red coloured solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Minims Povidone Iodine 5% w/v eye drops, solution is indicated for
cutaneous peri-ocular and conjunctival antisepsis prior to
ocular surgery and/or intravitreal injection to support
post-procedural infection control.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly)_
Instill 2 to 3 drops of the solution onto the eye / eyes and leave for
two minutes. See "Method of Administration" for further
details.
_ _
_Paediatric population_
The adult dose may be used in 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 single-dose 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 0.9% w/v solution until the
characteristic colour of the iodine solution disappears.
4.3 CONTRAINDICATIONS
This medicinal product must not be used in the following situations:
- Hypersensitivity to iodinated povidone, to iodine or to any of the
excipients listed in s