Vitreolent

Package Leaflet: Information for the User

VITREOLENT,(3 mg +3 mg)/ml, eye drops, solution
Potassium iodide + Sodium iodide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or 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 you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Vitreolent, eye drops and what is it used for
• 2. Important information before using Vitreolent
• 3. How to use Vitreolent
• 4. Possible side effects
• 5. How to store Vitreolent
• 6. Contents of the package and other information

1 What is Vitreolent, eye drops and what is it used for
Vitreolent, eye drops is a medicine used in cases of vitreous opacities and changes after vitreous hemorrhages, which may be caused by: age, hypertension, diabetes, myopia, perivascular changes. It is also used in lens opacities that are the first symptoms of cataracts.
2 Important information before using Vitreolent

When not to use Vitreolent

• If the patient has been diagnosed with abnormal thyroid function
• If the patient is allergic to the active substances (sodium iodide, potassium iodide) or any of the other ingredients of this medicine (listed in section 6)

In the case of using contact lenses by the patient, they can be put back on 15 minutes after administering the medicine. Do not administer the medicine to the eye with a contact lens on.

Warnings and precautions

Before starting to use Vitreolent, discuss it with your doctor or pharmacist.

Vitreolent and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to use.
Do not use Vitreolent at the same time as other eye medicines. If it is necessary to use other eye medicines, Vitreolent should be administered with an interval of at least 5 minutes from the administration of the other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Administration of Vitreolent may cause temporary vision disturbances in the form of blurred vision.
During this time, do not drive vehicles or operate machines.
3. How to use Vitreolent
This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Vitreolent is for use in the eye only.
The usual dose of the medicine is 1 drop into the affected eye from 1 to 3 times a day.
Using Vitreolent in children
It is not recommended to use the medicine in children under 12 years of age
Method of use
Before administering the medicine, wash your hands. Then unscrew the cap and hold the bottle with your index finger and thumb. With the index finger of your other hand, gently pull down the lower eyelid.
Drop the medicine into the conjunctival sac, gently squeezing the bottle. Do not touch the eye with the dropper tip. After administration, close your eye and gently press the inner corner of your eye with your finger for 1 to 2 minutes to reduce systemic absorption of the medicine. Close the bottle tightly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (more than 1 in 100, but less than 1 in 10 patients):

• transient burning sensation and "grit" under the eyelids for a short time after administering the medicine, thyroid enlargement or acne-like changes.

Uncommon side effects (more than 1 in 10,000, but less than 1 in 1,000 patients):

• increased tearing

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Vitreolent

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label. The expiry date refers to the last day of the month.
Store the medicine below 25°C.
Shelf-life after first opening the bottle: 1 month
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Vitreolent contains

• The active substances of the medicine are sodium iodide and potassium iodide. 1 ml of the medicine contains 3 mg of sodium iodide and 3 mg of potassium iodide.
• The other ingredients (excipients) are: chlorhexidine digluconate, sorbitol, α-tocopherol, hypromellose, hydrochloric acid 1M, water for injections

What Vitreolent looks like and contents of the package

Vitreolent is an eye drop solution in an LDPE bottle with a dropper, HDPE cap, and a protective ring in a cardboard box.
The bottle contains 10 ml of the medicine.

Marketing authorization holder and manufacturer

Marketing authorization holder
Pharm Supply Sp. z o.o., ul. Marconich 2/9, 02-954 Warsaw
Manufacturer
Excelvision, rue de la Lombardiére 27, 07100 Annonay, Cedex, France

Date of last revision of the package leaflet: