Posorutin

Package Leaflet: Information for the Patient

Posorutin

Troxerutin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Posorutin and what is it used for

Posorutin is a medicine used to stabilize blood vessels in the eye. Posorutin is used as a supplementary treatment in cases of weakened blood vessels, e.g., with changes in the eye fundus caused by diabetic retinopathy, or with hemorrhages into the conjunctiva.

2. Important information before using Posorutin

When not to use Posorutin

If the patient is allergic to troxerutin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Posorutin, discuss it with a doctor or pharmacist. During the use of Posorutin, do not wear contact lenses. If there are no contraindications to their use, remove the lenses before instilling the medicine and instill the medicine into the conjunctival sac. Lenses can be put back after 15 minutes. Due to the possibility of damage, avoid contact between soft lenses and the medicine.

Posorutin and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. Pregnancy: Before using the medicine, consult a doctor. There is not enough data on the use of the medicine during pregnancy. Breastfeeding: Before using the medicine, consult a doctor. There is not enough data on the use of the medicine during breastfeeding.

Driving and using machines

No special precautions are recommended.

3. How to use Posorutin

This medicine should always be used as directed by a doctor. In case of doubts, consult a doctor or pharmacist. To administer the medicine, wash your hands thoroughly, unscrew the bottle cap, tilt your head back slightly, pull the lower eyelid down, and then, squeezing the bottle gently, instill one drop into the conjunctival sac, and slowly close your eyelids. Avoid contact between the dropper and the eye and facial skin. After instillation, carefully close the container with the cap. The instillation of the medicine should be evenly distributed throughout the day. Posorutin is a medicine intended for long-term therapy. Its duration is determined by a doctor. Usually, one drop is instilled 3 times a day into the conjunctival sac. If you feel that the effect of the medicine is too strong or too weak, consult a doctor. In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Rarely (in 1 patient out of 1000 to 10,000 treated patients), eye burning occurred. Very rarely (in 1 patient out of 10,000 treated patients or less often), hypersensitivity symptoms may occur, consisting of allergic reactions to one of the ingredients of the medicine. In such a case, consult a doctor or pharmacist. In some people, during the use of the medicine, other side effects may occur. If other side effects occur that are not listed in this leaflet, inform a doctor about them.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform a doctor or pharmacist about them. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Posorutin

Store the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the given month. Store in a temperature below 25°C. Store in the original package. After the first opening of the bottle, the medicine can be used for 6 weeks. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Posorutin contains

The active substance of the medicine is troxerutin. The other ingredients are chlorhexidine digluconate solution 20%, sodium chloride, disodium edetate, water for injections, or highly purified water.

What Posorutin looks like and what the pack contains

Posorutin is a clear, colorless or slightly yellow solution in a plastic bottle with a dropper and cap. Each pack contains 1 plastic bottle of 10 ml with a dropper and cap.

Marketing authorization holder and manufacturer

Marketing authorization holder: URSAPHARM Poland Sp. z o.o., ul. Wybrzeże Gdyńskie 27, 01-531 Warsaw; phone: 022 732 07 90; fax: 022 732 07 99; e-mail: [email protected]; manufacturer: URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany

Date of the last update of the leaflet:

Edition 07/2024