Allergo-comod

1. What is Allergo-COMOD eye drops and what is it used for

The indication for use is acute and chronic allergic conjunctivitis, e.g. conjunctivitis caused by hay fever, spring allergic keratoconjunctivitis.

2. Important information before using Allergo-COMOD eye drops

When not to use Allergo-COMOD eye drops:

• if the patient is allergic to sodium cromoglicate or any of the other ingredients of the medicine (listed in section 6).

No interactions of sodium cromoglicate with other medicines used simultaneously locally in the eyes are known.

Warnings and precautions

Before starting to use Allergo-COMOD eye drops, discuss it with your doctor or pharmacist.
An ophthalmologist should determine whether, despite the presence of allergic conjunctivitis, it is possible to use contact lenses. If confirmed, remove the contact lenses before instilling the medicine, instill the medicine, and put the lenses back on after 15 minutes.
Consult a doctor, even if the above warnings concern situations that have occurred in the past.

Children and adolescents

The safety of using the medicine in children under 4 years of age has not been established.
Edition 07/2024
URSAPHARM * Allergo-COMOD eye drops * MA-No. 9762 * Application for variation

Allergo-COMOD eye drops and other medicines

Tell your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.

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. There are no data on the effect of the medicine on the fetus. The medicine should not be used in the first trimester of pregnancy and its use is not recommended during the rest of the pregnancy.
The medicine is not recommended for use in breastfeeding women.

Driving and operating machinery

After using the medicine, transient vision disturbances may occur, which may prolong the reaction time in people driving vehicles and operating machinery.

3. How to use Allergo-COMOD eye drops

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose is 1 drop 4 times a day.

Use in children

For adults and children, the dosage is the same.

Do not touch the dropper tip to the eye, eyelid, or surrounding areas.

Using a higher dose of Allergo-COMOD eye drops than recommended

No cases of overdose have been reported. There is no known specific treatment in such a case.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, transient eye burning, a feeling of a foreign body in the eye, conjunctival hyperemia, and edema may occur. These symptoms usually resolved on their own. If you suspect an allergy to Allergo-COMOD drops, you should contact your doctor.
In some people, other side effects may occur during the use of the medicine. If you experience other side effects not listed in this leaflet, inform your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. 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.
Edition 07/2024
URSAPHARM * Allergo-COMOD eye drops * MA-No. 9762 * Application for variation

5. How to store Allergo-COMOD eye drops

Keep 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.
After opening the bottle, the medicine can be used for 12 weeks.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Allergo-COMOD eye drops contain

• The active substance of the medicine is sodium cromoglicate
• The excipients are: disodium edetate, sorbitol, water for injections.

What Allergo-COMOD eye drops look like and what the package contains

Allergo-COMOD eye drops are a clear, colorless or slightly yellow solution in a bottle with a pump.
Each package contains 1 plastic bottle of 10 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

URSAPHARM Poland sp. z o.o.
ul. Wybrzeże Gdyńskie 27
01-531 Warsaw
Phone: 22 732 07 90
Fax: 22 732 07 99
e-mail: [email protected]

Manufacturer

URSAPHARM Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken
Germany

Date of last update of the leaflet:

Edition 07/2024