Allergocrom

1. What is Allergocrom and what is it used for

The medicine is used in cases of acute and chronic conjunctivitis.

2. Important information before using Allergocrom

When not to use Allergocrom:

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

Warnings and precautions

Before starting to use Allergocrom, you should discuss it with your doctor or pharmacist.

Children and adolescents

The safety of using the medicine in children under 4 years of age has not been established.

Allergocrom and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions between sodium cromoglicate and other medicines used locally in the eyes are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Your doctor will carefully weigh the benefits and risks of administering the medicine during the first trimester and subsequent trimesters of pregnancy and during breastfeeding.
Edition 06/2024
URSAPHARM * Allergocrom, eye drops * MA-No. 8980 *

Driving and using machines

After using the medicine, transient visual disturbances may occur for a few minutes, which may prolong the reaction time in people driving vehicles and operating machines.

Allergocrom contains benzalkonium chloride.

The medicine contains 0.50 mg of benzalkonium chloride in every 10 ml, which corresponds to 0.05 mg/ml.
An ophthalmologist should determine whether, despite the presence of allergic conjunctivitis, it is possible to use hard contact lenses.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. You should remove contact lenses before instillation and wait at least 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, you should contact your doctor.

3. How to use Allergocrom

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Usually, it is recommended to instill 1 drop into the conjunctival sac 4 times a day.
The dosage is the same for adults and children.

Discontinuation of Allergocrom

Treatment with Allergocrom eye drops should not be discontinued after the symptoms have subsided; it should be continued until the allergen (e.g., pollen, dust) is no longer present.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, transient eye burning, a feeling of a foreign body in the eye, conjunctival hyperemia, and edema may occur. These symptoms usually resolve on their own.
Some people may experience other side effects during use.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. 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 49-21-301; fax: +48 22 49-21-309; 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 Allergocrom

The medicine should be stored out of sight and reach of children.
Edition 06/2024
URSAPHARM * Allergocrom, eye drops * MA-No. 8980 *
Do not use this medicine after the expiry date stated on the carton.
Store in a temperature below 25°C, in the original packaging.
Shelf life after first opening the bottle: 6 weeks.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Allergocrom contains

• The active substance of the medicine is sodium cromoglicate
• The other ingredients are: benzalkonium chloride, disodium edetate, glucose monohydrate, water for injections.

What Allergocrom looks like and what the packaging contains

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

Marketing authorization holder and manufacturer

Marketing authorization holder

URSAPHARM Poland Sp. z o.o.,
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 06/2024