Package leaflet: information for the patient

Allergocrom, 20 mg/ml, eye drops, solution
Sodium cromoglicate
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
If there is no improvement after a few days, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

What Allergocrom is and what it is used for
Important information before using Allergocrom
How to use Allergocrom
Possible side effects
How to store Allergocrom
Contents of the pack and other information

1. What Allergocrom is and what it is used for

The medicine is used in the treatment of acute and chronic conjunctivitis.

2. Important information before using Allergocrom

When not to use Allergocrom:

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

Warnings and precautions
Before starting treatment with Allergocrom, discuss this with your doctor or pharmacist.
Children and adolescents
The safety of use in children under 4 years of age has not been established.
Allergocrom and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
No interactions between sodium cromoglicate and other medicines used topically in the eye are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The doctor will carefully weigh the benefits and risks of administering the medicine during the first trimester and subsequent trimesters of pregnancy and while breastfeeding.
Edition 06/2024
URSAPHARM * Allergocrom, eye drops * MA-No. 8980 *
Driving and operating machinery
After application of the medicine, transient visual disturbances may occur for a few minutes, which may prolong reaction time in persons driving vehicles or operating machinery.
Allergocrom contains benzalkonium chloride.
The medicine contains 0.50 mg of benzalkonium chloride in each 10 ml, equivalent to 0.05 mg/ml.
An ophthalmologist should determine whether, despite the presence of allergic conjunctivitis, it is possible to wear rigid contact lenses.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinsertion. Benzalkonium chloride may also cause eye irritation, particularly in persons with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging or pain occur after application of the medicine, 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 a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dose is to instill 1 drop into the conjunctival sac 4 times daily.
The dosage is the same for adults and children.
Discontinuation of Allergocrom treatment
Treatment with Allergocrom eye drops should not be stopped once symptoms have resolved; it should be continued until contact with the allergen (e.g., pollen, dust) has ceased.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In rare cases, transient eye burning, sensation of a foreign body in the eye, conjunctival hyperaemia and swelling may occur.
These symptoms usually resolve spontaneously.
Other adverse reactions may occur in some individuals during use.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw; tel: +48 22 49-21-301; fax: +48 22 49-21-309; website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Allergocrom

Keep the medicine out of the 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 below 25°C in the original packaging.
Do not use the medicine more than 6 weeks after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Allergocrom contains

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

What Allergocrom looks like and contents of the pack
Allergocrom is a clear, colourless or slightly yellow solution contained in a 0 ml plastic bottle with a dropper and cap.
Each pack contains 1 plastic bottle with dropper and cap.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
URSAPHARM Poland Sp. z o.o.,
Wybrzeże Gdyńskie 27
01-531 Warsaw
Telephone: 22 732 07 90
Telefax: 22 732 07 99
e-mail: [email protected]

Manufacturer:
URSAPHARM Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken, Germany

Edition 06/2024