Cusicrom 4%

Leaflet attached to the packaging: patient information

Cusicrom 4%,40 mg/ml, eye drops, solution
Sodium cromoglicate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cusicrom 4% and what is it used for
• 2. Important information before using Cusicrom 4%
• 3. How to use Cusicrom 4%
• 4. Possible side effects
• 5. How to store Cusicrom 4%
• 6. Package contents and other information

1. What is Cusicrom 4% and what is it used for

Cusicrom 4% is intended for the treatmentof allergic eye diseases, such as: seasonal and perennial allergic conjunctivitis, spring conjunctivitis and keratoconjunctivitis, allergic (atopic) keratoconjunctivitis, allergies related to contact lens use.
This is an anti-allergic medicine that prevents the release of histamine and other biologically active substances involved in the course of allergic reactions. Due to the action of disodium cromoglicate, allergic reactions dependent on mediators released from mast cells are prevented.
Cusicrom 4% is an eye drop solution containing the active substance - disodium cromoglicate at a concentration of 40 mg per 1 ml of solution.

2. Important information before using Cusicrom 4%

When not to use Cusicrom 4%

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

Warnings and precautions

Before starting treatment with Cusicrom 4%, consult your doctor or pharmacist.

• For use in the eyes only.

Children and adolescents

Cusicrom 4% is not recommended for use in children under 4 years of age due to the lack of safety data in this age group.

Cusicrom 4% and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No adverse interactions have been reported between disodium cromoglicate used topically in the eyes and other medicines.
If you are using other eye drops or ointments, wait at least 5 minutes between administering the next medicine. Eye ointments should be used last.

Pregnancy, breastfeeding, and fertility

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.
It is not known whether disodium cromoglicate passes into breast milk. Since many medicines pass into breast milk, caution should be exercised when using the medicine in breastfeeding women.
It is not known whether disodium cromoglicate affects fertility in humans.

Driving and using machines

Cusicrom 4% has no or negligible influence on the ability to drive and use machines.
After using Cusicrom 4%, blurred vision may occur for a while. Do not drive or operate machinery until your vision has returned to normal.

Cusicrom 4% contains benzalkonium chloride

If you wear contact lenses:

• do not wear contact lenses (hard or soft) during treatment of eye inflammation
• if you do wear contact lenses, remove them before using Cusicrom 4% and wait 15 minutes before putting them back. The preservative (benzalkonium chloride) in Cusicrom 4% may cause eye irritation and is known to discolor soft contact lenses.

3. How to use Cusicrom 4%

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Dosage
The usual dosage of Cusicrom 4% is one or two drops into the eye(s) four to six times a day, at regular intervals.
The number of daily doses and the duration of treatment can be adjusted according to the assessment criteria adopted by the doctor.
A therapeutic response to treatment usually occurs after a few days, but sometimes treatment for up to 6 weeks is necessary.
The treatment period is determined by the doctor.
Cusicrom 4% is for use in the eyes only.

• Prepare the bottle and a mirror.
• Wash your hands.
• Hold the bottle with the cap removed. If the protective collar is loose after removing the cap, discard it before using the medicine.
• Hold the bottle upside down with the thumb and middle finger.
• Tilt your head back and pull the lower eyelid down to create a "pocket" between the eyelid and the eye; the drop should fall into this pocket.
• Bring the tip of the bottle close to the eye. You can use a mirror to help.
• Do not touch the tip of the dropper to the eye, eyelid, or surrounding areas.Failure to follow this instruction may lead to contamination of the drops. Using contaminated drops can lead to serious complications, including loss of vision.
• Gently squeeze the bottom of the bottleto release a single drop of medicine.
• Do not squeeze the bottle too hard; it is designed to release a drop with a gentle squeeze. If the drop does not get into the eye,try again.
• After administering the medicine, gently close your eye and press the corner of your eye near your nose with your finger. This will help prevent the medicine from getting into the rest of your body.
• If using the drops in both eyes, repeat the above steps for the second eye.
• Immediately after use, tighten the bottle cap.

Using more Cusicrom 4% than recommended

In case of overdose, flush the eye with lukewarm water. Do not administer additional doses until the next scheduled dose.

Missing a dose of Cusicrom 4%

If you forget to use Cusicrom 4%, continue treatment by administering the next dose according to the dosage schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the recommended dosage schedule. Do notuse a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cusicrom 4% can cause side effects, although not everybody gets them.
The following side effects have been observed during treatment with Cusicrom 4%:

• - Common side effects (may affect up to 1 in 10 people):
• Eye disorders: eye discomfort.
• - Uncommon side effects (may affect up to 1 in 100 people):
• Eye disorders: eye discharge, eye itching, eye irritation, increased tearing, eye redness.

After the medicine was placed on the market, additional side effects were reported. The frequency of these side effects is unknown.

• Eye disorders: eye irritation.

Reporting side effects

If you experience any side effects, including any side effects not listed in the 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, Tel.: +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 this medicine.

5. How to store Cusicrom 4%

Keep the medicine out of the sight and reach of children.
To prevent infections, discard the bottle 4 weeks after first opening. Write the date of opening below.
Opened:
Store below 25°C. Protect from light. Store the bottle tightly closed. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the 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. Package contents and other information

What Cusicrom 4% contains

• The active substance is disodium cromoglicate. 1 ml of solution contains 40 mg of disodium cromoglicate.
• The other ingredients are benzalkonium chloride, polysorbate 80, disodium edetate dihydrate, purified water.

What Cusicrom 4% looks like and contents of the pack

Cusicrom 4% is a solution supplied in a 10 ml plastic bottle with a protected cap. The carton contains 1 bottle of 10 ml.

Marketing authorization holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, tel. +48 22 37 54 888

Importer/Manufacturer

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany, Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain, Novartis Farmaceutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Date of last revision of the leaflet:02/2022