Polcrom

Package Leaflet: Information for the Patient

POLCROM, 20 mg/ml, Eye Drops, Solution

Sodium Cromoglicate

Read the Package Leaflet Carefully Before Using the Medicinal Product

This medicinal product should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Polcrom and what is it used for

Polcrom is an anti-allergic medicinal product containing sodium cromoglicate. It inhibits the release of histamine and other substances involved in allergic reactions (so-called cellular mediators). This prevents the occurrence of an allergic reaction. The medicinal product is very well tolerated because the pH of the drops is the same as that of tears. Polcrom is used:

• for allergic conjunctivitis and keratitis (including spring and seasonal).

2. Important information before using Polcrom

When Not to Use Polcrom

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

Warnings and Precautions

Before starting to use Polcrom, discuss it with your doctor or pharmacist.

Polcrom and Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, as well as about the medicinal products you plan to take. No interactions with other medicinal products are expected.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product. Pregnancy The medicinal product may be used during pregnancy only if necessary. Breast-feeding It is not known whether sodium cromoglicate passes into breast milk. However, caution should be exercised, although it is unlikely that the medicinal product passes into breast milk and has adverse effects on the breast-fed child.

Driving and Using Machines

Sodium cromoglicate does not affect the ability to drive and use machines. However, as with other eye medicinal products, temporary blurred vision may occur after administration.

Polcrom Contains Benzalkonium Chloride and Phosphates

The medicinal product contains 0.05 mg of benzalkonium chloride per 1 ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before administration and not put back for at least 15 minutes. Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders. If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicinal product, contact your doctor. The medicinal product contains 2.30 mg of phosphates per 1 ml of solution. In patients with severe damage to the transparent front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to Use Polcrom

This medicinal product should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Dosage

• Instill 1 or 2 drops into the conjunctival sac 4 times a day at equal intervals. Note:
• Treatment should be started in the asymptomatic period before contact with the allergen and continued throughout the season.
• Systematic use of the medicinal product for a longer period is necessary. Method of administration The medicinal product is intended for external use only - locally into the conjunctival sac. Do not touch the dropper tip to the eye, eyelid, or surrounding areas.This may lead to infection of the drops. Using infected drops may lead to serious complications, even vision loss.
• Wash your hands before administration.
• Remove the cap.
• Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket"; the drop should fall into it.
• Administer the medicinal product into the eye, preferably in front of a mirror to see what you are doing. If the drop does not get into the eye, administer another one.
• Gently press the corner of the eye near the nose and close the eye, without blinking or opening it for about 2 minutes, to allow the medicinal product to be absorbed. This will help prevent the medicinal product from entering the entire body.
• If you are using the drops in both eyes, repeat the above procedure to administer the medicinal product to the second eye.
• Then wash your hands to remove any remaining medicinal product and close the bottle.

Missing a Dose of Polcrom

• If you miss a dose, use it as soon as possible.
• If it is almost time for the next dose, skip the missed dose and use the next one according to the schedule.
• Do not use a double dose to make up for a missed dose.

Stopping the Use of Polcrom

If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Polcrom can cause side effects, although not everybody gets them. Temporary burning or stinging of the conjunctiva may occur rarely. Other symptoms of local irritation have been reported rarely. In patients with significantly damaged cornea, very rare cases of corneal clouding due to calcium deposition during treatment have been observed.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 medicinal product.

5. How to Store Polcrom

Keep out of the sight and reach of children. Store in a temperature below 25°C. Keep the bottle tightly closed in the outer packaging. Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month. After opening the bottle, do not use the drops for more than 4 weeks. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Polcrom Contains

• The active substance is sodium cromoglicate. Each 1 ml of solution contains 20 mg of sodium cromoglicate.
• The other ingredients are: sorbitol; disodium phosphate dodecahydrate; sodium dihydrogen phosphate monohydrate; disodium edetate; sodium chloride; benzalkonium chloride solution; purified water.

What Polcrom Looks Like and Contents of the Package

Polcrom is a sterile eye drop solution. The package contains 2 polyethylene bottles of 5 ml, in a cardboard box.

Marketing Authorization Holder

Polpharma S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Polfa Warszawa S.A. ul. Karolkowa 22/24, 01-207 Warszawa

Date of Last Revision of the Package Leaflet: