Lecrolin

Package Leaflet: Information for the User

Lecrolyn, 40 mg/ml, Eye Drops, Solution

Sodium cromoglicate

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

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after two days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Lecrolyn and what is it used for

Lecrolyn contains the active substance sodium cromoglicate. It belongs to a group of medicines called antiallergic medicines.
Lecrolyn is used to treat symptoms of allergy in the eyes. Its action is to prevent the release of natural substances in the eyes, such as histamine, which can cause an allergic reaction. Symptoms of an allergic reaction include itching, tearing, redness, or inflammation of the eyes and swollen eyelids. Symptoms usually occur in both eyes.
Such symptoms most often appear in spring or summer, when grass or tree pollen reaches the eyes of people who are sensitive to them.
If after two days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Lecrolyn

When not to use Lecrolyn:

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

Warnings and precautions

You should talk to your doctor before starting to use Lecrolyn if you have symptoms in only one eye, as an allergic reaction usually affects both eyes.

Lecrolyn and other medicines

If you are using other eye drops, you should leave at least 15 minutes between putting different types of drops into your eye.

Pregnancy and breastfeeding

No adverse effects on the fetus have been observed. Lecrolyn can be used during pregnancy and breastfeeding.

Driving and using machines

Like other eye drops, Lecrolyn may cause temporary blurred vision. In this case, do not drive or operate machinery until your vision improves.

Contact lenses

Lecrolyn does not contain any preservatives. Therefore, it can be used while wearing contact lenses.

3. How to use Lecrolyn

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose for children and adults is 1-2 drops into each eye twice a day.
If the severity of symptoms requires more frequent administration, do not use more than 4 times a day.

Before administering the eye drops:

• wash your hands before opening the bottle,
• when opening the bottle for the first time, discard the first drop of the medicine,
• choose the most comfortable position for you to put the drops into your eye (you can sit, lie down, or stand in front of a mirror).

Administering the drops:

• 1. Hold the bottle directly under the cap and open it by twisting the cap. Do not touch the tip of the dropper to avoid contaminating the solution.
• 2. Tilt your head back and hold the bottle over your eye.

• 3. Pull down the lower eyelid, looking up. Gently squeeze the bottle until a drop falls into the eye. Remember that it may take a few seconds from squeezing the bottle to the drop appearing. Do not squeeze too hard.

• 4. Blink several times so that the medicine covers the entire eye.
• 5. Repeat steps 2 to 4 to put the drops into the other eye.
• 6. Before closing the bottle, shake it once downwards to remove any remaining solution from the tip of the dropper. This is necessary to keep the bottle usable.

If after two days of using Lecrolyn your eye condition does not improve or worsens, you should contact your doctor or pharmacist.
It is best to put the drops into your eyes regularly every day during the expected peak pollen period to keep your eye condition under control.

Using more than the recommended dose of Lecrolyn

There are no known effects of overdosing with Lecrolyn.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lecrolyn can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity) have been reported. However, it is not known how often they occur.

If you experience symptoms such as rash, swallowing or breathing problems, swelling of the face, lips, throat, or tongue, and increased redness, you should contact your doctor immediately.

A common side effect (may affect up to 1 in 10 people) is local burning during administration of the drops.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products ,Al. Jerozolimskie 181C ,PL-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 Lecrolyn

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the carton and bottle after “Expiry Date/EXP”. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 8 weeks. The bottle should be kept tightly closed.
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. Contents of the pack and other information

What Lecrolyn contains

• The active substance is sodium cromoglicate. One ml of solution contains 40 mg of sodium cromoglicate.
• The other ingredients are disodium edetate, glycerol, polyvinyl alcohol, and water for injections.

What Lecrolyn looks like and contents of the pack

Lecrolyn is a clear, colorless to slightly yellow solution, available in a white plastic bottle with a white dropper with a blue tip and a white plastic screw cap.
Pack sizes: 1 x 5 ml, 2 x 5 ml, 3 x 5 ml, and 1 x 10 ml
Not all pack sizes may be marketed

Marketing authorization holder

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

Date of last revision of the leaflet: 04/2021