LECROLYN

Package leaflet: Information for the user

Lecrolyn, 40 mg/ml, eye drops, solution
Sodium cromoglicate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after two days, or if your condition worsens, contact your doctor.

Contents of the leaflet

1. What Lecrolyn is and what it is 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 Lecrolyn is and what it is used for

Lecrolyn contains an active substance called sodium cromoglicate. It belongs to a group of medicines known as anti-allergic agents.
Lecrolyn is used to treat allergic symptoms affecting the eyes. It works by preventing 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. These symptoms usually affect both eyes.
Such symptoms most commonly occur in spring or summer, when grass or tree pollen comes into contact with the eyes of people who are sensitive to them.
If there is no improvement after two days, or if your condition worsens, contact your doctor.

2. Important information before using Lecrolyn

When not to use Lecrolyn:

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

Warnings and precautions
Talk to your doctor before starting to use Lecrolyn if the patient has symptoms in only one eye, since allergic reactions usually affect both eyes.
Lecrolyn and other medicines
If other eye drops are being used at the same time, an interval of at least 15 minutes should be maintained between instillation of different types of eye drops.
Pregnancy and breastfeeding
No adverse effects on the foetus have been observed. Lecrolyn may be used during pregnancy and breastfeeding.
Driving and operating machinery
As with other eye drops, Lecrolyn may cause transient blurred vision. In such a case, do not drive or operate machinery until vision has improved.
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 this patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for children and adults is 1-2 drops into each eye twice daily.
If symptoms are severe and require more frequent dosing, do not use more than 4 times per day.

Before administering 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 the patient when administering the drops (you may sit, lie down, or stand in front of a mirror).

Administering the drops:

1. Hold the bottle directly below the cap and open it by unscrewing the cap. Do not touch the dropper tip with anything to avoid contaminating the solution.

2. Tilt your head backward and hold the bottle over the eye.

3. Pull the lower eyelid downward and look upward. Gently squeeze the bottle so that one drop falls into the eye. Note that it may take a few seconds from squeezing the bottle until the drop appears. Do not squeeze too hard.

4. Blink several times to ensure the medicine spreads evenly over the eye.
5. Repeat steps 2 to 4 to administer Lecrolyn into the other eye.

6. Before closing the bottle, tap it once downward to remove any remaining solution from the dropper tip. This is necessary to ensure the bottle remains suitable for use.

If there is no improvement or if the condition of the eyes worsens after two days of using Lecrolyn,
consult your doctor or pharmacist.
It is best to administer the eye drops regularly every day during the expected peak pollen season
to keep eye symptoms under control.

Use of a higher than recommended dose of Lecrolyn
There are no known effects caused by overdosing on Lecrolyn.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Allergic reactions (hypersensitivity) have been reported. However, it is not known how often these
occur.
If the patient experiences symptoms such as rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, or worsening redness, contact a doctor immediately.
A common adverse reaction (which may occur in up to 1 in 10 people) is local burning sensation during instillation of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Lecrolyn

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Period of use after first opening the bottle: 8 weeks. Keep the bottle tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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, colourless to slightly yellow solution supplied in a white plastic bottle
with a dropper having 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 Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland