LECROLYN GTT 20MG/ML 10ML

ATC code: S01GX01 

Active substances: Natrii Cromoglicas

Vendor, principal: Santen Oy. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

LECROLYN 20MG/1ML 10ML

Package leaflet: Information for the user

LECROLYN 20 mg/mL eye drops, solution

Sodium cromoglycate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Although this medicine can be obtained without a prescription, you still need to use Lecrolyn eye drops according to instructions to achieve the best results.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
-   If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.

What is in this leaflet:

1.   What Lecrolyn eye drops are and what they are used for
2.   What you need to know before you use Lecrolyn eye drops
3.   How to use Lecrolyn eye drops
4.   Possible side effects
5.   How to store Lecrolyn eye drops
6.   Contents of the pack and other information

1.   What Lecrolyn eye drops are and what they are used for

Sodium cromoglycate inhibits the release of histamine and other mediators which cause inflammation. To achieve the best results, treatment with this medicine should be started prophylactically before symptoms occur. Lecrolyn eye drops are used to treat and prevent allergic conjunctivitis.

2.   What you need to know before you use Lecrolyn eye drops Do not use Lecrolyn eye drops

- if you are allergic to sodium cromoglycate or any of the other ingredients of Lecrolyn eye drops

Lecrolyn eye drops and other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Other concomitantly used medicines do not affect Lecrolyn eye drops.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine.

Driving and using machines

Lecrolyn eye drops have no effect on the ability to drive or perform activities that require sharp vision.

Important information about some of the ingredients of Lecrolyn

Lecrolyn eye drops contain benzalkonium chloride as a preservative. Benzalkonium chloride builds up in soft contact lenses and may change its colour. If you need to wear contact lenses during treatment with Lecrolyn, lenses should be removed from the eyes before dripping the medicine and placed back 15 minutes after the dripping.

3. How to use Lecrolyn eye drops

Use Lecrolyn eye drops according to the doctor’s instructions. Check with your doctor or pharmacist if you are not sure.
The medicine is only intended for dripping in the eye.
The usual dose for adults and children over the age of 4 is 1-2 drops in each eye 4 times a day.
Use in children under the age of 4 only according to a doctor’s prescription.
In order to treat seasonal allergic conjunctivitis, start treatment immediately when the first symptoms occur or start using the medicine prophylactically before the blossoming period of plants and trees. Continue the treatment throughout the blossoming season.
Your doctor may prescribe this medicine for you on another indication and/or in a different dose than indicated in the leaflet. Always follow the doctor’s instructions.

Before applying the eye drops:

-   Wash your hands
-   Choose a suitable position for applying the eye drops (you can either sit, lie down or stand in front of a mirror)

Application:

The bottle of eye drops is intended for individual use.
1. Open the bottle. To avoid contaminating the solution, do not touch any surfaces with the tip of the dropper.

2. Tilt your head back and place the bottle in line with the eye.
3. Pull the bottom eyelid down, look up and drip a drop in the eye.
4. Close the eye and hold your index finger on the inner corner of the eye (on the side of the nose) for about 1 minute. This way, you will prevent the eye drops from flowing into the pharynx through the lacrimal duct. Close the bottle.
If you drip different medicines in the same eye, keep at least a 5-minute interval between dripping different drops.

If you use more Lecrolyn eye drops than you should

In the case of topical administration in the eye, overdose is unlikely. According to available data, overdose has not caused side effects. If you suspect that overdosing may have caused adverse effects, talk to a doctor or pharmacist.

If you forget to take Lecrolyn

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Lecrolyn can cause side effects, although not everybody gets them.
Lecrolyn eye drops are tolerated well. After dripping, transient tingling or irritation symptoms, as well as transient blurred vision may occur.
Hypersensitivity occurs rarely.
Lecrolyn eye drops contain the preservative benzalkonium chloride, which may cause eye irritation.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lecrolyn eye drops

•   Keep this medicine out of the sight and reach of children.
•   This medicine does not require any special storage conditions.
•   Do not use Lecrolyn after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
•   After the initial opening of the bottle, the medicine should be used within 28 days.
•   Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Lecrolyn contains

•   The active substance is sodium cromoglycate. 1 mL of Lecrolyn eye drops contains 20 mg (2%) of sodium cromoglycate.
•   The other ingredients are benzalkonium chloride (50 micrograms/mL), glycerol, disodium edetate and water for injections.

What Lecrolyn looks like and contents of the pack

The solution is a transparent, colourless or slightly yellowish solution.
White plastic (LDPE) bottle with a plastic (HDPE) screw cap, which contains 10 mL of solution.

Marketing Authorisation Holder and Manufacturer

Santen Oy Niittyhaankatu 20 33720 Tampere Finland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Pärnu mnt. 501
76401 Laagri, Harju County
Telephone 6503680

This leaflet was last revised in May 2016

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