40 mg/ml eye drops,
sodium cromoglycate solution
What Lecrolyn is and what it is used for
Lecrolyn contains the active substance as sodium cromoglycate, which prevents the release of inflammatory substances into the mucous membranes of the eye.
Lecrolyn eye drops are used in the treatment of allergic eye problems such as pollen allergy with e.g. redness, itching, and increased tear flow.
Sodium cromoglycate contained in Lecrolyn may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Lecrolyn
Do not use Lecrolyn
if you are hypersensitive to sodium cromoglycate or any of the other ingredients of Lecrolyn (listed in section 6)
Warnings and cautions
If eye symptoms do not improve within a few days or only affect one eye, consult a doctor.
Other medicines and Lecrolyn
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When using other eye drops at the same time, there should be at least 15 minutes between the use of the different drops.
Pregnancy and breastfeeding
No adverse effects on the fetus have been demonstrated. Lecrolyn can be used during pregnancy and breastfeeding.
Driving and using machines
After dripping into the eye, vision may be temporarily affected. Therefore, do not drive or use dangerous machines until your eyesight has returned completely.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lecrolyn contains benzalkonium chloride
May cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
May discolor soft contact lenses.
How to use Lecrolyn
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is :
1-2 drops in each eye 2 times a day for adults and children.
Another dose according to the doctor’s prescription.
The treatment begins with the first symptoms and lasts throughout the pollen season. Contact a doctor if improvement does not occur within a few days.
Instructions for use
The eye drop bottle is personal.
If you use more Lecrolyn than you should
There is no information on side effects that could be due to overdose.
Possible side effects
Like all medicines, Lecrolyn can cause side effects, although not everybody gets them. A common side effect (may affect up to 1 in 10 people) is temporary burning in the eye or local irritation of the eyes.
How to store Lecrolyn
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP or EXP. The expiry date refers to the last day of that month.
Do not use this medicine if it has become cloudy.
The opened bottle must be used within 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is sodium cromoglycate. 1 ml solution contains 40 mg sodium cromoglycate.
- The other ingredients are benzalkonium chloride, glycerol , disodium edetate dihydrate, polyvinyl alcohol and water for injections.
What the medicine looks like and contents of the pack
Eye drops, solution. Clear, colorless, or slightly yellowish solution.
White plastic bottle, white plastic screw cap.
Pack size: 5 ml
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy,
Niittyhaankatu 20, 33720 Tampere
Finland
Manufacturer
Santen Oy,
Kelloportinkatu 1, 33100 Tampere
Finland