Lecrolyn Sine
Package Leaflet: Information for the user
Lecrolyn sine 40 mg/ml eye drops, solution
Sodium cromoglicate
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
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What is in this leaflet:
1. What Lecrolyn sine is, and what it is used for
2. What you need to know before you use Lecrolyn sine
3. How to use Lecrolyn sine.,
4. Possible side effects
How to store Lecrolyn sine
Contents of the pack and other information
1. What Lecrolyn sine is and what it is used for
Lecrolyn sine contains the active substance called sodium cromoglicate. This belongs to a group of medicines called anti-allergics.
Lecrolyn sine is used to treat eye symptoms due to allergy. It works by stopping the release of the natural substances like histamine in your eyes that can lead to an allergic reaction. Signs of an allergic reaction include itchy, watery, red or inflamed eyes and puffy eyelids. Usually both eyes are affected.
These symptoms occur usually in spring or summer when pollen from grasses or trees comes into contact with the eyes of people who are sensitive to them.
You must talk to a doctor if your symptoms do not get better, or if they get worse after two days.
2. What you need to know before you use Lecrolyn sine
Do not use Lecrolyn sine
if you are allergic to sodium cromoglicate, or any of the other ingredients of Lecrolyn sine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Lecrolyn sine if you only have symptoms in one eye, as allergic reactions normally involve both eyes.
Other medicines and Lecrolyn sine
During concomitant use of other eye drops, there should be at least 15 minutes between the use of different drops.
Pregnancy and breast-feeding
No adverse effects on the fetus have been demonstrated. Lecrolyn sine can be used during pregnancy and breast feeding.
Driving and using machines
As other eye drops, Lecrolyn sine may cause short-term blurring of vision. If this happens to you, do not drive or use machines until your vision is fully restored.
Contact Lenses
Lecrolyn sine does not contain any preservative. It can therefore be used together with contact lenses.
3. How to use Lecrolyn sine
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for children and adults is 1-2 drops in each eye two times a day.
Before instillation of the eye drops:
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wash your hands before opening the bottle
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when opening the bottle for the very first time, drop one drop to waste
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choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror)
Instillation:
Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.
Tilt your head backwards and hold the bottle above your eye.
Pull the lower eyelid down and look up. Squeeze the bottle gently and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.
Blink a few times so that the drop spreads over the eye.
5. Shake the bottle once downwards to get rid of any remaining solution from the top. Follow the instructions 2. – 4- for dropping Lecrolyn sine also into the other eye.
6. Before recapping the bottle, shake it once downwards in order to keep the tip surrounding dry.
There might remain a small amount of solution in the bottle at the end. This is accounted for by an overfill of all bottles ensuring that 5 ml solution can always be dispensed.
If your eyes do not get better, or if they get worse after two days of using Lecrolyn sine, see your doctor or pharmacist.
It is best to use your eye drops regularly every day while high pollen levels are expected, to keep your eye condition controlled.
If you use more Lecrolyn sine than you should
There are no known reactions of overdosing Lecrolyn sine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Lecrolyn sine can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity) have been reported. However, it is not known how often this occurs.
If you get symptoms like rash, swallowing or breathing problems, swelling of your lips, face throat, tongue and worsening of redness, you must immediately contact your doctor.
A common side effect (may affect up to 1 in 10 people) is local burning during application.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly via national reporting system {will be completed according to Annex 5}.
By providing side effects you can help provide more information on the safety of this medicine.
5. How to store Lecrolyn sine
Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
After first opening the bottle, the solution can be used for 8 weeks. The bottle must be kept tightly closed.
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 sine contains
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The active substance is sodium cromoglicate. 1 ml solution contains 40 mg sodium cromoglicate.
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The other ingredients are glycerol, disodium edetate, polyvinylalkohol, water for injections.
What Lecrolyn sine looks like and contents of the pack
Lecrolyn sine is a clear, colourless or slightly yellowish solution
provided in a white plastic bottlewith a whitedropper applicator witha blue tip and a white plastic screw cap.
Pack sizes: 1x5 ml, 2x5ml, 3x5ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Santen Oy,
Niittyhaankatu 20, 33720 Tampere
Finland
This leaflet was last revised in 2016-07-08
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