Lecrosine
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: information for the user
Lecrosine 40 mg/ml eye drops, solution
sodium cromoglicate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after two days.
Contents of this leaflet:
- What Lecrosine is and what it is used for
- What you need to know before using Lecrosine
- How to use Lecrosine
- Possible side effects
- How to store Lecrosine
- Contents of the pack and other information
1. What Lecrosine is and what it is used for
Lecrosine contains the active substance sodium cromoglicate, which belongs to a group of
medicines called anti-allergics.
Lecrosine is used to treat allergic eye symptoms. It works by blocking the release of natural substances in the eyes, such as histamine, which can cause an allergic reaction. Signs of an allergic reaction include itchy eyes, red or inflamed eyes, tearing, and swollen eyelids. Usually, both eyes are affected.
These symptoms generally occur in spring or summer, when pollen from plants comes into contact with the eyes of people who are sensitive to such plants.
Consult your doctor if symptoms do not improve or if they worsen within two days.
2. What you should know before using Lecrosine
Do not use Lecrosine
if you are allergic to sodium cromoglicate or to any of the other ingredients of Lecrosine (listed in
section 6).
Warnings and precautions
Consult your doctor before using Lecrosine if symptoms affect only one eye, since allergic reactions
typically involve both eyes.
Other medicines and Lecrosine
When using another eye drop at the same time, at least 15 minutes should elapse between the
application of each eye drop.
Pregnancy and breastfeeding
Adverse effects on the fetus have not been demonstrated. Lecrosine may be used during pregnancy and
breastfeeding.
Driving and use of machines
Like other eye drops, Lecrosine may cause temporary blurred vision. If this occurs, do not drive or
operate machinery until your vision has returned to normal.
Contact lenses
Lecrosine does not contain any preservative. Therefore, it can be used with contact lenses.
3. How to use Lecrosine
Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for children and adults is 1-2 drops in each eye twice daily.
If the severity of symptoms requires more frequent dosing, the frequency of administration should not exceed four times a day.
Before instilling the eye drops:
- Wash your hands before opening the bottle.
- After the first opening of the bottle, discard the first drop.
- Choose the position most comfortable for you when instilling the drops (sitting, lying on your back, or standing in front of a mirror).
Instillation:
- Hold the bottle just below the cap and twist the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contaminating the solution.
- Tilt your head backward and hold the bottle over the eye.
- Pull down the lower eyelid and look upward. Gently squeeze the bottle and let one drop fall into the eye. Please note that it may take a few seconds for the drop to come out after squeezing the bottle. Do not squeeze too hard.
- Blink several times to allow the medicine to spread over the eye.
- Follow instructions in points 2 to 4 to instill Lecrosine into the other eye as well.
- Before recapping the bottle, tap it once downward to remove any residual solution from the tip of the bottle. This is necessary to ensure proper functioning of the bottle.
If your eyes do not improve or worsen after two days of using Lecrosine, consult your doctor or pharmacist.
It is recommended to use the eye drops regularly every day during periods of high pollen concentration in the air to maintain control of the condition.
If you use more Lecrosine than you should
There are no known reactions associated with an overdose of Lecrosine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic (hypersensitivity) reactions have been reported. However, the frequency of such reactions is unknown.
If you notice symptoms such as skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat and tongue, or worsening redness, contact your doctor immediately.
A common side effect (may affect up to 1 in 10 people) is local burning during application.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Lecrosine
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 stated on the carton and bottle after Exp. The
expiry date refers to the last day of that month.
After first opening, the solution can be used for 8 weeks. The bottle must be kept tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Lecrosine contains
- The active substance is sodium cromoglicate. 1 ml of solution contains 40 mg of sodium cromoglicate.
- The other components are glycerol, edetate disodium, polyvinyl alcohol, water for injections.
Description of the appearance of Lecrosine and contents of the pack
Lecrosine is a clear, colourless or slightly yellowish solution supplied 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20, 33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland