Lecrosine 40 mg/ml - eye drops for conjunctivitis 10 ml

Product Description

Eye drops for allergic conjunctivitis

Indications

Lecrosine 40 Mg/Ml Eye drops Solution useful for the treatment of allergic conjunctivitis in adults and children.

Composition

Active Ingredients: Each ml contains 40 mg of sodium cromoglicate.
Excipients: Glycerol Disodium edetate Polyvinyl alcohol Water for injections.

Directions for use and Dosage

The dosage must be established for each patient.
Normal dosage for children and adults: 1 to 2 drops in each eye twice a day.
To obtain optimal control of symptoms, Lecrosine must be used be used regularly.

Warnings

For further information, read the package leaflet carefully.

Side Effects

Hypersensitivity to the active substance or to any of the excipients.

Interactions

No interaction studies have been performed.

Side Effects

The following adverse reactions are reported below (by MedDRA preferred term) by system organ class and absolute frequency.
The frequency has been defined as follows:

• Common (from >=1/100 to <1/10).
• Not known (cannot be estimated from the available data).

Immune system disorders. Not known: hypersensitivity reactions.
Ocular disorders. Common: transient local pain or irritation.
Report any suspected adverse reactions to the Italian Medicines Agency.

Pregnancy and Breastfeeding

Pregnancy. Data on a limited number of exposed pregnancies indicate no adverse effects of cromoglicate on pregnancy or the fetus/newborn.
Studies conducted in animals do not indicate direct or indirect harmful effects with respect to pregnancy, development of the embryo/fetus, parturition or postnatal development.
Since the systemic exposure of cromoglicate after topical application to the eye is negligible, no effects on the fetus/breastfed child are expected.
Lecrosine can be used during pregnancy.
Breastfeeding. No effects on breast-fed newborns/infants are anticipated, since systemic exposure to sodium cromoglicate in breast-feeding women is negligible.
Lecrosine can be used during breast-feeding.
Fertility. No effects on fertility are anticipated, since systemic exposure to sodium cromoglicate is negligible.
Sodium cromoglicate has no effect on fertility in animals, even at high systemic doses.

Storage

Store below 25°C.
Do not freeze.

Format

10 ml