LECROSINE * COLL FL 10ML 40MG / ML

LECROSINE * COLL FL 10ML 40MG / ML

Therapeutic indications

Symptomatic treatment of allergic conjunctivitis in adults and children.

Dosage and method of use

Posology The dose must be established individually for each patient. Recommended dose for children and adults: 1 to 2 drops in each eye twice a day. If the intensity of symptoms requires more frequent dosing, the frequency of dosing should not exceed 4 times a day. Use in the elderly No dosage adjustment is required in elderly patients. To achieve optimal symptom control, Lecrosine should be used regularly. It is recommended to continue treatment during the period of exposure to the allergen. Method of administration Lecrosine 40 mg / ml eye drops, solution is for ocular use only. It must be administered into the conjunctival sac of the eye. To prevent possible contamination of the solution, patients should not touch their eyelids, surrounding areas or any other surface with the applicator tip of the bottle. In case of concomitant treatment with other eye drops, the instillations should be performed 15 minutes apart.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Undesirable effects are listed below by MedDRA preferred term by system organ class and by absolute frequency. Frequencies are defined as follows: Common (≥1 / 100, Immune system disorders Not known: hypersensitivity reactions. Eye disorders Common: transient local pain or irritation. Reporting of suspected adverse reactions Reporting of adverse reactions suspected occurring after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https: //www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

If symptoms continue or worsen, the patient should see their doctor.

Pregnancy and breastfeeding

Pregnancy Data from a limited number of exposed pregnancies indicate no adverse effects of cromolyn on pregnancy or on the fetus / neonate. Animal studies do not indicate direct or indirect harmful effects on pregnancy, development of the embryo / fetus, parturition or postnatal development. Since the systemic exposure of cromolyn after topical application in the eye is negligible, no effects on the nursing fetus / child are expected. Lecrosine can be used in pregnancy. Breastfeeding No effects on breastfed newborns / infants are anticipated, since the systemic exposure of lactating women to cromolyn sodium is negligible. Lecrosine can be used during breastfeeding. Fertility No effects on fertility are expected as systemic exposure to cromolyn sodium is negligible. Sodium cromoglycate has no effect on fertility in animals, even at high systemic doses.

Expiration and retention

Store at a temperature below 25 ° C. Do not freeze.

Interactions with other drugs

No interaction studies have been performed.

Overdose

No information is available on adverse reactions related to overdose.

Active principles

Each ml contains 40 mg of cromolyn sodium. One drop (approximately 0.03 ml) contains approximately 1.2 mg of cromolyn sodium. For the full list of excipients, see section 6.1.

Excipients

Glycerol Disodium edetate Polyvinyl alcohol Water for injections.