Lecrolyn Mdu & Sdu 20 mg/mL, 40 mg/mL Eye drops, solution.

Allergic conjunctivitis.

Posology
LECROLYN 20 mg/mL and LECROLYN 20 mg/mL SDU eye drops
Adults and children over 4 years: Instil 1 u2013 2 drops into each eye four times a day. The dose in the pipette is sufficient for both eyes. A single dose unit is intended for use on one occasion only. Opened pipettes must be discarded after use. Since therapy with sodium cromoglicate is essentially prophylactic, it is important that patients who benefit are instructed to maintain regular dosage.
For children under 4 years: Consult your doctor.
LECROLYN 40 mg/mL and LECROLYN 40 mg/mL SDU eye drops
Adults and children over 4 years: Instil 1 u2013 2 drops into each eye four times a day. The dose in one pipette is sufficient for both eyes. A single dose unit is intended for use on one occasion only. Opened pipettes must be discarded after use. Since therapy with sodium cromoglicate is essentially prophylactic, it is important that patients who benefit are instructed to maintain regular dosage.
Method of administration
For ocular use only.

Hypersensitivity to sodium cromoglycate, benzalkonium chloride or to any of the excipients LECROLYN listed in section 6.1.

LECROLYN eye drops (multidose) contain benzalkonium chloride as a preservative and therefore cannot be used with soft contact lenses. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. The possibility of adverse effect on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological operations cannot be excluded, regular ophthalmological examination is required. Benzalkonium chloride should be used with caution in patients with dry eyes, patients where the cornea may be compromised or in patients over an extended period with extensive ocular disease. Patients should be monitored in case of prolonged use. LECROLYN can be used prophylactically. Patients should seek advice before they discontinue use of LECROLYN. For LECROLYN multidose units, the solution should be discarded 1 month after first opening the bottle or if any turbidity develops. Do not use if the bottle has been opened prior to receipt. Where concomitant steroid and LECROLYN treatment has rendered it possible to reduce the steroid dose, precautions must be taken to prevent a severe attack if/when LECROLYN is withdrawn from the treatment regime. LECROLYN SDU (single dose units) eye drops do not contain preservatives. LECROLYN SDU eye drops should be used immediately after opening the pipettes and any remaining contents discarded after use (see section 4.2). LECROLYN should be administered in the conjunctival sac of the affected eye. To avoid contamination, the tip of the container/pipette should not touch the eye or any surface (see section 4.4). As with most ophthalmic preparations, contact lenses should be removed before each application and may be inserted after 15 minutes. In case of concomitant treatment with other eye drops, instillations should be 15 minutes apart. LECROLYN 20 mg/mL eye drops contains benzalkonium chloride LECROLYN contains 0,00014 mg benzalkonium chloride in each drop (0,0035 mL) which is equivalent to 0,04 mg/mL. LECROLYN 40 mg/mL eye drops contains benzalkonium chloride LECROLYN contains 0,00024 mg benzalkonium chloride in each drop (0,0030 mL) which is equivalent to 0,08 mg/mL. Paediatric population From the limited data available, there is no difference in the adverse event profile in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.

None known.

Safety in pregnancy and lactation has not been established.

Transient stinging or blurred vision may occur on instillation (see section 4.8). Do not drive or operate machinery until proper vision is restored.

List of adverse reactions
Immune system disorders: Frequency unknown: Hypersensitivity reactions (including headache, skin rash, bronchospasm, breathlessness, anaphylaxis).
Eye disorders: Less frequent: Local irritation. Frequency unknown: Transient burning or stinging and blurring may occur after instillation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of LECROLYN is important. It allows continued monitoring of the benefit/risk balance of LECROLYN. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201cAdverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

As sodium cromoglicate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary. In the event of accidental ingestion, symptomatic treatment is recommended. If a hypersensitive reaction occurs, withdraw treatment.