LECROLYN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LECROLIN® (Lecrolyn®)

Composition:

Active substance: sodium cromoglicate;

1 ml of eye drops contains sodium cromoglicate 40 mg;

Excipients: glycerol, edetate disodium, polyvinyl alcohol, benzalkonium chloride, water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical properties: clear, colourless or slightly yellowish solution. Does not contain visible particles.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-inflammatory and antiallergic agents. Other antiallergic medicinal products. ATC code S01GX01.

Pharmacological properties.

Pharmacodynamics.

Sodium cromoglicate inhibits mast cell degranulation by stabilizing the cell membrane, thereby preventing the release of histamine and other mediators involved in inflammation. Due to the mechanism of action of the drug, the greatest effect is achieved when the drops are used also for prophylactic purposes. The use of Lecroline® eye drops reduces the need for steroids and antihistamines in the treatment of allergic conjunctivitis. This drug does not prevent the occurrence of bacterial or viral conjunctivitis.

Pharmacokinetics.

Sodium cromoglicate reversibly binds to plasma proteins, approximately 65%.

Ocular and systemic absorption of sodium cromoglicate is minimal. Bioavailability after ocular instillation is about 0.03%. Sodium cromoglicate is not metabolized and is excreted unchanged in bile and urine. After parenteral administration, the elimination half-life in plasma is approximately 80 minutes.

Clinical characteristics.

Indications.

Acute and chronic allergic conjunctivitis.

Contraindications.

Hypersensitivity to sodium cromoglicate, benzalkonium chloride, or to any other component of the medicine.

Interaction with other medicinal products and other forms of interaction.

When using this medicine simultaneously with other topical ophthalmic agents, a 15-minute interval should be maintained between instillations.

Sodium cromoglicate has no undesirable interactions.

Special precautions for use.

Lekrolin® contains benzalkonium chloride as a preservative. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinserting them.

Benzalkonium chloride may alter the color of soft contact lenses.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eye, and may affect the tear film and corneal surface. The product should be used with caution in patients with dry eye and in patients who may have compromised corneas. Patients should be monitored during prolonged use.

Use during pregnancy and breastfeeding

No adverse effects on the fetus have been observed following use in pregnancy. However, the product should be used during pregnancy only when the expected benefit to the woman outweighs the potential risk to the fetus.

Sodium cromoglicate may pass into breast milk, but adverse effects on the infant have not been reported when used at recommended doses.

Ability to affect reaction speed while driving or operating machinery

The medicinal product does not affect the ability to drive or operate machinery. As with other ophthalmic medicinal products, transient blurred vision may occur immediately after instillation. Therefore, patients should wait until vision clears before driving or operating machinery.

Dosage and Administration.

For adults and children aged 4 years and older: 1−2 drops into each eye twice daily.

For seasonal allergic conjunctivitis, treatment should be initiated immediately upon the first symptoms or for prophylaxis before the start of the pollen season. Treatment should continue throughout the entire pollen season, and, in cases of persistent allergic symptoms, longer.

Children

The use of the drug is not recommended for children under 4 years of age.

Overdose.

Studies in animals have shown that local or systemic toxicity of sodium cromoglicate is very low. Symptoms of overdose following topical administration are unlikely. In the event of overdose symptoms, symptomatic treatment should be administered if necessary.

Adverse reactions.

When administered locally, sodium cromoglicate is well tolerated; irritation symptoms have been reported rarely.

Frequent (>1/100): transient burning sensation, local irritation (including foreign body sensation, chemosis, conjunctival hyperemia); transient blurred vision.

Rare (<1/10,000): hypersensitivity reactions.

Severe generalized anaphylactic reactions with bronchospasm, associated with administration of sodium cromoglicate, may occur.

Shelf life.

3 years. The shelf life of eye drops after first opening the bottle is 28 days.

Storage conditions.

Store at a temperature not exceeding 25 **°**C. Keep out of reach of children.

Packaging.

5 ml in a dropper bottle; 1 bottle per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Santen Oy.

Manufacturer's name and address of the place of business.

Kellonportti 1, Tampere, 33100, Finland.