ZADITEN ophtha sine 0.25 mg/ml eye drops single dose

Dosage form:

Single-dose pipettes

Zaditen ^® ophtha (sine) 0.25 mg/ml eye drops

Active ingredient: Ketotifen fumarate.

Composition:
1 ml of solution contains 0.345 mg ketotifen fumarate (equivalent to 0.25 mg ketotifen). Other ingredients: Zaditen ophtha: Benzalkonium chloride, glycerol (E422), sodium hydroxide (E524), water. Zaditen ophtha sine: Glycerol (E422), sodium hydroxide (E524), water.

Indications:
Symptomatic treatment of seasonal allergic conjunctivitis (in children from 3 years and adults).

Contraindications:
Hypersensitivity to the active ingredient or to any of the other ingredients. Use with caution during pregnancy. Breastfeeding: No concerns.

Side effects:
Common (>1/100): Eye irritation, eye pain, sensitivity to light. Uncommon (>1/1,000): Blurred vision, dry eyes, eyelid irritation, conjunctivitis, conjunctival bleeding, headache, drowsiness, eczema, dry mouth, hypersensitivity reactions. For risks and side effects, read the package insert and ask your doctor or pharmacist. Available only from

pharmacies. Théa Pharma GmbH Schillerstr. 3 10625 Berlin. Status: January 2025.