Properties
What is it?
Composition: Active substance: 1 ml contains 0.3 mg flurbiprofen sodium. Excipients: potassium chloride, sodium chloride, sodium citrate, citric acid monohydrate, disodium edetate, thiomersal, povidone, highly purified water, hydrochloric acid or sodium hydroxide for pH adjustment. Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug for topical use. Indications: Inhibition of miosis during and after surgery, control of inflammatory response when using ophthalmic laser. Dosage and administration: Edolfen is used exactly as prescribed by the doctor. The safety and efficacy of the drug in children have not been established. Usual dose for surgical preparation: 1 drop every half hour for 2 hours before surgery (total 4 drops). For other clinical conditions: 1 drop 4 times a day. Eye drops are intended for ophthalmic use only and should be instilled into the conjunctival sac - the pocket between the eye and the eyelid. Before use, wash hands thoroughly, remove the cap from the bottle, and gently pull down the lower eyelid with a finger. Hold the dropper close to the eye so that the tip does not touch the surface. Gently squeeze the bottle with a finger and instill only one drop into the eye, then release the eyelid. For 1 minute after instillation, apply finger pressure to the inner corner of the closed eye. After use, close the bottle tightly with the cap. Side effects: Burning, stinging sensation, worsening of bronchial asthma, irritation of the eyelid skin, punctate keratitis with eye burning, tearing and photophobia, softening of the cornea with prolonged use of the drug. In case of side effects, consult a doctor. Contraindications: Hypersensitivity to flurbiprofen sodium or any other ingredient of Edolfen. Herpetic keratitis. Interaction with other drugs: Inform your doctor or pharmacist if you are taking or have recently taken any other medicines. Interactions of other drugs with Edolfen are not known. Special precautions: Special attention should be paid when using Edolfen in the presence of eye wounds, as wound healing may take longer. Edolfen may delay the healing of corneal lesions or ulcers. This medicine contains thiomersal, which may cause allergic reactions. If you forget to use the medicine, do not instill a double dose. Treatment should continue according to the usual schedule. Pregnancy and lactation: Do not use in pregnant or breastfeeding women. Consult your doctor before using any medication. Driving and operating machinery: If temporary blurred vision occurs after instilling Edolfen, do not drive or operate machinery until your vision returns. Overdose: If more than the recommended dose of the drug is used, drink plenty of fluids. Appearance and packaging: Edolfen is a sterile, clear, colorless, and odorless solution for ophthalmic use, presented in a low-density polyethylene dropper bottle with a high-density polyethylene cap. Each bottle contains 5 ml of solution. Storage conditions: Store at a temperature not exceeding 25°C, out of reach of children. Do not dispose of the drug in the sewage system or with household waste. Expiration date: Indicated on the label and outer box. Use within 28 days after first opening. Conditions of dispensing from pharmacy: By prescription. Manufacturer: Laboratorios Edol - Produtos Farmaceuticos, S.A. 25 de Abril Ave., 6-6A, 2795-225 Linda a Velha, Portugal.