Properties
What is it?
International Nonproprietary Name - DIMETINDENE Active Substance: Dimetindene Clinical-Pharmacological Group: Antihistamine, anti-allergy and anti-itch agent. Composition and Dosage Form: Drops for oral administration: 20 ml bottle 1 ml (20 drops) Dimetindene maleate ......... 1 mg Excipients: Methylparahydroxybenzoate (preservative E218), ethanol, dehydro-hydrogenated phosphate, sodium dihydrate, sorbitol, purified water. Gel for external use: 30 g tube 1 g Dimetindene maleate ........... 1 mg Excipients: Benzalkonium chloride, sodium edetate, carbopol 974 P (carbomer 934P), propylene glycol, sodium hydroxide, purified water. Clinical-Pharmacological Group: Antihistamine, anti-allergy and anti-itch agent. Indications: Symptomatic treatment of allergic diseases: Urticaria; Seasonal allergic rhinitis; Drug and food allergies; Various types of skin itching not associated with cholestasis (including diseases accompanied by skin rash); Insect bites; Gel is used for sun erythema and superficial burns. Dosage and Administration: For adults and children over 12 years of age, the daily dose is usually 3-6 mg (60-120 drops) divided into three doses. i.e. 20-40 drops 3 times a day. For patients prone to drowsiness, it is recommended to take 40 drops before bedtime, during dinner, and 20 drops in the morning. For children from 1 month to 12 years of age, doses are given in the table. Frequency of administration - 3 times a day. Fenistil drops should not be exposed to high temperatures. It is added to the baby's feeding bottle immediately before feeding. If the baby is already being fed with a spoon, the drops can be given undiluted with a teaspoon. The drops have a pleasant taste. Apply the gel to the affected skin area 2-4 times a day. Side Effects: Drowsiness is often observed during the intake of drops, especially at the beginning of treatment when using high doses. Rarely, gastrointestinal disorders (including vomiting), dryness in the mouth and throat, pronounced dizziness, headache are observed. Peripheral edema, skin rash, muscle spasms, and rare cases of respiratory distress may develop. With external use of the gel, temporary dryness or a mild burning sensation on the skin may occasionally occur. In rare cases - skin rash and itching. If any of the listed side effects occur, the patient should consult a doctor. Contraindications: * Hypersensitivity to dimetindene and other components of the preparation; * Angle-closure glaucoma; * Urinary retention disorders (e.g., prostatic hypertrophy); * Drops are not prescribed for children under 1 month of age, especially premature infants; * First trimester of pregnancy.