Properties
What is it?
International Nonproprietary Name - diphenhydramine hydrochloride Clinical-pharmacological group: Allergology → Histamine H1 receptor blockers → Topical preparations Dosage Form Topical gel Preparation Composition 100 g of gel contains: Active substance: diphenhydramine hydrochloride 1.0 g Excipients: Cetylpyridinium chloride 0.1 g as a preservative Macrogol-6-glycerol caprylate/caprate Trometamol Polyacrylic acid Water Pharmacotherapeutic Group H1-histamine receptor blocker ATC code: D04AA32 Pharmacological Action Psilo-Balsam's anti-allergic action is due to the presence of diphenhydramine hydrochloride in its composition, which is an H1-histamine receptor blocker and consequently rapidly reduces itching, pain, hyperemia, decreases increased capillary permeability, reduces tissue swelling, and causes local anesthesia. Psilo-Balsam has a pleasant cooling effect. The special gel component protects the skin and leaves no residue; it can be used as a skin cream. Indications for Use Sunburn or first-degree burns, insect bites (mosquitoes), urticaria, itching of various origins, chickenpox, allergic skin irritation (excluding itching during cholestasis), contact dermatitis caused by contact with plants. Contraindications Hypersensitivity to the components of the preparation. Use with caution during pregnancy and lactation, and in children under 2 years of age. Method of Administration and Dosage Apply a thin layer of the preparation (2–3 g of gel) to the affected skin area and spread with light rubbing. Side Effects In rare cases, skin hypersensitivity reactions may occur, manifested by redness and moderate swelling of the area where the preparation is applied. Systemic side effects are not noted with topical use of the preparation. Interactions with Other Medicinal Products Potentiates the effects of alcohol and central nervous system depressants. MAO inhibitors enhance the anticholinergic activity of diphenhydramine. Antagonistic interaction is observed when co-administered with psychostimulants. Dosage Form 20 g 1% gel in aluminum tubes. Each tube, along with the instructions for use, is placed in a cardboard box. Shelf Life 3 years. Do not use after the expiry date indicated on the packaging. Dispensing Conditions Pharmaceutical product group III (dispensing regime: over-the-counter).