Instructions Psilo-balm gel 1% tube 20 g
Composition
active ingredient: diphenhydramine;
1 g of gel contains 10 mg of diphenhydramine hydrochloride;
Excipients: cetylpyridinium chloride, polyethylene glycol glyceryl caprylocaprate, carbomers, tromethamine, purified water.
Dosage form
Gel.
Main physicochemical properties: light, transparent gel.
Pharmacotherapeutic group
Antihistamines for topical use. ATX code D04A A32.
Pharmacological properties
Pharmacodynamics.
Diphenhydramine hydrochloride is an antagonist of H1-histamine receptors. Diphenhydramine when applied to the skin has a local anesthetic and analgesic effect. Histamine, acting through H1-histamine receptors, causes vasodilation, which leads to the penetration of plasma into the tissue. In addition, this is the cause of increased formation of lymphatic fluid and stimulation of nerve endings of the skin, which causes itching. Easily penetrating intact and damaged skin, diphenhydramine suppresses this effect by competitively inhibiting H1-histamine receptors, which exhibits both local antihistamine and local anesthetic effects.
Pharmacokinetics.
Diphenhydramine hydrochloride penetrates intact and damaged skin due to its molecular structure. Diphenhydramine is almost completely metabolized in the liver: first dealkylated to mono- and didemethyldiphenhydramine, then oxidized to diphenylmethoxyacetic acid. The metabolite is conjugated with glycine or glutamine and excreted.
Indication
Sunburns, other first-degree burns,
insect bites,
urticaria, itching of various etiologies,
eczema with itching,
varicella.
Contraindication
Known hypersensitivity to cetylpyridinium chloride or to any other component of the drug,
Application to large areas of affected skin, especially with chickenpox, vesicular skin lesions,
Combinations with other agents containing diphenhydramine.
Interaction with other medicinal products and other forms of interactions
Enhances the effect of alcohol and drugs that depress the central nervous system. MAO inhibitors enhance the anticholinergic activity of diphenhydramine. Antagonistic interaction has been noted with the simultaneous use of diphenhydramine with psychostimulants.
Application features
Avoid contact with eyes. Avoid alcohol consumption. Due to the possibility of photosensitivity reactions, direct sunlight should be avoided on the skin areas where the medicine is applied.
It is not recommended to apply the drug to open wounds, fractures, or mucous membranes.
In cases of sleep apnea (or a known family history of sudden infant death syndrome), histamine H1 receptor antagonists should be used with caution.
Use with caution in elderly patients and patients with acute illnesses.
If symptoms worsen or if there is no improvement, you should consult a doctor regarding further treatment.
Use during pregnancy or breastfeeding
Psilo-Balsam should not be used during pregnancy or breastfeeding due to insufficient studies of the drug's effects on the fetus/infant.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when performing work that requires increased attention and quick mental reactions.
Method of administration and doses
Apply Psilo-Balsam to the damaged areas of the skin in a thin, even layer using light smoothing movements. The gel is quickly absorbed and does not leave any visible traces.
Adults and children over 2 years of age should apply the drug 3-4 times a day. The duration of treatment depends on the severity of the lesion and the effectiveness of therapy and is determined by the doctor individually.
Children.
The drug should be used in children over 2 years of age.
Overdose
Not observed.
Adverse reactions
The frequency of side effects is determined by the following criteria:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (≥1/10000); not known (cannot be estimated due to lack of data).
Skin and subcutaneous tissue disorders
Not known: hypersensitivity skin reactions (eczema, contact dermatitis).
In case of adverse skin reactions (eczema, photoallergic reactions), you should stop using Psilo-Balsam and immediately consult a doctor.
Excessive absorption may result in systemic hypersensitivity reactions, dry mouth, urinary disorders, and, especially in children, feelings of fear and spasms.
Expiration date
2 years.
Shelf life after opening: 12 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding +25 °C in a place inaccessible to children.
Packaging
Vacation category
Without a prescription.
Producer
STADA Arcneimittel AG, Germany.
Location of the manufacturer and its business address.
Stadtstrasse 2-18, 61118 Bad Vilbel, Germany.
