Each gram of Fenistil gel contains 1 mg of dimetindene maleate.
Excipients/Inactive Ingredients: Benzalkonium chloride, Sodium edetate, Carbomer, Propylene glycol, Sodium hydroxide, Purified water.
Pharmacotherapeutic group: Antihistamine for cutaneous use. ATC code: D04AA13.
Pharmacology: Pharmacodynamics: Mechanism of Action: Dimetindene maleate is an alkylamine-class first generation antihistamine (Inverse agonist of H1 receptor). Antihistamines diminish or abolish the action of antihistamine in the body by stabilizing the H1 - receptors in their inactive state. It considerably reduces the hypermeability og the capillaries which is associated with immediate hypersensitivity reactions. When topically applied, dimetindene maleate also presents local anaesthetic properties.
Pharmacodynamic effects: Fenistil Gel is effective against pruritus of various origins and rapidly relieves itching and irritation. The gel base facilitates the penetration of the active ingredient into the skin. Fenistil Gel penetrates rapidly into the skin and exerts its antihistaminic effect within a few minutes. The effect reaches its maximum after 1 to 4 hours.
Pharmacokinetics: Following topical application in healthy volunteers, the systemic availability of dimetindene maleate is approximately 10% of the dose applied.
Toxicology: Preclinical safety data: Non-clinical safety data on Dimetindine maleate have not revealed findings which are of relevance to the recommended dosage and use of the product.
Relief of pruritus associated with dermatoses, urticaria, insect bites, sunburn, superficial burns.
Apply to the affected area 2-4 times a day.
Maximum duration of use: If no improvement is seen after 7 days of Fenistil gel use, the patient should consult the physician.
In case of very severe pruritus or extensive lesions, please consult a doctor or pharmacist about supplementing the local application of Fenistil with an oral anithistamine form.
Signs and symptoms: Accidental swallowing of a considerate amount of topical dimetindene maleate might induce some symptoms characteristic of overdosage with H1 antihistamines: CNS depression with drowsiness (mainly in adults), CNS stimulation and antimuscarinic effects (especially in children and elderly), including excitement, ataxia, hallucinations, tonic-clonic spasms, mydriasis, dry mouth, flushed face, urinary retention and fever. Hypotension may also occur.
Treatment: Further management should be as clinically indicated.
Contraindicated in patients with a prior hypersensitivity reaction to dimetindene maleate or any other ingredient of the preparation.
In case of very severe pruritus or extensive lesions, the local application of Fenistil should be supplemented by a systemic treatment with an oral anithistamine form. Prolonged exposure to the sun of extensively treated ares should be avoided. In infants and small children, avoid use on extensive areas of the skin, particularly if raw or inflamed.
Information on excipients: Fenistil gel contains: Propylene glycol which may cause mild, localized skin irritation.
Benzalkonium chloride which is irritant, and may cause skin reactions.
Effects on ability to drive and use machines: Fenistil gel has no influence on the ability to drive or use machines.
Pregnancy: For Fenistil, no clincal data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or the health of foetus/new-born child. Fenistil should not be used on extensive areas of the skin, especially if raw or inflamed.
Lactation: During lactation, Fenistil should not be used on extensive areas of the skin, especially if raw or inflamed. Moreover, the product should not be applied to the nipples during lactation.
Fertility: There are no adequate data from the use of Fenistil in women of childbearing potential. No effects on fertilty have been observed in animal studies. Caution should be exercised when prescribing to women of childbearing potential.
Adverse reaction are listed below by system organ class (SOC) and frequency.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/10,000); rare (≥1/10,000 to <1/1,000; very rare (<1/10,000), or not known (cannot be estimated from available data). (See table.)
Click on icon to see table/diagram/image
No interaction studies have been performed; however since the systemic absorption of dimetindine maleate from topical application is very low, such interactions are very unlikely.
Incompatibilities: Not applicable.
D04AA13 - dimetindene ; Belongs to the class of topical antihistamines used in the treatment of pruritus.
Gel 0.1% (cooling, colorless, odorless, non-greasy) x 20 g.