Phenistil gel

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FENISTIL Gel (Fenistil Gel)

Composition:

Active substance: dimetindene maleate;

1 g of gel contains 1 mg of dimetindene maleate;

Excipients: benzalkonium chloride 50% solution, disodium edetate, carbomer, sodium hydroxide 30% solution, propylene glycol, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: Homogeneous gel, colorless to slightly yellowish, transparent or slightly opalescent.

Pharmacotherapeutic group. Topical antihistamines.

ATC code D04AA13.

Pharmacological properties.

Pharmacodynamics.

Dimetindene maleate is a phenindane derivative and an antagonist of histamine at H1-receptors. It exerts antiallergic and antipruritic effects. Due to the active ingredient dimetindene maleate contained in the medicinal product Fenistil gel, application of the preparation to the skin reduces itching and irritation associated with allergic skin reactions. The preparation also has local anesthetic properties and produces a cooling effect on the skin upon application.

When the gel is applied topically, its specially designed base enables the active ingredient to rapidly penetrate the skin and begin acting within a few minutes. Maximum effect is achieved within 1–4 hours.

Pharmacokinetics.

Systemic bioavailability of the active ingredient is 10%.

Clinical characteristics.

Indications.

Skin itching, for example due to insect bites, limited sunburn erythema, uncomplicated minor skin burns, and allergic irritations of small skin areas.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

Studies on drug interactions have not been conducted; however, since systemic absorption of dimethindene maleate when using this medicinal product is extremely low, interaction with other medicinal products is unlikely.

Special precautions for use.

The medicinal product contains benzalkonium chloride and propylene glycol, which may cause skin irritation.

The product must not be used in cases of known allergy to insect bites. In such cases, systemic-acting products should be used.

Avoid using the medicinal product Fenistil gel on large areas of skin, especially in children or adolescents.

During treatment with the product, prolonged exposure of affected skin areas to sunlight should be avoided.

In cases of very severe itching or extensive skin involvement, in addition to topical application of the product, oral dosage forms of the drug (Fenistil, oral drops) should also be used.

Use during pregnancy or breastfeeding.

There are no clinical data on the use of the product in pregnant women. Studies in animals have shown no harmful effects (either direct or indirect) on the course of pregnancy, fetal development, or subsequent offspring development. However, during pregnancy, Fenistil gel should not be used except when the benefit of use outweighs the potential risk to the fetus. In such cases, the product may be used only under medical supervision.

It is not recommended to apply Fenistil gel to large areas of skin, especially damaged or inflamed skin. This also applies to breastfeeding women. In addition, breastfeeding women should not apply the gel to the nipples of the breasts.

Ability to influence reaction rate while driving vehicles or operating machinery.

Dimetindene maleate, when applied topically, does not affect the reaction rate while driving vehicles or operating machinery.

Method of Administration and Dosage

The medication should be used in children under 2 years of age only as prescribed by a physician. It is not recommended to apply the medication to large areas of skin in infants and young children, especially if the skin is damaged or inflamed.

For adults and children aged 2 years and older, apply the gel to affected skin areas 2–4 times daily. If the condition does not improve after 7 days of treatment, consult a physician.

In cases of severe itching or extensive skin lesions, in addition to topical application, oral formulations of the medication (Phenistil, oral drops) should also be used.

Children.

The medication should be used in children under 2 years of age only as prescribed by a physician. It is not recommended to apply the medication to large areas of skin in infants and young children, especially if the skin is damaged or inflamed.

Overdose.

There have been no reports of overdose with this medication to date.

In case of accidental ingestion of a large amount of Phenistil gel, seek immediate medical attention.

Some symptoms typical of overdose with systemic H1-antihistamines may occur: central nervous system depression, accompanied by drowsiness (mainly in adults), central nervous system stimulation and antimuscarinic effects (particularly in children and elderly patients), including excitation, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, facial hyperemia, urinary retention, fever, and possible arterial hypotension.

In case of overdose, appropriate measures should be taken as recommended by a medical facility, depending on the symptoms that occur.

Side effects.

The most common side effects are mild and transient skin reactions at the application site. The product contains benzalkonium chloride and propylene glycol, which may cause skin irritation.

Possible side effects

Skin and subcutaneous tissue disorders:

Frequency unknown (cannot be estimated from available data): dry skin, skin burning sensation, allergic reactions including skin rash, itching and swelling, allergic dermatitis, urticaria*.

*Data obtained from post-marketing surveillance.

Shelf life. 2 years.

Storage conditions.

Store in a dry place at a temperature below 25 °C. Keep out of reach of children.

Packaging. 30 g in tubes.

Availability. Over-the-counter.

Manufacturer.

Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

Manufacturer's address and place of business.

Route De L’etraz 2, Nyon, 1260, Switzerland / Route De L’etraz 2, Nyon, 1260, Switzerland.