Phenistil emulsion

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FENISTIL EMULSION (FENISTIL EMULSION)

Composition:

Active substance: dimethindene maleate;

1 g of the preparation contains 1 mg of dimethindene maleate;

Excipients: benzalkonium chloride, benzyl alcohol, butylhydroxytoluene (E 321), disodium edetate, coco-caprylocaprate, mineral oil, polyethylene glycol cetylstearyl ether, carbomer, sodium hydroxide 30% solution, propylene glycol, purified water.

Pharmaceutical form. Topical emulsion.

Main physicochemical characteristics: homogeneous viscous emulsion.

Pharmacotherapeutic group. Dermatologicals. Topical antihistamines. Dimethindene.

ATC code D04A A13.

Pharmacological properties.

Pharmacodynamics.

Dimephenhydramine maleate is a histamine antagonist at the H1-receptor level. It has high affinity for H1-receptors and reduces capillary permeability associated with hypersensitivity reactions. The drug also possesses local anesthetic properties.

Phenistil Emulsion is effective against itching of various origins, providing rapid relief from itching and other allergic skin irritations. The base of the preparation is an emulsion exerting a cooling, soothing, softening, and moisturizing effect.

Pharmacokinetics.

Phenistil Emulsion rapidly penetrates the skin; the antihistaminic effect begins within a few minutes. After topical application, systemic absorption of dimephenhydramine maleate in healthy individuals is less than 10% of the applied dose.

Preclinical studies revealed no risk associated with the use of the drug at recommended doses. Dimephenhydramine maleate showed no mutagenic or clastogenic properties.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use

The product contains propylene glycol, which may cause local skin irritation. The product contains benzalkonium chloride, which has irritating properties and may cause skin reactions. The product contains butylated hydroxytoluene, which may cause local skin irritation (e.g. contact dermatitis), as well as eye and mucous membrane irritation.

The product should not be used in infants and young children on large areas of skin, especially on damaged or inflamed skin.

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, an oral form of Fenistil should be used after consultation with a physician.

Use during pregnancy or breastfeeding

There are no clinical data on the use of the product in pregnant women. Animal studies have shown that use of the product during pregnancy does not cause harmful effects (either direct or indirect) on the course of pregnancy, fetal development, or subsequent child development. However, Fenistil Emulsion is not recommended during pregnancy except when the benefit outweighs the potential risk to the fetus. In such cases, use of the product is possible only under medical supervision.

Application of Fenistil Emulsion on large skin areas, particularly on damaged or inflamed skin, is not recommended. This also applies to breastfeeding women. In addition, breastfeeding women should not apply the gel to the nipples.

Ability to influence reaction speed when driving vehicles or operating machinery

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

Dosage and Administration

Adults and children aged 2 years and older: apply the product to the skin from 2 to 4 times daily.

Children under 2 years of age: only as directed by a physician.

If the patient's condition does not improve after 7 days of using the product, medical advice should be sought.

In cases of severe itching or extensive skin involvement, in addition to topical application, an oral formulation of Fenistil should be used after consultation with a physician.

Children.

Fenistil should be used in children under 2 years of age only as directed by a physician. Large areas of skin, especially damaged or inflamed skin, should not be treated with the product in infants and young children.

Overdose.

In case of accidental ingestion of a large amount of Fenistil Emulsion, symptoms typical of overdose with H1-antihistamines may occur: central nervous system depression accompanied by drowsiness (mainly in adults), central nervous system stimulation and antimuscarinic effects (especially in children and elderly patients), including excitement, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, facial hyperemia, urinary retention, and fever. Arterial hypotension may also occur.

In case of overdose, measures recommended by a physician according to the symptoms presented should be taken.

Side effects.

Skin and connective tissue disorders

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

*Data obtained from post-marketing surveillance.

Shelf life. 3 years.

Storage conditions.

Store in a dry place out of reach of children, at a temperature below 30 °C.

Packaging. 8 ml in a bottle with a ball applicator. 1 bottle per cardboard box.

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.