Phazex®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FAZEX® (FAZEX®)

Composition:

Active substance: dimetindene maleate;

1 g of gel contains dimetindene maleate 1 mg;

Excipients: carbomer 974P, disodium edetate, benzalkonium chloride 50% solution, propylene glycol, sodium hydroxide pellets, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: homogeneous gel, colorless to slightly yellowish, transparent or slightly opalescent.

Pharmacotherapeutic group. Topical antihistamines.

ATC code D04AA13.

Pharmacological properties.

Pharmacodynamics.

Dimetindene maleate, a derivative of phenindene, is a histamine antagonist at the H1-receptor level. It exerts antiallergic and antipruritic effects. Due to the active ingredient – dimetindene maleate – contained in the medicinal product Phazek®, application of the product to the skin reduces itching and irritation associated with allergic skin reactions. The product also has local anesthetic properties and cools the skin.

Pharmacokinetics.

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. Systemic bioavailability of the active ingredient is less than 10% of the applied dose.

Clinical characteristics.

Indications.

Skin itching, for example from 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 interaction.

Studies on drug interactions have not been conducted. Since systemic absorption of dimetindene maleate after topical application of the gel is extremely low, interaction with other medicinal products is unlikely.

Concomitant use with other topical medicinal products is not recommended.

Special precautions for use.

The medicinal product Phazex® must not be used in cases of known allergy to insect bites. In such cases, systemic-acting agents should be used. Application of the gel should be avoided on large areas of skin, especially in children or adolescents. During treatment with this product, prolonged exposure of affected skin areas to sunlight should be avoided.

Excipients.

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

Use during pregnancy or breastfeeding.

There are no clinical data on the use of the product in pregnant women. Animal studies with dimetindene maleate gel did not reveal any harmful effects (either direct or indirect) on the course of pregnancy, fetal development, or subsequent offspring development.

However, use of Phazex® gel during pregnancy is not recommended except when the benefit of treatment outweighs the potential risk to the fetus. In such cases, the product may be used only under a physician's supervision.

Application of Phazex® gel on large skin areas, particularly on damaged or inflamed skin, is not recommended. The same applies to women who are breastfeeding. In addition, breastfeeding women should not apply the gel to the nipples.

Ability to affect reaction speed while driving or operating machinery.

Dimetindene maleate, when applied topically, has no effect or only a negligible effect on reaction speed while driving or operating machinery.

Method of Administration and Dosage.

Method of administration.

Phazex® gel is intended for topical application on intact skin (without damage to its integrity). Apply a small amount of the gel to the affected skin area and gently rub in. The treated area should not be covered with an occlusive dressing (a dressing that does not allow air passage). The drug should not be applied to large skin areas.

If there is no improvement after 7 days of treatment, consult a physician. In cases of severe itching or extensive skin lesions, in addition to local treatment, systemic therapy with oral antihistamines should be administered after consultation with a physician.

Dosage.

Adults and children aged 2 years and older.

Apply the gel 2–4 times daily.

Children under 2 years of age.

The drug may be used only under medical supervision.

Children.

Phazex® gel may be used in children under 2 years of age only under medical supervision. The drug should not be administered to premature infants during the first 4 weeks of life. The gel should not be applied to large skin areas, particularly damaged or inflamed skin, in infants and young children (see section "Special precautions for use").

Overdose.

There have been no reports of overdose with Phazex® gel to date.

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

Some symptoms typical of overdose with systemic H1-antihistamines may occur: central nervous system depression, manifested 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 flushing, urinary retention, fever, and possible arterial hypotension.

In case of overdose, measures recommended by a healthcare facility according to the symptoms presented should be implemented.

Side effects.

The most common side effects are mild and transient reactions at the site of gel application. Since the medicinal product contains benzalkonium chloride and propylene glycol, skin irritation symptoms may occur.

Skin and subcutaneous tissue disorders.

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

*Data obtained from post-marketing surveillance.

Reporting of suspected side effects.

Reporting suspected side effects after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

After first opening of the tube, the product should not be stored for more than 60 days.

Packaging.

30 g in an aluminum tube. One tube in a cardboard box with an instruction leaflet for medical use.

Prescription status.

Over-the-counter.

Manufacturer.

Kusum Healthcare Pvt Ltd / Kusum Healthcare Pvt Ltd.

Manufacturer's address and site of operations.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India / SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.