HERPEMIL DUO

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GHERPEMIL DUO (HERPEMILDUO)

Composition:

Active substances: acyclovir, hydrocortisone;

1 g of cream contains acyclovir 50 mg, hydrocortisone 10 mg;

Excipients: propylene glycol, cetostearyl alcohol, macrogol cetostearyl ether, light mineral oil, citric acid anhydrous, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white, smooth, soft, homogeneous cream, free from lumps.

Pharmacotherapeutic group. Drugs for treatment of skin disorders. Antibiotics and chemotherapeutic agents for treatment of skin diseases. Chemotherapeutic agents for topical treatment. Antiviral agents. Acyclovir in combination with other drugs. ATC code D06B B53.

Pharmacological properties.

Pharmacodynamics. Acyclovir is an antiviral agent with high in vitro activity against herpes simplex virus types I and II. Its toxic effect on host cells is minimal. After entering cells infected with the herpes virus, acyclovir is phosphorylated to form the active compound acyclovir triphosphate. The first step of this process depends on the presence of virally encoded thymidine kinase. Acyclovir triphosphate acts as both an inhibitor and a substrate for viral DNA polymerase, thereby inhibiting further viral DNA synthesis without affecting normal cellular processes.

Hydrocortisone is a weak corticosteroid that exhibits several immunomodulatory effects. When applied topically, its primary role is to control various inflammatory skin conditions.

The cream containing acyclovir and hydrocortisone combines the antiviral action of acyclovir with the anti-inflammatory action of hydrocortisone, reducing the progression of herpes labialis episodes to the stage of ulcerative lesions.

The exact mechanism is not fully understood, but it is believed to be mediated by viral clearance and reduction of the local inflammatory response on the lips, thus contributing to a decrease in the signs and symptoms of recurrent herpes.

Pharmacokinetics. No clinical pharmacokinetic studies have been conducted with the acyclovir and hydrocortisone cream.

Clinical characteristics.

Indications. For the treatment of early signs and symptoms of recurrent herpes labialis (cold sores) to reduce the progression of herpes blister episodes to the stage of ulceration in immunocompetent adults and children aged 12 years and older.

Contraindications. Hypersensitivity to acyclovir, valacyclovir, propylene glycol, or to any other components of the cream.

Do not use for the treatment of skin lesions caused by any virus other than herpes simplex, or for the treatment of fungal, bacterial, or parasitic skin infections.

Interaction with other medicinal products and other forms of interaction. No interactions have been identified.

Special precautions for use

The cream should be used for topical application only. It is not recommended to apply the cream to mucous membranes of the mouth, eyes, or for the treatment of genital herpes. Accidental contact of the cream with the eyes should be avoided.

Patients with particularly severe or recurrent episodes of Herpes labialis should consult a physician. Patients with herpes should be advised to avoid transmitting the virus to others, especially when open lesions are present (in particular, hands should be washed before and after applying the cream). Use in immunocompromised individuals is not recommended due to the potential risk of opportunistic infections or resistant strains, which may require systemic antiviral therapy. Such patients should consult a physician regarding treatment of any infection.

The cream should not be used with occlusive dressings such as adhesive bandages or special films/patches.

Prolonged continuous use should be avoided. Treatment should not exceed 5 days. Use in patients with concomitant dermatitis of other etiology has not been studied.

The medicinal product contains cetyl stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis), and propylene glycol, which may cause skin irritation.

Use of systemic and topical corticosteroids may lead to visual disturbances. If a patient develops symptoms such as blurred vision or other ocular abnormalities, they should be referred to an ophthalmologist to evaluate possible causes. These may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been observed following the use of systemic and topical corticosteroids.

Use during pregnancy or breastfeeding. This medicinal product is recommended for use in pregnant and breastfeeding women only if, in the opinion of the physician, the benefit outweighs the risk. Systemic exposure to acyclovir and hydrocortisone following topical application of the cream is very low.

During use in pregnant women, no increased incidence of fetal malformations has been observed. Clinical data on hydrocortisone do not indicate an increased risk of teratogenicity. In animal studies, embryofetal toxicity was observed at low doses. Acyclovir and hydrocortisone are excreted into breast milk following systemic administration; however, the amount transferred into breast milk is not clinically significant. Nevertheless, the product should not be used during breastfeeding unless absolutely necessary.

Ability to affect reaction speed when driving or operating machinery. HERPEMIL DUO has no or negligible effect on the ability to drive or operate machinery.

Dosage and Administration.

The medicinal product is intended for external use only.

For adults and children aged 12 years and older: apply the cream 5 times daily at approximately 4-hour intervals, excluding nighttime. Treatment should be started as early as possible, preferably immediately after the first signs or symptoms appear.

Each time, apply a sufficient amount of cream to cover the affected area, including the outer edge of the lesion.

Treatment duration is 5 days. Do not use the medicinal product for more than 5 days.

Hands should be washed before and after applying the cream. Avoid excessive rubbing or touching the affected areas with a towel to prevent aggravation or transmission of infection.

Children. There is insufficient data on the safety of using the medicinal product in children under 12 years of age; therefore, its use is recommended only for children aged 12 years and older.

Overdose. No adverse effects have been observed following oral or topical application of an entire tube of cream due to minimal systemic exposure. In case of suspected overdose, seek medical help.

Adverse Reactions

Skin and subcutaneous tissue disorders:

Common (≥ 1/100, < 1/10): skin dryness and desquamation.

Uncommon (≥ 1/1000, < 1/100): transient burning or stinging pain, pruritus (after application of the product), tingling sensation (immediately after application).

Rare (≥ 1/10000, < 1/1000): erythema, pigmentary changes. In skin safety studies, contact dermatitis was observed after application of the cream under occlusion. In sensitivity testing, the reaction was attributed to hydrocortisone or to a component of the cream base. Local site reactions were observed, including signs and symptoms of inflammation.

Immune system disorders:

Rare (< 1/1000): immediate hypersensitivity reactions, including angioneurotic edema.

Eye disorders:

Frequency unknown: blurred vision.

In sensitivity testing, these cases were more frequently associated with components of the cream base rather than with acyclovir. There have been rare reports of immediate hypersensitivity reactions, including angioneurotic edema, following topical application of acyclovir.

Reporting of adverse reactions following marketing authorization is of great importance. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children. Do not refrigerate or freeze.

Packaging. 2 g of cream in a tube. 1 tube per cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer. Mepro Pharmaceuticals Private Limited /
Mepro Pharmaceuticals Private Limited

Manufacturer's address and location of operations. Unit II, Q-Road, Phase IV, GIDC, Wadhwan, Surendranagar, Gujarat, 363 035, India /
Unit II, Q-Road, Phase IV, GIDC, Wadhwan, Surendranagar, Gujarat, 363 035, India.

Marketing Authorization Holder.
Mili Healthcare Limited / Mili Healthcare Limited.

Address of the Marketing Authorization Holder. Second Floor Office Suite, 4 Chartfield House, Castle Street, Taunton, Somerset, England, TA1 4AS, Great Britain /
Second Floor Office Suite, 4 Chartfield House, Castle Street, Taunton, Somerset, England, TA1 4AS, Great Britain.