Herpestil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HERPESTIL

Composition:

Active substance: penciclovir;

1 g of the preparation contains 10 mg of penciclovir;

Excipients: cetostearyl polyethylene glycol ether, cetostearyl alcohol, white soft paraffin, mineral oil, propylene glycol, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream.

Pharmacotherapeutic group. Chemotherapeutic agents for topical use. Antiviral agents. ATC code D06B B06.

Pharmacological Properties.

Pharmacodynamics. Penciclovir demonstrates high selectivity in vivo and in vitro against human herpes viruses, including Herpes simplex (types 1 and 2), including acyclovir-resistant strains with altered DNA polymerase, Varicella zoster virus, as well as Epstein-Barr virus and cytomegalovirus. In virus-infected cells, penciclovir is rapidly converted into its triphosphate form (by viral-induced thymidine kinase). Penciclovir triphosphate is retained in virus-infected cells for over 12 hours, where it inhibits viral DNA replication—significantly longer than acyclovir. By inhibiting viral replication, penciclovir considerably shortens the healing time, even after the development of papules and vesicles, reduces pain, and shortens the duration of crust desquamation resulting from viral activity.

Pharmacokinetics. The elimination half-life is 9, 10, and 20 hours in cells infected with Varicella zoster, Herpes simplex type 1, and Herpes simplex type 2 viruses, respectively. In uninfected cells treated with penciclovir, the concentration of penciclovir triphosphate is practically undetectable. Thus, penciclovir does not affect uninfected cells.

When applied topically as a 1% cream, the concentration of penciclovir in blood plasma and urine is not quantitatively detectable.

Clinical characteristics.

Indications. Cold sores (Herpes labialis).

Contraindications. Hypersensitivity to penciclovir, famciclovir, or to any other component of the medicinal product (e.g. propylene glycol).

Special precautions.

The cream should be applied only to herpes-affected areas on the lips or skin around the mouth. The cream should not be applied to mucous membranes (e.g. eyes, mouth, nose, or genital organs). Particular care should be taken to avoid contact of the cream with the eyes or surrounding areas.

If symptoms have not resolved after 4 days of treatment with the cream, consult a physician.

To prevent the spread of the virus to other parts of the body and transmission to others, the following precautions should be observed:

• always wash hands before and after applying the cream to the affected area;
• keep the tube of cream in its original packaging and do not allow others to use it;
• avoid rupturing the blisters formed due to prolonged viral activity;
• avoid touching the eyes (the virus may infect the cornea);
• avoid kissing, especially children;
• avoid sharing items through which the virus may spread: towels, cups, cutlery, cigarettes, etc.

Interaction with other medicinal products and other forms of interaction.

No interactions were observed during clinical studies when other medicinal products (topical or systemic) were used concomitantly with Herpestil.

Special precautions for use.

Use during pregnancy or breastfeeding.

Since systemic absorption of penciclovir is minimal, there are no concerns regarding the use of the cream during pregnancy or breastfeeding. However, as the safety of penciclovir use during these periods has not been established, the product should be used only after consulting a physician, when the expected benefit to the woman outweighs the potential risk to the fetus/child.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product has no effect on the ability to drive or operate machinery.

Method of Administration and Dosage.

For adults (including elderly patients) and children aged 12 years and older.

The cream should be applied every 2 hours (except during sleep). The treatment course lasts 4 days. Treatment should begin as early as possible, at the first signs of infection development. Hands should be washed before applying the cream.

Children.

The effect of the drug has not been studied in children under 12 years of age.

Overdose.

Overdose is unlikely with topical application. Even in case of accidental oral ingestion of the entire package contents, adverse effects are not expected due to the low oral absorption of penciclovir. However, some irritation of the oral mucosa may occur. No specific therapeutic measures are required in case of accidental oral ingestion of the entire package contents.

Side effects.

General disorders and application site reactions: common (>1/100, <1/10): pain at the application site, hypoesthesia, hypersensitivity reactions including urticaria, skin rash, pruritus, blisters, swelling, including of the face, lips, allergic dermatitis.

In isolated cases (less than 3%): burning sensation, tingling, numbness in the area of cream application. In addition, cases of contact dermatitis (as a reaction to cetyl stearyl alcohol) and irritation at the application site (as a reaction to propylene glycol) are possible. Cases of increased photosensitivity (pigmentation following exposure of cream-treated skin areas to light) have not been observed.

Shelf life. 2 years.

Storage conditions.

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

Keep out of the reach of children.

Packaging.

5 g of the drug in a tube in a box.

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

Manufacturer. Limited Liability Company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.