Pen-herpivir®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PENCICLOVIR® (PEN-HERPEVIR)

Composition:

Active substance: penciclovir;

1 g of cream contains penciclovir equivalent to 100 % substance – 10 mg;

Excipients: macrogol cetylstearyl ether, cetylstearyl alcohol, purified water, propylene glycol, soft white paraffin, mineral oil.

Pharmaceutical form. Cream.

Main physicochemical properties: white or almost 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 herpesviruses 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 penciclovir triphosphate (with the participation of virus-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 suppressing viral replication, penciclovir substantially shortens healing time, even after the development of papules and vesicles, reduces pain, and shortens the duration of crust desquamation caused by viral activity. The half-life is 9, 10, and 20 hours in cells infected with Varicella zoster, Herpes simplex type 1, and Herpes simplex type 2, respectively. In uninfected cells treated with penciclovir, the concentration of penciclovir triphosphate is practically undetectable. Thus, penciclovir does not affect uninfected cells.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Herpes labialis (Herpes labialis).

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

No interactions have been observed with concomitant administration of PENC-GERPEVIR**®** with other medicinal products (local or systemic action).

Usage Instructions

The cream should only be applied to herpes-affected areas on the lips or skin around the mouth. Application of the cream to mucous membranes (e.g., eyes, mouth, nose, or genital organs) is not recommended. 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 to avoid infecting others, the following precautions should be observed:

• Always wash hands before and after touching the affected area;
• Store the tube of cream in its original packaging and do not allow others to use it;
• Avoid rupturing blisters that form as a result of 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, tableware, cigarettes.

The cream contains cetylstearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis). The cream also contains propylene glycol, which may cause skin irritation.

Patients with immunodeficiency (e.g., AIDS patients or bone marrow transplant recipients) should consult their physician, who will determine whether systemic (oral) antiviral therapy is required.

Use during pregnancy or breastfeeding

Since clinical studies have shown minimal systemic absorption of penciclovir following topical application, there are no major concerns regarding the use of the cream during pregnancy or breastfeeding. However, because the safety of penciclovir use during pregnancy or breastfeeding has not been established, the product should only be used during these periods after consultation with a physician, and only when the expected benefit to the mother outweighs the potential risk to the fetus/infant.

There is no information available on the excretion of penciclovir into human breast milk.

Fertility

There are no data on the effect of penciclovir on human fertility. Studies in animals have not shown any effect on fertility following topical application of penciclovir.

Ability to affect reaction speed when driving or operating machinery

The product has no reported 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 be started as early as possible, at the first signs of infection development. Hands should be washed before application.

The cream should be applied with a clean finger in an amount sufficient to cover the affected area of skin.

Children.

The safety and efficacy of the drug in children under 12 years of age have not been established.

Overdose.

With topical application, overdose is unlikely. Even in case of accidental oral ingestion of the entire contents of the package, adverse effects are not expected due to the low oral absorption of penciclovir. However, irritation of the oral cavity is possible. No specific therapeutic measures are required in case of accidental oral ingestion of the entire contents of the package.

Adverse Reactions

The frequency of adverse reactions is classified as follows:

very common (≥ 1/10);
common (from ≥ 1/100 to < 1/10);
uncommon (from ≥ 1/1000 to < 1/100);
rare (from ≥ 1/10000 to < 1/1000);
very rare (< 1/10000);
frequency not known (cannot be estimated from available data).

The cream was well tolerated in clinical trials. The most commonly reported adverse reactions were local reactions at the application site.

General disorders and administration site conditions:
common (≥ 1/100, < 1/10): application site reactions (including pain at application site, hypoesthesia, burning sensation, tingling, numbness).

During post-marketing surveillance, the following adverse reactions have been identified (all reactions were local or generalized). The frequency of adverse reactions based on post-marketing data is difficult to estimate; therefore, the frequency of these reactions is considered not known.

Immune system disorders:
frequency not known: hypersensitivity reactions, including urticaria.

Skin and subcutaneous tissue disorders:
frequency not known: allergic dermatitis (including rash, pruritus, blisters, swelling, including of the face and lips).

Additionally, 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. During clinical trials of PENCICLOVIR CREAM**®**, no cases of increased photosensitivity (pigmentation due to exposure of cream-treated skin areas to ultraviolet radiation) were observed.

Reporting of suspected adverse reactions

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

Shelf life. 3 years.

Storage conditions.
Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of reach and sight of children.

Packaging. 2 g in a tube. 1 tube per carton.

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

Manufacturer/Marketing Authorization Holder. JSC "Kyivmedpreparat".

Address of manufacturer and location of its business activities / Address of the marketing authorization holder and/or its representative.
139 Saksaganskogo Street, Kyiv, 01032, Ukraine.