Penciclovir-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PENCICLOVIR-ZDOROVYE (PENCICLOVIR-ZDOROVYE)

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 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 inhibiting viral replication, penciclovir substantially shortens the healing time, even after the development of papules and vesicles, reduces pain sensations, and shortens the duration of crust desquamation resulting from 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 viruses, respectively. In uninfected cells treated with penciclovir, the concentration of penciclovir triphosphate is practically undetectable. Thus, penciclovir does not affect uninfected cells.

Pharmacokinetics.

After topical application of 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 of the excipients (e.g., propylene glycol).

Interaction with other medicinal products and other forms of interaction.

No interactions have been observed during clinical studies with concomitant administration of other medicinal products (local or systemic).

Special precautions for use

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, medical advice should be sought.

To prevent the spread of the virus to other parts of the body and transmission to other people, 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 the 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, cutlery, cigarettes.

The cream contains cetearyl 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 to determine whether systemic (oral) antiviral therapy is required.

Use during pregnancy or breastfeeding

Due to minimal systemic absorption of penciclovir following topical application observed in clinical studies, there are no major concerns regarding the use of the cream during pregnancy or breastfeeding. However, since the safety of penciclovir during pregnancy or breastfeeding has not been established, the product should only be used during these periods after consultation with a physician, 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 in 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 medicinal product has no influence 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 upon the first signs of infection. Hands should be washed before application.

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

Children.

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

Overdose.

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

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 the available data).

The cream was well tolerated in clinical trials. The most common adverse reactions were 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, paresthesia, 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 calculate; therefore, the frequency of such reactions is considered as not known.

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

Skin and subcutaneous tissue disorders: frequency not known: allergic dermatitis (including rash, pruritus, vesicles, and swelling).

In addition, cases of contact dermatitis (as a reaction to cetearyl alcohol) and irritation at the application site (as a reaction to propylene glycol) are possible. During clinical trials of the drug, no cases of increased photosensitivity (pigmentation due to exposure of treated skin areas to ultraviolet radiation) were observed.

Reporting of suspected adverse reactions

Reporting of adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or 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 in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

5 g in a tube, 1 tube in a cardboard box.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

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