Afлubin® penciclovir tonuing

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AFLUBIN® PENCICLOVIR CREAM

Composition:

Active substance: penciclovir;

1 g of cream contains penciclovir 10 mg;

Excipients: propylene glycol, white soft paraffin, cetostearyl alcohol, mineral oil, cetostearyl polyethylene glycol ether, iron oxide red (E 172), iron oxide yellow (E 172), purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: soft, homogeneous cream ranging in color from beige to brown.

Pharmacotherapeutic group. Chemotherapeutic agents for topical use. Antiviral agents. Penciclovir. 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 and cytomegalovirus. In virus-infected cells, penciclovir is rapidly converted into penciclovir triphosphate (by viral-induced thymidine kinase). Penciclovir triphosphate is retained in virus-infected cells for over 12 hours, where it inhibits viral DNA replication—longer than acyclovir. By inhibiting viral replication, penciclovir shortens the healing time, even after the development of papules and vesicles, reduces pain, and shortens the duration of crusting 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 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 acyclovir, penciclovir, famciclovir, or to any of the excipients 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 other medicinal products (local or systemic) when using this medicinal product.

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 body areas and transmission to other people, the following precautions should be observed:

• always wash hands before and after contact with the affected area;
• store the tube of cream in its original packaging and do not allow other people to use it;
• avoid puncturing blisters formed as a result of prolonged viral activity;
• avoid rubbing 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.

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

Due to its color, the cream helps to make herpes symptoms less visible.

Patients with immunodeficiency (e.g., those with AIDS or bone marrow transplant recipients) should consult their physician to determine the need for treatment with orally administered antiviral agents.

Use during pregnancy or breastfeeding

Clinical studies have shown minimal systemic absorption of penciclovir; therefore, there are no major concerns regarding the use of the cream during pregnancy or breastfeeding. However, as the safety of penciclovir during these periods has not been fully established, the product should be used only after consulting 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. Animal studies have not revealed any effect on fertility following topical application of penciclovir.

Ability to affect reaction speed when driving or operating machinery

The product has no known 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 applying the cream.

The cream should be applied with a clean finger, cotton swab, or single-use applicator (for packages containing applicators) in an amount sufficient to cover the affected skin area.

Children.

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

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 mucosa 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 usually classified as follows:

very common (≥ 1/10);

common (from ≥ 1/100 to < 1/10);

uncommon (from ≥ 1/1,000 to < 1/100);

rare (from ≥ 1/10,000 to < 1/1,000);

very rare (< 1/10,000);

frequency not known (cannot be estimated from the available data).

General disorders and application site reactions: common (from ≥ 1/100 to < 1/10): reactions at treated skin areas (including transient burning, skin pain, numbness).

Immune system disorders: frequency not known: hypersensitivity reactions, which may occur both at the application site and beyond.

Skin and subcutaneous tissue disorders: frequency not known: contact dermatitis, rash, urticaria, pruritus, vesicles and swelling, which may occur both at the application site and beyond.

No cases of increased photosensitivity (pigmentation due to exposure of cream-treated skin areas to ultraviolet radiation) were observed during clinical trials of Afлubin® Penciclovir Sunscreen Cream.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, patients, or their legal representatives should report all suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store out of reach of children at a temperature not exceeding 25 °C. Do not freeze.

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

Supply category. Over-the-counter

Manufacturer.

Medgenix Benelux NV / Medgenix Benelux NV.

Manufacturer's address and place of business.

Vliegveld 21, Wevelgem, 8560, Belgium / Vliegveld 21, Wevelgem, 8560, Belgium.