Penciclovir-fitofarm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PENCYCLOVIR-FITOPHARM

Composition:

Active substance: penciclovir;

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

Excipients: white soft paraffin, mineral oil, dimethicone, propylene glycol, polyethylene glycol (macrogol) cetylstearyl ether, cetylstearyl alcohol, titanium dioxide (E 171), acrylamide/sodium acryloyldimethyltaurate copolymer/isohexadecane/polysorbate 80, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white or almost white cream.

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 strains resistant to acyclovir 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 (with the participation of virus-induced thymidine kinase). Penciclovir triphosphate is retained within virus-infected cells, where it inhibits viral DNA replication for over 12 hours—significantly longer than acyclovir. By blocking viral replication, penciclovir substantially shortens healing time even after the development of papules and vesicles, reduces pain sensations, and shortens the duration of crust desquamation caused by 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, respectively. In non-infected 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.

Herpes labialis (Herpes labialis).

Contraindications. Hypersensitivity to penciclovir, famciclovir, or to any other components of the medicinal product (e.g. propylene glycol). Should not be used in patients with immunodeficiency.

Interaction with other medicinal products and other types of interactions. No interactions have been observed in clinical studies with concomitant use of other medicinal products (local or systemic action).

Special precautions for use.

The cream should be applied only to the affected herpes 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 the 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 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 other people 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, such as towels, cups, cutlery, cigarettes, etc.

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.

Use during pregnancy or breastfeeding.

Clinical studies have shown minimal systemic absorption of penciclovir. However, since the safety of penciclovir during pregnancy or breastfeeding has not been 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 regarding the passage of penciclovir into breast milk.

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), taking care to apply it only to the herpes-affected areas of skin.

The treatment course lasts 4 days. Treatment should be started as early as possible, at the first signs of infection. Hands should be washed before applying the cream.

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 cavity may occur. There is no need for specific therapeutic measures in case of accidental oral ingestion of the entire package content.

Adverse reactions.

General disorders and application site reactions: pain at the application site, hypoesthesia, hypersensitivity reactions including urticaria, skin rashes, pruritus, blisters, swelling, including of the face and lips, allergic dermatitis.

In isolated cases: burning sensation, tingling, numbness in the area where the cream was applied. 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 cream, no cases of increased photosensitivity (pigmentation due to exposure of cream-treated skin areas to ultraviolet radiation) were observed.

If any adverse effects occur, including those not listed in this instruction, a physician should be informed.

Shelf life.

3 years.

Do not use after the expiry date stated on the packaging.

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 tubes; 1 tube per carton.

Availability classification.

Over-the-counter (without prescription).

Manufacturer.

PJSC "PHYTOPHARM".

Manufacturer's address and location of its business activities.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing authorization holder.

PJSC "PHYTOPHARM".

Address of the marketing authorization holder.

7 Verkhovnoyi Rady Boulevard, Kyiv, 02100, Ukraine, floor 3, room 18.