Fenistil Pencivir, cream 1% 2g with toning effect (Novartis, GERMANY)

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

An antiviral drug, highly active against Herpes simplex , Epstein-Barr virus , Varicella zoster and cytomegalovirus . The mechanism of action of the drug is aimed at blocking the process of reproduction of the virus, which remains in the body of many people for a long time in an inactive form. Triggering factors for activating the reproduction of the virus are chronic fatigue syndrome, acute respiratory infections, and colds, which results in the appearance of fever in the form of blistering rashes localized on or around the lips. The use of the drug helps speed up recovery, reduce the severity of pain, and reduce the risk of infection transmission.

Pharmacokinetics

Since Fenistil Pencivir is used externally, systemic absorption is practically absent, and it is not possible to detect the drug in the blood or urine of patients. Penciclovir, after penetration into cells affected by the virus, is transformed into penciclovir triphosphate, which has pronounced pharmacological activity. In affected cells it persists for 12 hours.

Fenistil Pencivir, cream 1% 2g with toning effect (Novartis, GERMANY)

Compound.

Description of the dosage form.

Cream for external use:

homogeneous white cream.

Cream for external use (with tinting effect):

homogeneous cream from beige to brown.
Pharmachologic effect. Antiviral.

Pharmacodynamics.

Fenistil® Pencivir cream is intended for the treatment of herpes (colds) on the lips (Herpes labialis)

.

Penciclovir is an active component that is an antiviral agent against Herpes simplex

Types 1 and 2,
Varicella zoster
. The virus can remain in an inactive form in the body for an extended period of time. At the moment of activation (for example, due to fatigue, colds, flu), the virus begins to multiply, which leads to the development of a “fever” in the form of blistering rashes, especially often observed on the lips or areas around them.

Penciclovir blocks the virus and stops it from reproducing. The use of the drug leads to a faster recovery, a decrease in the intensity of pain, and the period of risk of transmitting a viral infection is reduced.

Pharmacokinetics.

When used externally, the drug is practically not subject to systemic absorption. Modern analytical methods fail to detect penciclovir in the blood or urine of healthy volunteers after using Fenistil® Pencivir cream in concentrations many times higher than therapeutic levels. Penetrating into cells affected by the virus, penciclovir quickly turns into penciclovir triphosphate, which has pharmacological activity and persists in the affected cells for 12 hours.

Indications.

Recurrent herpes simplex (Herpes labialis)

with localization on the lips.

Contraindications.

● hypersensitivity to penciclovir, famciclovir or any of the inactive ingredients included in the drug;

● children under 12 years of age.

Carefully:

pregnancy, breastfeeding period.

Use during pregnancy and breastfeeding.

Possibly as indicated by a doctor, when the expected benefit to the mother outweighs the possible risk to the fetus or child.

Side effects.

Burning, tingling or numbness at the site of application of the drug.

Interaction.

There are no known drug interactions with Fenistil® Pencivir cream.

Method of administration and dose.

Externally.

Cream for external use

. For adults and children over 12 years of age, squeeze a small amount of cream onto the tip of your finger and apply to the affected area every 2 hours (about 8 times a day). The cream can also be applied using a cotton swab or a disposable applicator (for packages containing applicators). The course of therapy is carried out for 4 days.

Cream for external use (with tinting effect)

. A cream with a tinting effect has camouflaging properties, covering areas affected by herpes on the lips and skin around the mouth.

Overdose.

No cases of drug overdose have been reported.

Special instructions.

It is necessary to wash your hands thoroughly before and after applying the cream. Treatment should begin as early as possible, when the first signs of infection appear. However, even with the development of herpes in the blistering stage, the use of Fenistil® Pencivir cream reduces the healing time (heals the affected areas, reduces pain and shortens the duration of peeling of the crust formed from viral exposure).

You should consult your doctor before using Fenistil® Pencivir cream if the patient has a weakened immune system or is not sure whether he or she is developing herpes.

The drug should be used only on areas affected by herpes on the lips and skin around the mouth. It is not recommended to apply the cream to the mucous membrane of the mouth, nose, or in the eye and genital area.

It is necessary to carry out the full course of therapy using Fenistil® Pencivir cream for 4 days in order to achieve the greatest effect from the therapy, even if signs of infection disappear after 1-2 days of treatment.

It is necessary to consult your doctor if your condition worsens or if there is no improvement after 4 days of therapy.

Impact on the ability to drive vehicles and operate machinery.

Does not affect.

Release form.

Cream for external use, 1%, cream for external use (with tinting effect) 1%.

2 or 5 g of the drug in an aluminum tube with a screw cap. The tube is placed in a cardboard box.

Cream for external use, 1% additional

2 or 5 g of the drug in an aluminum tube with a screw cap. The tube is placed in a plastic case with a mirror, two PE bags containing 10 disposable plastic applicators. The pencil case has a tamper evident label.

Manufacturer.

Novartis Pharma Products GmbH. Efflingerstrasse 44, D-79664 Wehr/Baden, Germany.

Marketing authorization holder: Novartis Consumer Health SA. Rue de Letraz, 1260 Nyon, Switzerland.

Consumer complaints should be directed to Novartis Consumer Health LLC

Legal address: 123317, Moscow, Presnenskaya embankment, 10.

Actual and postal address: 125315, Moscow, Leningradsky Prospekt, 72, bldg. 3.

Tel.; Fax.

e-mail

Conditions for dispensing from pharmacies.

Over the counter.

Fenistil Pencivir cream, instructions for use (Method and dosage)

Applied externally, a small volume of the drug is squeezed onto a cotton swab or fingertip and applied to the area of ​​skin or mucous membrane affected by herpes. The procedure is repeated after 2 hours up to 7-8 times a day for 4 days.

Treatment with Fenistil Pentsivir is recommended to begin at the first sign of infection. Instructions for use of Fenistil Pencivir indicate the need to comply with the duration of treatment with the drug, even in cases where the signs of the disease have disappeared after the first two days of treatment. Fenistil Pencivir cream should be applied exclusively to areas of the lips and skin around the mouth that are affected by herpes. The drug should not be applied to the mucous membranes of the nose, mouth, genitals and eyes.

Immunocompromised patients should consult a doctor. If there is no effect after 4 days of treatment or the condition worsens, consult a doctor.

Fenistil Pencivir

Release form, composition and packaging

Cream for external use 1% homogeneous, white.

1 g penciclovir 10 mg.

Excipients: cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, vaseline oil (liquid paraffin), propylene glycol, purified water.

Clinical and pharmacological group: Antiviral drug for external use.

pharmachologic effect

Antiviral drug for external use. Penciclovir is an antiviral drug, active against Herpes simplex viruses type 1 and 2, Varicella zoster virus. The virus can remain in an inactive form in the body for a long time. When activated (for example, due to fatigue, colds, flu), the virus begins to multiply, which leads to the development of fever in the form of blistering rashes, especially often observed on the lips or in the areas around them. Penciclovir blocks the virus and stops it from reproducing. The use of the drug leads to a faster recovery, a decrease in the intensity of pain, and the period of risk of transmitting a viral infection is reduced.

Pharmacokinetics

When used externally, the drug is practically not subject to systemic absorption. Modern analytical methods fail to detect penciclovir in the blood or urine of healthy volunteers after using Fenistil cream

Pentsivir in doses many times higher than therapeutic doses.

Penetrating into cells affected by the virus, penciclovir quickly turns into penciclovir triphosphate, which has pharmacological activity and persists in the affected cells for 12 hours.

Indications

• recurrent herpes simplex localized on the lips (herpes labialis).

Dosage regimen

The drug is used externally. Treatment should begin as early as possible, when the first signs of infection appear. However, even with the development of herpes in the blistering stage, the use of Fenistil Pencivir cream reduces the healing time (heals the affected areas, reduces pain and shortens the duration of the peeling of the crust formed from viral exposure).

Adults and children aged 12 years and older: a small amount of cream is squeezed onto the fingertip and applied to the affected area every 2 hours. The course of therapy is carried out for 4 days.

Side effect

Local reactions: burning, tingling or numbness may occur immediately after applying the drug.

Contraindications

• children under 12 years of age;
• hypersensitivity to penciclovir, famciclovir or other components of the drug.

Pregnancy and lactation

Use during pregnancy is possible according to strict indications in cases where the expected benefit to the mother outweighs the possible risk to the fetus.

If necessary, use during breastfeeding requires consultation with a doctor.

special instructions

In patients with weakened immune systems or if the manifestations of the disease are uncertain, the doctor decides the need to use the drug individually.

It is necessary to wash your hands thoroughly before and after applying the cream.

The drug should be used only on areas affected by herpes on the lips and on the skin around the mouth. It is not recommended to apply the cream to the mucous membranes of the mouth, nose, or around the eyes and genitals.

It is necessary to carry out a full course of therapy using Fenistil cream

Pencivir for 4 days in order to achieve the greatest effect from the therapy, even if signs of infection disappear after one or two days of treatment.

If the condition worsens or there is no improvement after 4 days of therapy, the patient should consult a doctor

Impact on the ability to drive vehicles and operate machinery

There was no observed effect of the drug on the ability to drive vehicles or operate machinery.

Overdose

No cases of drug overdose have been reported.

Drug interactions

There are no known drug interactions for Fenistil Pencivir cream.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Do not freeze.

Shelf life: 3 years.

Analogs

Level 4 ATC code matches: Aldara
Viru-Merz Serol

Zovirax Duo-Active

Acyclovir

Bonafton

Zovirax

Atsik

Alpizarin

Herpferon

Epigen Intim

Lysozyme

Gerpevir

Kondilin

Virolex

Gevisosh

Analogue drugs that have a similar ATX code and therapeutic effect: Agerp , Acivir , Acik , Acyclovir , Acyclostad , Vartek , Virolex , Gerpevir , Gerpetad , Herpferon , Zovirax , Medovir , Provirsan and others.