LIPSTER® MINT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIPSTER® MINT (LIPSTER MINT)

Composition:

Active substance: aciclovir;

1 g of cream contains aciclovir 50 mg;

Excipients: white soft paraffin, mineral oil, cetostearyl alcohol (type A) emulsifying, propylene glycol, poloxamer, dimethicone, glycerol monostearate, cetostearyl polyglycol ether, levomenthol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: a homogeneous cream of white or almost white color with a characteristic menthol odor.

Pharmacotherapeutic group. Antiviral agents. Aciclovir. ATC code D06B B03.

Pharmacological properties.

Pharmacodynamics.

Acyclovir is an antiviral agent that demonstrates high in vitro activity against herpes simplex virus types I and II. Its toxic effect on host organism cells is minimal. After entering virus-infected cells, acyclovir undergoes phosphorylation to form the active compound, acyclovir triphosphate. The initial step of this process depends on the presence of virus-coded thymidine kinase. Acyclovir triphosphate acts as both an inhibitor and a substrate for viral DNA polymerase, thereby preventing further viral DNA synthesis without affecting normal cellular processes.

The use of the preparation is accompanied by a cooling sensation and reduced itching due to the presence of menthol.

Pharmacokinetics.

Pharmacokinetic studies have shown minimal systemic absorption of acyclovir following repeated topical application of the cream.

Clinical characteristics.

Indications.

Treatment of infections of the lips and face caused by herpes simplex virus (Herpes labialis).

Contraindications.

Hypersensitivity to acyclovir, valacyclovir, propylene glycol, or to any of the other components of the cream.

Interaction with other medicinal products and other forms of interaction.

No interactions have been identified.

Special precautions for use

The cream should be used only for the treatment of herpes on the lips and face. It is not recommended to apply the cream to mucous membranes, such as the oral cavity or eyes. It should not be used for the treatment of genital herpes. Accidental contact of the cream with the eyes should be avoided.

Patients suffering from particularly severe or frequently recurring episodes of Herpes labialis should consult a physician. Patients with herpes should be advised to avoid transmitting the virus to others, especially when lesions are open (for example, hands should be washed before and after applying the cream). This medicinal product is not recommended for use in immunocompromised individuals. Such patients should consult a physician regarding the treatment of any infection.

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

Use during pregnancy or breastfeeding

This product should be used in pregnant or breastfeeding women only if the expected benefit outweighs the potential risk, as assessed by a physician. However, it should be noted that systemic absorption of acyclovir after topical application of the cream is very low.

Clinical studies have shown that the use of acyclovir in any formulation does not lead to an increased incidence of fetal developmental abnormalities.

Some clinical data indicate that acyclovir passes into breast milk following systemic administration. However, the amount of acyclovir that could be transferred to an infant during breastfeeding after topical application of the cream is considered negligible.

Clinical studies have shown that orally administered acyclovir has no clinically significant effect on male fertility. There are no data available regarding the effect of acyclovir on female fertility.

Ability to influence reaction speed when driving or operating machinery

No data available.

Method of Administration and Dosage

The product is intended for external use only.

For adults and children aged 12 years and older: apply the cream 5 times daily at approximately 4-hour intervals, excluding nighttime. It is important to start treatment as early as possible at the onset of infection, preferably during the prodromal stage or erythema phase. Treatment may also be initiated at later stages—papules or blisters.

Hands should be washed before and after applying the cream. Avoid excessive friction or touching the affected areas with a towel to prevent exacerbation or transmission of infection.

Treatment should last at least 4 days. If healing has not occurred, treatment may be continued for up to 10 days. If symptoms persist after 10 days of treatment, the patient should consult a physician.

Children.

There is insufficient safety data on the use of this medicinal product in children under 12 years of age; therefore, its use is recommended only for children aged 12 years and older.

Overdose.

Adverse effects following oral or topical application of the entire contents of the tube are not expected due to minimal systemic exposure. In case of suspected overdose, medical advice should be sought.

Adverse reactions.

Skin and connective tissue disorders.

Uncommon (≥ 1/1,000, < 1/100): transient burning or stinging pain after cream application, moderate skin dryness and desquamation, pruritus.

Rare (≥ 1/10,000, < 1/1,000): erythema, contact dermatitis after cream application (sensitivity testing has shown that these cases were mostly related to components of the cream base rather than to acyclovir).

Immune system disorders.

Very rare (< 1/10,000): immediate hypersensitivity reactions, including angioneurotic edema and urticaria.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the package.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 ºC. Keep out of reach of children.

Packaging. 5 g in a tube. 1 tube per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.