Aciclovir belupo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ACYCLOVIR BELUPO

Composition:

Active substance: acyclovir;

1 g of cream contains 50 mg of acyclovir;

Excipients: propylene glycol, polyethylene glycol glyceryl monostearate, cetyl stearyl alcohol, liquid paraffin, white soft paraffin, sodium lauryl sulfate, purified water.

Pharmaceutical form. Topical cream.

Main physicochemical properties: homogeneous white cream without mechanical inclusions.

Pharmacotherapeutic group. Antiviral agents. ATC code D06BB03.

Pharmacological properties.

Pharmacodynamics.

Acyclovir Belupo is an antiviral agent with high in vitro activity against herpes simplex virus types I and II.

The mechanism of action of acyclovir is based on inhibition of DNA synthesis. The virus-induced enzyme thymidine kinase facilitates penetration of acyclovir into the cell and its intracellular phosphorylation. Acyclovir monophosphate is phosphorylated to form the active compound, acyclovir triphosphate, which selectively and irreversibly inhibits viral DNA polymerase, thereby inhibiting DNA synthesis.

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

Apply the cream only for the treatment of herpes on the lips and face. The product should not be applied to the mucous membranes of the mouth or eyes, nor should it be used for the treatment of genital herpes. Accidental contact of the cream with the eyes should be avoided. Patients with particularly severe or recurrent episodes of Herpes labialis should consult a physician.

Patients with herpes should wash their hands before and after applying the cream to prevent contact transmission of the virus to other people, especially when open lesions are present.

The product is not recommended for immunocompromised individuals. Such patients should consult a physician regarding the treatment of any infection.

The medicinal product contains propylene glycol, which may cause skin irritation, and cetearyl 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 when, in the opinion of the physician, the benefit outweighs the risk. However, it should be noted that systemic absorption of acyclovir following 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 oral administration. However, the amount of acyclovir that could be transferred to an infant through breastfeeding after topical application of this cream is negligible.

Clinical studies have shown that orally administered acyclovir has no clinically significant effect on male fertility. Data regarding the effect of acyclovir on female fertility are not available.

Ability to influence reaction speed when driving or operating machinery

There are no data on the effect of topically applied acyclovir, used at therapeutic doses, on the ability to drive or operate machinery.

Method of Administration and Dosage.

The product is intended for topical use.

For adults and children aged 12 years and older: apply the cream approximately 5 times daily at 4-hour intervals, except during nighttime. The treatment duration should be at least 4 days. If skin lesions have not completely resolved after 4 days, treatment may be continued for an additional 6 days (a total of 10 days from the start of treatment). If symptoms persist after 10 days of treatment, the patient should consult a physician.

It is important to begin treatment as early as possible at the onset of infection.

Hands should be washed before and after applying the cream, and excessive rubbing or contact with towels on affected areas should be avoided to prevent aggravation or transmission of infection.

Children.

The use of this product is not recommended for children under 12 years of age due to lack of safety data.

Overdose.

No adverse effects have been reported following oral or topical application of an entire tube of cream due to minimal systemic exposure. In case of suspected overdose, medical advice should be sought.

Adverse reactions.

Skin and connective tissue disorders

Uncommon (≥ 1/1000; < 1/100): transient burning or stinging pain after application of the cream, moderate skin dryness and peeling, pruritus.

Rare (≥ 1/10000; < 1/1000): erythema, contact dermatitis after application of the cream (sensitivity testing has shown that these cases were most frequently associated with components of the cream base rather than with acyclovir).

Immune system disorders

Very rare (< 1/10000): immediate hypersensitivity reactions, including angioneurotic edema and urticaria.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

2 g, 5 g or 10 g in a tube; 1 tube per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

Belupo, Pharmaceuticals and Cosmetics, d.d., Croatia.

Manufacturer's address and location of business operations.

Danice 5, 48000 Koprivnica, Croatia.