ACICLOVIR DOROM CREAM 3G 5%

ACICLOVIR DOROM 5% CREMA

active ingredients

100 g cream at 5% contain: Active ingredient: aciclovir 5 g. Excipients with known effects: methyl parahydroxybenzoate, methyl parahydroxybenzoate sodium and propile parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Tefose 1500, glycerol, liquid paraffin, stearic acid, methyl parahydroxybenzoate, methyl sodium parahydroxybenzoate, propile parahydroxybenzoate, purified water.

Therapeutic indications

Aciclovir Dorom cream is indicated in the treatment of skin infections from Herpes simplex such as: Herpes genitalis primary or recurrent and Herpes labialis.

Contraindications

Aciclovir Dorom 5% cream is contraindicated in patients with hypersensitivity to the active ingredient, valaciclovir or any of the excipients listed in the paragraph 6.1.

Population

Aciclovir Dorom cream should be applied 5 times a day at intervals of about 4 hours. Aciclovir Dorom cream must be applied on injuries or areas where they are developing as early as possible after the infection begins. It is particularly important to begin the treatment of recurring episodes during the prodromi stage or the first appearance of injuries. Treatment can also be started during the later stages (papules or vesicles). Treatment must continue for at least 4 days forHerpes labialis and for 5 days forHerpes genitalia. If you did not have healing, the treatment can continue up to a maximum of 10 days.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Aciclovir Dorom 5% cream is not recommended for application on mucous membranes, such as in the mouth, eyes or vagina, as it can be irritating. Pay special attention to avoid accidental introduction into the eye. Studies on the animal indicate that the application of aciclovir cream in vagina can cause reversible irritation. In severely immunocompromised patients (e.g. patients with AIDS or bone marrow transplants), an oral aciclovir is to be administered. These patients should be encouraged to consult a doctor about the treatment of any infection. The use, especially if prolonged, of the product can give rise to phenomena of sensitization, where this happens, it is necessary to interrupt the treatment and consult the attending physician. There were no signs of drug addiction or addiction. Aciclovir Dorom contains methyl parahydroxybenzoate, methyl parahydroxybenzoate sodium, propile parahydroxybenzoate: can cause allergic reactions (also delayed).

Interactions

No clinically significant interactions have been identified.

Effects

The following convention was used for the classification of unwanted effects in frequency terms: very common ≥ 1/10, common (≥ 1/100 to Pathologies of the skin and subcutaneous tissue. Not common: burning or transient pain after application of aciclovir cream. Cute dry or skin exfoliation. Prurito. Rare: erythema. Contact dermatitis after application. Where sensitivity tests have been conducted, reactive substances have often been the components of the cream rather than aciclovir. Immune disorders. Very rare: type I hypersensitivity which includes angioedema and hives. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Even if the entire content of a tube containing 500 mg of aciclovir (crema) is ingested, there is no undesirable effect.

Pregnancy: The use of aciclovir should be taken into account only if potential benefits exceed the possibility of unknown risks, however the aciclovir systemic exposure due to the topical application of Aciclovir Dorom 5% cream is very low. A post-marketing registered study on pregnancy with aciclovir documented pregnancy outcomes in women exposed to any aciclovir formulation. The findings of recorded data did not show an increase in the number of congenital abnormalities in individuals exposed to aciclovir compared to the general population, and the congenital abnormalities observed did not reveal characters of uniqueness or concordance such as to suggest a possible common cause for their occurrence. Systemic administration of aciclovir in standard tests accepted internationally has not produced any embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard rat test, fetal abnormalities were observed but only after subcutaneous doses so high that maternal toxicity was caused. The clinical relevance of these reliefs is uncertain. Nursing: Limited human data shows that the drug passes into breast milk after systemic administration. However, the dose received by the infant after use by the mother of Aciclovir Dorom 5% cream should be insignificant.Fertility: The results of animal studies indicate that Aciclovir cream has no effect on fertility (see paragraph 5).

Source: Farmadati