CYCLOVIRAN CREMA 2G 5%

CYCLOVIRAN LABIQUE 5% CREMA

active ingredients

A gram of cream contains: Active ingredient Aciclovir 50 mg Excipients with known effects: Propylene glycol 400 mg cetostearilic alcohol 67,5 mg For the complete list of excipients, see paragraph 6.1

Excellent

Propylene glycol, White Vaseline, Cetosteari alcohol, Liquid paraffin, Arlacel 165, Polossamero 407, Dimeticone 20, Sodium laurilsolfato, Purified water.

Therapeutic indications

CYCLOVIRAN LABIALE is indicated in the treatment of virus infections herpes simplex lipsherpes labialis recurrent) in adults and adolescents over 12 years.

Contraindications

Hypersensitivity to the active ingredient, valaciclovir, or any of the excipients listed in the paragraph 6.1. Children under 12 years of age.

Population

Adults and teenagers over 12 years old CYCLOVIRAN LABIALE must be applied 5 times a day at intervals of about 4 hours, omitting the night application. CYCLOVIRAN LABIALE must be applied to 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 phase or the first appearance of injuries. Treatment can also be started during the later stages (papules or vesicles). The treatment must continue for at least 4 days and up to a maximum of 10 if you did not have healing. If after 10 days the injuries are still present, it is recommended that patients consult the doctor. Patients must wash their hands before and after the application of the cream and avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid worsening or transmitting the infection. Children under 12 years Security and effectiveness of CYCLOVIRAN LABIALE were not studied in patients under the age of 12.

Conservation

Do not store at temperature above 25°C, do not refrigerate.

Warnings

CYCLOVIRAN LABIALE must be used only for the labial herpes present on the lips. The product is not for ophthalmic use, nor is it advisable to apply on mucous membranes of the mouth, nose or vagina as it may be irritating. The product should not be used in the treatment of genital herpes. Special attention should be paid to avoid accidental application in the eyes. The long-term use of the product can result in awareness-raising, where this is necessary to stop treatment. There are no signs of drug addiction or addiction. In severely immunocompromised patients (patients with AIDS or patients with bone marrow transplant) should be considered the administration of aciclovir in oral formulations. It should be recommended that such patients consult the doctor regarding the treatment of any infection. Important information about some excipients CYCLOVIRAN WORK: CYCLOVIRAN LABIALE contains propylene glycol. It can cause skin irritation. CYCLOVIRAN LABIALE contains cetosterial alcohol. It can cause skin reactions (e.g. contact dermatitis).

Interactions

Other types of dermatologic products (such as cosmetics, sunscreen creams, cocoa butter) or medications that treat herpes simultaneously CYCLOVIRAN LABIALE.

Effects

The following Convention was used for the classification of unwanted effects in frequency term: Very common (≥ 1/10), Common (≥1/100, Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

No known overdose effects.

Fertility

There are no fertility data available in the woman. The cream aciclovir has not proved to have effect on the number, morphology and motility of spermatozoa in man (see paragraph 5.3).

Pregnancy

You should consider the use of CYCLOVIRAN LABIALE only if potential benefits exceed the possibility of unknown risks, however, exposure to aciclovir following the topical application of aciclovir cream is very low. A register relating to the use of pregnant aciclovir after marketing, provided data on pregnancy outcomes in women exposed to various aciclovir formulations. Such observations did not show an increase in the number of birth defects among individuals exposed to aciclovir in comparison to the general population and all defects found at birth showed no common peculiarities or characteristics, such as to suggest a unique cause.

Food

Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by a complainant following the use of CYCLOVIRAN LABIALE in the mother should be insignificant.

Source: Farmadati