Descrizione Clinica
ACICLOVIR ALTER 5% CREMA
active ingredients
A gram of cream contains: Active Ingredient: aciclovir 50 mg For full list of excipients, see paragraph 6.1.Excellent
Tefose 1500, glycerin, stearic acid, liquid paraffin, methylparaben, purified water.Therapeutic indications
ACICLOVIR ALTER 5% cream is indicated in the treatment of skin infections from Herpes simplex such as: herpes genitalis primary or recurrent and herpes labialis.Contraindications
ACICLOVIR ALTER cream is contraindicated in patients with hypersensitivity known to aciclovir, valaciclovir or any of the excipients listed in paragraph 6.1.Population
ACICLOVIR ALTER cream should be applied 5 times a day at intervals of about 4 hours. ACICLOVIR ALTER cream should be applied on lesions or areas where they are developing as soon as possible preferably during the precocious phases (prodromes or erythema). Treatment can also be started during the later stages (papules or vesicles). The treatment must continue for at least 4 days for herpes labialis and for 5 days for herpes genitalis. If you did not have healing the treatment can continue up to a maximum of 10 days.Conservation
Store at a temperature not exceeding 25°C.Warnings
Aciclovir cream is not recommended for ophthalmic use, nor is it advisable to apply on mucous membranes of the mouth or vagina as it may be irritating. Special attention should be paid to avoid accidental application in the eyes. Studies on the animal indicate that the application of aciclovir cream in vagina can cause reversible irritation. 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. The prolonged use of the product may result in awareness-raising, where this happens, it is necessary to stop the treatment and consult the doctor. There are no signs of drug addiction or addiction. The drug contains methylparahydroxybenzoate which 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 term: very common > 1/10, common > 1/100 and 1/1.000 and 1/10.000 and pathologies of skin and subcutaneous tissue Not common: Burn or transient pain after application of aciclovir cream. Raro: Moderate dryness and skin dequamation. Prurito. Eritema. Contact dermatitis after application. Where sensitivity tests were conducted, substances that gave reactivity phenomena were the components of the base cream rather than aciclovir. Immune system disorders Very rare: immediate hypersensitivity reactions that include 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 through the national reporting system http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospe tta-reaction-adversa.Overdosing
Even in case the entire content of a cream tube is ingested, there should be no undesirable effects.Fertility See Clinical studies in paragraph 5.2. Pregnancy You should consider using aciclovir only if potential benefits exceed the possibility of unknown risks, however, systemic 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. Systemic administration of aciclovir in standard tests accepted internationally has not produced effects of embryo toxicity or teratogenic effects in rabbits, rats or mice. In an experimental trial in rats not included in the classic teratogenesis tests, there were abnormalities of the fetus after subcutaneous doses of aciclovir so high to produce toxic effects in the mother. However, the clinical relevance of these results is uncertain. Food Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by a milker following the use of aciclovir cream in the mother should be insignificant.
Source: Farmadati
