ACICLOVIR MY CREAM 3G 5%

ACICLOVIR MYLAN GENERICS 5% CREMA

active ingredients

A gram of cream contains 50 mg of aciclovir. Excipient with known effects: methyl parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient, valaciclovir or any of the excipients listed in the paragraph 6.1.

Population

Posology Aciclovir cream should be applied 5 times a day at intervals of about 4 hours. Aciclovir cream should be applied on injuries or areas where infections 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). 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 application to mucous membranes, such as those of the mouth, eyes or vagina, since it can be irritating. Special attention should be paid to avoid accidental introduction in the eyes. Studies on the animal indicate that the application of aciclovir cream in vagina can cause reversible irritation. In severely immunocompromised patients (e.g. AIDS patients or patients with bone marrow transplant) should be considered an oral aciclovir administration. It should be recommended for those patients to consult the doctor regarding 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 doctor curante.Non phenomena of addiction or drug dependence are reported. Contains parahydroxybenzoate methyl, 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 terms: very common ≥1/10, common ≥1/100 and pathologies of skin and subcutaneous tissue Not common: Burning or transient pain after applying aciclovir cream Moderate dryness or skin dequamation Prurito Raro: Eritema. Contact dermatitis following the application. Where sensitivity tests were conducted, it was shown that substances that gave reactivity phenomena were the components of the base cream rather than aciclovir. Immune system disorders Very rare: Reactions of immediate hypersensitivity including 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 professionals are required to report any adverse reaction suspected through the national reporting system to the Italian Pharmaco Agency, Website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Even if the entire content of a cream tube containing 500 mg of aciclovir is ingested, there should be no side effects.

Pregnancy Using aciclovir cream should only be taken into account when potential benefits exceed the possibility of unknown risks. However systemic exposure following the topical application of aciclovir cream is very low. A register relating to the use of pregnant aciclovir provided data on pregnancy outcomes in women exposed to various formulations of aciclovir after marketing. Such observations did not show an increase in the number of birth anomalies among individuals exposed to aciclovir in comparison to the general population. All defects found at birth showed no unique or constant characteristic to suggest a common cause. Systemic administration of aciclovir, in internationally accepted conventional tests, has not produced any embryotoxic or teratogenic effects in rabbits, rats or mice. In an experimental test not included in the standard tests of teratogenesis, rats, abnormality of the fetus after subcutaneous doses of aciclovir so high to produce toxic effects on the mother. The clinical relevance of these results is uncertain. Milking Limited data in the human species, indicate that aciclovir is found in breast milk after systemic administration. However, the dose received by a milker following the use of aciclovir cream in the mother should be insignificant. Fertility See clinical studies in paragraph 5.2 and 5.3.

Source: Farmadati