ACICLOVIR ALTER * 3G CREAM 5%

ACICLOVIR ALTER * 3G CREAM 5%

Therapeutic indications

ACICLOVIR ALTER 5% cream is indicated in the treatment of skin infections fromHerpes simplexsuch as: primary or recurrent herpes genitalis and herpes labialis.

Dosage and method of use

ACICLOVIR ALTER cream should be applied 5 times a day at intervals of approximately 4 hours. ACICLOVIR ALTER cream should be applied to the lesions or areas where they are developing as soon as possible, preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later stages (papules or vesicles). Treatment should continue for at least 4 days for herpes labialis and for 5 days for herpes genitalis. If there is no healing, treatment can continue for up to 10 days.

Contraindications

ACICLOVIR ALTER cream is contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir or to any of the excipients listed in section 6.1.

Side effects

The following convention has been used for the classification of undesirable effects in terms of frequency: very common> 1/10, common> 1/100 and 1 / 1,000 and 1 / 10,000 and Skin and subcutaneous tissue disorders Uncommon: Burning or transient pain after applying aciclovir cream. Rare: Moderate dryness and peeling of the skin. Itching. Erythema. Contact dermatitis after application. Where sensitivity tests were conducted, it was shown that the substances that gave phenomena of reactivity were the components of the base cream rather than acyclovir.Disorders of the immune systemVery rare: immediate hypersensitivity reactions including angioedema and urticaria.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospe tta-adverse-reaction.

Special warnings

Aciclovir cream is not recommended for ophthalmic use, nor is it recommended for application on the mucous membranes of the mouth or vagina as it may be irritating. Particular care should be taken to avoid accidental application into the eye. Animal studies indicate that the application of aciclovir cream in the vagina may cause reversible irritation. In severely immunocompromised patients (AIDS patients or bone marrow transplant patients) administration of aciclovir in oral formulations should be considered. Such patients should be recommended to consult their physician regarding the treatment of any infection. The use of the product especially if prolonged can give rise to sensitization phenomena, where this happens it is necessary to stop the treatment and consult the attending physician. There are no reports of addiction or dependence on the drug. The medicine contains methyl parahydroxybenzoate which may cause allergic reactions (including delayed).

Pregnancy and breastfeeding

FertilitySeeClinical Studiesin paragraph 5.2.PregnancyThe use of aciclovir should only be considered if the potential benefits outweigh the possibility of unknown risks, however, the systemic exposure to aciclovir following topical application of aciclovir cream is very low. A registry of post-marketing use of aciclovir in pregnancy provided data on pregnancy outcomes in women exposed to the various aciclovir formulations. These observations did not show an increase in the number of birth defects among acyclovir exposed subjects compared to the general population, and all birth defects found did not show any particularities or common characteristics that would suggest a single cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryonic toxicity or teratogenic effects in rabbits, rats or mice. In an experimental test in rats not included in the classic teratogenic tests, abnormalities of the fetus were observed after subcutaneous doses of aciclovir so high as to produce toxic effects in the mother. However, the clinical relevance of these findings is uncertain.Feeding timeLimited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by an infant following the use of aciclovir cream in the mother should be insignificant.

Expiry and retention

Store at a temperature not exceeding 25 ° C.

Interactions with other drugs

No clinically significant interactions have been identified.

Overdose

Even if the entire contents of a tube of cream are ingested, no undesirable effects should be expected.

Active principles

One gram of cream contains: Active substance: 50 mg aciclovir For the full list of excipients, see section 6.1.

Excipients

Tefose 1500, glycerin, stearic acid, liquid paraffin, methyl paraben, purified water.