ACICLOVIR ALM CREMA 3G 5%

ALMUS PHARMA 5% CREMA

active ingredients

A gram of cream contains: Active ingredient: Aciclovir: 50 mg. Excipient: para-hydroxybenzoate For the full list of excipients, see paragraph 6.1.

Excellent

Tefose 1500, glycerin, stearic acid, liquid paraffin, methyl-para-hydroxybenzoate, purified water.

Therapeutic indications

Aciclovir Almus Pharma is indicated in the treatment of herpes simplex virus infections of the lips (herpes labialis recurrent) in adults and adolescents (aged over 12 years).

Contraindications

Aciclovir cream is contraindicated in patients with hypersensitivity known to aciclovir, a valaciclovir or any of the excipients. Children under 12 years of age.

Population

Adults and teenagers (aged 12 years) Aciclovir Almus Pharma must be applied 5 times a day at intervals of about 4 hours omitting the night application. Aciclovir Almus Pharma 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 stage or the first appearance of injuries. The treatment must continue for at least 5 days and up to a maximum of 10 if you did not have healing. 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 The safety and effectiveness of Aciclovir Almus Pharma have not been studied in patients under the age of 12.

Conservation

Store at a temperature not exceeding 25°C. Don't refrigerate.

Warnings

Aciclovir Almus Pharma should only be used for labial herpes on the lips. The drug is not for ophthalmic use, nor is it advisable to apply on mucous membranes of the mouth, eyes or nose, since it can cause irritation. 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 phenomena: where this happens, the treatment must be stopped. There were no signs of drug addiction or addiction. It is recommended that persons with particularly severe forms of recurrent labial herpes consult the doctor. It is recommended that those suffering from labial herpes avoid the transmission of the virus especially when active injuries are present. The safety and effectiveness of Aciclovir Almus Pharma have not been studied in patients with altered immune system, so the use of Aciclovir Almus Pharma is not recommended in severely immunocompromised patients (patients with AIDS or patients with bone marrow transplant). In these patients should be considered the administration of aciclovir in oral formulations. It should also be recommended that such patients consult the doctor regarding the treatment of any infection. Important information about some Aciclovir Almus Pharma excipients Methyl-para-hydroxybenzoate contained in the medicinal product may cause allergic reactions (also delayed).

Interactions

Other types of dermatologic products (such as cosmetics, sunscreen creams, cocoa butter) or medications that treat herpes at the same time as Aciclovir Almus Pharma. Special clinically significant interactions have not 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 tissues Not common: burning or transient pain after application, moderate dryness, skin dequamation and itching. Rare: erythema, contact dermatitis following the application. Where sensitivity tests have been conducted, it has been shown that reactivity phenomena were related to the components of the cream rather than to aciclovir. Immune system disorders Very rare: immediate hypersensitivity reactions that include angioedema and hives.

Overdosing

Even in case the entire content of a cream tube containing 150 mg of aciclovir is ingested, no side effects should be expected.

Pregnancy It should be considered the use of Aciclovir Almus Pharma only when potential benefits exceed the possibility of unknown risks, however the systemic exposizone to aciclovir after 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. In conventional tests, internationally accepted, Aciclovir's systemic administration has not produced any embryotoxic or teratogenic effects in rabbits, rats or mice. In an experimental test 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. 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