Aciclovir Almus 5% Cream 3 g

Therapeutic indications

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

Dosage

Adults and adolescents (over 12 years of age) Aciclovir Almus Pharma should be applied 5 times a day at intervals of approximately 4 hours, omitting the nocturnal application. Aciclovir Almus Pharma should be applied to lesions or areas where they are developing as early as possible after the infection begins. It is especially important to start treatment for recurrent episodes during the prodrome phase or when lesions first appear. Treatment should continue for at least 5 days and up to a maximum of 10 if there is no healing. Patients should wash their hands before and after applying the cream and avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid worsening or transmission of the infection. Children below 12 years of age The safety and efficacy of Aciclovir Almus Pharma have not been studied in patients below 12 years of age.

Overdose

Even if the entire contents of a tube of cream containing 150 mg of aciclovir are ingested, no undesirable effects should be expected.

Contraindications

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

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 <1/10), uncommon (≥1 / 1000 and <1 / 100), rare (≥1 / 10,000 and <1/1000), very rare (<1 / 10,000). Data from clinical trials were used to assign frequency categories to adverse reactions observed during clinical studies performed with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse events observed, it is not possible to uniquely determine which events were related to drug administration and which were related to disease. Data from spontaneous reporting was used as a basis for assigning the frequency for those events from post-marketing observation. Skin and subcutaneous tissue disorders Uncommon: transient burning or pain after application, moderate dryness, skin peeling and itching. Rare: erythema, contact dermatitis following application. Where susceptibility tests were conducted, it was shown that the reactivity phenomena were related to the components of the cream rather than to acyclovir. Immune system disorders Very rare: immediate hypersensitivity reactions including angioedema and urticaria.

Pregnancy and breastfeeding

Pregnancy The use of Aciclovir Almus Pharma should only be considered when the potential benefits outweigh the possibility of unknown risks, however systemic exposure to aciclovir after topical application of aciclovir cream is very low. A post-marketing registry of aciclovir use 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. In conventional, internationally accepted tests, systemic administration of Aciclovir did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In an experimental test not included in the classic teratogenic tests, fetal abnormalities were observed after subcutaneous doses of Aciclovir so high as to produce toxic effects in the mother. The clinical relevance of these findings is uncertain. Lactation Limited 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.

Special warnings

Aciclovir Almus Pharma should only be used for cold sores present on the lips. The drug is not for ophthalmic use, nor is it recommended to apply to the mucous membranes of the mouth, eyes or nose, as it can cause irritation. The product should not be used in the treatment of genital herpes. Particular care should be taken to avoid accidental application into the eye. The use of the product, especially if prolonged, can give rise to sensitization phenomena: if this happens, the treatment must be interrupted. No addiction or dependence phenomena have been reported to the drug. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. It is recommended that those suffering from cold sores avoid transmission of the virus particularly when active lesions are present. The safety and efficacy of Aciclovir Pharma have not been studied in patients with impaired immune systems, therefore the use of Aciclovir Pharma is not recommended in severely immunocompromised patients (AIDS patients or bone marrow transplant patients). Administration of aciclovir in oral formulations should be considered in these patients. Furthermore, it should be recommended that such patients consult their physician regarding the treatment of any infections. Important information about some of the ingredients of Aciclovir Almus Pharma The methyl para-hydroxybenzoate contained in the medicine can cause allergic reactions (possibly delayed).

Expiry and Retention

Store at a temperature not exceeding 25 ° C. Do not refrigerate.

Active principles

One gram of cream contains: Active ingredient : Aciclovir: 50 mg. Excipients : para-hydroxybenzoate For a full list of excipients, see section 6.1.

Excipients

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