ACICLOVIR EG CR 3G 5%

ACICLOVIR EG 5% CREMA

active ingredients

1 g cream contains: Active ingredient: aciclovir: 50 mg. Excipients with known effects: 67,5 mg of cetosterial alcohol, 7.5 mg of lauril sulphate sodium, 200 mg of glycol propylene (E1520). For the full list of excipients, see paragraph 6.1.

Excellent

Polossamero 407; cetostearilic alcohol; Sodium laurilsulfate; White Vaseline; Liquid paraffin; Monopalmitate sucrose; Propilene glycol (E1520); Purified water.

Therapeutic indications

ACICLOVIR EG cream is indicated in the treatment of skin infections from Herpes Simplex such as: Herpes genitalis primary or recurrent and Herpes labialis.

Contraindications

ACICLOVIR EG cream is contraindicated in patients with hypersensitivity known to aciclovir, valaciclovir, propylene glycol or any of the excipients listed in paragraph 6.1.

Population

ACICLOVIR EG CREMA should be applied 5 times a day at intervals of about 4 hours. ACICLOVIR EG cream should be applied on lesions, or on 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 since it could be irritating. Special attention should be paid to avoid accidental application in the eyes. Studies on the animal indicate that the application of ACICLOVIR EG vagina cream 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. Important information about some excipients This medicine contains cetosterial alcohol that can cause reactions on the localized skin (e.g. contact dermatitis). This medicine contains 7.5 mg laurilsulphate sodium for g cream. Sodium lauril sulphate can cause skin irritation (sting or burning sensation) or intensify reactions on the skin caused by other medicines when applied on the same area. This medicine contains 200 mg of glycol propylene per g cream.

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 pathologies of skin and subcutaneous tissue. Not common: Burn or transient pain after application of aciclovir cream. Moderate dryness and skin dequamation. Prurito. Rare: 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 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 via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Even if the entire content of a 10 g cream tube containing 500 mg of aciclovir is ingested, it should not be expected to have side 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. Limited data indicates that the drug is found in breast milk as a result of systemic administration. However, the dose received by a milker following the use of aciclovir cream in the mother should be insignificant.

Source: Farmadati