Fidia Aciclin Labiale Aciclovir 5% Cream For Cold Sores 2g

Aciclovir-based cream.

Therapeutic indications

Aciclinlabiale is used in the treatment of Herpes simplex skin infections such as: primary or recurrent herpes genitalis and herpes labialis in adults and adolescents (over 12 years of age).

Dosage and Posology

The drug must be taken according to the following doses and methods: it must be applied 5 times a day at intervals of about 4 hours. Aciclovir cream should be applied to the 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 4 days. If there is no healing, treatment can continue for up to 10 days. If after 10 days the lesions are still present it is recommended that patients consult their doctor. 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.

The safety and efficacy of the drug have not been studied in patients younger than 12 years. Aciclovir is eliminated primarily via the kidney, but systemic absorption of aciclovir after topical application is negligible. Consequently, no dose modification is required in patients with renal or hepatic insufficiency.

Overdose

Even if the entire contents of a tube containing 500 mg of Aciclovir (cream) are ingested, no side effects should be expected, as single doses of 600 mg and daily doses up to 3600 mg have been administered orally without that there are unwanted effects. Single intravenous doses up to 80 mg / kg have been accidentally administered without adverse effects. In any case, any excess of Aciclovir Alter can be removed from the blood by dialysis.

Contraindications

• Hypersensitivity to the active substance or to 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 to <1/10, uncommon> 1/1000 to <1/100, rare > 1 / 10,000 to <1/1000, very rare <1 / 10,000. Data from clinical trials were used to assign frequency categories to undesirable effects observed during clinical studies performed with Aciclovir Alter 3% ophthalmic ointment. Due to the nature of the side effects observed, it is not possible to unambiguously determine which effects are related to the administration of the medicine and which are related to the disease itself. Data from spontaneous reporting was used as a basis for determining the frequency of those effects observed after marketing.

- Skin and subcutaneous tissue disorders

• Uncommon: transient burning or irritation after application of Aciclinlabiale moderate dryness or peeling of the skin itching
• Rare: contact dermatitis erythema after application. Where susceptibility tests were conducted, it was shown that the reactivity phenomena were related to the components of the cream rather than to Aciclovir Alter.

- Disorders of the immune system

• Very rare: immediate hypersensitivity reactions including angioedema and urticaria.

Pregnancy and breastfeeding

The use of Aciclinlabiale cream 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 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. Systemic exposure to aciclovir following topical application of aciclovir cream is very low.

Although some data indicate that aciclovir passes into breast milk following systemic administration, the dose to an infant following use of Aciclinlabiale cream in the mother should be insignificant. In pregnancy and lactation Aciclinlabiale cream should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in the individual case.

Limited data in humans indicate that the medicinal product passes into breast milk after systemic administration. However, the dose received by an infant following the use of Aciclinlabiale by the mother is insignificant.

Special warnings

Aciclovir cream should only be used for cold sores present on the mouth. It is not recommended for application to mucous membranes such as those of the mouth, eyes and should not be used in the treatment of genital herpes. Particular care should be taken to avoid accidental application into the eye. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. The use of the product, especially if prolonged, can give rise to sensitization phenomena: if this happens, the treatment must be interrupted and consult the attending physician. It is recommended that those suffering from cold sores avoid transmission of the virus particularly when active lesions are present.

The use of Aciclinlabiale cream in immunocompromised patients is not recommended. It is recommended that such patients consult their physician regarding the treatment of any infections. Important information about some of the ingredients Aciclinlabiale cream contains propylene glycol. It can cause skin irritation. Aciclinlabiale cream contains cetostearyl alcohol. It can cause local skin reactions (e.g. contact dermatitis).

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. After first opening the container, the medicine should be used within 3 months; after this period, the residual medicinal product must be discarded. Store at a temperature not exceeding 25 ° C in the original package to protect the medicine from light. Do not refrigerate.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

1 gr of Aciclinlabiale contains:

Active principle

Aciclovir 50 mg

Excipients

Tefose 1500, Glycerin, Stearic acid, Liquid paraffin, Methyl-para-hydroxybenzoate, Purified water