Recordati Alovexlabiale 5% Aciclovir Cutaneous Pencil for Cold Sores
Treatment of herpes simplex virus infections of the lips (recurrent herpes labialis) in adults and adolescents (over 12 years of age).
Contraindications - Side effects
Patients with hypersensitivity to aciclovir, valaciclovir, or to any of the excipients. Children under 12 years of age.
Dosage and method of use
Adults and adolescents (over 12 years of age): the medicine should be applied 5 times a day at approximately 4-hour intervals, omitting the nighttime application. The medication should be applied to the lesions or areas where they are developing as soon as possible after the onset of the infection. It is particularly important to begin treatment for recurrent episodes during the prodrome phase or at the first appearance of the lesions. Treatment should continue for at least 5 days and up to 10 days if healing has not occurred. The medication should be applied directly to the lesions without contact with the hands; patients should, however, wash their hands after application. Unnecessary rubbing of the lesions or touching them with a towel should be avoided to prevent worsening or transmission of the infection. The medication should be considered for personal use only; therefore, once opened, it should be used by the same patient for the entire shelf life of the medication and should not be shared with other patients. Children under 12 years: Safety and efficacy have not been studied in patients under 12 years of age.
Storage
Store below 25 degrees C in the original package to protect from light. Do not refrigerate.
Warnings
The medicine should only be used for cold sores on the lips. Application to the mucous membranes of the mouth or nose is not recommended. The medicine should not be used to treat genital herpes. Particular care should be taken to avoid accidental application to the eyes. Use of the product, especially if prolonged, may cause sensitization. If this occurs, treatment should be discontinued. No signs of habituation or dependence on the drug have been reported. People with particularly severe forms of recurrent cold sores are advised to consult their doctor. Those suffering from cold sores are advised to avoid transmitting the virus, especially when active lesions are present. Safety and efficacy have not been studied in patients with compromised immune systems; therefore, use is not recommended in severely immunocompromised patients (AIDS patients or bone marrow transplant recipients). In these patients, oral acyclovir administration should be considered. Furthermore, it is recommended that these patients consult their doctor regarding the treatment of any infection. The butylhydroxytoluene contained in the medicine can cause allergic reactions (possibly delayed). It may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Interactions
Other types of dermatological products (such as cosmetics, sunscreens, cocoa butter) or drugs that treat herpes should not be applied at the same time as the product.
Undesirable effects/Side effects
Frequency of undesirable effects: very common >= 1/10, common >= 1/100e < 1/10, uncommon >= 1/1000 e < 1/100, rare >= 1/10,000 e < 1/1000, very rare < 1/10,000. Disorders of the skin and subcutaneous tissue. Uncommon: Transient burning or pain after application, moderate dryness and peeling of the skin, itching; rare: Erythema, contact dermatitis after application. Where sensitivity testing was conducted, the substances that caused reactivity were shown to be the components of the base skin pencil rather than aciclovir. Immune system disorders. Very rare: Immediate hypersensitivity reactions including angioedema. Report any suspected adverse reactions via the national reporting system.
Pregnancy and breastfeeding
A post-marketing pregnancy registry of aciclovir has provided data on pregnancy outcomes in women exposed to various aciclovir formulations. These observations have not shown an increase in the number of birth defects among subjects exposed to aciclovir compared with the general population, and any birth defects observed showed no unique or consistent patterns to suggest a single cause. Use should be considered only if the potential benefits outweigh the possibility of unknown risks. Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by a nursing infant following maternal use is expected to be insignificant.
Active ingredients
One gram contains: aciclovir 50 mg.
Excipients
Castor oil, semi-synthetic glycerides, carnauba wax, white paraffin, beeswax, octyldodecanol, butylhydroxytoluene, vanilla flavor.
Format
3g applicator.
Product Code:FRCM046657
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