Zoviraxlabiale 5% Cream 2g
- Brand: GLAXOSMITHKLINE SpA
- Product Code: 037868015
- Availability: In Stock
- Purchase 3 items for 8.09€ each
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One gram of cream contains: Active ingredient: acyclovir 50 mg. For excipients, see section. 6.1
Poloxamer 407, cetostearyl alcohol, sodium lauryl sulphate, white Vaseline, liquid paraffin, Arlacel 165, 20 Dimethicone, Propylene Glycol, Purified Water.
ZOVIRAXLABIALE 5% cream is indicated for the treatment of herpes simplex virus infections of the lips (recurrent herpes labialis) in adults and adolescents (over 12 years).
Hypersensitivity to aciclovir, valaciclovir to, propylene glycol or other components of ZOVIRAXLABIALE 5% cream. Children under 12 years.
Adults and adolescents over the age of 12 years ZOVIRAXLABIALE 5% cream should be applied five times daily at approximately 4 hours intervals omitting the night application. ZOVIRAXLABIALE 5% cream should be applied as early as possible, preferably during the earliest stages (prodrome or erythema). However, the treatment can be also started in the later stages (papules or vesicles). Treatment should continue for at least four days. If there has not been healing, treatment may continue up to a maximum of 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 unnecessary rubbing of the lesions or touching them with a towel in order to avoid worsening or transmission of infection. Children under the age of 12 years The safety and efficacy of ZOVIRAXLABIALE have not been studied in patients younger than 12 years.
Warnings and Precautions
ZOVIRAXLABIALE 5% cream should only be used for the present cold sores on the mouth. Not the application on mucous membranes is recommended as those of the mouth, eyes and should not be used in the treatment of genital herpes. Care must be taken to avoid inadvertently applying in the eye. It is recommended that people with particularly severe forms of recurrent herpes labialis to consult your doctor. The use especially if prolonged product may result in sensitization: if this happens you must stop the treatment and consult your doctor. It is recommended that those who suffer from cold sores avoid transmission of the virus especially when there are active lesions. It is not recommended to use ZOVIRAXLABIALE 5% cream in immunocompromised patients. It is recommended that these patients should consult their doctor about the treatment of any infection. The excipient propylene glycol can cause skin irritation and excipient cetostearyl alcohol may cause local skin reactions (eg contact dermatitis).
No clinically significant interactions have been identified.
Side effects reported for ZOVIRAXLABIALE 5% cream, are listed below in terms of location and the frequency of occurrence (very common: ≥ 1/10, common: ≥ 1/100 and <1/10, uncommon: ≥ 1 / 1,000 to <1/100, rare: ≥ 1/10000 to <1/1000, very rare <1/10000). Skin and subcutaneous tissue disorders Uncommon: • transient burning or pain after application of ZOVIRAXLABIALE 5% cream • moderate peeling or flaking of the skin • itching Rare: • erythema • Contact dermatitis following application. Where sensitivity tests have been conducted, it has been shown that the substances which gave the reactivity phenomena were the components of the cream base rather than aciclovir. Immune system disorders Very rare: • Immediate hypersensitivity reactions including angioedema and urticaria.
Pregnancy and breastfeeding
A record of marketing aciclovir pregnancy after marketing has documented pregnancy outcomes in women exposed to any formulation of acyclovir. These findings have not shown an increase in the number of birth defects among subjects exposed to acyclovir in comparison to the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. You should consider the use of ZOVIRAXLABIALE 5% cream only if the potential benefits outweigh the possibility of unknown risks. Systemic exposure to aciclovir from topical application of ZOVIRAXLABIALE 5% cream is very low. Although some data suggest that acyclovir passes into breast milk following systemic administration, the dose that takes on a nursing infant following the mother of ZOVIRAXLABIALE 5% cream, expected to be insignificant. Fertility See clinical trials. Clinical trials are not available data on the effects of ZOVIRAXLABIALE 5% cream or aciclovir oral or iv formulation for infusion on fertility in women. In Pregnancy and ZOVIRAXLABIALE 5% cream should be used only after consulting the doctor and assessing with him the individual risk / benefit ratio in each case.