Cream useful for treating labial and genital herpes.
Indications
Aciclovir Alter 5% Cream is used in the treatment of skin infections caused by Herpes simplex such as: primary or recurrent genital herpes and herpes labialis.
Composition
1 g of Aciclovir Alter Cream contains:
Active ingredient: Aciclovir 50 mg.
Excipients: Tefose 1500, Glycerin, Stearic acid, Liquid paraffin, Methylparaben, Purified water.
Directions for use and Dosage
The medicine should be taken according to the following doses and methods: it should be applied 5 times a day at intervals of approximately 4 hours.
Aciclovir Alter cream should be applied on the lesions or areas where they are developing as early as possible after the onset of the infection.
It is particularly important to start treatment of 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 a maximum of 10 if healing has not occurred.
Warnings
Aciclovir cream is not recommended for application to mucous membranes, such as those of the mouth, eyes or vagina, as it may cause irritation. be irritating.
Particular care should be taken to avoid accidental introduction into the eyes.
In severely immunocompromised patients (e.g. AIDS patients or patients with bone marrow transplants), oral administration of aciclovir should be considered.
Such patients should be advised to consult their doctor regarding the treatment of any infection.
Use of the product, especially if prolonged, may give rise to sensitization phenomena; if this occurs, discontinue treatment and consult your doctor.
Contains methyl parahydroxybenzoate, which may cause allergic reactions. cause allergic reactions (even delayed).
Overdose
Even if the entire contents of a tube containing 500 mg of Aciclovir Alter (cream) are ingested, no adverse effects should be expected, since single doses of 600 mg and daily doses of up to 3600 mg have been administered orally without any adverse effects being observed.
Single intravenous doses of up to 80 mg/kg have been accidentally administered without any adverse effects.
In any case, a possible excess of Aciclovir Alter may cause serious side effects. be removed from the blood by dialysis.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients
- Generally contraindicated in pregnancy and breastfeeding.
Side effects
The following convention has been used for the classification of undesirable effects in terms of frequency: very common >1/10, common from > 1/100 to < 1/10, uncommon from >1/1000 to <1/100, rare from >1/10,000 to <1/1000, very rare < 1/10,000.
Data from clinical studies have been used to assign frequency categories to the adverse reactions observed during clinical studies with Aciclovir Alter 3% ophthalmic ointment.
Due to the nature of the adverse reactions observed, it is not possible to determine unequivocally which effects are related to the administration of the drug and which are related to the disease itself.
Data from spontaneous reports have been 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 Aciclovir Alter cream, moderate dryness or peeling of the skin, itching.
- Rare: erythema, contact dermatitis after application. Where sensitivity testing has been conducted, reactivity has been shown to be related to the components of the cream rather than to Aciclovir Alter.
- Immune system disorders
- Very rare: immediate hypersensitivity reactions including angioedema and urticaria.
Pregnancy and breastfeeding
The use of Aciclovir Alter should be considered only when the potential benefits outweigh the possibility of unknown risks, even though systemic exposure to Aciclovir Alter following topical application of Aciclovir Alter cream is very low.
A post-marketing pregnancy registry has provided data on pregnancy outcomes in women exposed to various formulations of Aciclovir Alter.
The registry results did not show an increase in the number of birth defects. congenital defects among subjects exposed to Aciclovir Alter compared to the general population and all congenital defects did not show any peculiarities or common characteristics, such as to suggest a single cause.
In conventional, internationally accepted tests, the systemic administration of Aciclovir Alter did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.
In an experimental test in rats, not included in the standard tests, fetal abnormalities were observed after subcutaneous doses of Aciclovir Alter as high as 100 mg/kg. high enough to produce maternal toxicity.
The clinical relevance of these findings is uncertain.
Limited data in humans indicate that the medicinal product passes into breast milk following systemic administration.
However, the dose received by a nursing infant following maternal use of Aciclovir Alter cream is insignificant.
Storage
Check the expiry date indicated on the package.
The expiry date indicated on the package refers to the product in its intact packaging, stored correctly.
Do not store above 25°C.
Caution: Do not use the medicinal product after the expiry date indicated on the package.
Format
3 g
Product Code:FRCM061107
Richiedi info sul prodotto
