Treatment of skin infections.
Indications
Aciclovir Sofar 5% cream is indicated for the treatment of Herpes simplex skin infections such as: primary or recurrent genital herpes and herpes labialis.
How to use
Aciclovir Sofar must be applied 5 times a day at approximately 4-hour intervals.
Aciclovir Sofar must be applied to 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 (the first symptoms of the infection, itching and/or burning and/or pain) or when the lesions first appear.
Treatment must continue for at least 5 days and up to a maximum of 10 days if healing has not occurred.
Warnings
The product is not for ophthalmic use, nor is it recommended for application to the mucous membranes of the mouth or vagina, as it may be irritating.
Pay particular attention to avoid accidental introduction into the eye.
Animal studies indicate that the application of Aciclovir cream in the vagina can cause reversible irritation.
Use of the product, especially if prolonged, may give rise to sensitization phenomena. If this occurs, discontinue treatment and consult your doctor.
In severely immunocompromised patients (AIDS patients or patients with bone marrow transplants), the administration of aciclovir in oral formulations should be considered.
It should be recommended that such patients 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, treatment should be discontinued and the treating doctor should be consulted.
Interactions
No clinically significant interactions have been identified.
Undesirable effects
The following convention has been used for the classification of adverse effects in terms of frequency: very common ≥ 1/10, common ≥ 1/100 and ≥ 1/10, uncommon ≥ 1/1,000 and ≥ 1/100, rare ≥ 1/10,000 and ≥ 1/1,000, very rare ≥ 1/10,000. Given the nature of the adverse events observed, it is not possible to determine unequivocally which of these events are related to the administration of the drug and which are related to the underlying disease.
The frequency categories associated with the adverse events reported below are based on data from spontaneous post-marketing reports.
Skin and subcutaneous tissue disorders: uncommon: transient burning or stinging after application of aciclovir cream; moderate: dryness and peeling of the skin; pruritus; rare: erythema; contact dermatitis after application.
Where sensitivity testing has been conducted, the substances responsible for the reactivity have been shown to be components of the cream base rather than aciclovir.
Immune system disorders: Very rare: immediate hypersensitivity reactions, including angioedema and urticaria.
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Overdose
Even if the entire contents of a tube of cream are ingested, no adverse effects should be expected, as single doses of 600 mg and daily doses of up to 3600 mg have been administered orally without any adverse effects.
Single intravenous doses of up to 80 mg/kg have been accidentally administered without adverse effects. Aciclovir is dialyzable.
Pregnancy and breastfeeding
In pregnancy The use of aciclovir should be considered only if the potential benefits outweigh the possibility of unknown risks, however, systemic exposure to aciclovir following topical administration of aciclovir cream is very low.
A post-marketing pregnancy registry has provided data on pregnancy outcomes in women exposed to various formulations of aciclovir.
These observations have not shown an increase in the number of birth defects among subjects exposed to aciclovir compared to the general population and any birth defects found did not show any unique or common features to suggest a single cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats, or mice.
In an experimental test in rats not included in the classic teratogenicity tests, fetal abnormalities were observed after subcutaneous doses of aciclovir high enough to produce toxic effects on the mother.
The clinical relevance of these findings, however, is uncertain.
Breastfeeding: Limited data in humans indicate that the drug is found in breast milk following systemic administration.
However, the dose received by a nursing infant following maternal use of aciclovir cream is expected to be insignificant.
Storage
Store below 25°C.
Format
3 g tube.
Product Code:FRCM116953
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