Aciclovir Mylan Generics 5% Herpes Crema 3g

Aciclovir-based cream.

Therapeutic indications

Aciclovir Mylan Cream is used in the treatment of Herpes simplex skin infections such as: primary or recurrent herpes genitalis and herpes labialis.

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 Mylan RANBAXY 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. The treatment must continue for at least 5 days and up to a maximum of 10 if there is no healing.

Overdose

Even if the entire contents of a tube containing 500 mg Aciclovir Mylan (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 Mylan can 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> 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 trials with Aciclovir Mylan 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 applying Aciclovir Mylan cream 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 Mylan.

- Disorders of the immune system

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

Pregnancy and breastfeeding

The use of Aciclovir Mylan should only be considered when the potential benefits outweigh the possibility of unknown risks, even if systemic exposure to Aciclovir Mylan following topical application of Aciclovir Mylan cream is very low. . A post marketing registry of Aciclovir Mylan in pregnancy provided data on pregnancy outcomes in women exposed to the various formulations of Aciclovir Mylan. The registry results did not show an increase in the number of congenital defects among subjects exposed to Aciclovir Mylan compared to the general population and all congenital defects did not show any particularities or common characteristics, suggesting a single cause. In conventional, internationally accepted tests, systemic administration of Aciclovir Mylan did not produce embrotoxic 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 Mylan so high that they produced toxicity in the mother. The clinical relevance of these findings is uncertain.

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 mother's use of Aciclovir Mylan cream is insignificant.

Special warnings

Aciclovir cream is not recommended for application to mucous membranes, such as those in the mouth, eyes or vagina, as it can be irritating. Particular care should be taken to avoid accidental introduction into the eye. In severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant patients) oral administration of aciclovir should be considered. Such patients should be advised to consult their physician regarding the treatment of any infection.

The use, especially if prolonged of the product, can give rise to sensitization phenomena, where this happens it is necessary to interrupt the treatment and consult the attending physician. Contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed).

Expiration 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. Do not store above 25 ° C.

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

Composition

1 gr of Aciclovir Mylan Cream contains:

Active principle

Aciclovir Mylan 50 mg

Excipients

Tefose 1500, glycerol, stearic acid, liquid paraffin, methyl parahydroxybenzoate, purified water.