Aciclovir Doc Generici Crema Derm 3g 5%

Aciclovir Doc based cream.

Therapeutic indications

Aciclovir Doc Crema 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 Doc 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 Doc (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 undesirable effects were encountered. Single intravenous doses up to 80 mg / kg have been accidentally administered without adverse effects. In any case, any excess of Aciclovir Doc 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 Doc 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 application of Aciclovir Doc cream moderate dryness or peeling of the skin itching
• Rare: contact dermatitis erythema after application. Where sensitivity tests were conducted, it was shown that the reactivity phenomena were related to the components of the cream rather than to Aciclovir Doc.

- Disorders of the immune system

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

Pregnancy and breastfeeding

The use of Aciclovir Doc should only be considered when the potential benefits outweigh the possibility of unknown risks, even if systemic exposure to Aciclovir Doc following topical application of Aciclovir Doc cream is very low. . A registry relating to the use of Aciclovir Doc after marketing in pregnancy provided data on pregnancy outcomes in women exposed to the various formulations of Aciclovir Doc. The results of the registry did not show an increase in the number of congenital defects among exposed subjects. Aciclovir Doc compared to the general population and all congenital defects did not show any particularity or common characteristics, such as to suggest a single cause. In conventional, internationally accepted tests, systemic administration of Aciclovir Doc 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 Doc so high as to produce 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 use of Aciclovir Doc cream by the mother is insignificant.

Special warnings

It is not recommended to apply Aciclovir Doc cream to mucous membranes such as those of the mouth, eyes or vagina as it can cause irritation. Particular care should be taken to avoid accidental application into the eye. Animal studies indicate that the application of Aciclovir Doc RANBAXY cream in the vagina may cause reversible irritation. The use of the product, especially if prolonged, can give rise to sensitization phenomena, where this happens it is necessary to stop the treatment and consult the treating doctor. There are no reports of addiction or dependence on the drug. In severely immunocompromised patients (AIDS patients or bone marrow transplant patients) administration of Aciclovir Doc in oral formulations should be considered. Such patients should be recommended to consult their physician regarding the treatment of any infection. The excipient propylene glycol can cause skin irritation and the excipient cetostearyl alcohol can cause local skin reactions (e.g. contact dermatitis).

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 Doc Crema contains:

Active principle

Aciclovir Doc 50 mg

Excipients

Poloxamer 407; cetostearyl alcohol; sodium lauryl sulfate; white petroleum jelly; liquid paraffin; propylene glycol; purified water.