Aciclovir Sandoz 5% Antiviral Cream 3 g

Acyclovir-based antiviral topical cream .

Therapeutic indications

Aciclovir Sandoz Cream 5% is used in the treatment of Herpes simplex skin infections such as: primary or recurrent Herpes genitalis and Herpes labialis.

Dosage and posology

Aciclovir Sandoz Cream 5% should be applied 5 times a day at intervals of approximately 4 hours to the lesions or areas where they are developing as early as possible after the onset of the infection. It is especially important to start treatment for recurrent episodes during the prodrome phase or when lesions first appear. Treatment should continue for at least 5 days and up to a maximum of 10 if there is no healing.

Overdose

If you accidentally take an excessive amount of Aciclovir Sandoz Cream 5%, contact your doctor immediately or go to the emergency room of the nearest hospital.

Contraindications

• Known hypersensitivity to aciclovir, valaciclovir and to any of the excipients.
• Generally contraindicated in pregnancy and breastfeeding.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

• Uncommon: (may affect up to 1 in 100 people) - transient burning or pain; - dryness and peeling of the skin; - itch.
• Rare: (may affect up to 1 in 1,000 people) - redness of the skin (erythema); - inflammatory skin reaction (contact dermatitis), mainly due to the components of the base cream.
• Very rare: (may affect up to 1 in 10,000 people) angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing), hives.

Pregnancy and breastfeeding

• Pregnancy

The use of Aciclovir Sandoz Cream 5% should only be considered if the potential benefits outweigh the possibility of unknown risks, however systemic exposure to aciclovir due to topical application of the drug is very low. A pivotal post-marketing pregnancy study with aciclovir documented pregnancy outcomes in women exposed to any formulation of aciclovir.

The conclusions of the pivotal data did not show an increase in the number of congenital anomalies in subjects exposed to aciclovir compared to the general population, and the observed congenital anomalies did not reveal characteristics of uniqueness or concordance that would suggest a possible common cause for their onset. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, fetal abnormalities were observed but only following subcutaneous doses so high as to induce maternal toxicity. The clinical relevance of these findings is uncertain.

• Feeding time

Limited human data show that the drug passes into breast milk after systemic administration. However, the dose received by the infant after the mother's use of the drug should be insignificant. Results from animal studies indicate that Aciclovir cream has no effect on fertility.

Special warnings

The medicine is not recommended for application on mucous membranes, such as 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 recipients), oral aciclovir should be considered.

These patients should be encouraged to consult a physician regarding the treatment of any infection. The use, especially if prolonged, of the product can give rise to sensitization phenomena.

Expiry 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.

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

Composition

100 g of Aciclovir Sandoz 5% cream contain:

Active principle

Acyclovir 5.00 g.

Excipients

Purified water; propylene glycol; labrafil; Vaseline oil; polassamer 407; sodium lauryl sulfate; tefose.