Aciclovir EG 5% 3g cream

Aciclovir EG 5% 3 g cream is an antiviral cream specifically formulated for the treatment of Herpes Simplex skin infections , such as cold sores (herpes labialis) and genital herpes (herpes genitalis) . Thanks to its 5% concentration of aciclovir , this cream acts directly on the lesions, helping to reduce the duration and intensity of the typical symptoms of herpes, such as blisters, itching and burning. The 3g tube formulation is practical and ideal for targeted and discreet application, both on the lips and genital areas.

Aciclovir EG cream is indicated for those looking for an effective drug against herpes , both in the initial and in the more advanced stages of the lesions. Local application allows for timely intervention on the affected areas, promoting rapid healing and limiting the spread of the virus. The cream contains selected excipients to ensure good skin tolerability, including cetostearyl alcohol, sodium lauryl sulfate and propylene glycol , which contribute to an easily absorbed and comfortable texture on the skin.

Ideal for those who suffer from blisters on the lips or in the genital area , Aciclovir EG 5% cream represents a reliable solution for the local treatment of herpes . Its targeted action helps to quickly reduce symptoms and prevent the appearance of new lesions, offering relief and protection in the most annoying phases of the infection. Choose Aciclovir EG cream for an effective and safe treatment against the herpes virus , with the guarantee of a quality product designed for the needs of sensitive skin and subject to viral infections.

ACTIVE INGREDIENTS

Active ingredients contained in Aciclovir EG 5 % 3 g cream - What is the active ingredient of Aciclovir EG 5 % 3 g cream?

1 g of cream contains : Active ingredient: aciclovir: 50 mg. Excipients with known effect: 67.5 mg of cetostearyl alcohol, 7.5 mg of sodium lauryl sulphate, 200 mg of propylene glycol (E1520). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Aciclovir EG 5 % 3 g cream - What does Aciclovir EG 5 % 3 g cream contain?

Poloxamer 407; Cetostearyl alcohol; Sodium lauryl sulphate; White petrolatum; Liquid paraffin; Sucrose monopalmitate; Propylene glycol (E1520); Purified water.

DIRECTIONS

Therapeutic indications Aciclovir EG 5 % 3 g cream - Why is Aciclovir EG 5 % 3 g cream used? What is it used for?

ACICLOVIR EG cream is indicated in the treatment of skin infections caused by Herpes Simplex such as: primary or recurrent genital herpes and herpes labialis.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Aciclovir EG 5 % 3 g cream - When should Aciclovir EG 5 % 3 g cream not be used?

ACICLOVIR EG cream is contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir, propylene glycol or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Aciclovir EG 5 % 3 g cream - How to take Aciclovir EG 5 % 3 g cream?

ACICLOVIR EG CREAM should be applied 5 times a day at approximately 4-hour intervals. ACICLOVIR EG cream should be applied to the lesions, or to areas where they are developing, as soon as possible, preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later stages (papules or vesicles). Treatment should continue for at least 4 days for herpes labialis and for 5 days for herpes genitalis. If there has been no healing, treatment can continue for up to 10 days.

CONSERVATION

Storage Aciclovir EG 5 % 3 g cream - How is Aciclovir EG 5 % 3 g cream stored?

Store at a temperature not exceeding 25°C.

WARNINGS

Warnings Aciclovir EG 5 % 3 g cream - About Aciclovir EG 5 % 3 g cream it is important to know that:

Aciclovir cream is not recommended for ophthalmic use, nor is it advisable to apply it to the mucous membranes of the mouth or vagina as it may be irritating. Particular care should be taken to avoid accidental application to the eyes. Animal studies indicate that application of ACICLOVIR EG cream in the vagina may cause reversible irritation. 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 stopped and the treating doctor consulted. No phenomena of habituation or dependence on the drug have been reported. Important information about some of the excipients This medicinal product contains cetostearyl alcohol which may cause localized skin reactions (e.g. contact dermatitis). This medicinal product contains 7.5 mg of sodium lauryl sulphate per g of cream. Sodium lauryl sulphate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area. This medicine contains 200 mg propylene glycol per g of cream.

INTERACTIONS

Interactions Aciclovir EG 5 % 3 g cream - Which medicines or foods can modify the effect of Aciclovir EG 5 % 3 g cream?

No clinically significant interactions have been identified.

SIDE EFFECTS

Like all medicines, Aciclovir EG 5 % 3 g cream can cause side effects - What are the side effects of Aciclovir EG 5 % 3 g cream?

The following convention has been used for the classification of undesirable 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. Data from clinical trials with aciclovir cream have been used to assign frequency categories to the adverse reactions observed during clinical trials. Due to the nature of the adverse events observed, it is not possible to determine unequivocally which events are related to the administration of the drug and which are related to the disease itself. Data from spontaneous reporting have been used as a basis for determining the frequency of those events detected by post-marketing surveillance. 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 was performed, the substances that gave reactivity were the components of the base cream 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Aciclovir EG 5 % 3 g cream - What are the risks of Aciclovir EG 5 % 3 g cream in case of overdose?

Even if the entire contents of a 10 g tube of cream containing 500 mg aciclovir are ingested, no adverse effects should be expected.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Aciclovir EG 5% 3 g cream.

Fertility See Clinical studies in section 5.2. 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 application of aciclovir cream is very low. A post-marketing pregnancy registry has provided information on pregnancy outcomes in women exposed to various formulations of aciclovir. These findings have not shown an increase in the number of birth defects among subjects exposed to aciclovir compared with the general population and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce any embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard teratogenicity study in rats, fetal abnormalities were observed after subcutaneous doses of aciclovir high enough to produce toxic effects in the mother. The clinical relevance of these findings is, however, uncertain. Breast-feeding Limited data 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.

DRIVING AND USE OF MACHINERY

Taking Aciclovir EG 5 % 3 g cream before driving or using machines - Does Aciclovir EG 5 % 3 g cream affect driving or using machines?

None known.