Metronidazolo Same*gel 30g 1%

NAME
METRONIDAZOLE SAME 1% GEL

PHARMACOTHERAPEUTIC CATEGORY
Topical chemotherapy drugs.

ACTIVE PRINCIPLES
Metronidazole.

EXCIPIENTS
Octyldodecanol, caprilocaproil macrogol-8 glycerides, carbomer, methylparahydroxybenzoate, sodium hydroxide, sodium edetate, purified water.

INDICATIONS
The medicine is indicated for topical application in the treatment of papules, inflammatory pustules and erythema of rosacea.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; contraindicated in pregnancy and lactation.

DOSAGE
Apply a thin layer of metronidazole 1-2 times a day, according to medical indications and after cleansing the affected areas. Significant therapeutic results should be observed within three weeks of starting treatment. Clinical studies have shown progressive improvement for up to nine weeks of therapy. After the application of metronidazole it is possible to use cosmetics.

STORAGE
Do not freeze or refrigerate.

WARNINGS
However, due to the minimal absorption of metronidazole applied locally and, consequently, to negligible plasma concentrations, the undesirable effects reported following oral administration of the drug were not recorded following topical application. Avoid contact with eyes and mucous membranes; it has been reported that metronidazole applied to the face causes tearing. In case of contact with the eyes, the gel must be carefully removed with water. The patient should be advised that if irritation occurs, he should use Metronidazole less frequently or temporarily discontinue therapy. Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during metronidazole therapy. Since the drug is a nitroimidazole derivative, it should be used with caution in patients presenting with blood dyscrasias or with anamnestic data relating to them. The product must be used according to the instructions provided by the attending physician. Do not exceed the recommended dose. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. There are no adequate clinical data on the efficacy and safety of dimetronidazole in children, therefore metronidazole should not be used in children. Do not swallow.

INTERACTIONS
In consideration of the low blood levels following the topical application of Metronidazole, interactions with other drugs are unlikely. However, it should be borne in mind that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol at the same time and when treating patients receiving concomitant anticoagulant therapy, it should be borne in mind that metronidazole, following oral administration, determines an enhancement of the anticoagulant effects of coumarins and warfarin which occurs by inducing a prolongation of the prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

SIDE EFFECTS
The following side effects have been reported with the use of topical metronidazole. Skin and subcutaneous tissue disorders: contact dermatitis, dry skin, erythema, itching, rash, skin discomfort (burning and stinging sensation), skin irritation, transient redness and worsening of rosacea. Eye disorders: lacrimation. None of these undesirable effects occurred in more than 2% of treated patients.

PREGNANCY AND BREASTFEEDING
The safety of metronidazole use during pregnancy has not been sufficiently demonstrated. Contradicting reports are available, especially regarding the first stage of pregnancy. Some studies have given indications of an increase in the rate of malformations. The risk of possible sequelae, including a carcinogenic risk, has not yet been clarified. Metronidazole is contraindicated during the first quarter of pregnancy. During the middle and last trimester of pregnancy, metronidazole should only be given if other treatments have failed. Following oral administration, metronidazole is secreted into breast milk in concentrations similar to those found in plasma. Following topical application, the drug reaches plasma levels significantly lower than those obtained after oral administration, therefore deciding whether to stop breastfeeding or treatment with the drug by appropriately evaluating the importance of therapeutic treatment for the mother.