METRONIDAZLE SAME GEL 30G 1%

METRONIDAZA SAME 1% GEL

active ingredients

100 g gel contains: Active ingredient: METRONIDAZOLO 1.0 g. Excipient with known effects: methyl parahydroxybenzoate (E218) (0.18 g per 100 g). For the full list of excipients, see paragraph 6.1.

Excellent

Octyldodecanol, caprilocaproil macrogol-8 glycerides, carbomer, methyl parahydroxybenzoate (E218), sodium hydroxide, sodium edetate, purified water.

Therapeutic indications

METRONIDAZOLO SAME is indicated for topical application in the treatment of papules, inflammatory pustulas and rosacea erythema.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Contraindicated in pregnancy and nursing (see p.4.6).

Population

Apply 1-2 times a day, according to medical indication and after detersion of the affected areas, a thin layer of METRONIDAZOLO SAME. Significant therapeutic results should be observed within three weeks of the beginning of treatment. Clinical studies have shown a progressive improvement up to nine weeks of therapy. After application of METRONIDAZOLO SAME you can use cosmetics.

Conservation

Do not freeze or refrigerate.

Warnings

However, due to the minimal absorption of the Metronidazole applied locally and, consequently, negligible plasma concentrations, the undesirable effects reported following oral administration of the drug were not recorded following topical application. Avoid contact with eyes and mucosa; it has been reported that the Metronidazole applied on the face determines tearing. In case of contact with the eyes, the gel must be removed carefully with water. You should inform the patient that if you experience irritation, you should use Metronidazolo Same less frequently or temporarily suspend therapy and inform the doctor. Avoid exposure to ultraviolet light (soles, UV lamps, tanning equipment) during treatment with Metronidazolo Same. As the drug is a nitroimidazolic derivative it must be used with caution in patients presenting hematic disorders or anamnestic data related to them. The product must be used according to the indications given by the doctor. Do not exceed the recommended doses. The use, especially if prolonged, of products for topical use, can give rise to phenomena of sensitization. There are no adequate clinical data on the effectiveness and safety of Metronidazolo Same in children, so Metronidazolo Same should not be used in children. Don't swallow. Keep out of reach of children. This medicine contains methyl parahydroxybenzoate, which can cause allergic reactions (also delayed).

Interactions

In view of the poor blood levels resulting from the topical application of Metronidazolo, interactions with other drugs are unlikely. However, it should be remembered that disulfiram-like reactions were reported in a small number of patients taking metronidazole and alcohol at the same time and in case of treatment of patients subjected to anticoagulant therapy, it should be borne in mind that Metronidazole, following oral administration, determines an increase in the anticoagulant effects of the cumarines and warfarin that is manifested in inducement of protrombine time. It is not known the effect of metronidazole by topical way on the time of protrombine.

Effects

Following the use of topical Metronidazole, the following side effects were reported: Pathologies of skin and subcutaneous tissue: contact dermatitis, skin dryness, erythema, itching, rash, skin discomfort (burning and puncture sensation), skin irritation, transient redness and rosacea worsening. Eye pathologies: tearing. None of these side effects manifested in more than 2% of treated patients. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No overdose cases were reported following the topical application of Metronidazolo.

The safety of use of metronidazole during pregnancy has not been sufficiently demonstrated. Contradictory reports are available, especially regarding the first phase of pregnancy. Some studies showed an increase in the rate of malformation. The risk of possible sequels, including a cancer risk, has not yet been clarified. Metronidazolo Same is contraindicated during the first trimester of pregnancy. During the central quarter and during the last trimester of pregnancy, Metronidazolo Same must be administered only in case of failure of other treatments. Following oral administration, Metronidazole is secreted in breast milk in concentrations similar to those found in plasma. As a result of the topical application, the drug reaches significantly lower plasma levels than those obtained after oral administration, so the doctor will have to determine whether to stop breastfeeding or treatment with the drug by properly assessing the importance of therapeutic treatment for the mother.

Source: Farmadati