Savoma medicinali Metronidazole same 1% gel - rosacea treatment 30 g (damaged package)

Product Description

Gel

Composition:

100 g of gel contain: Active ingredient: METRONIDAZOLE 1.0 g.

Excipients

Octyldodecanol, caprylocaproyl macrogol-8 glycerides, carbomer, methyl parahydroxybenzoate, sodium hydroxide, sodium edetate, purified water.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients. Contraindicated during pregnancy and breastfeeding.

Dosage

Apply a thin layer of METRONIDAZOLE SAME 1–2 times a day, as directed by your doctor 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. Cosmetics can be used after applying METRONIDAZOLE SAME.

Warnings and precautions

However, due to the minimal absorption of locally applied Metronidazole and, consequently, negligible plasma concentrations, the adverse effects reported following oral administration of the drug have not been recorded following topical application. Avoid contact with eyes and mucous membranes; Metronidazole applied to the face has been reported to cause tearing. In case of contact with eyes, the gel must be carefully removed with water. Patients should be advised that if irritation occurs, they should use Metronidazole Same less frequently or temporarily discontinue therapy and inform their doctor. Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during therapy with Metronidazole Same. Since the drug is a nitroimidazole derivative, it should be used with caution in patients with blood dyscrasias or a history of such. The product should be used according to the instructions provided by the attending physician. Do not exceed the recommended dose. The use of topical products, especially if prolonged, may give rise to sensitization phenomena. There are no adequate clinical data on the efficacy and safety of Metronidazole Same in children, therefore Metronidazole Same should not be used in children. Do not ingest. Keep out of reach of children.

Interactions

Given the low blood levels resulting from topical application of Metronidazole, interactions with other drugs are unlikely. However, it should be remembered that disulfiram-like reactions have been reported in a small number of patients taking Metronidazole and alcohol concomitantly. When treating patients receiving concomitant anticoagulant therapy, it should be borne in mind that Metronidazole, following oral administration, potentiates the anticoagulant effects of coumarins and warfarin, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is unknown.

Undesirable effects

The following side effects have been reported following the use of topical metronidazole: Skin and subcutaneous tissue disorders: contact dermatitis, dry skin, erythema, pruritus, rash, skin discomfort (burning and stinging sensation), skin irritation, transient redness, and worsening of rosacea. Eye disorders: lacrimation.

None of these side effects occurred in more than 2% of treated patients.

Pregnancy and breastfeeding

The safety of metronidazole during pregnancy has not been adequately demonstrated. Contradictory reports are available, especially regarding the early phase of pregnancy. Some studies have shown an increased rate of malformations. The risk of possible sequelae, including a carcinogenic risk, has not yet been clarified. Metronidazole Same is contraindicated during the first trimester of pregnancy. During the middle and last trimester of pregnancy, Metronidazole Same should be administered only 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 significantly lower plasma levels than those obtained after oral administration. Therefore, the treating physician must decide whether to discontinue breastfeeding or treatment with the drug, appropriately assessing the importance of the therapeutic treatment for the mother.