ROZEX CREMA DERM 50G 0.75%

ROZEX 0,75% CREMA

active ingredients

100 g cream contain: Active Principle: Metronidazole 0.75 g Excipients with known effects: Cetilstearilic alcohol 81-106 mg/g A gram of cream contains 22 mg of benzilic alcohol (E1519). For the full list of excipients, see paragraph 6.1

Excellent

Emulsified waxes (cetylstearilic alcohol and polysorbate 60), non crystallized sorbitol to 70%, glycerol, isopropylpalmitate, benzilic alcohol (E1519), lactic acid and/or sodium hydroxide to adjust the pH, purified water.

Therapeutic indications

Rozex 0.75% cream is indicated in the topical treatment of rosacea in its erythematous and papulo-pustolose manifestations.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Apply twice a day, morning and evening, a thin layer of Rozex 0.75% cream on the affected area, suitably cleansed with a delicate detergent, frying slightly. After application of Rozex 0.75% cream you can use non-comedogenic and non-astringent cosmetics. Treatment in elderly patients does not require a dosage adjustment. During clinical use improvements occurred within the first three weeks of treatment and continued progressively until the 12th week. The average duration of treatment varies, usually, from three to four months. The recommended duration of the treatment should not be exceeded. However, if an obvious benefit has been shown, the treatment may be prolonged according to medical advice for a further period of three to four months depending on the severity of the condition. In clinical studies, topical therapy with metronidazole for the treatment of rosacea continued until two years. In the absence of obvious clinical improvement, therapy must be interrupted. Pediatric population In the absence of data on safety and effectiveness, the use of Rozex 0.75% cream is not recommended in children.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Avoid contact with eyes and mucosa. In the course of metronidazole therapy avoid exposure to UV rays ( exposure to sun rays, solarium and solar lamps). The metronidazole is converted into an inactive metabolite due to UV exposure, therefore its effectiveness decreases significantly. In clinical studies there were no undesirable effects of phototoxicity in relation to metronidazole. If a reaction due to local irritation occurs, it is recommended to reduce the number of daily applications of the drug or to suspend administration according to the doctor's opinion. Metronidazole is a nitroimidazolic compound and is therefore used with caution in patients with blood disorder. Avoid unnecessary and prolonged use of this medicine. It is shown that metronidazole is carcinogenic in some animal species. There is no data that shows its carcinogenic effect in humans. Important information about some excipients. Rozex 0.75% cream contains: cetilstearilic alcohol that can cause reactions on the localized skin (e.g. contact dermatitis). This medicine also contains 22 mg of benzilic alcohol (E1519) per gram, equivalent to 2.2% w/w, which can cause allergic reactions and mild local irritation.

Interactions

Considering the poor systemic absorption of Rozex 0.75% cream applied by topical means, negative interactions with other drugs are quantitatively irrelevant. The metronidazole administered by mouth can lead to an increase in the effects of anticoagulant drugs. An increase in protrombine time was observed after contemporary administration of oral metronidazole and an oral anticoagulant of cumarinic type (Warfarin). The effect of the topical metronidazole on the protrombine time is not known. In addition, in a small number of patients taking oral metronidazole and alcohol at the same time, a reaction similar to that occurred with Disulfiram.

Effects

During the topical use of Rozex 0.75% cream only mild local reactions occurred. The following spontaneous adverse reactions have been reported and these have been ordered by frequency within classifications for systems and organs, according to the following convention: very common (≥ 1/10) common (≥ 1/100, Pathology of skin and subcutaneous tissue: Common: skin dryness, erythema, itching, skin discomfort (burner, skin pain, pungent pain), skin irritation, rosacea worsening. Note: contact dermatitis, skin exfoliation, facial swelling. Diseases of the nervous system: Not common: hypoesthesia, parestesia, disgeusia (metallic taste).Gastrointestinal diseases: Not common: nausea. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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.agenziafarmaco.gov.it/it/responsabili.

Overdosing

No hyperdosage cases have been reported with the topical use of Rozex 0.75% cream in man. Oral acute toxicity studies with topical formulation of metronidazole gel at 0.75% p/p in rats showed no toxic action at doses up to 5 g maximum dose administered of finished product per body kilo. This dose is equivalent to the oral intake of 12 30 g Rozex cream tubes for an adult whose weight is 72 kg and 2 30 g tubes for a child whose weight is 12 kg.

Pregnancy

In animal studies, the metronidazole administered by mouth passes through the placenta, enters the fetal circulation and is neither therapeutic nor embryotoxic; since there is no clinical data on the effects of topical preparations administered during pregnancy, during this period the drug must be used only in cases of actual need under the direct control of the doctor.

Food

After oral administration, metronidazole concentrations in breast milk are similar to those found in plasma. With regard to the topical administration of Rozex 0.75% lactation cream, it is appropriate to assess the possibility of suspending breastfeeding or the use of the drug according to the actual need, although serum levels of the drug are significantly reduced compared to the levels reached following oral administration.

Source: Farmadati