Rozex 0,75% 50g cream

Rozex 0.75% cream 50g is a dermatological cream specifically formulated for the topical treatment of rosacea , particularly in its erythematous and papulopustular manifestations. The active ingredient, 0.75% metronidazole , acts directly on skin lesions, helping to reduce inflammation, redness and the appearance of papules and pustules typical of rosacea. Thanks to its targeted action, Rozex cream is considered a reference drug for rosacea , indicated for those seeking an effective and localized treatment of skin symptoms.

The formulation of Rozex cream is enriched with emollient and moisturizing excipients, such as cetylstearyl alcohol, sorbitol, glycerol and isopropyl palmitate , which promote skin tolerability and help keep the skin soft and protected during treatment. The presence of benzyl alcohol also guarantees an antiseptic action, while the pH adjustment with lactic acid and sodium hydroxide ensures respect for the physiological balance of the skin.

Rozex 0.75% cream 50g is particularly indicated for those suffering from rosacea with erythema, papules and pustules , offering a topical treatment that can be integrated into the daily skin care routine. The cream is easy to apply and quickly absorbed, allowing the use of non-comedogenic cosmetics after application. Thanks to its clinically proven efficacy, Rozex represents a reliable solution for controlling the symptoms of rosacea and improving the appearance of the skin.

If you are looking for a rosacea cream that combines efficacy, safety and ease of use, Rozex 0.75% cream is the ideal choice for the treatment of skin manifestations of rosacea, helping to visibly reduce erythema and papulopustular lesions and improve the quality of life of sensitive skin.

ACTIVE INGREDIENTS

Active ingredients contained in Rozex 0.75% 50g cream - What is the active ingredient in Rozex 0.75% 50g cream?

100 g of cream contain: Active ingredient: Metronidazole 0.75 g Excipients with known effect: Cetearyl alcohol 81-106 mg/g One gram of cream contains 22 mg of benzyl alcohol (E1519). For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Rozex 0.75% 50g cream - What does Rozex 0.75% 50g cream contain?

Emulsified waxes (cetylstearyl alcohol and polysorbate 60), 70% non-crystallized sorbitol, glycerol, isopropyl palmitate, benzyl alcohol (E1519), lactic acid and/or sodium hydroxide to adjust pH, purified water.

DIRECTIONS

Therapeutic indications Rozex 0.75% 50g cream - Why is Rozex 0.75% 50g cream used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Rozex 0.75% 50g cream - When should Rozex 0.75% 50g cream not be used?

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

DOSAGE

Quantity and method of taking Rozex 0.75% 50 g cream - How to take Rozex 0.75% 50 g cream?

Apply a thin layer of Rozex 0.75% cream to the affected area twice daily, morning and evening, after cleansing with a mild cleanser, rubbing in lightly. After applying Rozex 0.75% cream, non-comedogenic and non-astringent cosmetics may be used. Treatment in elderly patients does not require dosage adjustment. During clinical use, improvements occurred within the first three weeks of treatment and continued progressively up to the 12th week. The average duration of treatment usually varies from three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated, treatment may be extended according to medical advice for a further period ranging from three to four months depending on the severity of the condition. In clinical studies, topical metronidazole therapy for the treatment of rosacea was continued for up to two years. In the absence of clear clinical improvement, therapy should be discontinued. Paediatric population In the absence of data on safety and efficacy, the use of Rozex 0.75% cream is not recommended in children.

CONSERVATION

Storage Rozex 0.75% 50g cream - How to store Rozex 0.75% 50g cream?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Rozex 0.75% 50 g cream - About Rozex 0.75% 50 g cream it is important to know that:

Avoid contact with eyes and mucous membranes. During treatment with metronidazole, avoid exposure to UV rays (sunlight, solarium and sun lamps). Metronidazole is converted into an inactive metabolite by UV exposure, therefore its efficacy decreases significantly. In clinical studies, no undesirable effects of phototoxicity in relation to metronidazole have been reported. If a reaction due to local irritation occurs, it is advisable to reduce the number of daily applications of the drug or to suspend its administration according to the doctor's opinion. Metronidazole is a nitroimidazole compound and should therefore be used with caution in patients with blood dyscrasia. Avoid unnecessary and prolonged use of this medicine. Metronidazole has been shown to be carcinogenic in some animal species. There are no data demonstrating its carcinogenic effect in humans. Important information about some of the excipients. Rozex 0.75% cream contains: cetylstearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). This medicinal product also contains 22 mg benzyl alcohol (E1519) per gram, equivalent to 2.2% w/w, which may cause allergic reactions and mild local irritation.

INTERACTIONS

Interactions Rozex 0.75 % 50 g cream - Which medicines or foods can modify the effect of Rozex 0.75 % 50 g cream?

Given the poor systemic absorption of Rozex 0.75% cream applied topically, negative interactions with other drugs are quantitatively irrelevant. Metronidazole administered orally may lead to an enhancement of the effects of anticoagulant drugs. An increase in prothrombin time has been observed after concomitant administration of oral metronidazole and an oral coumarin-type anticoagulant (Warfarin). The effect of topical metronidazole on prothrombin time is not known. In addition, a reaction similar to that observed with Disulfiram has occurred in a small number of patients taking oral metronidazole and alcohol at the same time.

SIDE EFFECTS

Like all medicines, Rozex 0.75% 50g cream can cause side effects - What are the side effects of Rozex 0.75% 50g cream?

Only mild local reactions occurred during topical use of Rozex 0.75% cream. The following spontaneous adverse reactions have been reported and these have been ranked under headings of frequency using the following convention: very common (≥ 1/10) common (≥ 1/100, < 1/10) uncommon (≥ 1/1,000, < 1/100) rare (≥ 1/10,000, < 1/1,000) very rare (< 1/10,000) not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders: Common: dry skin, erythema, pruritus, skin discomfort (burning, skin pain, stinging), skin irritation, worsening of rosacea. Not known: contact dermatitis, skin exfoliation, facial swelling. Nervous system disorders: Uncommon: hypoesthesia, paraesthesia, dysgeusia (metallic taste). Gastrointestinal disorders: Uncommon: nausea. 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 www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose Rozex 0.75% 50g cream - What are the risks of Rozex 0.75% 50g cream in case of overdose?

No cases of overdose have been reported with topical use of Rozex 0.75% cream in humans. Acute oral toxicity studies with topical formulation of gel based on metronidazole at 0.75% w/w in rats have not shown a toxic action at doses up to 5 g maximum administered dose of finished product per kg of body weight. This dose is equivalent to the oral intake of 12 tubes of 30 g of Rozex cream for an adult weighing 72 kg and 2 tubes of 30 g for a child weighing 12 kg.

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 Rozex 0.75% 50 g cream.

Pregnancy In animal studies, orally administered metronidazole crosses the placenta, enters the fetal circulation and has not been found to be teratogenic or embryotoxic at therapeutic doses; since there are no clinical data on the effects of topical preparations administered during pregnancy, during this period the drug should be used only in cases of real need under the direct supervision of a physician. Breastfeeding After oral administration, concentrations of metronidazole in breast milk are similar to those found in plasma. With regard to topical administration of Rozex 0.75% cream during breastfeeding, it is advisable to evaluate the possibility of suspending breastfeeding or use of the drug depending on the real needs, even if the serum levels of the drug are significantly reduced compared to the levels achieved following oral administration.

DRIVING AND USE OF MACHINERY

Taking Rozex 0.75% 50g cream before driving or using machines - Does Rozex 0.75% 50g cream affect driving or using machines?

Rozex 0.75% cream does not alter the ability to drive vehicles or use machines.