Rosiced Crema 0,75% Metronidazolo Rosacea Tubo 30g

Metronidazole -based cream

Therapeutic indications

Rosiced is used in the topical or treatment of the inflammatory papulopustular manifestations of rosacea.

Dosage and Posology

The drug should be taken according to the following doses and methods: apply and gently massage a thin layer of cream on the affected skin of the face twice a day, for a usual duration of treatment from 6 to 12 weeks. If necessary, the treatment can be continued. In the absence of clinical improvement, therapy should be discontinued.

There are no adequate clinical data on the efficacy and safety of Rosiced cream in children; therefore Rosiced cream should not be used in children. The areas to be treated must be cleansed before applying the cream. Patients can use non-comedogenic and non-astringent cosmetics after applying the cream.

Overdose

Overdose is extremely unlikely. The cream should be removed by rinsing with warm water. There are no data on overdose in humans. Acute oral toxicity studies with the topical gel formulation containing 0.75% metronidazole in rats showed no toxic action with doses up to 5g of finished product per kg body weight, the highest dose used. . This dose is equivalent to oral administration of 12 x 30g tubes of 0.75% metronidazole cream for an adult weighing 72 kg and 2 tubes of cream for a child weighing 12 kg.

Contraindications

• First trimester of pregnancy
• Hypersensitivity to medicines containing metronidazole or other 5-nitroimidazoles. The only exception is cases of life-threatening infections or where other medicines have been found to be ineffective.
• Patients with hypersensitivity to any of the excipients.
• In patients with severe hepatic injury, dyshematopoiesis and central or peripheral nervous system disease, a careful risk / benefit assessment is required prior to treatment.

Side effects

The following spontaneous adverse reactions have been reported which are categorized by system organ class by frequency using the following convention: very common (≥ 1/10), common (≥1 / 100 to <1/10) , uncommon ((≥ 1 / 1,000 <1/100), rare (≥1 / 10,000, <1 / 1,000), very rare (<1 / 10,000), including isolated reports.

- Immune system disorders:

• Rare: anaphylaxis.

- Skin and subcutaneous tissue disorders

• Common: contact dermatitis, dry skin, erythema, itching, rash, skin discomfort (burning and stinging sensation), skin irritation, worsening of rosacea.
• Rare: angio-edema.

.- Nervous system disorders:

• Uncommon: hypoesthesia, paraesthesia.

- General disorders and administration site conditions:

• Common: pain.

- Gastrointestinal disorders:

• Rare: metallic taste, nausea.

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 indicated an increase in the rate of malformations. The risk of possible sequelae, including a carcinogenic risk, has not yet been clarified. In case of uncontrolled use of nitroimidazoles by the mother, the fetus and / or the neonate are exposed to a carcinogenic or genotoxic risk. To date, there is no proven evidence of damage to the embryo or fetus. In experimental animal studies, metronidazole did not exhibit teratogenic properties.

Rosiced Cream is contraindicated during the first trimester of pregnancy. During the middle and last trimester of pregnancy, Rosiced Cream should only be given if other treatments have failed. Metronidazole passes into breast milk. Following oral administration, 100% of the plasma value can be achieved. Following cutaneous application of Rosiced Cream, plasma levels are lower than those seen after oral administration of metronidazole. However, breastfeeding should be discontinued or treatment with Rosiced Cream should be discontinued.

Special warnings

Avoid contact with eyes and mucous membranes. In case of contact, the cream should be carefully removed with water. If irritation occurs, the patient should be advised to use Rosiced less frequently or to temporarily discontinue therapy and to seek advice from the physician if necessary. Avoid exposure to ultraviolet light (sun baths, solariums, sunlamps) during therapy with Rosiced cream. The recommended duration of therapy should not be exceeded. If required, the therapy can be repeated, but an interval of 6 weeks should be kept between the two treatments.

There are no adequate clinical data on the efficacy and safety of Rosiced cream in children, therefore Rosiced cream should not be used in children. The cream should be used with caution in patients with evidence or a history of blood dyscrasia. Unnecessary or prolonged use of this medicinal product should be avoided. Evidence suggests that metronidazole is carcinogenic in some animal species. There is no evidence so far of a carcinogenic effect in humans. The drug contains propylene glycol, which can cause skin irritation.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 30 ° C. Do not refrigerate or freeze.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

1 gr of Rosiced Crema contains:

Active principle

Metronidazole 7.5 mg (0.75% m / m)

Excipients

Glyceryl monolaurate, Glyceryl monomyristate, Propylene glycol, Anhydrous citric acid (pH regulator), Sodium hydroxide (pH regulator), Carbomers, Purified water.