Rosamet cream 1%, 25 g

Rosacea treatment.

For external use only.

Adults. Rosamet cream is applied in a thin layer to previously cleansed affected areas of the skin twice a day, in the morning and in the evening, avoiding contact with the eyes, lips and nasal mucous membranes. Before applying the cream, the affected skin area should be washed with warm water or a mild detergent that does not irritate the skin. After applying the cream, it is possible to use cosmetics that do not have comedogenic and astringent properties. The average duration of treatment is 3-4 months. However, if there are clear signs of the effectiveness of therapy, the attending physician may consider continuing treatment for an additional 3-4 months, depending on the severity of the patient's condition. In the absence of obvious clinical improvement, treatment should be discontinued.

Elderly patients do not need dose adjustment.

Rosamet is not recommended for use in children under 18 years of age due to the lack of data on the safety and efficacy of metronidazole in patients of this age category.

If after treatment there is no improvement or new symptoms appear, you should consult your doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions.

1 g of cream contains:

active substance : metronidazole 10.00 mg;

excipients : glycerol, liquid paraffin, Lanette SX emulsifier [cetostearyl alcohol, sodium lauryl sulfate, purified water], propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Hypersensitivity to metronidazole and other components of the drug.

Children under the age of 18.

Application during pregnancy and during breastfeeding

Pregnancy

There are no data on clinical experience of external use of metronidazole in pregnant women. When taken orally, metronidazole crosses the placental barrier and quickly enters the fetal bloodstream. After oral administration of metronidazole to rats or mice, no signs of fetal toxicity were observed. However, since reproductive toxicity studies in animals do not always predict the response in humans, and since oral administration of metronidazole has demonstrated its carcinogenic properties in rodents, the drug is used during pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus. after consulting a doctor. If you are pregnant, or suspect that you may be pregnant, or are planning to become pregnant, you should consult your doctor.

Breastfeeding period

After oral administration, metronidazole passes into breast milk in concentrations similar to those found in blood plasma. Despite the fact that after external use of metronidazole in breastfeeding women, its concentration in blood plasma is significantly lower than after oral administration, the decision to stop breastfeeding or discontinue use of the drug should be made taking into account the assessment of the importance of using the drug for the mother and the risk to the child after consulting a doctor.

Composition:

1 g of cream contains:

active substance : metronidazole 10.00 mg;

excipients : glycerol, liquid paraffin, Lanette SX emulsifier [cetostearyl alcohol, sodium lauryl sulfate, purified water], propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Pharmacotherapeutic group

Antimicrobial and antiprotozoal agent.

Pharmacological properties

Pharmacodynamics

Metronidazole is a nitroimidazole derivative. Possesses antimicrobial and antiprotozoal activity against gram-negative aerobic and anaerobic microorganisms and protozoa. When applied topically, metronidazole is especially effective against papulopustular inflammatory elements of rosacea. The mechanism of action also appears to include an anti-inflammatory effect.

Pharmacokinetics

The maximum concentration of metronidazole in blood plasma with external application of 1 g of Rosamet cream on the face is on average 32.9 ng / ml (range 14.8Ц54.4 ng / ml) and is reached after 6-24 hours. The maximum concentration of metronidazole in blood plasma when applied externally does not exceed 0.5% of the average maximum concentration of metronidazole in blood plasma after oral administration of 250 mg of metronidazole in the form of tablets. When applied externally, the concentration of metronidazole at the site of application of the cream is significantly higher than in blood plasma. The connection with plasma proteins is negligible. The lowest concentration of metronidazole is found in adipose tissue. It is excreted by the kidneys unchanged and in the form of metabolites.

Indications for use:

Rosacea treatment.

Mode of application:

For external use only.

Adults. Rosamet cream is applied in a thin layer to previously cleansed affected areas of the skin twice a day, in the morning and in the evening, avoiding contact with the eyes, lips and nasal mucous membranes. Before applying the cream, the affected skin area should be washed with warm water or a mild detergent that does not irritate the skin. After applying the cream, it is possible to use cosmetics that do not have comedogenic and astringent properties. The average duration of treatment is 3-4 months. However, if there are clear signs of the effectiveness of therapy, the attending physician may consider continuing treatment for an additional 3-4 months, depending on the severity of the patient's condition. In the absence of obvious clinical improvement, treatment should be discontinued.

Elderly patients do not need dose adjustment.

Rosamet is not recommended for use in children under 18 years of age due to the lack of data on the safety and efficacy of metronidazole in patients of this age category.

If after treatment there is no improvement or new symptoms appear, you should consult your doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions.

Side effect

Classification of adverse reactions by organs and systems, indicating the frequency of their occurrence:

Very often (? 1/10)

Often (? 1/100 to <1/10)

Uncommon (? 1/1000 to <1/100)

Rarely (? 1 / 10,000 to <1 / 1,000)

Very rare (<1 / 10,000), including isolated reports

The frequency is unknown (the frequency cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Often: dry skin, erythema, itching, skin discomfort (burning sensation of the skin, skin soreness / tingling), skin irritation, increased manifestations of rosacea.

Frequency unknown: contact dermatitis, peeling of the skin, swelling of the face.

Nervous system disorders

Uncommon: hypesthesia, paresthesia, dysgeusia ('metallic' taste in the mouth).

Gastrointestinal disorders

Uncommon: nausea.

If any of the side effects indicated in the instructions are aggravated, or any other side effects not indicated in the instructions are noted, you should immediately inform your doctor about it.

Contraindications:

Hypersensitivity to metronidazole and other components of the drug.

Children under the age of 18.

Application during pregnancy and during breastfeeding

Pregnancy

There are no data on clinical experience of external use of metronidazole in pregnant women. When taken orally, metronidazole crosses the placental barrier and quickly enters the fetal bloodstream. After oral administration of metronidazole to rats or mice, no signs of fetal toxicity were observed. However, since reproductive toxicity studies in animals do not always predict the response in humans, and since oral administration of metronidazole has demonstrated its carcinogenic properties in rodents, the drug is used during pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus. after consulting a doctor. If you are pregnant, or suspect that you may be pregnant, or are planning to become pregnant, you should consult your doctor.

Breastfeeding period

After oral administration, metronidazole passes into breast milk in concentrations similar to those found in blood plasma. Despite the fact that after external use of metronidazole in breastfeeding women, its concentration in blood plasma is significantly lower than after oral administration, the decision to stop breastfeeding or discontinue use of the drug should be made taking into account the assessment of the importance of using the drug for the mother and the risk to the child after consulting a doctor.

Overdose

To date, there have been no reports of overdose cases with external use of the drug. When using the drug in accordance with the instructions for use, an overdose is unlikely.

Interaction with other medicinal products

When using Rosamet cream, there were no cases of interaction with other drugs. Interaction with systemic drugs is unlikely due to the low absorption of metronidazole when used externally.

However, a disulfiram-like reaction has been observed in a small number of patients with concomitant oral administration of metronidazole and ethanol.

The warning to be careful with the simultaneous use of metronidazole with warfarin or other indirect anticoagulants due to a possible increase in prothrombin time applies only to metronidazole when taken orally.

If you are using the above or other drugs (including over-the-counter), consult your doctor before using the drug.

special instructions

If signs of skin irritation appear due to the use of Rosamet cream, you should reduce the frequency of its application, temporarily suspend or stop using the drug and consult a doctor.

Avoid getting the cream in the eyes and mucous membranes. In case of accidental contact, rinse thoroughly with warm water.

During treatment, exposure to ultraviolet (UV) radiation (direct sunlight, tanning beds, sunlight lamps) should be avoided. Under the influence of UV radiation, metronidazole passes into an inactive metabolite, therefore its activity is significantly reduced.

Avoid excessive and prolonged use of the drug.

Metronidazole is a nitroimidazole derivative and should be used with caution in patients with blood disorders, including a history.

This product contains propylene glycol, which may irritate the skin.

Given that the drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, there is a risk of allergic reactions.

Influence on the ability to drive vehicles, mechanisms

The drug does not affect the ability to drive vehicles and mechanisms (based on the pharmacodynamic profile and clinical experience of use).

Packing type:

25 g of the drug in an aluminum tube coated with a protective varnish on the inside and outside, with a sealed protective membrane hole and a plastic cap equipped with a cone-shaped device for piercing the protective membrane. The tube together with the instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature not exceeding 25 ? C, out of the reach of children.

Shelf life

2 years. Do not use after the expiration date.

Vacation conditions

Available without a prescription.

Manufacturer: JADRAN-GALENSKI LABORATORIES a.s., Svilno 20, 51000 Rijeka, Croatia.