Rosamet - instructions for use, dose, side effects, contraindications

Excipients: glycerin 12.90 mg, paraffin liquid 90.00 mg, wax emulsifying 100.00 mg, propylene glycol 20.00 mg, methyl parahydroxybenzoate 0.70 mg, propyl parahydroxybenzoate 0.30 mg, water purified 766.10 mg.

Description:

Homogenous white cream odorless.

Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug

ATX: & nbsp

P.01.A.B Nitroimidazole derivatives

P.01.A.B.01 Metronidazole

Pharmacodynamics:

Metronidazole has antiparasitic and antimicrobial properties and is active against many pathogenic microorganisms. Metronidazole has anti-acne action and is especially effective against papulo-pustular inflammatory elements of rosacea. The mechanism of action, apparently, also includes an anti-inflammatory effect. The drug is active against gram-negative aerobic microorganisms: Helicobacter pylori; anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium, Bilophila, Clostridium, Clostridium difficile, Clostridium perfringens, Eubacterium, Fusobacterium, Peptostreptococus, Prevotella, Prophyromonas, Veillonella; protozoa: Entamoeba histolytica, Glardia intestinalis, Trichomonas vaginalis.

Pharmacokinetics:The maximum concentration of metronidazole in the blood serum with external application of 1 g of Rosamet cream on the face is an average of 32.9 ng / ml (range 14.8 - 54.4 ng / ml).This amount does not exceed 0.5% of the average maximum concentration of metronidazole in the blood serum after oral administration of 250 mg of metronidazole in the form of tablets. The peak concentration of metronidazole in the blood serum after the skin application of Rosamet cream is observed after 6-24 hours. With external application, the concentration of the drug at the site of application is much higher than in the blood plasma.

Indications:Treatment of rosacea and acne.

If necessary, please consult with your doctor before using the medication.

Contraindications:

Hypersensitivity to the active ingredient or one of the ingredients of the drug.

Carefully:

Pregnancy and lactation:Pregnancy

Data on the use of metronidazole in pregnant women are absent. Cream Rosamet should be used during pregnancy only if there are clear indications after consulting a doctor.

Breastfeeding period

After oral administration metronidazole penetrates into breast milk in concentrations similar to those found in blood plasma. Despite the fact that after external application of Rosamet cream in breast-feeding women, its level in the blood is much lower than after taking metronidazole inside,the decision to stop breastfeeding or discontinue the use of the drug should be made taking into account the importance of the use of the drug for the mother and the risk to the child.

Dosing and Administration:

For external use only.

Cream Rosamet put a thin layer on the previously cleaned affected areas of the skin and lightly rub twice a day, morning and evening, avoiding contact with the eyes, lips and mucous membranes of the nose. Between skin cleansing and applying cream it is recommended to take a break 15-20 minutes. The average duration of treatment is 3-4 months. However, in the presence of obvious signs of the benefits of therapy, the treating physician may consider the continuation of the patient's treatment for an additional 3-4 months, depending on the severity of the condition.

Older patients are not required to adjust the dose. Preparation Rosamet It is not recommended for use in children due to the lack of data on the safety and efficacy of the drug in patients of this age category.

If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor.

Use the drug only according to the method of administration and the doses specified in the instructions. If necessary, please consult with your doctor before using the medication.

Side effects:

When applying the Rosamet cream, the following spontaneous reports of undesirable events were recorded, which within each class of organ systems were divided according to the frequency of occurrence using the following categories:

Very often (≥1 / 10)

Often (≥1 / 100 to <1/10)

Infrequently (≥1 / 1,000 to <1/100)

Rarely (≥1 / 10,000 to <1/1 000)

Very rarely (<1/10 000), including individual messages.

Disturbances from the skin and subcutaneous tissues

Often: dry skin, erythema, pruritus, skin discomfort (burning sensation of the skin, soreness of the skin / pricking), skin irritation, increased manifestations of rosacea

Unknown frequency: contact dermatitis, skin peeling, swelling of the face.

Disturbances from the nervous system

Infrequently: hypoesthesia, paresthesia, dysgeusia (metallic taste in the mouth).

Disorders from the gastrointestinal tract

Infrequently: nausea.

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

Overdose:

Cases of overdose are not marked.

Interaction:

When using Rosamet cream, no cases of interaction with other drugs were recorded. The caution warning when concomitantly prescribing metronidazole with warfarin or other indirect anticoagulants due to a possible increase in prothrombin time refers only to the oral form of metronidazole.

Special instructions:

If there are signs of skin irritation due to the use of Rosamet cream, you should reduce the frequency of its application, temporarily suspend or permanently discontinue the use of the drug and, if necessary, consult a doctor.

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

After applying the drug, it is possible to use cosmetics that do not possess comedogenic and astringent properties.

During treatment, exposure to UV radiation (direct sunlight, solarium, sunlight) should be avoided. Under the action of UV radiation metronidazole goes into an inactive metabolite, so its effectiveness is significantly reduced.

Avoid excessive and prolonged use of the drug.

Metronidazole is a derivative of nitroimidazole and should be used with caution in patients with impaired blood.

Read the instructions carefully before using the product. Keep the manual, it may be needed again. If you have any questions, contact your doctor. The medicine you are treating is intended for you personally, and it should not be passed on to others, as it can harm them even if you have the same symptoms as you.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:

Cream for external use, 1%.

Packaging:

For 25 g of the preparation in an aluminum tube coated with a double protective varnish, with a sealed hole, a protective membrane and a plastic cap provided with a tapered device for puncturing the protective membrane. The tube together with the instruction for use is placed in a cardboard box.

Storage conditions:At a temperature not higher than 25 ° C, out of the reach of children.

Shelf life:2 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012373 / 01

Date of registration:23.07.2010 / 29.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:Yadran Galensky Laboratories a.o.Yadran Galensky Laboratories a.o. Croatia

Manufacturer: & nbsp

JADRAN Galenski Laboratorij, d.d. Croatia

Representation: & nbspYadran Galen Laboratory as.Yadran Galen Laboratory as.Croatia

Information update date: & nbsp22.05.2017

Illustrated instructions

Instructions

Rosamet (Rozamet)