Rosamet (metronidazole) cream 1% tube 25 g

Product form, composition and packaging Cream for external use 1% white, homogeneous, odorless.

1 g

metronidazole

10 mg

glycerol - 12.9 mg, liquid paraffin - 90 mg, emulsifying wax - 100 mg, propylene glycol - 20 mg, methyl parahydroxybenzoate - 0.7 mg, propyl parahydroxybenzoate - 0.3 mg, purified water - 766.1 mg.

25 g - aluminum tubes (1) - packs of cardboard. Pharmacological action When applied topically, it has an anti-acne effect, the mechanism of which is not exactly known (not associated with the effect on the Demodex folliculorum mite, found in hair follicles and the secretion of the sebaceous glands, and any effect on products of this secret). Metronidazole for external use may have antioxidant activity. It has been found that it significantly reduces the production of active oxygen, hydroxyl radicals and hydrogen peroxide by neutrophils, which are potential oxidants that can cause tissue damage at the site of inflammation. Metronidazole for external use is ineffective against telangiectasias observed with rosacea. Pharmacokinetics When applied topically, the drug is practically not absorbed.Indications for use - inflamed papules, pustules

- erythema with rosacea and acne vulgaris (acne rozacea, acne vulgaris)

- balanoposthitis

- vulvovaginitis. Contraindications for use - hypersensitivity.

With care: pregnancy (I trimester), lactation period. Dosing regimen

Treatment of inflamed papules, pustules, erythema with rosacea and acne vulgaris (acnerozacea, acnevulgaris): apply a thin layer to the skin previously cleaned with warm water or a light detergent and rub in 1-2 times a day, morning and evening.

The course of treatment is 1-2 months.

It is recommended to take a break of 15-20 minutes between cleansing the skin and applying the cream.

The therapeutic effect occurs in about 3 weeks.

The average duration of treatment is 3-4 months.

Balanoposthitis, vulvovaginitis: after squeezing out a small amount of cream from the tube, apply to the surface of the lesions of the glans penis, foreskin, labia minora, vaginal vestibule, using a cotton swab or fingers, rubbing slightly, 1-2 times a day. The duration of treatment is 8-10 days. Side effect Side effects after external use of metronidazole are extremely rare. Allergic reactions are possible (urticaria, skin rash) hyperemia, peeling and burning of the skin, lacrimation. Drug interactions After external use, the concentration of metronidazole is very low and the possibility of interaction is minimal. With the simultaneous appointment, it enhances the effect of warfarin and other indirect anticoagulants. Use during pregnancy and lactation With caution: pregnancy (I trimester), lactation period.Special instructions The drug is intended for external use only. Avoid contact with eyes as this can cause eye inflammation and watery eyes. In case of contact with eyes, rinse with plenty of water. In case of skin inflammation, the frequency of use of the drug should be reduced or temporarily stopped. Avoid direct sunlight while using the drug.

Name ENG

ROZAMET

ATX code

Metronidazole

Dosage

1% x 25g

Structure

1 g metronidazole 10 mg Excipients: glycerol - 12.9 mg, liquid paraffin - 90 mg, emulsifying wax - 100 mg, propylene glycol - 20 mg, methyl parahydroxybenzoate - 0.7 mg, propyl parahydroxybenzoate - 0.3 mg, purified water - 766.1 mg.

Indications

Inflamed papules pustules erythema of rosacea and acne vulgaris.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

INN / Active ingredient

metronidazole

Specifications

Category

Acne

Scope of the drug

Leather

Release form

Cream

Manufacturer country

Croatia

Package quantity, pcs

one

Scope of application

Virology

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Jadran

The amount of the dosage form in the primary package

25 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antimicrobial and antiprotozoal agent

Anatomical and therapeutic characteristics

D06BX01 Metronidazole

Dosage form

Cream for external use

Expiration date in days

730

Dosage (volume) of the substance in the preparation

10 mg

Package weight, g

35

Mode of application

:

Outwardly. < br> < br> Treatment of inflamed papules, pustules, erythema with rosacea and acne vulgaris (acne rozacea, acne vulgaris): apply a thin layer to the skin previously cleaned with warm water or a light detergent and rub in 1–2 times a day , in the morning and in the evening. The course of treatment is 1–2 months. It is recommended to take a break of 15–20 minutes between cleansing the skin and applying the cream. The therapeutic effect occurs in about 3 weeks. The average duration of treatment is 3-4 months. < br> < br> Balanoposthitis, vulvovaginitis: a small amount of cream is applied to the surface of the lesions of the glans penis, foreskin, labia minora, the vestibule of the vagina using a cotton swab or fingers, rubbing slightly, or using an applicator (intravaginally) 1-2 times a day. < br> < br> Duration of treatment is 8-10 days.