Took tab. 500mg # 20

Release form, composition and packaging

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The tablets are pale yellow in color, round, flat, with beveled edges, scored on one side and engraved MICRO" on the other.

1 tab.

metamizole sodium 500 mg

pitofenone hydrochloride 5 mg

fenpiverinium bromide 0.1 mg

lactose, corn starch (anhydrous), povidone, methylhydroxybenzoate, purified talc, magnesium stearate.

10 pieces.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (2) - cardboard packs.

10 pieces.

- blisters (10) - cardboard packs.

pharmachologic effect

Combined analgesic and antispasmodic agent.

The combination of the components of the drug leads to a mutual enhancement of their pharmacological action.

Metamizole sodium - a derivative of pyrazolone, has an analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with the inhibition of prostaglandin synthesis.

Pitofenone hydrochloride has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation (papaverine-like action).

Fenpiverinium bromide has an m-anticholinergic effect and has an additional myotropic effect on smooth muscles.

Pharmacokinetics

Metamizole sodium After oral administration, metamizole sodium is rapidly absorbed from the gastrointestinal tract. In the intestinal wall, it is hydrolyzed to form an active metabolite. Unchanged metamizole sodium in the blood is not detected (only after intravenous administration is it found in blood plasma in an insignificant concentration and quickly becomes unavailable for determination). After i / m administration, the active substances of the drug are rapidly and largely absorbed from the injection site. Plasma protein binding is 50-60%. When taken in therapeutic doses, it is excreted in breast milk. Metamizole sodium undergoes intensive biotransformation in the liver. The main metabolites are 4-methylaminoantipyrine, 4-formylaminoantipyrine, 4-aminoantipyrine, and 4-acetylaminoantipyrine. About 20 additional metabolites have been identified, including derivatives of glucuronic acid.The main four metabolites are found in the cerebrospinal fluid. It is excreted mainly by the kidneys. Pitofenone is rapidly absorbed from the gastrointestinal tract when taken orally. Cmax in blood plasma is reached after 30-60 minutes. It is quickly distributed in organs and tissues, does not penetrate the BBB. It is metabolized in the liver by oxidative reactions. It is excreted in the urine. T1 / 2 is 1.8 hours. Fenpiverinium bromide When taken orally, it is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is reached within 1 hour. Does not penetrate the BBB. It is excreted unchanged in the urine 32.4-40.4%, in the bile - 2.3-5.3%.It is metabolized in the liver by oxidative reactions. It is excreted in the urine. T1 / 2 is 1.8 hours. Fenpiverinium bromide When taken orally, it is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is reached within 1 hour. Does not penetrate the BBB. It is excreted unchanged in the urine 32.4-40.4%, in the bile - 2.3-5.3%.It is metabolized in the liver by oxidative reactions. It is excreted in the urine. T1 / 2 is 1.8 hours. Fenpiverinium bromide When taken orally, it is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is reached within 1 hour. Does not penetrate the BBB. It is excreted unchanged in the urine 32.4-40.4%, in the bile - 2.3-5.3%.

Indications for use

Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of the ureter and bladder

biliary colic

biliary dyskinesia

postcholecystectomy syndrome

intestinal colic

chronic colitis

algodismenorrhea

diseases of the pelvic organs.

For the short-term treatment of arthralgia

myalgia

neuralgia, sciatica.

As an adjunct drug for pain syndrome after surgery and diagnostic procedures.

Contraindications for use

Severe hepatic and / or renal failure

oppression of bone marrow hematopoiesis

deficiency of glucose-6-phosphate dehydrogenase

tachyarrhythmia

severe angina

decompensated chronic heart failure

collapse

angle-closure glaucoma

hyperplasia of the prostate (with clinical manifestations)

intestinal obstruction

megacolon

pregnancy (especially the first trimester and the last 6 weeks)

lactation period

children under 3 months of age or body weight less than 5 kg (for intravenous administration)

children under 5 years of age (for tablets)

hypersensitivity (including to pyrazolone derivatives).

Precautions: renal / hepatic impairment

bronchial

Name ENG

BRAL

Clinical and pharmacological group

Spasmodic analgesic

ATX code

Metamizole sodium in combination with other drugs (excluding psycholeptics)

Dosage

500mg + 5mg + 100mcg

Structure

Metamizole sodium 500 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 100 μg.

Indications

Trichomoniasis (genitourinary infections in women and men caused by Trichomonas vaginalis)

amoebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, and all extraintestinal forms of amebiasis, especially amoebic liver abscess).

giardiasis

prevention of anaerobic infections during operations on the colon and during gynecological interventions.

INN / Active ingredient

metamizole sodium, fenpiverinium bromide, pitofenone hydrochloride

Contraindications

Hypersensitivity to the drug or other nitroimidazole derivatives.

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 5 years

Specifications

Category

Pain relievers

,

Migraine

,

Pain and fever

Scope of the drug

General

Release form

Tablet

Manufacturer country

India

Package quantity, pcs

twenty

Minimum age from

12 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Micro labs

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Dosage form

Pills

The target audience

Children

Expiration date in days

1825

Package weight, g

twenty

Mode of application

:

Inside: adults and adolescents over 15 years of age: 1-2 tablets 2-3 times / without chewing, drinking a small amount of liquid.

Children 12-14 years old: single dose - 1 tablet, maximum daily dose - 6 tablets (1.5 tablets 4), 8-11 years old - 0.5 tablets, maximum daily dose - 4 tablets (1 tablet 4 each), 5-7 years old - 0.5 tablets, maximum daily dose - 2 tablets (0.5 tablets 4).

Pharmaco-therapeutic group

:

Combined analgesic (non-narcotic analgesic + antispasmodic)

Anatomical and therapeutic characteristics

:

N02BB52 Metamizole sodium, in combination with other drugs (excluding psychotropic drugs)

Dosage (volume) of the substance in the preparation

:

metamizole sodium 500 mg, pitofenone hydrochloride 5 mg and fenpiverinium bromide 0.1 mg

Information on technical characteristics, delivery set, country of manufacture "