Spazmalgon tab. # 20

Dosage form

Tablets are round, flat, scored on one side, white or almost white.

Structure

1 tab.

metamizole sodium 500 mg

pitofenone (in the form of hydrochloride) 5 mg

fenpiverinium bromide 100 mcg

Excipients: lactose monohydrate, wheat starch, talc, magnesium stearate, gelatin, sodium bicarbonate.

pharmachologic effect

A spasmodic analgesic of a combined composition, the combination of the components of which leads to a mutual enhancement of their pharmacological action.

Metamizole sodium is an analgesic-antipyretic, a pyrazolone derivative.

It has a pronounced analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with the inhibition of prostaglandin synthesis.

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

Fenpiverinium bromide, being an m-anticholinergic blocker, has an additional relaxing effect on smooth muscles.

Pharmacokinetics

Absorption and distribution

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.

Metabolism and excretion

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.

Side effects

From the nervous system and sensory organs: headache, dizziness.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): hypotension, tachycardia, thrombotic or leukopenia, agranulocytosis.

Allergic reactions: skin rash, itching, anaphylactic shock.

Others: bronchospasm, dry mouth, burning sensation in the epigastric region, cyanosis.

Selling features

Available without a prescription

Special conditions

The urine may turn red.

With prolonged (more than a week) use of the drug, it is necessary to control the picture of peripheral blood (leukocyte count) and the functional state of the liver.

If you suspect agranulocytosis or if you have thrombocytopenia, you should stop taking the drug.

During the period of drug treatment, alcohol should not be taken.

During treatment, it is not recommended to drive vehicles and engage in potentially hazardous activities that require quick physical and mental reactions.

The use of the drug in nursing mothers requires the termination of breastfeeding

Indications

Weak or moderately severe pain syndrome with spasms of smooth muscles of internal organs:

- renal colic, spasm of the ureter and bladder

- biliary colic

- intestinal colic

- biliary dyskinesia

- postcholecystectomy syndrome

- chronic colitis

- algodismenorrhea

- diseases of the pelvic organs.

Contraindications

Hypersensitivity, severe liver and / or kidney dysfunction, tachyarrhythmia, decompensation of heart failure, angle-closure glaucoma, prostatic hypertrophy, gastrointestinal obstruction, megacolon, blood system diseases, glucose-6-phosphate dehydrogenase deficiency, collaptoid conditions, breastfeeding, pregnancy, age up to 6 years.

Drug interactions

Sedatives and tranquilizers enhance the analgesic effect.

Dr.

non-narcotic analgesics, drugs that depress the central nervous system, incl.

alcohol can increase toxic effects.

Tricyclic antidepressants, oral contraceptives, allopurinol disrupt liver metabolism and increase

Name ENG

SPASMALGON

Clinical and pharmacological group

Spasmodic analgesic

ATX code

Metamizole sodium in combination with other drugs (excluding psycholeptics)

Dosage

1 tablet: metamizole sodium 500 mg, fenpiverinium bromide 100 μg, pitofenone 5 mg

Structure

1 tab.

- metamizole sodium 500 mg, pitofenone (in the form of hydrochloride) 5 mg, fenpiverinium bromide 100 μg.

Excipients: lactose monohydrate, wheat starch, talc, magnesium stearate, gelatin, sodium bicarbonate.

Indications

Weak or moderate pain syndrome with spasms of smooth muscles of internal organs: renal colic, hepatic colic, spastic pain along the intestine, algomenorrhea

can be used for short-term symptomatic treatment for: joint pain, neuralgia, sciatica, myalgia

as an adjuvant, it can be used to reduce pain after surgical and diagnostic interventions

if necessary, the drug can be used to reduce elevated body temperature in case of colds and infectious and inflammatory diseases.

Contraindications

Hypersensitivity to pyrazolone derivatives (butadione, tribuzone), other components of the drug

severe liver or kidney dysfunction

oppression of bone marrow hematopoiesis

stable and unstable angina pectoris

chronic heart failure in the stage of decompensation

tachyarrhythmia

angle-closure glaucoma

hyperplasia of the prostate

intestinal obstruction and megacolon

granulocytopenia

deficiency of glucose-6-phosphate dehydrogenase

pregnancy and lactation

children under 6 years of age.

With care: mild to moderate severity of liver or kidney dysfunction

tendency to arterial hypotension (systolic pressure below 100 mm Hg)

tendency to bronchospasm

increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics.

Storage conditions and periods

Store in a dry and dark place at a temperature not exceeding 25 ° C._x000D_

Keep out of the reach of children ._x000D_

Shelf life 3 years.

INN / Active ingredient

Analgin, Pitofenone, Fenpiverinium bromide

Specifications

Category

Pain relievers

,

Migraine

Scope of the drug

General

Release form

Tablet

Manufacturer country

Serbia

Package quantity, pcs

twenty

Minimum age from

6 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Spazmalgon

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

Expiration date in days

1095

The target audience

Children

Package weight, g

35

Mode of application

:

Inside, after eating, drinking water, adults and children over 15 years old - 1-2 tables.

2-3 times a day.

The daily dose is no more than 6 tablets.

Duration of admission - no more than 5 days.

An increase in the daily dose or duration of treatment is possible only under medical supervision.

Children (only as prescribed by a doctor): 6–8 years old - 1/2 tab., 9–12 years old - 3/4 tab., 13–15 years old - 1 tab.

2-3 times a day.

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

:

1 tablet: metamizole sodium 500 mg, fenpiverinium bromide 100 μg, pitofenone 5 mg

Information on technical characteristics, delivery set, country of manufacture