Spazmalin tablets, No. 20

• Pain syndrome (mild or moderate) 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.

For short-term treatment:

• arthralgia,

• myalgia,

• neuralgia,

• sciatica.

As an auxiliary medicine:

• diseases of the pelvic organs,

• pain syndrome after surgical interventions and diagnostic procedures.

Inside: adults and adolescents over 15 years old: 1-2 tablets 2-3 times a day, without chewing, with a small amount of liquid.

The daily dose should not exceed 6 tablets.

Duration of admission is no more than 5 days.

Children 12-14 years old: single dose - 1 tablet, maximum daily dose - 6 tablets (1.5 tablets 4 times a day),

8-11 years old - 0.5 tablets, the maximum daily dose is 4 tablets (1 tablet 4 times a day).

Each tablet contains:

active ingredients:

metamizole sodium (analgin) - 500 mg,

pitofenone hydrochloride - 5 mg

fenpiverinium bromide - 0.10 mg;

excipients: microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, talc, magnesium stearate.

• Hypersensitivity (including to pyrazolone derivatives),

• oppression of bone marrow hematopoiesis,

• severe hepatic and / or renal failure,

• deficiency of glucose-6-phosphate dehydrogenase,

• tachyarrhythmias,

• severe angina pectoris,

• decompensated chronic heart failure,

• angle-closure glaucoma,

• hyperplasia of the prostate gland (with clinical manifestations),

• intestinal obstruction,

• megacolon,

• collapse,

• pregnancy,

• breastfeeding period,

• children's age (up to 8 years).

Carefully

Renal / hepatic failure, bronchial asthma, tendency to arterial hypotension, hypersensitivity to non-steroidal anti-inflammatory drugs; complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Trade name of the drug:

SpazmalinЃ

INN or grouping name:

Metamizole sodium + Pitofenone + Fenpiverinium bromide

Dosage form:

pills

Composition:

Each tablet contains:

active ingredients:

metamizole sodium (analgin) - 500 mg,

pitofenone hydrochloride - 5 mg

fenpiverinium bromide - 0.10 mg;

excipients: microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, talc, magnesium stearate.

Description

White or white with a yellowish sheen, round, flat tablets with a scored on one side.

Pharmacotherapeutic group:

Combined analgesic (non-narcotic analgesic + antispasmodic)

ATX code N02BB52

pharmachologic effect

Pharmacodynamics
SpazmalinЃ is a combined drug, which includes: non-narcotic analgesic metamizole sodium, myotropic antispasmodic agent pitofenone and m-anticholinergic agent fenpiverinium bromide.
Metamizole sodium, a pyrazolone derivative, has analgesic, antipyretic and mild anti-inflammatory effects. Pitofenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation. Fenpiverinium bromide, due to its m-anticholinergic action, has an additional myotropic effect on smooth muscles.
Pharmacokinetics
Metamizole sodium: well and quickly absorbed in the gastrointestinal tract. In the intestinal wall, it is hydrolyzed to form an active metabolite - unchanged sodium metamizole is absent in the blood. The connection of the active metabolite with proteins is 50-60%. It is metabolized in the liver, excreted by the kidneys. In therapeutic doses, it passes into breast milk.
Pitofenone is rapidly absorbed in the gastrointestinal tract; the maximum plasma concentration is reached within 30-60 minutes; quickly distributed in organs and tissues and quickly excreted in the urine. The half-life is 1.8 hours.
Fenpiverinium bromide is also rapidly absorbed from the gastrointestinal tract and reaches its maximum plasma concentration within 1 hour. It is excreted by the kidneys 32.4-40.4% unchanged, 2.5-5.3% of the substance is excreted with bile.

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, intestinal colic;

• biliary dyskinesia, postcholecystectomy syndrome, chronic colitis;

• algodismenorrhea.

For short-term treatment:

• arthralgia,

• myalgia,

• neuralgia,

• sciatica.

As an auxiliary medicine:

• diseases of the pelvic organs,

• pain syndrome after surgical interventions and diagnostic procedures.

Contraindications

• Hypersensitivity (including to pyrazolone derivatives),

• oppression of bone marrow hematopoiesis,

• severe hepatic and / or renal failure,

• deficiency of glucose-6-phosphate dehydrogenase,

• tachyarrhythmias,

• severe angina pectoris,

• decompensated chronic heart failure,

• angle-closure glaucoma,

• hyperplasia of the prostate gland (with clinical manifestations),

• intestinal obstruction,

• megacolon,

• collapse,

• pregnancy,

• breastfeeding period,

• children's age (up to 8 years).

Carefully

Renal / hepatic failure, bronchial asthma, tendency to arterial hypotension, hypersensitivity to non-steroidal anti-inflammatory drugs; complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Method of administration and dosage

Inside: adults and adolescents over 15 years old: 1-2 tablets 2-3 times a day, without chewing, with a small amount of liquid.

The daily dose should not exceed 6 tablets.

Duration of admission is no more than 5 days.

Children 12-14 years old: single dose - 1 tablet, maximum daily dose - 6 tablets (1.5 tablets 4 times a day),

8-11 years old - 0.5 tablets, the maximum daily dose is 4 tablets (1 tablet 4 times a day).

Side effect

Allergic reactions: urticaria (including on the conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.
From the urinary system: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining red.
On the part of the cardiovascular system: lowering blood pressure.
On the part of the hematopoietic organs: thrombocytopenia, leukopenia, agranulocytosis (may manifest with the following symptoms: unmotivated fever, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of symptoms of vaginitis or proctitis).
Anticholinergic effects: dry mouth, decreased sweating, accommodation paresis, tachycardia, difficulty urinating.

Overdose

Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, abnormal liver and kidney function, convulsions.
Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy.

Interaction with other medicinal products

When used together with H1-histamine receptor blockers, derivatives of butyrophenone and phenothiazine, tricyclic antidepressants, amantadine and quinidine, the m-anticholinergic action may be enhanced.
Metamizole sodium enhances the effects of ethanol; simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.
Tricyclic antidepressants, oral contraceptives, and allopurinol increase the toxicity of the drug.
Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes, when used simultaneously, reduce the effectiveness of metamizole sodium.
Sedative and anxiolytic drugs (tranquilizers) enhance the analgesic effect of metamizole sodium.
Radiopaque drugs, colloidal blood substitutes and penicillins should not be used during treatment with drugs containing metamizole sodium.
With the simultaneous use of cyclosporine, the concentration of the latter in the blood decreases.
Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin from the connection with plasma proteins, can increase the severity of their action.
Thiamazole and cytostatics increase the risk of developing leukopenia. The effect is enhanced by codeine, blockers of H2-histamine receptors and propranolol (slows down the inactivation of sodium metamizole).

special instructions

During the period of drug treatment, it is not recommended to take ethanol.
With prolonged (more than a week) treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver.
If agranulocytosis is suspected or if thrombocytopenia is present, the drug should be discontinued.
It is unacceptable to use it to relieve acute abdominal pain (until the cause is clarified).
Intolerance is very rare, but the threat of anaphylactic shock after intravenous administration of the drug is relatively higher than after taking the drug inside. Patients with atonic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.
When treating patients receiving cytostatic drugs, metamizole sodium should be taken only under the supervision of a physician.
It is possible to stain the urine in red due to the release of the metabolite of metamizole sodium (has no clinical significance).
During treatment, caution should be exercised by vehicle drivers and persons engaged in potentially hazardous activities that require quick physical and mental reactions.