Spazmaton pills, 20pcs

Composition

of 1 tab. :

• Active ingredients: metamizole sodium (in the form of monohydrate) 500 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg;
• Excipients: lactose monohydrate-50 mg, sodium bicarbonate-12.23 mg, talc-22.5 mg, magnesium stearate-7.5 mg, corn starch-152.67 mg

Pharmacological action

Combined analgesic and antispasmodic agent. Metamizole-a derivative of pyrazolone, has analgesic, antipyretic and anti-inflammatory effects. Pitofenone has a direct myotropic antispasmodic effect on smooth muscles (papaverine-like effect). Fenpiverinium bromide has an m-holinoblocking effect and has an additional myotropic antispasmodic effect on smooth muscles. The combination of the three components of the drug has a combined analgesic effect, helps to reduce somatic and psychological symptoms associated with meteorological sensitivity.

Indications

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;
• pelvic diseases.

For short-term treatment:

• Arthralgia;
• myalgia;
• neuralgia;
• sciatica.

As an auxiliary tool:

• Pain syndrome after surgical interventions and diagnostic procedures.

Use during pregnancy and lactation

Use during pregnancy is contraindicated. Use in nursing mothers requires discontinuation of breast-feeding. Contraindicated for children under 6 years of age.

Recommendations for use

Inside: after eating, without chewing, with water. The duration of admission should not exceed 5 days.

Contraindications

• Hypersensitivity (including to the pyrazolone derivative);
• the oppression of bone marrow hematopoiesis;
• severe hepatic and/or renal failure,
• deficiency of glucose-6-phosphate dehydrogenase;
• lactase deficiency;
• lactose intolerance,
• glucose-galactose malabsorption;
• tachyarrhythmia;
• severe angina;
• decompensated chronic heart failure;
• angle-closure glaucoma;
• prostatic hyperplasia (clinical manifestations);
• intestinal obstruction;
• megacolon;
• severe arterial hypotension.

With caution:  renal / hepatic insufficiency, bronchial asthma, a tendency to hypotension, hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs) or non-narcotic analgesics; urticaria or acute rhinitis caused by taking acetylsalicylic acid or other NSAIDs.

Side effects

Allergic reactions:  urticaria (including on the conjunctiva and nasopharyngeal mucosa), angioedema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospastic syndrome, anaphylactic shock.

From the urinary system:  renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, red urine staining.

From the cardiovascular system:  reducing blood pressure.

From the side of hematopoietic organs:  thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unmotivated fever, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of vaginitis or proctitis phenomena).

Anticholinergic effects:  dryness of the oral mucosa, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.

Interaction

Due to each of the components of the drug.

Metamizole. When used concomitantly with H1-histamine receptor blockers, butyrophenone and phenothiazine derivatives, tricyclic antidepressants, amantadine and quinidine, the m-holinoblocking effect may be enhanced.

Enhances the effects of ethanol. Concomitant use with chlorpromazine or other phenothiazine derivatives may lead to severe hyperthermia.

Tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of the drug.

Phenylbutazone, barbiturates, etc. inducers of microsomal liver enzymes with simultaneous use reduce the effectiveness of metamizole.

Sedative and anxiolytic drugs (tranquilizers) enhance the analgesic effect of metamizole.

Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole.

With simultaneous use of cyclosporine, the concentration of the latter in the blood decreases.

Metamizole, replacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and Indometacin from protein binding, may increase the severity of their action.

Thiamazole and cytostatics increase the risk of leukopenia.

The effect is enhanced by codeine, H2-histamine receptor blockers and propranolol (slows down the inactivation of metamizole).

Cherry and currant juices enhance the absorption of metamizole in the gastrointestinal tract (GIT) and increase the concentration of its active metabolites in plasma.

Pitophenon. Increases the effect of myotropic antispasmodics (drotaverine, papaverine, Mebeverinee, otilonium bromide), antisecretory agents (ranitidine, famotidine).

Fenpiverinium. When used together, it enhances the hypotensive effect of calcium channel blockers (nifedipine, amlodipine), clonidine and dibazole.

How to take, course of use and dosage

Recommended daily doses:

For adults and children over 15 years of age:  1-2 tablets 2-3 times a day. The maximum daily dose is 6 tablets.

In children, the drug is used only as prescribed by a doctor.

For children:

From 13 to 15 years – 1 tablet 2-3 times a day. The maximum daily dose is 6 tablets (1.5 tablets 4 times a day).

From 9 to 12 years – 1/2 tablet 2-3 times a day. The maximum daily dose is 4 tablets (1 tablet 4 times a day).

From 6 to 8 years – 1/2 tablet 2 times a day. The maximum daily dose is 2 tablets (1/2 tablet 4 times a day).

Overdose

Symptoms: vomiting, low blood pressure, drowsiness, confusion, nausea, epigastric pain, impaired liver and kidney function, convulsions.

Treatment: gastric lavage, taking activated charcoal, symptomatic therapy.

Special instructions

During treatment with the drug, it is not recommended to take ethanol. If agranulocytosis is suspected or if thrombocytopenia is present, the drug should be discontinued.

It is unacceptable to use it for the relief of acute abdominal pain (until the cause is clarified).

Intolerance is very rare, but the risk of developing anaphylactic shock after intravenous use of the drug is relatively higher than after oral use of the drug. Patients with atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.

In the treatment of patients receiving cytostatic drugs, metamizole should be administered only under the supervision of a doctor. Possible staining of urine in red due to the release of a metabolite (does not have clinical significance).

Influence on the ability to drive vehicles and mechanisms:

During treatment, caution should be exercised by drivers of vehicles and persons engaged in potentially dangerous activities that require rapid physical and mental reactions.

Active ingredient

Metamizole sodium, Pitofenone, Fenpiverinium bromide

Dosage form

Tablets