Spasmalgon Duo tablets 50 pcs.

Symptomatic treatment of mild to moderate pain syndrome in spasms of smooth muscles of internal organs:

• renal colic and inflammatory diseases of the urinary tract accompanied by pain and dysuric disorders;
• stomach and intestinal spasms, hepatic colic, biliary dyskinesia;
• spastic dysmenorrhea.

• active ingredients: metamizole sodium, pitophenone hydrochloride, fenpiverinium bromide;
• 1 tablet contains metamizole sodium 500 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg;
• excipients: lactose monohydrate, wheat starch, talc, magnesium stearate, gelatin, sodium bicarbonate.

• Hypersensitivity to metamizole, to pyrazolone or pyrazolidine derivatives or to any other component of the drug.
• Gastrointestinal obstruction and megacolon.
• Atony of the gallbladder or bladder.
• Severe renal and hepatic dysfunction.
• Blood diseases (agranulocytosis, leukopenia, anemia of any etiology, cytostatic or infectious neutropenia).
• Glucose-6-phosphate dehydrogenase deficiency.
• Porphyria.
• Angle-closure glaucoma.
• Suspicion of acute surgical pathology.
• Bronchial asthma.
• Collaptoid states.
• Tachyarrhythmia.
• Prostatic hypertrophy with a tendency to urinary retention.
• Pregnancy and breastfeeding.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with metamizole treatment.

Immune system: urticaria, skin rash, itching, conjunctivitis; rarely – bronchospasm, angioedema, anaphylactic shock, toxic epidermal necrolysis and Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS).

Gastrointestinal: discomfort, dry mouth, intestinal obstruction, exacerbation of gastritis and gastric and duodenal ulcers.

Hepatobiliary system: drug-induced liver injury, including acute hepatitis, jaundice and increased serum liver enzymes (see section “Special warnings and precautions for use”).

From the cardiovascular system: palpitations, decreased blood pressure, tachycardia, heart rhythm disturbances.

From the nervous system: dizziness, visual disturbances.

From the hematopoietic system: granulocytopenia, anemia, agranulocytosis, thrombocytopenia, leukopenia.

Spazmalgon DUO tablets are taken orally after meals, with water. The recommended daily dose for adults and children over 15 years of age is 1–2 tablets per day; the maximum daily dose is 2 tablets.

The duration of use of Spazmalgon DUO is no more than 3 days.

Use during pregnancy or breastfeeding

Do not use during pregnancy or breastfeeding.

Children

Spazmalgon DUO is not prescribed to children under 15 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

When using the drug Spazmalgon DUO, caution should be exercised when driving or working with other mechanisms, as due to the presence of an anticholinergic effect, prolonged use of Spazmalgon DUO may lead to dizziness and impaired accommodation.

Symptoms. In case of overdose, symptoms of metamizole intoxication in combination with anticholinergic effects predominate; impaired liver and kidney function, respiratory paralysis. Most often, toxic-allergic syndrome, symptoms of impaired hematopoietic functions, gastrointestinal disorders, and in severe cases, symptoms of brain damage are observed.

Treatment. If an overdose is suspected, the drug should be immediately discontinued and measures should be taken to rapidly eliminate it from the body (induce vomiting, perform gastric lavage, increase urine output). Symptomatic measures are used. There is no specific antidote.

Metamizole increases plasma concentrations of chloroquine, reduces plasma concentrations and effects of coumarin anticoagulants and cyclosporine.

Increases the hematotoxic effect of myelotoxic drugs, chloramphenicol.

Neuroleptics, sedatives and tranquilizers enhance the analgesic effect of metamizole.

Tempidone and tricyclic antidepressants, oral contraceptives, allopurinol slow down the metabolism of metamizole and increase its toxicity.

Barbiturates, phenylbutazone and other inducers of liver microsomal enzymes may reduce the effect of metamizole.

Simultaneous use of Spazmalgon DUO with other analgesics and nonsteroidal anti-inflammatory drugs increases the risk of developing allergic reactions.

The combination of Spazmalgon DUO and other drugs requires special caution, given the content of metamizole, which is an enzyme inducer. Metamizole can induce drug-metabolizing enzymes, including CYP2B6 and CYP3A4. Concomitant use of metamizole with bupropion, efavirenz, methadone, valproate, cyclosporine, tacrolimus or sertraline may cause a decrease in the concentration of these drugs in the blood plasma with a potential decrease in clinical efficacy. Therefore, caution is recommended when using metamizole simultaneously, and if necessary, the clinical response and/or drug levels should be monitored.

Store in a dry place, protected from light, at a temperature not exceeding 25 ºС.

Keep out of reach of children.