Spasmoblock is an analgesic combination medicine.
. Sodium metamizole, a pyrazolone derivative has analgesic, antipyretic and mild anti-inflammatory effects, whose mechanism is related to inhibition of prostaglandin synthesis.
Pitophenone is a myotropic antispasmodic that has a direct effect on the smooth muscles of internal organs and causes their relaxation. Phenpiverinia bromide – m-cholinoblocker has an additional antispasmodic effect on the smooth muscles.
Sodium metamizole: well and quickly absorbed from the gastrointestinal tract (GIT). In the intestinal wall it is hydrolyzed to form the active metabolite – unchanged sodium metamizole is absent in the blood (only after IV administration a small concentration is found in plasma).
The binding of the active metabolite with plasma proteins: 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into breast milk.
Pitophenone is quickly absorbed from the gastrointestinal tract; maximum concentration in plasma is reached within 30-60 minutes; it is quickly distributed in the organs and tissues and excreted rather quickly in the urine.
Half-life is 1.8 hours. Phenpivernia bromide is also quickly absorbed from the gastrointestinal tract and reaches maximum concentration in blood plasma within 1 hour. Excreted by the kidneys 32.4 – 40.4% unchanged, 2.5 – 5.3% of the substance is excreted in the bile.
Gallic Colic, Back Pain, Renal Colic, Arthrosis and Arthritis, Headache, Colds, Muscle Pain (myalgia), Neuralgia (nerve pain), Fever, Migraine, Colic, Toothache, Menstrual pain (algodysmenorrhea), Rheumatoid arthritis, Gastrointestinal cramps, Pain after injuries or operations, Colitis, Biliary dyskinesia, Radiculitis, Common acne (vulgaris), Neck pain, Sciatica, Lumbago<> Mild to moderate pain, mild to moderate.p> Mild to moderate pain syndrome with spasms of smooth muscles of internal organs:
- renal colic,
- spasm of the ureter and bladder;
- biliary colic,
- intestinal colic;
- postcholecystectomy syndrome,
- chronic colitis,
For short-term treatment:
As adjunctive medicine: diseases of the pelvic organs, pain syndrome after surgical interventions and diagnostic procedures.
Sodium metamizole, Pitofenone, Phenpiperinia bromide
1 tablet contains:
the active ingredients:
Sodium metamisole monohydrate 527 mg converted to sodium metamisole 500 mg,
pitophenone hydrofloride 5.25 mg converted to pitophenone 5 mg and phenpivirinium bromide 0.1 mg.
gelatin and magnesium stearate.
How to take, the dosage
Overly, after a meal with water.
Frequency of administration: 2-3 times a day.
Adults and adolescents over 15 years of age: 1-2 tablets 2-3 times a day.
The maximum daily dose is 6 tablets.
The dose of the drug for children is adjusted according to their age:
- Ages 8-11 years old have a recommended single dose of 1/2 tablet, maximum daily dose is 4 tablets,
- 12-14 years old have 1 tablet, maximum daily dose is 6 tablets.
Duration of treatment: not more than 5 days.
An increase in the daily dose of the drug or the duration of treatment is only possible under medical supervision.
Simultaneous use of Spasmoblock with other non-opioid analgesics may result in mutually reinforcing effects.
In concomitant use tricyclic antidepressants, oral contraceptives, allopurinol impair the metabolism of sodium metamizole in the liver and increase its toxicity.
When used concomitantly, barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effects of sodium metamizole.
Rentgen contrast agents, colloidal blood substitutes and penicillins should not be used during treatment with drugs containing sodium metamizole.
The concomitant use of cyclosporine decreases the blood concentrations of the latter. Sodium metamizole displaces oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin from binding to plasma proteins and may increase the severity of their effects.
When used concomitantly, sedatives and tranquilizers increase the analgesic effect of Spasmoblock.
Concomitant use with H1-histamine receptor blockers, butyrophenone and phenothiazine derivatives, amantadine and quinidine may increase m-cholinolytic effects of the drugs.
In concomitant use with ethanol mutual enhancement of effects is possible.
The metabolite of sodium metamizole may cause red staining of the urine, which has no clinical significance and disappears after discontinuation of the drug.
If agranulocytosis is suspected or if thrombocytopenia is present, the drug should be discontinued.
When long-term (more than one week) use of the drug it is necessary to monitor peripheral blood count and liver function.
It is unacceptable to use to relieve acute abdominal pain (until the cause is clarified). Patients with atonic bronchial asthma and pollinosis have an increased risk of allergic reactions. Alcohol must not be consumed during the period of using the drug.
Impact on the ability to use vehicles and machinery
When taking the drug it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring rapid psychomotor reactions.
- hypersensitivity to any of the drugs and/or excipients of Spasmoblock (including to pyrazolone derivatives)
- inhibition of medullary hematopoiesis,
- deficiency of glucose-6-phosphate dehydrogenase,
- lactase deficiency.
- lactose intolerance,
- glucose-galactose malabsorption,
- severe angina pectoris,
- closed angle glaucoma,
- prostate hyperplasia (with clinical manifestations),
- intestinal obstruction,
With caution and under medical supervision, the drug should be used in patients with impaired liver or renal function, susceptibility to arterial hypotension, bronchospasm, hypersensitivity to nonsteroidal anti-inflammatory drugs, full or partial combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Digestive system disorders: very rare – a burning sensation in the epigastric region, dry mouth.
Cardiovascular system disorders: rarely – decreased blood pressure (BP), tachycardia.
Hematopoietic system: very rare (usually with long-term use) – thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unexplained fever, chills, sore throat, difficulty in swallowing, stomatitis, and the development of vaginitis or proctitis). Urinary system disorders: rarely (usually with prolonged use or when prescribed in high doses) – renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, staining of urine red, difficulty in urination.
Allergic reactions: rare – urticaria (including conjunctivitis and mucous membranes of the nasopharynx), very rare – angioedema, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospastic syndrome, anaphylactic shock.
Others: dizziness is possible; very rare decreased sweating, accommodation paresis; in single cases – headache.
Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, liver and kidney dysfunction, seizures.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
It is contraindicated in children under 8 years of age, pregnancy and lactation.
Spasmalin, Maxigan, Spasmalgon, Bral, Spazgan, Revalgin
|Conditions of storage|
In a light-protected place, at a temperature not exceeding 25 °C
Adipharm EAD, Bulgaria
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