Spasmalgon is a spasmoanalgesic of combined composition.
Methamisole sodium is a derivative of pyrazolone. It has analgesic, antipyretic and anti-inflammatory effects, the mechanism of which is associated with inhibition of prostaglandin synthesis.
Pitophenone hydrochloride is a myotropic antispasmodic; it has a direct effect on the smooth muscles of internal organs and causes their relaxation.
Phenpiperinia bromide, being a m-cholinoblocker, has an additional relaxing effect on the smooth muscles.
The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.
Radiculitis, Back pain, Renal colic, Gallic colic, Lumbago, Colds, Sciatica, GI spasms, Biliary dyskinesia, Arthrosis and arthritis, Colic, Headache, Common acne (vulgaris), Migraine, Pain after trauma and surgery Mild to moderate pain syndrome with spasms of smooth muscles of internal organs – renal and hepatic colic, pain spastic in the bowel, algodysmenorrhea. It can be used for short-term symptomatic treatment of joint pain, neuralgia, ischialgia, myalgia. As an adjuvant it can be used to reduce pain after surgical and diagnostic interventions.
Sodium metamizole, Pitofenone, Phenpiperinia bromide
Sodium metamizole 500 mg;
Pitophenone hydrochloride 5 mg;
Phenpiperinia bromide 0.1 mg.
Lactose monohydrate 10 mg,
Wheat starch 85.9 mg,
Talc (magnesium disilicate) b mg,
magnesium stearate 4 mg,
gelatin 4 mg,
sodium hydrogen carbonate 5 mg.
How to take, the dosage
Adults and children over 15 years
1-2 tablets 2-3 times a day. The drug is best taken after a meal with water. Daily dose should not exceed 6 tablets. The duration of treatment should not exceed 5 days. Increasing the daily dose of the drug or the duration of treatment is possible only under the supervision of a doctor.
In children under 15 years of age
In children, the drug is used only with a doctor’s prescription.
- Children 6-11 years: half a tablet 2-3 times daily.
- Children 12-14 years: one tablet 2-3 times daily.
Other dosage regimens are possible only after consultation with your doctor.
Simultaneous use of Spasmalgon with other non-narcotic analgesics may lead to mutual enhancement of toxic effects.
Sedatives and tranquilizers increase the analgesic effect of sodium metamizole.
Tricyclic antidepressants, oral contraceptives, allopurinol impair metabolism of metamizole in the liver and increase its toxicity.
Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effects of sodium metamizole.
Rentgen contrast drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing sodium metamizole.
Simultaneous use with cyclosporine reduces the blood level of the latter.
Sodium metamizole displaces oral hypoglycemic drugs, indirect anticoagulants, glucocorticoids and indomethacin from binding to plasma proteins and may increase their potency.
When co-administered with N 1 -histamine receptor blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine may increase m-cholinoblocking action.
It enhances the effects of ethanol.
Concomitant use with chlorpromazine or other phenothiazine derivatives may result in marked hyperthermia.
Thiamazole and cytostatics increase the risk of leukopenia. The effect is increased by codeine, H 2 -histamine receptor blockers and propranololol (delays inactivation of sodium metamizole).
The physician should be consulted if simultaneous use of the above and other medicinal products is necessary.
In patients suffering from bronchial asthma, taking the drug may provoke a seizure.
When using the drug it is necessary to monitor the peripheral blood picture (leukocyte count) and the functional state of the liver.
In case of suspected agranulocytosis or thrombocytopenia the drug should be discontinued.
Alcohol should not be taken during treatment with the drug.
The effect of the drug on the ability to drive vehicles and other mechanisms requiring high concentration
When taking the drug, it is not recommended to drive vehicles and engage in potentially dangerous activities requiring rapid physical and mental reaction.
Hypersensitivity to pyrazolone derivatives (butadion, tribuzone), to other components of the drug. Inhibition of bone marrow hematopoiesis, stable and unstable angina pectoris, decompensated chronic heart failure, marked liver or renal dysfunction, glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmia, closed-angle glaucoma, prostatic hyperplasia with a tendency to urinary retention, intestinal obstruction and megaloconus, granulocytopenia, pregnancy, lactation, children under 6 years old.
The drug should be used with caution and under medical supervision in patients with mild to moderate degree of liver or renal dysfunction, with a tendency to arterial hypotension (systolic pressure below 100 mm Hg), bronchospasm, and with increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics.
Digestive system: burning sensation in the epigastric region, dry mouth.
Nervous system disorders: headache, dizziness, anticholinergic effects (decreased sweating, accommodation paresis, difficulty in urination).
Cardiovascular system: decreased blood pressure, tachycardia, cyanosis.
Urinary system disorders: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, staining of urine red.
Hematopoietic organs: with prolonged use – thrombocytopenia, leukopenia, agranulocytosis.
Allergic reactions: urticaria, bronchospastic syndrome, anaphylactic shock, Quincke’s edema, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).
Symptoms: vomiting, dry mouth, decreased perspiration, impaired accommodation, decreased blood pressure, drowsiness, confusion, liver and kidney dysfunction, seizures.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
It is contraindicated in pregnancy.
Breastfeeding should be stopped during treatment.
Spasmalin, Maxigan, Bral, Spazgan, Revalgin
|Conditions of storage|
Store in a dry place protected from light, at a temperature not exceeding 25 ° C. Keep out of reach of children.
Balkanfarma – Dupnitsa AD, Bulgaria
Balkanfarma – Dupnitsa AD
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