Pharmacological action – analgesic, antipyretic, anti-inflammatory.
Methamisole (derivative of pyrazolone) has analgesic, antipyretic and mild anti-inflammatory effects, pitophenone has direct myotropic effect on smooth muscles, causing their relaxation, phenpiperinium has cholinolytic effect and consequently also relaxing effect on smooth muscles.
It relieves pain, eliminates spasm of smooth muscles, reduces elevated body temperature.
Pain syndrome in spasms of smooth muscles of internal organs – renal and biliary colic, intestinal spasms, algodysmenorrhea and other spastic conditions of internal organs, as well as headache and migraine pain. It can be used for short-term symptomatic treatment of arthralgia, neuralgia, ischialgia, myalgia.
As an adjuvant it can be used to reduce pain after surgical and diagnostic interventions.
Sodium metamizole, Pitofenone, Phenpiperinia bromide
1 tablet contains metamizole sodium 500 mg,
pitophenone hydrochloride 5 mg and phenpivery bromide 0.1 mg
Auxiliary substances: lactose, corn starch (anhydrous), povidone, methylhydroxybenzoate, purified talc, magnesium stearate.
How to take, the dosage
Ingestion, preferably after meals.
Adults: and children over 15 years of age 1-2 tablets 2-3 times a day, the maximum daily dose of Bral is 6 tablets.
Children: only when prescribed by a physician: 6-8 years 1/2 tab., 9-12 years – 3/4 tab., 13-15 years – 1 tab. 2-3 times a day.
The duration of administration is not more than 5 days.
Simultaneous use of Bral with other non-narcotic analgesics may result in mutually reinforcing effects.
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.
Simultaneous use with cyclosporine reduces the blood levels of the latter. Sedatives and tranquilizers increase the analgesic effect of the drug.
When co-administration with ethanol – mutual enhancement of the effects.
Physician should be consulted if it is necessary to use the above and other medicinal products at the same time.
Methamizole metabolites can stain urine red.
Hypersensitivity to pyrazolone derivatives (butadione) and to other drug components; granulocytopenia, marked liver or renal dysfunction; glucose-6-phosphate dehydrogenase deficiency; tachyarrhythmia, acute “intermittent” porphyria; closed angle glaucoma; prostatic hyperplasia; intestinal obstruction and megacolon; blood diseases; collaptoids; pregnancy (first trimester and last 6 weeks); lactation; children (under 5 years); hypersensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics.
In therapeutic doses the drug is usually well tolerated. Allergic reactions (skin rash, itching, very rarely – anaphylactic shock) are sometimes possible. In single cases, a burning sensation in the epigastric region, dry mouth, headache. Dizziness, decreased blood pressure, tachycardia, cyanosis are possible. With long-term use – cases of blood system disorders (thrombocytopenia, leukopenia, agranulocytosis). With a tendency to bronchospasm may provoke an attack.
In very rare cases – erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), decreased sweating, accommodation palsy, urinary retention. Rarely (usually with prolonged use or high doses) – renal dysfunction: oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.
All side effects should be reported to the attending physician.
Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, liver and kidney function disorders, seizures. Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
Bral is contraindicated in pregnant women, nursing mothers and children in the first three months of life.
Spasmalin, Maxigan, Spasmalgon, Spazgan, Revalgin
|Conditions of storage|
In a dry, light-protected place at a temperature not exceeding 20 °C.
Micro Labs Ltd, India
Micro Labs Ltd
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