Algospazmin (inj)

Metamizolum + Pitofenonum hydrochloridum + Fenpiverinum bromidum

1 ml solution for injection contains metamizole sodium 500 mg, pitofenone hydrochloride 2 mg and fenpiverinium bromide 0.02 mg (1 ampoule of 2 ml: metamizole sodium 1000 mg, pitofenone hydrochloride 4 mg, fenpiverinium bromide 0.04 mg; 1 ampoule of 5 ml: metamizole sodium 2500 mg, pitofenone hydrochloride 10 mg, fenpiverinium bromide 0.1 mg). Excipient with known effect: sodium.

Indication: Short-term symptomatic treatment of moderate to severe acute pain associated with spasm of the smooth muscle of internal organs (gastric/intestinal colic, renal colic in nephrolithiasis, spastic dyskinesia of the biliary tract, dysmenorrhoea) and for fever not controlled by other antipyretics; in children under 18 years only strictly under medical supervision, in emergency situations.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
History of agranulocytosis caused by metamizole, other pyrazolones or pyrazolidines
Bone marrow dysfunction or disorders of the haematopoietic system
Severe hepatic and renal impairment
Acute hepatic porphyria
Glucose-6-phosphate dehydrogenase deficiency
Gastrointestinal ileus and megacolon
Grade II and III prostatic adenoma
Atony of the gallbladder and urinary bladder
Hypotonic states and haemodynamic instability
Pregnancy and breast-feeding
Children under 18 years of age.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
During treatment with Algospazmin, potentially life-threatening adverse reactions induced by the metamizole contained in the product may occur: agranulocytosis and anaphylactic shock.
Agranulocytosis
Treatment with metamizole may cause agranulocytosis, which may be fatal (see section 4.8). It may occur even after metamizole has previously been used without complications. Metamizole-induced agranulocytosis is an idiosyncratic adverse reaction. It is not dose-dependent and may occur at any time during treatment, including shortly after treatment discontinuation. Patients should be instructed to discontinue treatment and seek immediate medical attention if symptoms suggestive of agranulocytosis occur (e.g. fever, chills, sore throat and painful mucosal lesions, particularly […]