Spasmopharm 500 mg/ml+2 mg/ml+0,02 mg/ml solution for injection 2 ml x 10

Metamizole/ Pitofenone hydrochloride/ Fenpiverinium bromide
Prescription medicinal product

Spasmopharm solution for injection is a combination medicinal product that removes spasms in the gastrointestinal tract smooth muscles, the biliary and urinary tracts, the reproductive organs, and exerts a pronounced analgesic effect.

Spasmopharm solution for injection is intended  for short term use to influence colic with acute, moderately severe to severe pain, of the gastrointestinal tract, bile duct, renal colic in case of kidney stone disease, or in painful menstruation (dysmenorrhea).

  • For 2 ml amoules Мetamizole sodium 1000 mg, pitofenone hydrochloride 4 mg, fenpiverinium bromide 0,04 mg in 2 ml solution for injection;
  • For 5 ml ampoules: Меtamizole sodium 2 500 mg, pitofenone hydrochloride 10 mg, fenpiverinium bromide 0,1 mg in 5 ml solution for injection.

Spasmopharm solution for injection is for intramuscular administration only.

For short term treatment only.

The solution for injection should be administered under strict medical control and preparedness to provide emergency medical services due to a risk of anaphylactic shock in patients with hypersensitivity to metamizole or pyrazolone derivatives.

Adults and children over 15 years of age

Adults and children over 15 years of age (> 53 kg) are given 2 to 5 ml solution for injection intramuscularly. If required, the dose is repeated after 6-8 hours. The maximum daily dose should not exceed 6 ml solution for injection (equivalent to 3 g metamizole sodium).

Treatment duration:  2-3 days.

Upon reaching a therapeutic effect, treatment may be switched to oral analgesic and spasmolytic agents.

If there is no therapeutic effect, the treatment with this product shall be discontinued.

Patients over 65 years of age Usually no dose reduction is required. In patients with age-related disorders of the kidney and liver functions, it is necessary to reduce the dose because of potential increase in the half life of metamizole metabolites (see section 5.2).

Patients with impaired kidney function

Меtamizole is excreted with urine in the form of metabolites. In patients with mild to moderate impairment of the kidney function it is recommended to use ½ of the dose for adults.

Patients with impaired liver function

In these patients the elimination half life of the active metabolites of metamizole may be prolonged.  In patients with impaired liver function the administration of high doses should be avoided. In short term administration no dose reduction is required.

There is no sufficient experience in longer term administration to patients with impaired kidney or liver function.

Spasmopharm solution for injection is contraindicated in children less than 15 years.

Always follow the instructions of your doctor!

Always read the leaflet before use!

DANHSON-BG LTD., BULGARIA