Expiration date: 07/2026

The composition and form of issue:

Tablets, 1 tablet contains:

Metamizole sodium 500 mg

pitofenone hydrochloride 5 mg

fenpiverinia bromide 0, 1 mg

in a contour acheikova packing 10 PCs in a carton 2 or 10 packs.

Feature:

Spasgan is a combined preparation, belongs to the group of analgesic and spasmolytic.

Description pharmacological action:

In the preparation includes: non-narcotic analgesic — Metamizole sodium, myotropic antispasmodic — pitofenone hydrochloride and anticholinergic remedy fenpiverinia bromide. Metamizole is a pyrazolone derivative. It has analgesic, antipyretic and weak anti-inflammatory action.

Pitofenon, similar to papaverine, has a direct myotropic effect on smooth muscles of internal organs and causes its relaxation.

Fenpiverinia due holinoblokirutego action has an additional relaxing effect on smooth muscles. The combination of the three components of a preparation leads to mutual strengthening of their pharmacological action, being expressed in pain relief, relaxation of smooth muscle, reduce elevated body temperature.

Indications:

Weak or moderate pain syndrome spasm of smooth muscles of internal organs:

• renal and biliary colic
  
• spasms of the intestines
  
• dysmenorrhea and other spastic conditions of the internal organs
  
• short-term symptomatic treatment for joint pains, neuralgia, sciatica, myalgia
  
• as an aid to reduce pain after surgical and diagnostic interventions
  
• to reduce elevated body temperature in cold and infectious and inflammatory diseases.
  

Contraindications:

• hypersensitivity to the pyrazolone derivative (phenylbutazone, tribuson), other ingredients
  
• expressed human liver or kidney
  
• genetic absence of glucose-6-phosphate dehydrogenase
  
• tachyarrhythmia
  
• zakratougolnaya form of glaucoma
  
• prostatic hypertrophy with a tendency to urinary retention
  
• gastro-intestinal obstruction
  
• megacolon
  
• diseases of the blood system
  
• collaptoid state
  
• The first trimester and last 6 weeks of pregnancy
  
• lactation
  
• children under 5 years of age.
  

Application of pregnancy and breast-feeding:

Contraindicated in the first trimester and last 6 weeks of pregnancy and during lactation.

Side effects:

In therapeutic doses the drug is generally well tolerated. Sometimes allergic reactions (skin rash, itching, rarely — anaphylactic shock). In a few cases — a burning sensation in the epigastric region, dry mouth, headache.

Possible dizziness, reducing AD, tachycardia, cyanosis. With prolonged use — cases of violations of the blood system (thrombocytopenia, leukopenia, agranulocytosis). The tendency to bronchospasm may provoke attack.

Drug interactions:

The simultaneous use of Spasgan with other non-narcotic analgesics can lead to mutual reinforcement of toxic effects. Tricyclic antidepressants, contraceptives for admission inside, allopurinol violate metabolism of metamizol in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizol. Concurrent use with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers increase the analgesic effect of Spasgan. If necessary, the simultaneous application of these and other drugs should consult a doctor.

Method of application and dose:

Inside, (better after eating), adults and children over the age of 15 — usually at the 1-2 table. 2-3 times a day. Daily dose should not exceed 6 table. Duration of reception no more than 5 days. Increase in daily dose or duration of treatment only under the supervision of a physician. Dosage for children: in children the drug is used only on prescription. The dosage for children 6-8 years — half tablet, 9-12 years — 3/4 table. 13-15 years — 1 table. 2-3 times a day. Other dosing regimens are possible only after consulting your doctor.

Precautions:

With caution and under the supervision of a physician should use the drug in patients with impaired function of liver or kidneys, with tendency to hypotension, bronchospasm, and with increased individual sensitivity to NSAIDs or narcotic analgesics. Sometimes the metabolites of Metamizole can color urine red.

Prolonged (more than 1 week) use of the drug needed to be monitored picture peripheral blood and functional state of the liver.