Spazmalgon - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 10 mg, wheat starch 85.9 mg, gelatin 4 mg, talc (magnesium hydrosilicate) 6 mg, magnesium stearate 4 mg, sodium hydrogen carbonate 5 mg.

Description:

round, flat tablets with a bevel and with a risk on one side, white or almost white.

Pharmacotherapeutic group:analgesic means (analgesic non-narcotic remedy + antispasmodic)

ATX: & nbsp

N.02.B.B.52 Metamizole sodium in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

The composition of the drug includes: non-narcotic analgesic metamizol sodium, myotropic antispasmodic pitophenone and m-cholin-blocking agent fenpiverinia bromide.

Metamizol sodium is a derivative of pyrazolone. It has analgesic, antipyretic and anti-inflammatory action. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation. Fentipierinium bromide due to m-Cholinoblocking action has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug results in relief of pain, relaxation of smooth muscles, reduction in elevated body temperature.

Indications:

Weak or moderately expressed pain syndrome with spasms of smooth muscles of internal organs - renal and hepatic colic, spasmodic pain along the bowel, algodismenorea. It can be used for short-term symptomatic treatment for pain in the joints, neuralgia, ischialgia, myalgia.

As an adjuvant can be used to reduce pain after surgical and diagnostic interventions.

If necessary, the drug can be used to reduce high fever with colds and infectious inflammatory diseases.

Contraindications:

Hypersensitivity to pyrazolone derivatives (butadione, tribuzone), to other components of the drug. Inhibition of bone marrow hemopoiesis, stable and unstable angina, chronic heart failure in the stage of decompensation, expressed violations of the liver or kidney function, deficiency of glycose-6-phosphate dehydrogenase, tachyarrhythmias, zakratougolnaya form of glaucoma, prostatic hyperplasia with a tendency to retention of urine, intestinal obstruction and megalocone, granulocytopenia, pregnancy, lactation, children under 6 years.

Carefully:With caution and under the supervision of a doctor, the drug should be used for patients with mild or moderate severity of liver or kidney function, with a tendency to arterial hypotension (systolic pressure below 100 mm Hg), bronchospasm, and also with increased individual sensitivity to non-steroidal anti-inflammatory drugs drugs or non-narcotic analgesics.

Pregnancy and lactation:

Application during pregnancy and during lactation is contraindicated.

Dosing and Administration:

Adults and children over 15 years of age apply inside (better after eating), usually 1-2 tablets 2-3 times a day. The daily dose should not exceed 6 tablets.

Duration of reception no more than 5 days.

An increase in the daily dose of the drug or the duration of treatment is possible only on the recommendation and under the supervision of a physician.

Doses for children. In children, the drug is used only as directed by a doctor.

The dose for children 6-11 years - half the tablet, 12-14 years - one tablet 2-3 times a day. Other dosing regimens are possible only after consulting a doctor.

Side effects:

From the digestive system: burning sensation in the epigastric region, dry mouth.

From the nervous system: headache, dizziness, anticholinergic effects (decreased sweating, paresis of accommodation, difficulty urinating). From the cardiovascular system: lowering blood pressure, tachycardia, cyanosis.

From the urinary system: renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

From the hematopoiesis: with prolonged admission - thrombocytopenia, leukopenia, agranulocytosis.

Allergic reactions: urticaria, bronchospastic syndrome, anaphylactic shock, Quincke's edema, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Overdose:

In case of an overdose, the following symptoms may occur: vomiting, dry mouth, decreased sweating, discomfort, lower blood pressure, drowsiness, confusion, impaired liver and kidney function, convulsions.

Treatment - gastric lavage, the appointment of activated charcoal, symptomatic therapy.

Interaction:

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 metamizole sodium.

Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizol sodium. Simultaneous use with cyclosporine reduces the concentration of the latter in the blood. Metamizol sodium, displacing from the connection with plasma proteins, oral hypoglycemic drugs, indirect anticoagulants, glucocorticoids and indomethacin, can increase the severity of their action.

When combined with blockers Hi-gistaminovyh receptors, butirofenonami, phenothiazines, tricyclic antidepressants, amantadine and quinidine may increase m-hol and non-blocking effect.

Enhances the effects of ethanol.

Simultaneous use with chlorpromazine or other derivatives of phenothiazine may lead to the development of severe hyperthermia.

Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced codeine, Hg-histamine receptor blockers and propranolol (slows the inactivation of metamizole sodium).

If it is necessary to simultaneously apply the above and other medications, you should consult your doctor.

Special instructions:

When using the drug, it is necessary to monitor the pattern of peripheral blood (leukocyte count) and the functional state of the liver. If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.

During the treatment with the drug, you should not take alcohol.

The use of the drug in nursing mothers requires the cessation of breastfeeding.

Effect on the ability to drive transp. cf. and fur:During treatment, it is not recommended to drive vehicles and engage in potentially dangerous activities that require quick physical and mental reactions.

Form release / dosage:

Pills. 10 tablets per blister of three-layer PVC / PVDC / PVC film and aluminum foil.

For 2 or 5 blisters together with instructions for use in a cardboard box.

Packaging:blister (2) / together with a UTI in a cardboard bundle / -Carton pack
blister (5) / together with UTI in a cardboard bundle / -Carton pack

Storage conditions:

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013079 / 01

Date of registration:05.12.2011

The owner of the registration certificate:AKTAVIS, LTD. AKTAVIS, LTD. Russia

Manufacturer: & nbsp

BALKANPHARMA-DUPNITSA, AD Bulgaria

Representation: & nbspAktavis, Open Company Aktavis, Open Company

Information update date: & nbsp16.10.2014

Illustrated instructions

Instructions

Spazmalgon® (Spasmalgon®)