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

Each tablet contains: active ingredients: metamizole sodium (analgin) 500 mg, pituopenona hydrochloride 5 mg and fenpiverinia bromide 0.10 mg; Excipients: microcrystalline cellulose, sodium carboxymethyl starch, silicon dioxide colloid, talc, magnesium stearate.

Description:

White or white with a yellowish hue, round, flat pills with a risk on one side.

Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic agent + antispasmodic)

ATX: & nbsp

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

Pharmacodynamics:

Spasmalin® is a combined preparation that includes: non-narcotic analgesic metamizol sodium, myotropic spasmolytic agent of pitophenone and m-cholinoblocking agent fenpiverinia bromide.

Metamizole sodium, a derivative of pyrazolone, has an analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fenpiverinia bromide due to m-holinoblokiruyuschego action has an additional myotropic effect on smooth muscles.

Pharmacokinetics:

Metamizol sodium: well and quickly absorbed into the digestive tract. In the intestinal wall it hydrolyzes with the formation of an active metabolite - unchanged metamizol sodium in the blood is absent. The association of the active metabolite with proteins is 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into breast milk. Pitophenone is rapidly absorbed into the digestive tract; the maximum concentration in the plasma is reached within 30 - 60 min; quickly distributed in organs and tissues and quickly removed with urine. The elimination half-life is 1.8 hours.

Fenpiverinia bromide is also rapidly absorbed from the gastrointestinal tract and reaches a maximum concentration in the blood plasma for 1 hour. It is excreted by the kidneys 32.4-40.4% unchanged, 2.5-5.3% of the substance is excreted with bile.

Indications:

Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of ureter and bladder; bilious colic, intestinal colic; biliary dyskinesia, postcholecystectomy syndrome, chronic colitis; algodismenorea. For short-term treatment: arthralgia, myalgia, neuralgia, ischialgia.
As an auxiliary medicine: pelvic organs diseases, pain syndrome after surgical interventions and diagnostic procedures.

Contraindications:

Hypersensitivity (including pyrazolone derivatives), oppression of bone marrow hematopoiesis, marked hepatic and / or renal insufficiency, deficiency of glucose-6-phosphate dehydrogenase, tachyarrhythmias, severe angina pectoris, decompensated chronic heart failure, closed angle glaucoma, prostatic hyperplasia with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy, the period of breastfeeding, children's age (up to 8 years).

Carefully:

Renal / hepatic insufficiency, bronchial asthma, propensity to arterial hypotension,hypersensitivity to non-steroidal anti-inflammatory drugs; complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Inside: adults and adolescents over 15 years: 1-2 tablets 2-3 times a day, without chewing, squeezed a small amount of liquid. The daily dose should not exceed 6 tablets. Duration of reception no more than 5 days.

Degas 12-14 years: single dose - 1 tablet, the maximum daily dose - 6 tablets (1.5 tablet 4 times a day), 8-11 - 0.5 tablets, the maximum daily dose - 4 tablets (1 tablet 4 times a day) .

Side effects:

Allergic reactions: urticaria (including conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

From the urinary system: a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red. From the cardiovascular system: lowering of blood pressure.

From the hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (can be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of phenomena of vaginitis or proctitis).

Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.

Overdose:

Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions. Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Interaction:

When combined with H1-gnathamine receptor blockers, butyrophenone and phenothiazine derivatives, tricyclic antidepressants, amantadine and quinidine, m-cholinoblocking action is possible.

Metamizole sodium enhances the effects of ethanol; simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

Tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of the drug.

Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes with simultaneous use reduce the effectiveness of metamizole sodium. Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole sodium.

Radiopaque drugs, colloidal blood substitutes and penicillins should not be used during treatment with drugs containing metamizol sodium.

With the simultaneous use of cyclosporine, the concentration of the latter in the blood decreases.

Metamizole sodium, displacing from the connection with plasma proteins, oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, can increase the severity of their action.

Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced codeine, H2-histamine receptor blockers and propranolol (slows the inactivation of metamizole sodium).

Special instructions:

During treatment with the drug is not recommended to take ethanol. At long (more than a week) treatment control of a picture of peripheric blood and a functional status is necessaryliver.

If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.

It is not allowed to use acute pains in the abdomen for relief (until the cause is clarified).

Intolerance is very rare, but the threat of anaphylactic shock after IV injection is relatively higher than after taking the drug inside. Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

When treating patients receiving cytotoxic drugs, the use of metamizole sodium should only be performed under the supervision of a physician.

It is possible to stain urine red due to the release of metamizole metabolite sodium (it has no clinical significance).

Effect on the ability to drive transp. cf. and fur:Care should be taken during the treatment of drivers of vehicles and persons engaged in potentially hazardous activities requiring quick physical and mental reactions.

Form release / dosage:

Pills. For 10 tablets in a blister of aluminum foil and PVC film. 1, 2 or 10 blisters for 10 tablets with instructions for use in a cardboard box. The sample is not for sale: 10 tablets in a blister of aluminum foil and PVC film. 1 blister with instructions for use in a cardboard box.

Packaging:tablets (blister) 10 x1 / 2/10

Storage conditions:

At temperatures below 30 ° C in a dark place. Keep out of the reach of children.

Shelf life:3 years. Do not use later than the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015008 / 02

Date of registration:22.04.2008

The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

TORRENT PHARMACEUTICALS, Ltd. India

Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India

Information update date: & nbsp24.01.2013

Illustrated instructions

Instructions

Spazmaline® (Spasmalin®)