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

Each tablet contains active ingredients: metamizole sodium monohydrate 527 mg in terms of metamizole sodium 500 mg, pituophenone hydrochloride 5.25 mg in terms of 5 mg pituopenone and fenpiverinia bromide 0.1 mg.

Excipients: gelatin 4 mg, wheat starch 38.65 mg, lactose monohydrate 5 mg, magnesium stearate 4 mg, sodium hydrogen carbonate 5 mg, talc 6 mg, microcrystalline cellulose 25 mg.

Description:

Round, flat cylindrical tablets of white with a weak yellowish shade of color with a risk on one side

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

ATX: & nbsp

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

Pharmacodynamics:

Metamizole sodium, the derivative of pyrazolone has analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with the inhibition of the synthesis of prostaglandins.Pitophenone - myotropic antispasmodic has a direct effect on the smooth muscles of the internal organs and causes her relaxation. Fenpiverinia bromide - m-holinoblokator has an additional spasmolytic effect on smooth muscles.

Pharmacokinetics:

Metamizol sodium: well and quickly absorbed from the gastrointestinal tract (GIT). In the intestinal wall it hydrolyzes with the formation of an active metabolite - unchanged metamizol sodium in the blood is absent (only after intravenous administration of an insignificant of its concentration is detected in the plasma). The association of the active metabolite with plasma proteins: 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into breast milk.

Pitophenone is rapidly absorbed from 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:

Weak or moderately expressed pain syndrome with spasms of smooth muscles of internal organs: renal colic, spasm of the ureter and bladder; biliary colic, intestinal colic; dyskinesia of bile ducts through hyperkinetic type, postcholecystectSyndrome, cronichHeavy stock; 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 to any of the medicinal and / or auxiliary substances (including pyrazolone derivatives), oppression of bone marrow hematopoiesis, marked hepatic and / or renal insufficiency, deficiency glucose-6-phosphate dehydrogenase, lactose deficiency, lactose intolerance, glucose-galactose malabsorption, tachyarrhythmias, severe angina, closed angle glaucoma, prostatic hyperplasia (with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy, lactation period, children under 8 years.

Carefully:

With caution and under the supervision of a doctor, the drug should be used for violations of the liver or kidney function, with a tendency to arterial hypotension, bronchospasm, hypersensitivity to non-steroidal anti-inflammatory drugs, a 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, after eating, washed down with water. Multiplicity of admission: 2-3 times / day.

Adults and teens over 15 years of age: 1-2 tablets 2-3 times a day. The maximum daily dose is 6 tablets.

Children dose of the drug is determined depending on the age: in Ages 8-11 years old the recommended single dose is 1/2 tablet, the maximum daily dose is 4 tablets, 12-14 years old - 1 tablet, the maximum daily dose of 6 tablets. Duration of treatment: not more than 5 days. Increase in the daily dose of the drug or duration of treatment possiblebut only Pod physicianMr.th controlleat.

Side effects:

Frequency: very often (more than 10%), often (1-10%), infrequently (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01%).

From the digestive system: very rarely - a burning sensation in the epigastric region, dry mouth.

From the side of the cardiovascular system: rarely - lowering blood pressure (BP), tachycardia.

On the part of the hematopoiesis system: very rarely (usually with prolonged admission) - thrombocytopenia, leukopenia, agranulocytosis (can manifest itself with the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of phenomena of vaginitis or proctitis).

From the urinary system: rarely (usually with prolonged admission or with high doses) - renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red, difficulty urinating.

Allergic reactions: rarely - urticaria (including conjunctiva and mucous membranes of the nasopharynx), very rarely - angioedema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock. Other: possibly dizziness; very rarely - decreased sweating, paresis of accommodation; in isolated cases - headache.

Overdose:

Symptoms: Vomiting, decreased blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, violations of the liver and kidneys, convulsions.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Interaction:

Simultaneous use of Spasmoblock with other non-opioid analgesics may lead to mutual enhancement of effects.

With the simultaneous use of tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

With the simultaneous use of barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium. Radiocontrast agents, 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. Metamizol sodium, displacing from the connection with plasma proteins, oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, can increase the severity of their action. With the simultaneous use of sedatives and tranquilizers increase the analgesic effect of the spasmodicator.
When used simultaneously with H1-histamine receptor blockers, derivatives of butyrofenone and phenothiazine, amantadine and quinidine, the m-cholinolytic action of the drugs may be enhanced.
With simultaneous use with ethanol, mutual enhancement of effects is possible.

Special instructions:

Metabolite metamizole sodium can cause red staining of urine, which has no clinical significance and disappears after drug withdrawal.

If suspected of agranulocytosis or in the presence of thrombocytopenia, it is necessary to stop taking the drug,

At long (more than a week) application of a preparation the control of a picture is necessary peripheral blood and functionalth, liver condition.

It is inadmissible to use acute pains in the abdomen for relief (until the cause is clarified).

Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

During the period of drug use, you should not drink alcohol.

Effect on the ability to drive transp. cf. and fur:During the period of taking the drug, it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring rapidity of psychomotor reactions.

Form release / dosage:

Pills

2 or 10 tablets per blister. 1 blister with 2 tablets. For 2 and / or 10 blisters for 10 tablets together with instructions for use in a pack of cardboard.

Packaging:blisters (1) -tacks, cardboard (2)
blisters (10), cardboard tacks
blisters (2), cardboard tacks

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008173/10

Date of registration:17.08.2010

The owner of the registration certificate:Adifarm, EADAdifarm, EAD Bulgaria

Manufacturer: & nbsp

ADIPHARM, EAD Bulgaria

Representation: & nbspADIFARMADIFARMBulgaria

Information update date: & nbsp20.02.2013

Illustrated instructions

Instructions

Spasmblock (Spasmoblock)