Spazgan Neo, 400 mg+5 mg+0.1 mg 20 pcs

Combined drug, has analgesic, anti-inflammatory and antispasmodic effect. Inhibits the synthesis of prostaglandins (Pg). The composition of the drug includes non-steroidal anti-inflammatory agent ibuprofen, myotropic antispasmodic agent pitofenone hydrochloride and m-cholin blocking agent of central and peripheral action fenpiveryinia bromide.

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of prostaglandin biosynthesis – modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea it decreases the increased level of prostaglandins in myometrium thus reducing intrauterine pressure and frequency of uterine contractions.

Pitophenone hydrochloride, similarly to papaverine, has a direct myotropic effect on smooth muscles of internal organs and causes its relaxation. Phenpiverinia bromide due to its m-cholinoblocking action has an additional relaxing effect on the smooth muscles. The combination of the three drug components leads to the mutual enhancement of their pharmacological action.

Pharmacokinetics

The drug components SPAZGAN NEO are well absorbed in the gastrointestinal tract. Peak plasma concentrations are reached approximately 1-2 hours after drug administration. The main component of the drug ibuprofen is 99% bound to plasma proteins, may accumulate in synovial fluid, is metabolized in the liver and excreted 90% in the urine as metabolites and conjugates. A small part of the drug is excreted with bile. Blood plasma elimination half-life is 2 hours.

Indications

Toothache, Colic, Colitis, Headache, Tendon inflammation, Gallic Colic, Neuralgia, Renal Colic, Radiculitis, GI spasms, Bursitis, Migraine, Biliary dyskinesia – Weak and moderately expressed pain syndrome in spasms of smooth muscles of internal organs: renal and gallic colic, biliary dyskinesia, colic.

– Gynecological diseases: dysmenorrhea.

– Headache, including migraine character.

– Short-term symptomatic treatment of joint pain, neuralgia, ischialgia, myalgia.

Active ingredient

Ibuprofen, Pitofenone, Phenpiveryinia bromide

Composition

Active ingredients: ibuprofen 400.0 mg, pitophenone hydrochloride 5.0 mg, phenpiperinia bromide 0.1 mg.

Auxiliary substances: Corn starch 88.0 mg, microcrystalline cellulose 85.9 mg, sodium carboxymethyl starch (type A) 14.7 mg, alginic acid 10.6 mg, dihydrate dihydrate 0,6 mg, povidone (PVP K-90) 11.0 mg, colloidal silicon dioxide (aerosil 200) 7.0 mg, croscarmellose sodium 4.7 mg, sodium lauryl sulfate 2.4 mg, magnesium stearate 5.0 mg, talc 5.0 mg.

Ancillary substances (coating): Opadray II 85668918 white 19.2 mg: polyvinyl alcohol 7.4 mg, titanium dioxide 5.76 mg, talc 3.36 mg, macrogol 2.1 mg, soy lecithin 0.58 mg.

How to take, the dosage

Orally, 1 h before or 3 h after a meal. To avoid irritation of the stomach, the drug may be taken immediately after a meal or with milk. In the absence of special physician’s orders, it is recommended to take SPASGAN NEO for spastic pain 1 tablet up to 3 times a day. The maximum daily dose is 3 tablets. Do not exceed the stated dose!

The course of treatment with the preparation SPAZGANEO without physician’s consultation should not exceed 5 days. A longer course of treatment is possible under a physician’s supervision with control of peripheral blood picture and functional state of the liver.

Interaction

In therapeutic doses the drug SPAZGAN NEO does not interact significantly with commonly used drugs.

Inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase production of hydroxylated active metabolites increasing the risk of severe intoxications.

Microsomal oxidation inhibitors reduce the risk of hepatotoxic action.

Reduces hypotensive activity of vasodilators and natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs. Increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics (which increases the risk of bleeding).
It increases the side effects of mineralocorticosteroids, glucocorticosteroids (increased risk of gastrointestinal bleeding), estrogen, ethanol. When concomitant use of the drug with hypoglycemic agents for oral administration may increase their effect, thereby contributing to the risk of hypoglycemia.

Antacids and colestyramine reduce absorption of ibuprofen.

Increases the blood concentration of digoxin, lithium and methotrexate drugs.

It increases the effect of M-cholinoblockers, H1-histamine blockers, butyrophenones, phenothiazines, amantadine and quinidine.

Simultaneous administration of other NSAIDs increases the frequency of side effects.

Caffeine increases analgesic (analgesic) effect.

Simultaneous use decreases anti-inflammatory and antiplatelet effects of acetylsalicylic acid (possibility of increased frequency of acute coronary failure in patients receiving low-dose acetylsalicylic acid as an antiplatelet agent, after the beginning of taking the drug SPAZGAN NEO.

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the incidence of hypoprothrombinemia when administered simultaneously.

Myelotoxic drugs increase manifestations of hematotoxicity of the drug.

Cyclosporine and gold drugs increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys that is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase the plasma concentration of ibuprofen.

Special Instructions

In case of long-term use it is necessary to monitor peripheral blood picture and functional state of the liver and kidneys.

To reduce the risk of adverse events in the gastrointestinal tract the minimum effective dose should be used. In case of gastropathy symptoms a thorough control including esophagogastroduodenoscopy, blood test with hemoglobin and hematocrit determination, fecal occult blood test is required.

If 17-ketosteroids determination is required the preparation should be discontinued 48 hours prior to the test.

During the treatment the patient should refrain from taking alcohol.

Impact of the medicinal product for medical use on the ability to drive vehicles, mechanisms

During the treatment the patient should refrain from potentially dangerous activities that require high concentration and rapid psychomotor reactions.

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Contraindications

Hypersensitivity to any of the ingredients included in the drug; erosive-ulcerative changes of the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; inflammatory bowel disease in the acute phase, including ulcerative colitis; anamnestic evidence of an attack of bronchoobstruction, rhinitis, urticaria, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drug – NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome – rhinosinusitis, urticaria, polyps of nasal mucosa, bronchial asthma); hepatic insufficiency or active liver disease; renal insufficiency (creatinine clearance less than 30 ml/min), advanced renal disease; confirmed hyperkalemia; hemophilia and other coagulation disorders including hypocoagulation), hemorrhagic diathesis; period after coronary artery bypass surgery; Acute intermittent porphyria; granulocytopenia; hematopoiesis disorders; glucose-b-phosphate dehydrogenase deficiency; tachyarrhythmia; closed-angle glaucoma; optic nerve disease; prostatic hyperplasia; intestinal obstruction; pregnancy and lactation, age under 16.

With caution

. Elderly age, congestive heart failure, cerebrovascular disease, arterial hypertension, coronary heart disease, hyperlipidemia, diabetes mellitus, peripheral artery disease, nephrotic syndrome, creatinine clearance less than 30-60 ml/min, hyperbilirubinemia, gastric and duodenal ulcer (history), Helicobacter pylori infection, gastritis, enteritis, colitis, long-term use of NSAIDs, blood diseases of unclear etiology (leukopenia, anemia), smoking, frequent alcohol consumption (alcoholism), severe somatic diseases, concomitant therapy with the following drugs anticoagulants (e.g., warfarin), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Frequency of side effects is classified according to the World Health Organization recommendations: very frequently – at least 10%; frequently – at least 1%, but less than 10%; infrequently – at least 0,1%, but less than 1%; rarely – at least 0,01%, but less than 0,1%; very rarely, including some reports – less than 0,01%.
In recommended doses the drug SPASGAN NEO causes no side effects.

Co digestive system: often – NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation; infrequently – gastrointestinal mucosal eruptions, which, in some cases, are complicated by perforation and bleeding; irritation and dryness of the oral mucosa, pain in the mouth, gingival mucosa ulceration, aphthous stomatitis; very rarely – pancreatitis, hepatitis, liver dysfunction, hepatotoxicity.

As for the respiratory system: rarely – shortness of breath, bronchospasm.

Sensory system: Hearing disorders: rare – hearing loss, ringing or noise in the ears; visual impairment; infrequent – blurred vision, scotoma, dry and irritated eyes, conjunctival and eyelid edema (allergic genesis), amblyopia, very rare – accommodation palsy, toxic damage of the optic nerve.

Central and peripheral nervous system disorders:not infrequently – headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, very rarely – mental confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

Cardiovascular system: infrequently – tachycardia, increased blood pressure; rarely – heart failure.

Since the urinary system: infrequent – nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining in red; rarely – acute renal failure, allergic nephritis.

Allergic reactions: infrequent – skin rash (usually erythematous or urticaria), skin itching, very rare – Quincke’s edema, anaphylactoid reactions, anaphylactoid shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), allergic rhinitis.

With the organs of hematopoiesis:not infrequently – thrombocytopenia and thrombocytopenic purpura, very rarely – anemia (including hemolytic, aplastic), agranulocytosis, leukopenia, eosinophilia.

Others: very rarely – increase or decrease of sweating.

In terms of laboratory parameters: Bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), liver transaminase activity (may increase).

If taking the drug has caused a change in your usual condition, stop taking it and see your doctor immediately.

Overdose

Do not exceed the specified dose. If you exceed the dose, see your doctor or the nearest medical facility immediately. Take the packet of medication with you.

Symptoms: Abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

treatment: gastric lavage (only within 1 hour after intake), activated carbon, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, blood pressure). There is no specific antidote.