Spazmaton Neo (Tablets) Instructions for Use

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

ATC Code

M01AE51 (Ibuprofen in combination with other drugs)

Active Substances

Ibuprofen (Rec.INN registered by WHO)

Pitofenone (Rec.INN registered by WHO)

Fenpiverinium bromide (Rec.INN registered by WHO)

Dosage Form

Spazmaton Neo

Film-coated tablets, 400 mg+5 mg+0.1 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, with a biconvex surface.

Excipients: microcrystalline cellulose (type 102), croscarmellose sodium, glycerol (glycerin), colloidal anhydrous silicon dioxide, talc, magnesium stearate, starch 1500 (partially pregelatinized corn starch).

Shell composition opadry II series 85, code 85F 18422 (white): partially hydrolyzed polyvinyl alcohol, macrogol 3350 (polyethylene glycol), talc, titanium dioxide (E171).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Clinical-Pharmacological Group

Spasm analgesic

Pharmacotherapeutic Group

Analgesic and antispasmodic agent

Pharmacological Action

A combined medicinal product with analgesic, anti-inflammatory, and antispasmodic action. It suppresses the synthesis of prostaglandins and stimulates the formation of endogenous interferon.

Ibuprofen is an NSAID, pitofenone hydrochloride is an antispasmodic agent, and fenpiverinium bromide has an m-cholinolytic action.

Pharmacokinetics

The components are well absorbed in the gastrointestinal tract. C_max in blood plasma is reached in approximately 1-2 hours. The main component, Ibuprofen, is 99% bound to plasma proteins, can accumulate in synovial fluid, is metabolized in the liver, and 90% is excreted in the urine as metabolites and conjugates. A small portion is excreted in the bile. T_1/2 from blood plasma is 2 hours.

Indications

Pain syndrome, smooth muscle spasm: renal colic; biliary colic; intestinal colic; algodysmenorrhea; headache, including migraine-type.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

Take tablets during or after meals to minimize gastrointestinal irritation.

The standard single dose is one to two tablets.

Do not exceed four doses per 24-hour period.

Maintain an interval of at least 4-6 hours between individual doses.

The maximum daily dose must not exceed eight tablets.

This equates to a maximum daily intake of 3200 mg of ibuprofen.

Use the lowest effective dose for the shortest duration necessary to control symptoms.

Do not use for more than 5 consecutive days as an analgesic or for more than 3 consecutive days as an antipyretic without medical supervision.

Discontinue use and consult a physician if symptoms persist or worsen.

This product is contraindicated for individuals under 16 years of age.

Adverse Reactions

From the digestive system:NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation), ulceration of the gastrointestinal mucosa, aphthous stomatitis, dry oral mucosa.

From the respiratory system: shortness of breath, bronchospasm.

From the nervous system: headache, dizziness, anxiety, nervousness.

From the cardiovascular system : tachycardia.

From the urinary system: oliguria, anuria, proteinuria, interstitial nephritis, red discoloration of urine.

From the organ of vision : accommodation paresis.

Allergic reactions urticaria, including on the conjunctiva and mucous membranes of the nasopharynx, angioedema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylactic shock.

From laboratory parameters: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), activity of “liver transaminases” (may increase).

Other decreased sweating.

Contraindications

Hypersensitivity; granulocytopenia; acute “intermittent” porphyria; glucose-6-phosphate dehydrogenase deficiency; peptic ulcer of the stomach and duodenum; tachyarrhythmia; closed-angle glaucoma; prostatic hyperplasia; intestinal obstruction; megacolon; hepatic insufficiency or active liver disease; renal failure (creatinine clearance less than 30 ml/min); pregnancy and breastfeeding period, age under 16 years.

With caution

Elderly age, congestive heart failure, cerebrovascular diseases, arterial hypertension, coronary artery disease, long-term use of NSAIDs, blood diseases of unclear etiology (leukopenia, anemia), bronchial asthma.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency or active liver diseases.

Use in Renal Impairment

Contraindicated in renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Use is contraindicated in children under 16 years of age.

Special Precautions

With long-term use, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During treatment, alcohol consumption should be avoided.

Effect on ability to drive vehicles and mechanisms

During treatment, it is necessary to refrain from potentially hazardous activities requiring increased attention.

Drug Interactions

Enhances the effect of m-cholinolytics, histamine H₁-receptor blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine, and quinidine.

Reduces the plasma concentration of cyclosporine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.