Vocivus^® (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Medisorb, JSC (Russia)

ATC Code

M01AE51 (Ibuprofen in combination with other drugs)

Active Substances

Ibuprofen (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Dosage Form

Vocivus®

Film-coated tablets, 400 mg+325 mg: 7, 10, 14, 20, 21, 28, 30, or 42 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white in color, round, biconvex; the core is white on the cross-section.

Excipients: microcrystalline cellulose (type 102), potato starch, hypromellose (hydroxypropylcellulose), sodium starch glycolate, colloidal silicon dioxide (aerosil) (A-380), magnesium stearate; coating*.

Film coating composition: polyvinyl alcohol, titanium dioxide, macrogol 4000 (PEG 4000), talc.

* OPADRY^® II (85F18422) or a ready-made film coating of identical composition.

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

A combined medicinal product containing Ibuprofen (NSAID) and Paracetamol (analgesic-antipyretic).

Ibuprofen has analgesic, anti-inflammatory, and antipyretic effects. By inhibiting COX-1 and COX-2, it disrupts arachidonic acid metabolism, reduces the amount of prostaglandins (mediators of pain, inflammation, and hyperthermic reaction), both in the inflammation focus and in healthy tissues, and suppresses the exudative and proliferative phases of inflammation.

Paracetamol non-selectively blocks COX, mainly in the CNS, and has a weak effect on water-salt metabolism and the gastrointestinal mucosa. It has analgesic and antipyretic effects. In inflamed tissues, peroxidases neutralize the effect of paracetamol on COX-1 and COX-2, which explains the low anti-inflammatory effect.

Pharmacokinetics

Ibuprofen. Absorption is high. C_max in plasma is reached 1-2 hours after administration. Plasma protein binding is 90%. T_1/2 is 2 hours. It slowly penetrates into the joint cavity, is retained in the synovial tissue, creating higher concentrations there than in plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It undergoes metabolism. It is excreted by the kidneys (unchanged, not more than 1%) and, to a lesser extent, with bile.

Paracetamol. Absorption is high. C_max in plasma is reached 0.5-2 hours after administration. Plasma protein binding is 15%. It penetrates the blood-brain barrier. It is metabolized in the liver (90-95%): 80% undergoes conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug. T_1/2 is 1-4 hours. It is excreted by the kidneys as metabolites, mainly conjugates. Less than 5% is excreted unchanged. T_1/2 is 4-5 hours.

Indications

For adults: moderate intensity pain syndrome; traumatic inflammation of soft tissues and the musculoskeletal system (including bruises, sprains, dislocations, fractures); postoperative period; primary dysmenorrhea; toothache; neuralgia; myalgia; lumbago; fibrositis; tenosynovitis; headache; febrile syndrome; joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gouty arthritis); sinusitis; tonsillitis.

For children (as an auxiliary medicinal product): tonsillitis; acute infectious and inflammatory diseases of the upper respiratory tract (pharyngitis, tracheitis, laryngitis).

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

For adults and adolescents over 18 years of age, take one tablet every 6-8 hours as needed for pain or fever.

Do not exceed three tablets within any 24-hour period.

For short-term use only; do not use for more than 3 days for fever or 5 days for pain without medical supervision.

If symptoms persist or worsen, discontinue use and consult a physician.

Take the tablet after meals to minimize potential gastrointestinal discomfort.

Ensure a minimum 4-hour interval between doses.

For pediatric patients under 18 years of age, use only dosage forms specifically approved for the corresponding age category; this formulation is not intended for children.

Avoid concomitant use with other products containing paracetamol or NSAIDs.

In elderly patients and patients with renal or hepatic impairment, use the lowest effective dose for the shortest possible duration.

Adverse Reactions

From the digestive system: NSAID-gastropathy – nausea, vomiting, heartburn, anorexia, discomfort or pain in the epigastrium, diarrhea, flatulence; rarely – erosive and ulcerative lesions, bleeding; impaired liver function, hepatitis, pancreatitis; irritation or dryness in the oral cavity, mouth pain, ulceration of the gum mucosa, aphthous stomatitis; constipation.

From the nervous system: headache, dizziness, insomnia, anxiety, nervousness, irritability, agitation, drowsiness, depression, confusion, hallucinations; rarely – aseptic meningitis (more often in patients with autoimmune diseases).

From the sensory organs: hearing loss, tinnitus, visual disturbances, toxic damage to the optic nerve, blurred vision or double vision, scotoma, amblyopia.

From the cardiovascular system: heart failure, increased blood pressure, tachycardia.

From the hematopoietic organs: anemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia.

From the respiratory system: shortness of breath, bronchospasm.

From the urinary system: allergic nephritis, acute renal failure, nephrotic syndrome, edema, polyuria, cystitis.

Allergic reactions: skin rash, itching, urticaria, angioedema, bronchospasm, dyspnea, allergic rhinitis, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids, eosinophilia, fever, anaphylactic shock, erythema multiforme exudativum (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Laboratory parameters: decreased serum glucose concentration, decreased hematocrit and hemoglobin, increased bleeding time, increased serum creatinine concentration, increased activity of liver transaminases.

Other: increased sweating.

With long-term use in high doses: ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia).

Contraindications

Peptic ulcer of the stomach and duodenum in the acute phase; gastrointestinal bleeding; severe renal failure (creatinine clearance less than 30 ml/min); complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history); damage to the optic nerve; genetic absence of glucose-6-phosphate dehydrogenase; blood system diseases; period after coronary artery bypass surgery; progressive kidney diseases; severe hepatic failure or active liver disease; confirmed hyperkalemia; inflammatory bowel diseases; children under 2 years of age (for dosage forms containing 100 mg ibuprofen); children and adolescents under 18 years of age (for dosage forms containing more than 200 mg ibuprofen); III trimester of pregnancy, breastfeeding period; hypersensitivity to ibuprofen, paracetamol, to other NSAIDs.

With caution

History of a single episode of gastric ulcer or gastrointestinal ulcer bleeding, gastritis, enteritis, colitis, impaired renal function, liver function, arterial hypertension and/or heart failure, cerebrovascular diseases, diabetes mellitus, blood diseases of unknown etiology (leukopenia, anemia, thrombocytopenia), I and II trimesters of pregnancy, elderly age.

In children over 2 years of age, preparations containing the combination Ibuprofen + Paracetamol are used in dosage forms intended for the corresponding age category.

Use in Pregnancy and Lactation

In the I and II trimesters of pregnancy, use is possible only as prescribed by a doctor in cases where the potential benefit outweighs the possible risk to the mother and the potential risk to the fetus. The use of this combination in the III trimester of pregnancy is contraindicated.

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

Use is contraindicated in children under 2 years of age.

In children over 2 years of age, preparations containing the combination Ibuprofen + Paracetamol are used in dosage forms intended for the corresponding age category.

Special Precautions

With caution: coronary artery disease, chronic heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery diseases, smoking, creatinine clearance less than 60 ml/min, history of gastrointestinal ulcerative lesions, presence of Helicobacter pylori infection, elderly age, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), viral hepatitis, mild or moderate hepatic and/or renal insufficiency, benign hyperbilirubinemias (Gilbert’s syndrome, Dubin-Johnson syndrome, Rotor syndrome), liver cirrhosis with portal hypertension, nephrotic syndrome.

Avoid simultaneous use with other medicinal products containing Paracetamol and/or NSAIDs. When using the drug for more than 5-7 days as prescribed by a doctor, peripheral blood counts and the functional state of the liver should be monitored.

When used simultaneously with indirect anticoagulants, indicators of the blood coagulation system should be monitored.

Avoid concomitant use of this combination with other NSAIDs.

To avoid possible damaging effects on the liver during the period of taking the drug, alcohol should not be consumed.

The drug may distort the results of laboratory tests in the quantitative determination of glucose, uric acid in blood serum, 17-ketosteroids (it is necessary to discontinue the drug 48 hours before the study).

Effect on the ability to drive vehicles and mechanisms

During the treatment period, the patient should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with acetylsalicylic acid, Ibuprofen reduces its anti-inflammatory and antiplatelet effect (an increase in the frequency of acute coronary insufficiency is possible in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting Ibuprofen).

Combination with ethanol, glucocorticosteroids increases the risk of erosive and ulcerative lesions of the gastrointestinal tract.

Ibuprofen enhances the effect of direct (heparin) and indirect (coumarin and indandione derivatives) anticoagulants, thrombolytic agents (alteplase, anistreplase, streptokinase, urokinase), antiplatelet agents, colchicine – the risk of hemorrhagic complications increases.

This combination enhances the hypoglycemic effect of insulin and oral hypoglycemic medicinal products.

It weakens the effects of antihypertensive medicinal products and diuretics (by inhibiting the synthesis of renal prostaglandins).

Increases the concentration in the blood of digoxin, lithium preparations and methotrexate.

Caffeine enhances the analgesic effect of ibuprofen.

With simultaneous use of this combination with cyclosporine, gold preparations, nephrotoxicity increases.

With simultaneous use of this combination with cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the frequency of hypoprothrombinemia development increases.

Antacids and cholestyramine reduce the absorption of the Ibuprofen+Paracetamol combination.

Myelotoxic medicinal products contribute to the manifestation of the hematotoxicity of the Ibuprofen+Paracetamol combination.

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.