Zorex Utro^® (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Manufactured By

Pharmaestica Manufacturing, OU (Estonia)

Packaging and Quality Control Release

VALENTA PHARM, JSC (Russia)

ATC Code

N02BA51 (Acetylsalicylic acid in combination with other drugs, excluding psycholeptics)

Active Substances

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Citric acid (Ph.Eur. European Pharmacopoeia)

Sodium bicarbonate (BP British Pharmacopoeia)

Dosage Form

Zorex Utro®

Effervescent tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets white or white with a creamy tint, flat-cylindrical in shape with a rough surface, with a bevel and a characteristic odor; slight marbling is allowed.

Excipients: succinic acid – 0.08 g, sodium benzoate – 0.048 g, povidone – 0.001 g, lemon flavor – 0.04 g, lime flavor – 0.02 g.

2 pcs. – strips (5) – cardboard packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

Non-narcotic analgesic agent (NSAID + antacid agent)

Pharmacological Action

Combined medicinal product.

Acetylsalicylic acid has analgesic, antipyretic, and anti-inflammatory effects, which is due to the inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A₂.

Sodium bicarbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritating effect of the drug.

Citric acid promotes faster absorption of active substances.

Indications

Symptomatic treatment of pain syndrome, including headache (including after excessive alcohol consumption), toothache, sore throat, back and muscle pain, joint pain, menstrual pain.

Elevated body temperature in colds and other infectious and inflammatory diseases (in adults and children over 15 years of age).

ICD codes

Dosage Regimen

Administer orally after dissolving one effervescent tablet in a glass of water.

Use a single dose containing the fixed combination of active substances.

The maximum frequency is up to 6 times per day.

Maintain an interval of at least 4 hours between consecutive doses.

Do not exceed the maximum daily dosage of acetylsalicylic acid.

For self-treatment of pain, the duration of use must not exceed 5 days.

For self-treatment of fever, the duration of use must not exceed 3 days.

Discontinue use and consult a physician if symptoms persist beyond these durations.

This product is contraindicated in children and adolescents under 15 years of age.

Avoid concomitant use with other products containing acetylsalicylic acid or NSAIDs.

Adverse Reactions

From the digestive system abdominal pain, heartburn, nausea, vomiting, overt (vomiting blood, tarry stools) or hidden signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive and ulcerative lesions (including with perforation) of the gastrointestinal tract, in isolated cases – impaired liver function (increased liver transaminases).

From the nervous system: dizziness, tinnitus (usually are signs of overdose).

From the hematopoietic system increased risk of bleeding, which is a consequence of the effect of acetylsalicylic acid on platelet aggregation.

Allergic reactions skin rash, anaphylactic reactions, bronchospasm, angioedema.

Contraindications

Hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the combination; erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); hemorrhagic diathesis; combined use of methotrexate at a dose of 15 mg per week or more; asthma induced by the use of salicylates or other NSAIDs; I and III trimesters of pregnancy; breastfeeding period; children under 15 years of age.

Should not be used in children under 15 years of age with acute respiratory diseases caused by viral infections due to the risk of developing Reye’s syndrome (encephalopathy and acute fatty liver degeneration with acute development of liver failure).

With caution

During concomitant therapy with anticoagulants, gout, gastric and/or duodenal ulcer (in history), including chronic or recurrent peptic ulcer disease, or episodes of gastrointestinal bleeding; renal and/or hepatic insufficiency, glucose-6-phosphate dehydrogenase deficiency.

Use in Pregnancy and Lactation

Contraindicated for use in the I and III trimesters of pregnancy.

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

Use in Hepatic Impairment

With caution hepatic insufficiency.

Use in Renal Impairment

With caution renal insufficiency.

Pediatric Use

Should not be used in children under 15 years of age. Children should not be prescribed drugs containing acetylsalicylic acid, since in case of a viral infection the risk of Reye’s syndrome increases. Symptoms of Reye’s syndrome are prolonged vomiting, acute encephalopathy, and liver enlargement.

Special Precautions

Acetylsalicylic acid can cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions.

Risk factors are the presence of bronchial asthma, nasal polyps, fever, chronic bronchopulmonary diseases, history of allergies (allergic rhinitis, skin rashes).

Acetylsalicylic acid can increase the tendency to bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be taken into account when surgical interventions are necessary, including minor interventions such as tooth extraction. Before surgery, to reduce bleeding during the operation and in the postoperative period, the drug should be discontinued 5-7 days in advance and the doctor should be informed.

Acetylsalicylic acid reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients.

Drug Interactions

Concomitant use

with methotrexate at a dose of 15 mg per week or more: increases the hemolytic cytotoxicity of methotrexate (renal clearance of methotrexate is reduced and methotrexate is displaced by salicylates in connection with plasma proteins);

with anticoagulants, for example, heparin the risk of bleeding increases due to inhibition of platelet function, damage to the gastrointestinal mucosa, displacement of (oral) anticoagulants from the connection with plasma proteins;

with other NSAIDs, as well as with large doses of salicylates (3 g per day or more): as a result of synergistic interaction, the risk of ulcers and bleeding increases;

with uricosurics, for example benzbromarone reduces the uricosuric effect;

with digoxin the concentration of digoxin increases due to decreased renal excretion;

with antidiabetic drugs, for example, insulin the hypoglycemic effect of antidiabetic drugs is enhanced due to the hypoglycemic effect of acetylsalicylic acid;

with drugs of the thrombolytic group the risk of bleeding increases;

with diuretics at a dose of 3 mg per day and more glomerular filtration decreases due to decreased synthesis of prostaglandins;

with systemic corticosteroids, excluding hydrocortisone used as replacement therapy for Addison’s disease when using corticosteroids, the level of salicylates in the blood decreases due to increased excretion of the latter;

with ACE inhibitors at a dose of 3 g per day and more, glomerular filtration decreases due to inhibition of prostaglandins and, as a result, the antihypertensive effect decreases;

with valproic acid the toxicity of valproic acid increases;

with ethanol the risk of damaging effects on the gastrointestinal mucosa increases and bleeding time increases.

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.