Upsarin Upsa^® with vitamine C (Tablets) Instructions for Use

Marketing Authorization Holder

Upsa Laboratoires a division of Bristol-Myers Squibb (France)

ATC Code

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

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Dosage Form

Upsarin Upsa® with vitamine C

Effervescent tablets 330 mg+200 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – polypropylene tubes (1) – cardboard packs.
10 pcs. – polypropylene tubes (2) – cardboard packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

Combined analgesic agent (NSAID + vitamin)

Pharmacological Action

A combined medicinal product that has antipyretic and analgesic effects.

Acetylsalicylic acid is an NSAID that inhibits COX-1 and COX-2 enzymes, disrupting arachidonic acid metabolism, which leads to impaired prostaglandin synthesis. It has a strong analgesic, antipyretic, and anti-inflammatory effect; reduces thromboxane synthesis and inhibits platelet aggregation, lowering the coagulation status of the blood.

Ascorbic acid (vitamin C) is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; increases the body’s resistance to infections, reduces vascular permeability, and decreases the need for vitamins B₁, B², A, E, folic acid, and pantothenic acid. It satisfies the increased needs of the body for vitamin C in diseases accompanied by fever.

Indications

Febrile syndrome in infectious and inflammatory diseases; pain syndrome (of various origins) in adults: headache (including that associated with alcohol withdrawal syndrome), migraine, toothache, neuralgia, myalgia, arthralgia, dysmenorrhea.

ICD codes

Dosage Regimen

Administer orally. Dissolve one effervescent tablet in a glass of water.

For adults and children over 15 years, the single dose is one to two tablets, providing 330 mg to 660 mg of acetylsalicylic acid.

Take the dose two to four times per day. Maintain an interval of at least four hours between doses.

Do not exceed a maximum single dose of two tablets (660 mg acetylsalicylic acid).

Do not exceed a maximum daily dose of eight tablets, equivalent to 2.64 g of acetylsalicylic acid and 1.6 g of ascorbic acid.

For fever or mild to moderate pain, use the lowest effective dose for the shortest duration necessary.

In patients with renal or hepatic impairment, extend the dosing interval. Avoid use in severe renal impairment.

Do not use for more than three days for fever or for more than five days for pain without medical consultation.

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

Adverse Reactions

From the digestive system abdominal pain, nausea, vomiting, overt (black stools, bloody vomit) or covert signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive and ulcerative lesions (including with perforation) of the gastrointestinal tract; rarely – impaired liver function (increased liver transaminases).

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

From the hematopoietic system: hemorrhagic syndrome, thrombocytopenia.

From the urinary system when used in high doses – hyperoxaluria and formation of urinary stones from calcium oxalate, damage to the glomerular apparatus of the kidneys.

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

Contraindications

Hypersensitivity to the components of the drug; erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); gastrointestinal bleeding; bronchial asthma, urticaria or acute rhinitis induced by the intake of acetylsalicylic acid or other NSAIDs; hemophilia; hemorrhagic diathesis; hypoprothrombinemia; portal hypertension; vitamin K deficiency; renal failure; first and third trimesters of pregnancy; lactation period (breastfeeding); glucose-6-phosphate dehydrogenase deficiency; children’s age (under 15 years – risk of Reye’s syndrome in children with hyperthermia due to viral diseases).

With caution

Gout, liver diseases.

Use in Pregnancy and Lactation

Contraindicated for use in the first and third trimesters of pregnancy and during the lactation period (breastfeeding).

Use in Hepatic Impairment

With caution : liver diseases.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated for use in children under 15 years of age (risk of Reye’s syndrome in children with hyperthermia due to viral diseases).

Special Precautions

Children should not be prescribed medications containing acetylsalicylic acid, as in the case of a viral infection they can increase the risk of Reye’s syndrome. Symptoms of Reye’s syndrome are prolonged vomiting, acute encephalopathy, and liver enlargement.

With prolonged use of the drug, monitoring of peripheral blood and the functional state of the liver is necessary.

Since Acetylsalicylic acid slows down blood clotting, a patient who is to undergo surgery should inform the doctor in advance about taking the drug.

Patients with hypersensitivity, or with asthmoid reactions to salicylates or their derivatives acetylsalicylic acid can be prescribed only with special precautions (in an emergency care setting).

Acetylsalicylic acid in low doses reduces the excretion of uric acid. In patients with a corresponding predisposition, this can in some cases provoke a gout attack.

During treatment, one should refrain from consuming ethanol (increased risk of gastrointestinal bleeding).

Drug Interactions

It enhances the effect of heparin, oral anticoagulants, reserpine, steroid hormones, and hypoglycemic drugs.

Concomitant use of NSAIDs, methotrexate increases the risk of side effects.

It reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, as well as anti-gout drugs that promote the excretion of uric acid.

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.