Aquacitramon (Granules) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

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

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Paracetamol (Rec.INN WHO registered)

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Dosage Form

Aquacitramon

Granules for oral solution 0.36 g+0.27 g+0.045 g/1 sachet: 3 g sachets 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Granules for the preparation of an oral solution in the form of a mixture of granules and powder of light yellow color with a faint citrus odor.

Excipients: citric acid – 1.34 g, sodium bicarbonate – 0.782 g, sodium benzoate – 0.048 g, orange flavor – 0.04 g, lemon flavor – 0.02 g, sodium saccharin – 0.015 g, colorant curcumin – 0.08 g.

3 g – single-dose sachets (5) – cardboard packs.
3 g – single-dose sachets (10) – cardboard packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

Combined medicinal product.

Acetylsalicylic acid has antipyretic and anti-inflammatory effects, relieves pain, especially that caused by the inflammatory process, and also moderately inhibits platelet aggregation and thrombus formation, improving microcirculation in the focus of inflammation.

Caffeine increases the reflex excitability of the spinal cord, stimulates the respiratory and vasomotor centers, dilates blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, feeling of fatigue, increases mental and physical performance. In this combination, Caffeine in a small dose has practically no stimulating effect on the CNS, but helps to normalize the tone of cerebral vessels and accelerate blood flow.

Paracetamol has analgesic, antipyretic and very weak anti-inflammatory effects, which is associated with its influence on the thermoregulation center in the hypothalamus and a weakly expressed ability to inhibit the synthesis of prostaglandins in peripheral tissues.

Indications

Mild to moderate pain syndrome (of various origins): headache; migraine; toothache; neuralgia; myalgia; arthralgia; primary dysmenorrhea.

Febrile syndrome: in acute respiratory diseases; in influenza.

ICD codes

Dosage Regimen

Orally (during or after meals) taken every 4 hours. On average, taken 3-4 times/day. Maximum frequency of administration – 8 times/day. The course of treatment is no more than 7-10 days.

In case of impaired renal or hepatic function, the interval between doses is at least 6 hours.

The drug should not be taken for more than 5 days when prescribed as an analgesic and for more than 3 days as an antipyretic. Other doses and regimens are determined by the doctor.

Adverse Reactions

From the digestive system gastralgia, nausea, vomiting, hepatotoxicity, erosive and ulcerative lesions of the gastrointestinal tract.

From the urinary system nephrotoxicity,

Allergic reactions: skin manifestations, Stevens-Johnson syndrome, Lyell’s syndrome, bronchospasm.

From the cardiovascular system tachycardia, increased blood pressure,

With prolonged use dizziness, headache, visual disturbances, tinnitus, decreased platelet aggregation, hypocoagulation, hemorrhagic syndrome (including nosebleeds, gum bleeding, purpura), kidney damage with papillary necrosis; deafness; Reye’s syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

Contraindications

Hypersensitivity to the components of the drug; erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); gastrointestinal bleeding; “aspirin” asthma; hemophilia; hemorrhagic diathesis; hypoprothrombinemia; portal hypertension; vitamin K deficiency; renal failure; I and III trimesters of pregnancy; lactation period (breastfeeding); glucose-6-phosphate dehydrogenase deficiency; severe arterial hypertension; severe coronary artery disease; glaucoma; increased excitability; sleep disorders; surgical interventions accompanied by bleeding; 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 I and III trimesters of pregnancy and during lactation (breastfeeding).

Acetylsalicylic acid has a teratogenic effect; when used in the I trimester of pregnancy, it leads to a developmental defect – cleft palate; in the III trimester – to inhibition of labor (inhibition of prostaglandin synthesis), to closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the pulmonary circulation.

It is excreted in breast milk, which increases the risk of bleeding in the child due to impaired platelet function.

Use in Hepatic Impairment

With caution liver diseases.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Children under 15 years of age should not be prescribed medicines containing acetylsalicylic acid, since in 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.

Special Precautions

Children should not be prescribed medicines containing acetylsalicylic acid, since in 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 asthmatic 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 may in some cases provoke a gout attack.

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

Drug Interactions

Enhances the effect of heparin, indirect anticoagulants, reserpine, steroid hormones and hypoglycemic drugs.

Concomitant administration with other NSAIDs, methotrexate increases the risk of side effects.

Reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, as well as antigout drugs that promote the excretion of uric acid.

Barbiturates, rifampicin, salicylamide, antiepileptic drugs and other stimulators of microsomal oxidation contribute to the formation of toxic metabolites of paracetamol that affect liver function.

Metoclopramide accelerates the absorption of paracetamol.

Under the influence of paracetamol, the T_1/2 of chloramphenicol increases 5 times. With repeated administration, Paracetamol may enhance the effect of anticoagulants (dicoumarol derivatives).

Concomitant use of paracetamol and ethanol increases the risk of hepatotoxic effects.

Caffeine accelerates the absorption of ergotamine.

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.