Nextrim^® Pluc (Tablets) Instructions for Use

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

ATC Code

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

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Acetylsalicylic acid (Ph.Eur. European Pharmacopoeia)

Dosage Form

Nextrim® Plus

Tablets 300 mg+50 mg: 10 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs of combined composition

Pharmacotherapeutic Group

Non-narcotic analgesic agent (NSAID + psychostimulant)

Pharmacological Action

A combined medicinal product, the action of which is determined by its constituent components.

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

Caffeine increases the reflex excitability of the spinal cord, stimulates the respiratory and vasomotor centers, dilates the blood vessels of skeletal muscles, the brain, heart, and kidneys, reduces platelet aggregation; reduces drowsiness, feeling of fatigue, increases mental and physical performance.

Indications

Headache; toothache; myalgia; arthralgia; neuralgia; algodysmenorrhea; febrile syndrome in colds and acute respiratory viral infections.

ICD codes

Dosage Regimen

Take orally, after meals, with a full glass of water.

For adults and adolescents 15 years and older, administer 1 tablet as a single dose.

Repeat the dose 3 to 4 times per day as needed for pain or fever relief.

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

Do not exceed a maximum daily dose of 10 tablets.

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

Discontinue use and consult a physician if symptoms persist for more than 3 days for fever or 5 days for pain.

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

Adverse Reactions

Possible gastralgia, nausea, vomiting, allergic reactions, thrombocytopenia, insomnia, tachycardia, increased blood pressure.

With prolonged use – erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding; hepatic and/or renal failure; in predisposed patients – bronchospasm; dizziness, headache, visual disturbances, tinnitus, decreased platelet aggregation, hypocoagulation, bleeding tendency.

Contraindications

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; first and third trimesters of pregnancy; lactation period; children under 15 years of age – risk of developing Reye’s syndrome in children with hyperthermia due to viral diseases; hypersensitivity to acetylsalicylic acid and/or caffeine.

With caution

Gout, liver diseases.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Hepatic Impairment

With caution: liver diseases.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

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

Special Precautions

Children should not be prescribed medicines containing acetylsalicylic acid, since in the case of a viral infection they can increase the risk of Reye’s syndrome. Symptoms of Reye’s syndrome include 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 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 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, oral anticoagulants, reserpine, steroid hormones and hypoglycemic drugs.

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

Reduces the effectiveness of spironolactone, furosemide, antihypertensive and antigout 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.