Instructions for Use




Package leaflet Read this information carefully before use of this medicine MAXFLU • effervescent tablets • effervescent tablets, lemon flavour Composition Each effervescent tablet contains 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride and 60 mg of ascorbic acid. Excipients: Citric acid ................................................................... 1100,0 mg Sodium hydrogen carbonate ................................. 1400,0 mg Povidone ........................................................................... 2,3 mg Dioctyl sodium sulfosuccinate ..................................... 0,2 mg Sodium carbonate ..................................................... 140,0 mg Sorbitol ......................................................................... 339,0 mg Aspartame + lactose (50 :50) .................................. 100,0 mg Polyethylene glycol ..................................................... 120,0 mg Sodium benzoate ......................................................... 75,0 mg Excipients (lemon flavour): Citric acid ................................................................... 1100,0 mg Sodium hydrogen carbonate ................................. 1400,0 mg Povidone ........................................................................... 2,3 mg Dioctyl sodium sulfosuccinate ..................................... 0,2 mg Sodium carbonate ...................................................... 140,0 mg Sorbitol ......................................................................... 339,0 mg Aspartame + lactose (50 :50) ................................... 100,0 mg Polyethylene glycol ..................................................... 120,0 mg Sodium benzoate .......................................................... 75,0 mg Riboflavine-5-phosphate sodium ................................ 0,5 mg Lemon flavour ................................................................ 60,5 mg Pharmaco-therapeutic group Maxflu is a combined preparation that contains three active ingredients: paracetamol, pseudoephedrine and vitamin C (ascorbic acid). Maxflu acts against pain and fever, and have weak antiinflamatory action (paracetamol). Maxflu reduces hyperaemia and edema of nasal and synus mucous membranes (pseudoephedrine). Vitamin C supplements increased requirement of this vitamin due to common cold and flu. It acts within half an hour after oral administration and has duration of action 4-6 hours. Therapeutic indications Maxflu temporary relief symptoms due to the common cold or flu: • fever • nasal or sinus congestion and /or sinus pain • headache, muscle aches. Contraindications Maxflu should not be taken in following conditions: • hypersensitivity to paracetamol, pseudoephedrine, ascorbic acid or any substance of the effervescent tablet • acute hepatitis • chronic active hepatitis • hepatic failure due to other reasons • severe hypertension • during or within 14 days following the use of monoamine oxidase inhibitors). Precautions for use Maxflu shouldn’t be taken for self-medication for longer than 7 successive days. If symptoms do not improve or are accompanied by fever that lasts for more than 3 days, physician should be consulted. Special warnings In patients with renal function impairment Maxflu should be used with caution (due to paracetamol component) and physician should be consulted. Paracetamol-containing products should not be used for self-medication in patients who drink alcoholic beverages or have alcoholic liver disease. Such patients should consult physician and never take more than 2 grams of paracetamol per day. Due to the pseudoephedrine component product should be used with caution in patients with controlled or mild hypertension, diabetes mellitus, peripheral vascular disease, glaucoma, hyperthyroidism, or prostatic hypertrophy. Due to ascorbic acid Maxflu should be taken with caution by patients with a history of hyperoxaluria or renal calculi, glucose-6-phosphate dehydrogenase deficiency, hemocromatosis, thalassemia and sideroblastic anaemia. Maxflu is not recommended for children under 12 years of age due to high doses of active ingredients. Pregnancy and lactation This product should not be taken during pregnancy and lactation without first advising the physician. Effects on ability to drive and use machines No effects of Maxflu on ability to drive and use machines have been observed. Drug interactions Patients taking probenecid (as it may alter plasma levels of paracetamol) and drugs which induce hepatic isoenzymes such as carbamazepine, barbiturates, isoniazid, phenytoin, rifampicin, ritonavir, zidovudine and chloramphenicol (because of possible liver damage) before taking Maxflu should consult physician. Maxflu may decrease efficacy of some antihypertensive drugs (bretylium, bethanidine, guanethidine, methyldopa, alpha- and beta-adrenergic blocking agents) and also may decrease efficacy of nitrates. Concomitant use of Maxflu with cardiac glycosides can cause arrhythmias. Concomitant use of Maxflu with nasal decongenstants, tricyclic antidepressants, ergot alkaloids and amphetamine-like psychostimulants may occasionally cause a rise in blood pressure. Due to ascorbic acid concomitant use of Maxflu with iron and estrogens may increase concentration these compounds in human body. Other drugs available over-the-counter for treatment cough, cold, allergy, diet, pain, or sleep aids may also contain paracetamol and pseudoephedrine, physician should be consulted to avoid accidental overdose. If you are taking any of these medicines, before using Maxflu tell your physician. Other interactions Ascorbic acid is a strong reducing agent interfering with some laboratory test results (e.g. urine glucose, ethylestradiol, hepatic transaminases, serum lactate dehydrogenase, occult stool blood, serum bilirubin, plasma iron and ferritin, urine pH, uric acid, oxalates). Dosage and administration Adults and children over 12 years of age: 1 to 2 tablets every 6 hours as needed, while symptoms persist. The maximum daily dose is 8 tablets. Dissolve 1 to 2 effervescent tablets in a glass of water and drink freshly prepared solution. Overdosage and treatment In any case of overdosage patient should seek emergency medical attention. Following single administration of paracetamol in the dose of 140 mg/kg severe liver damage can occur in adults. During the first day general weakness, pallor, nausea, vomiting, and abdominal pain occur. Acute renal failure may also occur. Clinical signs of liver damage appear 24 to 48 hours following administration of the drug. Prompt initiation of the treatment is of essential. Stomach lavage should be performed or vomiting induced and antidote administered (N-acetylcysteine). Symptoms due to pseudoephedrine overdose, mostly include mild anxiety, tachycardia and mild hypertension. Symptoms usually appear within 4 to 8 hours of ingestion and are transient, usually requiring no treatment. Due to small content in Maxflu overdosage with ascorbic acid is hardly possible. Adverse effects Maxflu is usually well tolerated. Adverse reactions are rare and mild. Due to paracetamol skin rash and other allergic reactions, agranulocytosis, haemolitic anaemia, thrombocytopenia and hepatitis may occur occasionally. Pseudoephedrine may occasionally cause restlessness, tremor, insomnia and sweating. Very rarely pseudoephedrine may cause low blood sugar, hypertension, cardiac arrhythmias and ocular hypertension. Pseudoephedrine may also cause excitability, especially in children. Please advise your physician or pharmacist on any adverse effect. Dispensation Without medical prescription. Storage precautions Store at room temperature (15-25 °C), protected from moisture. KEEP OUT OF THE REACH OF CHILDREN! Shelf life Denoted on the packing. Do not use the drug after the expiry of shelf life. Package Box with 10 effervescent tablets. Manufacturer PLIVA Pharmaceutical industry, incorporated Ulica grada Vukovara 49, Zagreb, Croatia