Adolef

ADOLEF 1000 mg effervescent tablets
Paracetamol
Generic medicine
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Each effervescent tablet contains:
Active substance: Paracetamol 1000 mg
Excipients: anhydrous citric acid, sodium bicarbonate, sorbitol, anhydrous sodium carbonate, sodium benzoate, orange flavour, acesulfame K, simethicone, sodium docusate.
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Effervescent tablets – Tube containing 16 tablets of 1000 mg
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Analgesic-antipyretic
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BIOMED PHARMA S.R.L.
Via Colla n. 6
17014 Cairo Montenotte (SV)
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E-PHARMA TRENTO S.P.A.
Via Provina n. 2
38123 Trento
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Symptomatic treatment of painful conditions of any kind (e.g., headache, toothache, stiff neck, joint and lumbosacral pain, menstrual pain, minor surgical procedures).
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Hypersensitivity to the active substance or to any of the excipients.
Patients under 15 years of age.
The product contains sorbitol; therefore, it is contraindicated in hereditary fructose intolerance.
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In rare cases of allergic reactions, administration must be discontinued and appropriate treatment initiated.
Paracetamol must be administered with caution in patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure, acute hepatitis, concomitant treatment with drugs affecting liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia.
Use with caution in patients with renal insufficiency. High or prolonged doses of the product may cause high-risk hepatopathy and serious adverse effects on the kidney and blood.
During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active substance, since overdose of paracetamol may lead to serious adverse reactions. Patients should be advised to contact their doctor before combining with any other medication.
See also section “Interactions”.
Do not administer for more than 10 consecutive days without consulting a doctor.
In case of prolonged use, monitoring of liver and kidney function and blood count is advisable.
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During therapy with oral anticoagulants, a reduction in their dosage is recommended.
Use with extreme caution and under close monitoring during chronic treatment with drugs that may induce hepatic monooxygenases or in case of exposure to substances that may have such effect (e.g., rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). The same applies in cases of alcoholism and in patients treated with zidovudine. Drugs that delay gastric emptying (e.g., anticholinergics) may cause antral stasis, delaying the absorption of paracetamol and thus the onset of analgesic effect.
Administration of paracetamol may interfere with the determination of uric acid levels (by the phosphotungstic acid method) and blood glucose levels (by the glucose-oxidase-peroxidase method). Concomitant administration of chloramphenicol may increase the half-life of paracetamol, increasing the risk of toxicity.
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The medicine is not contraindicated for patients with coeliac disease.
For patients on a low-sodium diet, it should be noted that each tablet of ADOLEF 1000 mg provides approximately 18.17 mEq of sodium. The product contains sorbitol; therefore, it may cause gastrointestinal disturbances and diarrhoea.
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It is recommended to administer the product only when strictly necessary and under direct medical supervision.
If necessary, Adolef can be used during pregnancy. It is advisable to use the lowest possible dose that reduces pain and/or fever, and to take it for the shortest possible duration. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
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The use of this medicine does not affect the ability to drive or operate machinery.
KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN.
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Adults (over 15 years): 1 effervescent tablet, to be dissolved in a glass of water, 1-2 times daily; in more severe cases, the daily dosage may be increased up to 3 tablets per day.
The interval between administrations must not be less than four hours.
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In case of accidental ingestion of very high doses, acute intoxication manifests as anorexia, nausea, vomiting, pallor, abdominal pain, followed by a profound deterioration in general condition; these symptoms usually appear within the first 24 hours.
In case of overdose (more than 10 g of paracetamol in adults and more than 150 mg/kg body weight in children), paracetamol may cause hepatic cytolysis which may progress to massive and irreversible necrosis leading to hepatocellular failure, metabolic acidosis and encephalopathy, potentially resulting in coma and death. Simultaneously, increased levels of liver transaminases, lactate dehydrogenase and bilirubin, and decreased prothrombin levels may be observed within 12–48 hours after ingestion.
Management includes early gastric emptying and hospitalization for appropriate treatment.
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Skin reactions of various types and severity have been reported with the use of paracetamol, including cases of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Hypersensitivity reactions such as skin rash with erythema or urticaria, angioedema, laryngeal oedema and anaphylactic shock have also been reported. Other reported adverse effects include: thrombocytopenia, leucopenia, anaemia, agranulocytosis, altered liver function and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness.
The appearance of allergic reactions requires discontinuation of treatment.
Following the instructions in the package leaflet reduces the risk of adverse effects.
It is important to inform your doctor or pharmacist of any adverse effect, even if not described in this leaflet.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse effects, you can help provide more information on the safety of this medicine.
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See the expiry date stated on the packaging; this date refers to the product when properly stored in its original packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store in the original container, protected from moisture; keep away from sources of heat.
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