ACETAMOL
active ingredients
ACETAMOL 300 mg effervescent granulate A bag contains:
Active ingredient: paracetamol 300 mg Excipients with known effects:
sodium 356 mg sucrose 300 mg ACETAMOL adults 500 mg tablets One tablet contains: Active ingredient: paracetamol 500 mg ACETAMOL early childhood 25 mg/mL syrup 1 ml syrup contains:
Active ingredient:
paracetamol 25 mg Excipients with known effects:
sucrose 300 mg methyl parahydroxybenzoate 0,90 mg propyl parahydroxybenzoate 0.10 mg sodium 2,85 mg 100 ml of syrup contain: Active ingredient: 2.5 g Excipients with known effects:
sucrose 30 g methyl parahydroxybenzoate 90 mg propyl parahydroxybenzoate 10 mg sodium 285 mg ACETAMOL early childhood 100 mg/mL oral drops, solution 30 ml of oral drops contain:
Active ingredient: 3 g Excipients with known effects:
sorbitol(E420) 1.5 g sodium 0,30 mg One drop contains: Active ingredient: 2,8 mg paracetamol Excipients with known effects:
sorbitol(E420) 1.4 mg sodium 0.04 mg ACETAMOL adults 1 g supposed A suppository contains: Active ingredient: 1 g ACETAMOL 500 mg suppositories A suppository contains:
Active ingredient: paracetamol 500 mg ACETAMOL children 250 mg suppositories A suppository contains: Active ingredient: 250 mg paracetamol ACETAMOL early childhood 125 mg suppositories A suppository contains: Active ingredient: paracetamol 125 mg For the full list of excipients, see paragraph 6.1.
Excellent
ACETAMOL 300 mg effervescent granulate: Citric acid, sodium bicarbonate, sucrose ACETAMOL 500 mg tablets: Potato starch, polyvinylpyrrolidone, magnesium stearate. ACETAMOL early childhood 25 mg/mL syrup: Macrogol 6000, glycerol, methyl parahydroxybenzoate, propile parahydroxybenzoate, sucrose, sodium dihydrate dibasic phosphate, sodium dihydrate monobasic phosphate, fragola cream aroma, purified water. ACETAMOL early childhood 100 mg/mL oral drops, solution: Macrogol 300, glycerol(E422), monoethyleneglycol, sorbitol(E420), sodium saccharin, gallant propile, orange aroma, lemon aroma, purified water. ACETAMOL suppose: Semisynthetic glycerides, soy lecithin.
Therapeutic indications
Symptomatic treatment of mild or moderate fever and pain.
Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 or other substances closely related to the chemical; in particular towards other analgesic and antipyretic.
Population
Under three months, in case of jaundice, the single dose should be reduced by mouth. For children it is essential to respect the defined dosage according to their body weight and therefore to choose the suitable formulation. In adults the maximum paracetamol posology per day is 3000 mg per oral and 4000 mg per rectal.
ACETAMOL 300 mg effervescent granulate Children from 8 to 12 years and weighing more than 25 kg Use the drug only after consulting your doctor and comply with its prescriptions about doses and duration of treatment. One bag of 300 mg every 4-6 hours (less than 4 hours between one and the other). Do not exceed 6 sachets in 24 hours.
Teenagers from 12 to 18 years and weighing more than 40 kg One bag of 300 mg every 4-6 hours (less than 4 hours between one and the other). If necessary, the dose can be increased up to 600 mg by taking two sachets together. Do not exceed 3 g (10 sachets) in 24 hours.
Adults A dose of 600-900 mg of paracetamol (corresponding to 2-3 sachets) repeatable, in case of need, every 4-6 hours. Do not exceed 3 g (10 sachets) in 24 hours.
Duration of treatment Usually common causes of fever or pain resolve quickly. Consult your doctor if the disorders last more than three days.
ACETAMOL adults 500 mg tablets Adolescents weighing between 41 and 50 kg (approximately between 12 and 15 years) :1 compressed at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day.
Teenagers weighing more than 50 kg (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
Adults . 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours.
Duration of treatment Usually common causes of fever or pain resolve quickly. Consult your doctor if the disorders last more than three days.
ACETAMOL early childhood 25 mg/mL syrup Use the drug only after consulting your doctor and comply with its prescriptions about doses and duration of treatment. The package contains a dosing syringe for oral administration of 5 mL, graduated with 0.5 mL notches; a notch corresponds to 12.5 mg of paracetamol.
Children up to 18 months and weighing more than 3 kg It can normally be given the dose of 25 mg per 2 kg of weight, corresponding to 1 ml (mL) of syrup every 6 hours (less than 4 hours between one dose and the other). The table contains some examples of administrations (in mL of syrup) in relation to weight.
| | Doses to be administered every 6 hours |
| weight In Kg | in milliliters of syrup | Do not exceed 4 doses in 24 hours |
| 3 | 1,5 |
| 4 | 2 |
| 5 | 2,5 |
| 8 | 4 |
| 10 | 5 |
Children over 18 months and weighing more than 11 kg It can normally be given the dose of 25 mg per 2 kg of weight corresponding to 1 ml (mL) of syrup every 4 hours (less than 4 hours between one dose and the other). The table contains some examples of administrations (in mL of syrup) in relation to weight.
| | Doses to be administered every 4 hours |
| weight In Kg | in milliliters of syrup | Do not exceed 6 doses in 24 hours |
| 11 | 5,5 |
| 12 | 6 |
| 13 | 6,5 |
| 14 | 7 |
| 15 | 7,5 |
ACETAMOL early childhood 25 mg/mL syrup can be taken by children of any age by calculating the correct dose based on weight. However, the medicinal product is identified as
First Infancy since, being packaged in 100 mL bottles, it may be insufficient for children weighing more than 15 kg, failing to cover an adequate number of days of treatment.
ACETAMOL early childhood 100 mg / mL oral drops, solution Use the drug only after consulting your doctor and comply with its prescriptions about doses and duration of treatment.
Children up to 18 months and weighing more than 3 kg A drop of
ACETAMOL 100 mg/mL oral drops solution contains 2.8 mg of paracetamol. It can normally be given the dose of 4 drops per kg of weight every 6 hours (less than 4 hours between one dose and the other). The table contains some examples of administrations (in drops) in relation to weight.
| | Doses to be administered every 6 hours |
| weight In Kg | in drops solution | Do not exceed 4 doses in 24 hours |
| 3 | 12 |
| 4 | 16 |
| 5 | 20 |
| 6 | 24 |
| 8 | 32 |
| 10 | 40 |
Children over 18 months and weighing more than 11 kg A drop of
ACETAMOL 100 mg/mL oral drops solution contains 2.8 mg of paracetamol. It can normally be given the dose of 4 drops per kg of weight every 4 hours (less than 4 hours between one dose and the other). The table contains some examples of administrations (in drops) in relation to weight.
| | Doses to be administered every 4 hours |
| weight In Kg | in drops solution | Do not exceed 6 doses in 24 hours |
| 11 | 44 |
| 12 | 48 |
| 13 | 52 |
| 14 | 56 |
| 15 | 60 |
ACETAMOL early childhood 100 mg/mL oral drops solution can be taken by children of any age by calculating the correct dose based on weight. However, the medicinal product is identified as
First Infancy since, being packaged in 30 mL bottles, it may be insufficient for children weighing more than 15 kg, failing to cover an adequate number of days of treatment.
ACETAMOL adults 1 g supposed Adolescents weighing between 41 and 50 kg (approximately between 12 and 15 years): Use the drug only after consulting the doctor and comply with his prescriptions about doses and duration of treatment.1 supposes at a time, to be repeated if necessary after 8 hours, without exceeding 3 administers per day
Teenagers weighing more than 50 kg (approximately over 15 years): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day
Adults 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day
Duration of treatment Usually common causes of fever or pain resolve quickly. Consult your doctor if the disorders last more than three days.
ACETAMOL 500 mg suppositories Children Children weighing between 21 and 25 kg (approximately between 6 and 10 years): 1 supposes at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day.
Children weighing between 26 and 40 kg (approximately between 8 and 13 years) : 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day.
Adults One 500 mg suppository every 4-6 hours (less than 4 hours between one and the other). Do not exceed 8 assumptions in 24 hours
Duration of treatment Usually common causes of fever or pain resolve quickly. Consult your doctor if the disorders last more than three days.
ACETAMOL children 250 mg suppositories Use the drug only after consulting your doctor and comply with its prescriptions about doses and duration of treatment.
Children weighing between 11 and 12 kg (approximately between 18 and 24 months) 1 supposes at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day.
Children weighing between 13 and 20 kg (approximately between 2 and 7 years): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day.
ACETAMOL early childhood 125 mg suppositories Use the drug only after consulting your doctor and comply with its prescriptions about doses and duration of treatment.
Children weighing between 6 and 7 kg (approximately between 3 and 6 months): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day.
Children weighing between 7 and 10 kg (approximately between 6 and 18 months): 1 supposes at a time, to be repeated if necessary after 4 - 6 hours, without exceeding the 5 administrations per day.
Children weighing between 11 and 12 kg (approximately between 18 and 24 months): 1 supposes at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day
Special popularity Patients with liver impairment In patients with hepatic function impairment or Gilbert syndrome, the dose should be reduced or extended (see paragraph 4.4).
Patients with kidney failure In case of severe renal failure (creatiny clearance below 10ml/min) the time interval between administrations must be at least 8 hours.
Chronic Alcoholism Chronic alcohol consumption can reduce the toxicity threshold of paracetamol. In these patients should take at least 8 hours between two doses. The total dose of 2 g paracetamol should not be exceeded per day.
Conservation
ACETAMOL early childhood 25 mg/mL syrup: keep at a temperature below 25°C For all other presentations, the medicinal product does not require any special conservation conditions.
Warnings
In case of allergic reactions, the administration of the medicinal product must be suspended (see paragraph 4.8). High or prolonged doses of the product may result in high-risk hepatopathy and alterations, even severe to the kidney and blood. The medicine should not be taken along with other nonsteroidal analgesic, antipyretic or anti-inflammatory drugs (see paragraph 4.5). The usual intake of analgesics, in particular of an association of different analgesic substances, can determine a permanent kidney damage with risk of kidney failure (nephropathy from analgesics). It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. During treatment with paracetamol before prescribing any other medicinal product, check that it does not contain the same active ingredient, since if the paracetamol is taken in high doses (see paragraph 4.9) severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medicine (see paragraph 4.5). It is also indicated caution in case of administration under conditions of dehydration, chronic malnutrition and underweight adults, as the risk of liver damage has increased. In case of incorrect and prolonged use of analgesics at high doses, it can be observed onset or aggravation of cephalea. The headache caused by excessive use of analgesics (MOH - medication-overuse headache) should not be treated with an increase in the dose of the drug. In these cases, the use of analgesics must be suspended. The sudden interruption of the intake of analgesics after a prolonged period of incorrect use at high doses can cause headache, muscle pain, fatigue, nervousness and autonomic symptoms. These suspension symptoms resolve within a few days; the further assumption of analgesics must be avoided.
Special popularity Patients with kidney or liver failure Paracetamol should be administered with caution to patients with severe kidney failure (cancerance of creatinine Patients with glucose-6-phosphate dehydrogenase deficiency Paracetamol should be given with caution to patients with glucose-6-phosphate dehydrogenase deficiency.
Patients with hemolytic anemia Paracetamol should be given with caution to patients with hemolytic anemia.
Patients with asthma The use of paracetamol in asthmatic patients may result in a worsening of asthmatic symptomatology. In this case, the administration must be suspended. Paracetamol should be given with caution to patients with bronchospasm history following the intake of aspirin or NSAID (see paragraph 4.8).
Patients with chronic alcohol abuse. Concurrent use of alcohol increases the risk of liver damage (see paragraph 4.5). Overdose risks are higher in patients with non cirrhotic alcoholic hepatopathy. In patients with alcohol abuse, the dose must be reduced (see paragraph 4.2). During oral anticoagulant therapy, it is recommended to reduce doses (see paragraph 4.5).
Notices related to excipients Oral drops, solution solution : contains
sorbitol: patients with hereditary fructose intolerance should not be given this medicine. This medicine contains less than 1 mmol (23 mg) of
sodium per dose (up to 60 drops), i.e. essentially without sodium.
Effervescent granulate: contains
sucrose; patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains 356 mg of
sodium per sachet equivalent to 17,8% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. To be considered in people with reduced kidney function or following a low sodium diet.
Syrup: contains
para-hydroxybenzos which can cause allergic reactions (also delayed). Contains
sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains less than 1 mmol (23 mg) of
sodium per dose (up to 7.5 ml), i.e. essentially without sodium.
Interactions
Use with extreme caution and under strict control during chronic treatment with medicines that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. rifampin, cimetidine, anti-epileptics such as glutetimmide, phenobarbital, carbamazepine). The administration of zidovudine can increase the liver toxicity of the paracetamol. Concurrent administration of alcohol and paracetamol may increase the metabolism and hepatotoxicity of paracetamol (see paragraph 4.4). Medicines that slow gastric emptying (e.g. anti-linergics) can determine antral stasis by delaying the absorption of the paracetamol and therefore the onset of the analgesic effect. Colestramine reduces the absorption of paracetamol and should not therefore be administered before an hour has passed since paracetamol is administered. The simultaneous intake of paracetamol and chloramphenicol can lead to an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Concurrent use of paracetamol with oral anticoagulants can induce variations in INR values. In these cases a more frequent monitoring of INR values should be conducted during concurrent use and after its interruption. In the course of therapies with oral anticoagulants it is recommended to reduce doses. The probenecid decreases renal clearance and increases the half-life of the paracetamol. In patients with probenecid, the dose of paracetamol should be reduced. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).
Interaction with laboratory tests Paracetamol administration may interfere with the determination of uricemia (by the method of phospho-tungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase).
Effects
Adverse events are listed below, divided by systemic-organic class and by frequency. The frequencies are defined as: very common (≥1/10); common (≥1/100,
Pathologies of skin and subcutaneous tissue Very rare: severe skin reactions, including cases of multiform erythema, Stevens-Johnson syndrome and epidermal necrolysis (see paragraph 4.4).
Immune system disorders Not known: hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock, bronchospasmo
Emolinfopoietic system pathologies Notable: Trombocytopenia, anemia, agranulocytosis. Very rare: leucopenia.
Gastrointestinal disorders Not known: Haemorrhage, abdominal pain, diarrhoea, nausea, vomiting.
Hepatobiliary pathologies Not known: liver function disorders, hepatitis.
Kidney and urinary disorders Notable: acute kidney failure, interstitial nephritis, hematuria, auria.
Systemic pathologies and conditions for administration Not known: dizziness.
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Overdose
Symptoms: Paracetamol in massive doses can cause hepatotoxicity, therefore in cases of suspected accidental ingestion of high doses of the drug it is advisable to hospitalize the patient.In case of overdose, paracetamol can cause hepatic cytolysis which can evolve into complete and irreversible necrosis.Symptoms of overdose generally appear within 24 hours and are: vomiting, anorexia, nausea and epigastric pain;clinical and laboratory data attesting to hepatotoxicity are evident within 48-72 hours of ingestion.In adults, liver toxicity is rarely reported with an acute overdose of less than 10 g.It is fatal when this is 15 g and above.Children appear to be less sensitive than adults to the hepatotoxic effect of paracetamol.Determination of plasma concentrations of paracetamol reveals the degree of intoxication;with concentrations of 300 mcg/ml after 4 hours serious liver damage can develop;with plasma concentrations of 120 mcg/ml within 4 hours and 50 mcg/ml at 12 hours, only mild liver damage may develop.Once the acute phase of toxicity has passed, no structural or functional abnormalities of the liver remain.Treatment: The recommended treatment, in addition to common practices (gastric lavage or induced emesis), consists of the administration of antidotes acetylcysteine or methionine, at least within 10 hours of ingestion to obtain the best results.Acetylcysteine is administered by intravenous infusion in an initial dose of 150 mg/kg of body weight, for 15 minutes followed by 50 mg/kg for 4 hours and 100 mg/kg during the first 16 hours.Alternatively, methionine 2.5 g can be administered orally every 4 hours for a total of 4 doses.
Pregnancy
A large amount of data on pregnant women indicate neither malformative nor fetal/neonatal toxicity.Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.If clinically needed, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible duration and with the lowest possible frequency.
Breastfeeding
Paracetamol is excreted in small quantities in breast milk.No effect has been demonstrated in breast-fed infants.Paracetamol can be used for a short time during breast-feeding, provided that the recommended doses are not exceeded.
Fertility
The data relating to the use of paracetamol is not sufficient to determine whether the paracetamol has direct or indirect effects on fertility in man. Use the paracetamol only in cases of actual need and under the direct control of the doctor.
Source: Farmadati
