Active ingredients: Paracetamol
ACETAMOL 300 mg effervescent granules
ACETAMOL ADULTS 500 mg tablets
ACETAMOL EARLY CHILDHOOD 25 mg / mL syrup
ACETAMOL EARLY CHILDHOOD 100 mg / mL oral drops, solution
ACETAMOL ADULTS 1 g suppositories
ACETAMOL 500 mg suppositories
ACETAMOL CHILDREN 250 mg suppositories
ACETAMOL EARLY CHILDHOOD 125 mg suppositories
Acetamol package inserts are available for pack sizes: - ACETAMOL 300 mg effervescent granules, ACETAMOL ADULTS 500 mg tablets, ACETAMOL EARLY CHILDHOOD 25 mg / mL syrup, ACETAMOL EARLY CHILDHOOD 100 mg / mL oral drops, solution, ACETAMOL ADULTS 1 g suppositories, ACETAMOL 500 mg suppositories, ACETAMOL CHILDREN 250 mg suppositories, ACETAMOL EARLY CHILDHOOD 125 mg suppositories
- ACETAMOL ADULTS 1000 mg effervescent tablets
Why is Acetamol used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Analgesics-Antipyretics
THERAPEUTIC INDICATIONS
Symptomatic treatment of fever and mild or moderate pain.
Contraindications When Acetamol should not be used
Hypersensitivity to the active ingredient, to any of the excipients or other closely related substances from a chemical point of view; in particular towards other analgesics and antipyretics.
Precautions for use What you need to know before taking Acetamol
Children
Consult your doctor before giving this medicine to a child.
Teenagers (12-18 years) and adults
See your doctor if the cause of the pain or fever is in doubt.
To avoid toxicity even at therapeutic doses of paracetamol, the proposed dosages must be reduced in case of excessive consumption of alcohol, fasting or poor nutritional status. In such situations, it is advisable to consult your doctor.
High or prolonged doses of the product can cause a high-risk liver disease and alterations to the kidney and blood, even serious.
Paracetamol should be administered with caution to patients with renal insufficiency, mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency, acute hepatitis, concomitant treatment with drugs that impair liver function, glucose-6 deficiency -phosphate dehydrogenase, haemolytic anemia.
During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses.
Contact your doctor before combining any other medication. See also the "Interactions" section. During therapy with oral anticoagulants it is recommended to reduce the doses.
Do not take this medicine together with other analgesics, antipyretics or non-steroidal anti-inflammatory drugs.
In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted.
Do not administer for more than 3 consecutive days without consulting your doctor.
Interactions Which drugs or foods can modify the effect of Acetamol
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (eg anticholinergics, opioids) or increase (eg.prokinetics) the rate of gastric emptying may determine respectively a decrease or an increase in the bioavailability of the product.
Concomitant administration of cholestyramine reduces the absorption of paracetamol. The concomitant intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of elevating its toxicity.
The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may induce slight variations in INR values. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its interruption.
The drug should be used with caution in patients receiving tranquilizers, antidepressants.
Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine) . The same is true in cases of ethylism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uricaemia (by the phospho-tungstic acid method) and with that of glycaemia (by the glucose oxidase method). peroxidase).
There are known interactions with substances used as antidote and listed in the section "Overdose".
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Although clinical studies in pregnant or lactating patients have not revealed particular contraindications to the use of paracetamol, nor caused unwanted effects affecting the mother or child, it is advisable to administer the product only in cases of real need and under the direct control of the doctor.
Driving and using machines
The product does not affect the ability to drive or use machines.
Warnings relating to excipients
Effervescent granules, syrup, oral drops: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Oral drops: any browning of the solution does not affect in any way the efficacy and tolerability of the product.
Syrup: contains para-hydroxybenzoates which can cause allergic reactions (even delayed).
Dosage and method of use How to use Acetamol: Dosage
AI under three months, in case of jaundice, it is advisable to reduce the single oral dose.
For children it is essential to respect the dosage defined according to their body weight, and therefore to choose the suitable formulation
In adults, the maximum oral dose is 3000 mg and rectally is 4000 mg of paracetamol per day.
ACETAMOL 300 mg effervescent granules
Children from 8 to 12 years and weighing more than 25 kg
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment. One sachet of 300 mg every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 6 sachets in 24 hours.
Adolescents from 12 to 18 years and weighing more than 40 kg
One sachet of 300 mg every 4-6 hours (never 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, if necessary, every 4-6 hours. Do not exceed 3 g (10 sachets) in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly. Consult your doctor if the complaints last more than three days.
ACETAMOL ADULTS 500 mg tablets
Adolescents from 12 to 18 years and weighing more than 40 kg
One 500 mg tablet every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 3 g (6 tablets) in 24 or
Adults
A dose of 500-1000 mg of paracetamol (1-2 tablets) every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 3 g (6 tablets) in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly. Consult your doctor if the complaints last more than three days.
ACETAMOL EARLY CHILDHOOD 25 mg / mL syrup
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment. The pack contains a 5 mL oral dosing syringe, graduated with 0.5 mL markings; one notch corresponds to 12.5 mg of paracetamol.
Children up to 18 months and weighing more than 3 kg
Normally a dose of 25 mg can be administered for every 2 kg of weight corresponding to 1 milliliter (mL) of syrup every 6 hours (never less than 4 hours between one dose and the other). The table contains some examples in relation to weight
Dose to be administered every 6 hours
Children over 18 months and weighing more than 11 kg
Normally a dose of 25 mg can be administered for every 2 kg of weight corresponding to 1 milliliter (mL) of syrup every 4 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
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 medicine is identified as Early Childhood because, 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.
INSTRUCTIONS FOR USING THE SYRUP
Warning: The bottle is equipped with a closure system that is difficult to open for children.
1- To open: press and unscrew at the same time.
2- To close: tighten fully pressing.
ACETAMOL EARLY CHILDHOOD 100 mg / mL oral drops, solution
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
Children up to 18 months and weighing more than 3 kg
10-15 mg of paracetamol per kg of weight.
One drop of ACETAMOL 100 mg / mL oral drops solution contains 2.8 mg of paracetamol. Normally the dose of 4 drops per kg of weight can be administered every 6 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
Children over 18 months and weighing more than 11 kg
10-15 mg of paracetamol per kg of weight.
One drop of ACETAMOL 100 mg / mL oral drops solution contains 2.8 mg of paracetamol. Normally the dose of 4 drops per kg of weight can be administered every 4 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
Dose to be administered every 4 hours
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 drug is identified as Early Childhood because, 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.
INSTRUCTIONS FOR THE USE OF THE ORAL DROPS
Warning: The bottle is equipped with a closure system that is difficult to open for children.
1- To open: press and unscrew at the same time.
2- To close: tighten fully pressing.
ACETAMOL ADULTS 1 g suppositories
Adolescents from 12 to 18 years and weighing more than 40 kg
One suppository of 1 g every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 3 suppositories in 24 hours
Adults
One suppository of 1 g every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 4 suppositories in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly. Consult your doctor if the complaints last more than three days.
ACETAMOL 500 mg suppositories
Children from 8 to 12 years and weighing more than 25 kg
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment. One suppository of 500 mg every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 4 suppositories in 24 hours.
Adolescents from 12 to 18 years and weighing more than 40 kg
One suppository of 500 mg every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 6 suppositories in 24 hours.
Adults
One suppository of 500 mg every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 8 suppositories in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly. Consult your doctor if the complaints last more than three days.
ACETAMOL CHILDREN 250 mg suppositories
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
Children from 2 to 8 years and weighing more than 12 kg
One suppository of 250 mg every 4-6 hours (never less than 4 hours between one and the other). Do not exceed 4 suppositories in 24 hours
ACETAMOL EARLY CHILDHOOD 125 mg suppositories
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
Children from 3 to 24 months and weighing more than 6 kg
One suppository of 125 mg every 4-6 hours (never less than 4 hours between one and the other). The maximum number of suppositories in 24 hours is 4 for 6-7 kg children, 5 for 7-10 kg children. kg, in children weighing more than 6 suppositories cannot be exceeded.
Overdose What to do if you have taken an overdose of Acetamol
In case of accidental ingestion / intake of an excessive dose of ACETAMOL, notify your doctor immediately or go to the nearest hospital. Paracetamol in very high doses can cause hepatotoxicity so in cases of suspected accidental intake of high doses of the drug it is advisable to hospitalize the patient. Symptoms of overdose usually appear within 24 hours and are: vomiting, anorexia, nausea and epigastric pain followed by profound decay of the general condition. In case of overdose, paracetamol can cause hepatic cytolysis which can evolve towards massive and irreversible necrosis. The recommended treatment, in addition to common practices (gastric lavage or induced emesis), consists in the administration of acetylcysteine or methionine antidotes, at least within 10 hours of taking it in order to have the best results. Once the acute phase of toxicity is overcome, no structural abnormalities or functions of the liver.
IF IN ANY DOUBT ABOUT THE USE OF ACETAMOL, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Acetamol
Like all medicines, ACETAMOL can cause side effects, although not everybody gets them.
Skin reactions of various types and severities have been reported with the use of paracetamol including cases of erythema multiforme, Stevens Johnson syndrome and epidermal necrolysis.
Hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock have been reported. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness. In any case, the patient is invited to report any undesirable effect not described to his doctor or pharmacist.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
Warning: do not use ACETAMOL after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
ACETAMOL EARLY CHILDHOOD 100 mg / mL oral drops, solution: the shelf life after first opening is 6 months
Keep ACETAMOL out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
COMPOSITION
ACETAMOL 300 mg effervescent granules
One sachet contains:
Active substance: paracetamol 300 mg. Excipients: Citric acid, compressible sugar, sodium bicarbonate.
ACETAMOL ADULTS 500 mg tablets
One tablet contains:
Active substance: paracetamol 500 mg. Excipients: Potato starch, magnesium stearate, polyvinylpyrrolidone.
ACETAMOL EARLY CHILDHOOD 25 mg / mL syrup
1 ml of syrup contains: Active substance: paracetamol 25 mg.
100 ml of syrup contain:
Active substance: paracetamol 2.5 g.
Excipients: Macrogol 6000, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, disodium phosphate dihydrate, monobasic sodium phosphate dihydrate, cream strawberry flavor, purified water
ACETAMOL EARLY CHILDHOOD 100 mg / mL oral drops, solution
One drop contains: Active substance: paracetamol 2.8 mg.
30 ml of oral drops contain: Active substance: paracetamol 3 g.
Excipients: Macrogol 300, glycerol, diethylene glycol monoethyl ether, sorbitol, sodium saccharin, propyl gallate, orange flavor, lemon flavor, purified water.
ACETAMOL ADULTS 1 g suppositories
One suppository contains: Active substance: paracetamol 1.0 g. Excipients: Semi-synthetic glycerides, soy lecithin
ACETAMOL 500 mg suppositories
One suppository contains: Active substance: paracetamol 500 mg. Excipients: semi-synthetic glycerides, soy lecithin.
ACETAMOL CHILDREN 250 mg suppositories
One suppository contains: Active substance: paracetamol 250 mg. Excipients: Semi-synthetic glycerides, soy lecithin.
ACETAMOL EARLY CHILDHOOD 125 mg suppositories
One suppository contains: Active substance: paracetamol 125 mg. Excipients: Semi-synthetic glycerides, soy lecithin.
PHARMACEUTICAL FORM AND CONTENT
Effervescent granules: box of 10 sachets of 300 mg of paracetamol.
Tablets: box of 20 tablets of 500 mg of paracetamol.
Syrup: glass bottle 100 ml solution.
Oral drops, solution: glass bottle 30 ml solution.
Suppositories: packs of 10 suppositories of 1 g of paracetamol, of 10 suppositories of 500 mg of paracetamol, of 10 suppositories of 250 mg of paracetamol, of 10 suppositories of 125 mg of paracetamol.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ACETAMOL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACETAMOL 300 mg effervescent granules
One sachet contains:
Active principle: paracetamol 300 mg
ACETAMOL adults 500 mg tablets
One tablet contains:
Active principle: paracetamol 500 mg
ACETAMOL early childhood 25 mg / mL syrup
1 ml of syrup contains:
Active principle: paracetamol 25 mg
100 ml of syrup contain:
Active principle: paracetamol 2.5 g
ACETAMOL early childhood 100 mg / mL oral drops, solution
30 ml of oral drops contain:
Active principle: paracetamol 3 g
One drop contains:
Active principle: paracetamol 2.8 mg
ACETAMOL adults 1 g suppositories
One suppository contains:
Active principle: paracetamol 1 g
ACETAMOL 500 mg suppositories
One suppository contains:
Active principle: paracetamol 500 mg
ACETAMOL children 250 mg suppositories
One suppository contains:
Active principle: paracetamol 250 mg
ACETAMOL early childhood 125 mg suppositories
One suppository contains:
Active principle: paracetamol 125 mg
03.0 PHARMACEUTICAL FORM
Effervescent granules; tablets; syrup; oral drops, solution; suppositories.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of fever and mild or moderate pain.
04.2 Posology and method of administration
Below three months, in case of jaundice, it is advisable to reduce the single oral dose.
For children it is essential to respect the dosage defined according to their body weight and therefore to choose the suitable formulation.
In adults, the maximum oral dose is 3000 mg and rectally is 4000 mg of paracetamol per day.
ACETAMOL 300 mg effervescent granules
Children from 8 to 12 years and weighing more than 25 kg
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
One sachet of 300 mg every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 6 sachets in 24 hours.
Adolescents from 12 to 18 years and weighing more than 40 kg
One sachet of 300 mg every 4-6 hours (never 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, if necessary, every 4-6 hours.
Do not exceed 3 g (10 sachets) in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly.
Consult your doctor if the complaints last more than three days.
ACETAMOL adults 500 mg tablets
Adolescents from 12 to 18 years and weighing more than 40 kg
One 500 mg tablet every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 3 g (6 tablets) in 24 hours.
Adults
A dose of 500-1000 mg of paracetamol (1-2 tablets) every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 3 g (6 tablets) in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly.
Consult your doctor if the complaints last more than three days.
ACETAMOL early childhood 25 mg / mL syrup
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
The pack contains a 5 mL oral dosing syringe, graduated with 0.5 mL markings; one notch corresponds to 12.5 mg of paracetamol.
Children up to 18 months and weighing more than 3 kg
Normally a dose of 25 mg can be administered for every 2 kg of weight, corresponding to 1 milliliter (mL) of syrup every 6 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
Children over 18 months and weighing more than 11 kg
Normally a dose of 25 mg can be administered for every 2 kg of weight corresponding to 1 milliliter (mL) of syrup every 4 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
ACETAMOL early childhood 25 mg / mL syrup it can be taken by children of any age by calculating the correct dose based on weight. However, the medicinal product is identified as Early Childhood 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 respecting his prescriptions regarding the 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. Normally the dose of 4 drops per kg of weight can be administered every 6 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
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. Normally the dose of 4 drops per kg of weight can be administered every 4 hours (never less than 4 hours between one dose and the other).
The table contains some examples in relation to weight.
ACETAMOL early childhood 100 mg / mL oral drops solution it can be taken by children of any age by calculating the correct dose based on weight. However, the medicinal product is identified as Early Childhood 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 suppositories
Adolescents from 12 to 18 years and weighing more than 40 kg
One suppository of 1 g every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 3 suppositories in 24 hours.
Adults
One suppository of 1 g every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 4 suppositories in 24 hours.
Duration of treatment
Common causes of fever or pain usually resolve quickly.
Consult your doctor if the complaints last more than three days.
ACETAMOL 500 mg suppositories
Children from 8 to 12 years and weighing more than 25 kg
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
A suppository of 500 mg every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 4 suppositories in 24 hours.
Adolescents from 12 to 18 years and weighing more than 40 kg
A suppository of 500 mg every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 6 suppositories in 24 hours.
Adults
A suppository of 500 mg every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 8 suppositories in 24 hours
Duration of treatment
Common causes of fever or pain usually resolve quickly.
Consult your doctor if the complaints last more than three days.
ACETAMOL children 250 mg suppositories
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
Children from 2 to 8 years and weighing more than 12 kg
A 250 mg suppository every 4-6 hours (never less than 4 hours between one and the other).
Do not exceed 4 suppositories in 24 hours.
ACETAMOL early childhood 125 mg suppositories
Use the drug only after consulting your doctor and respecting his prescriptions regarding the doses and duration of treatment.
Children from 3 to 24 months and weighing more than 6 kg
One suppository of 125 mg every 4-6 hours (never less than 4 hours between one and the other).
The maximum number of suppositories in 24 hours is 4 for children of 6-7 kg, 5 for those of 7-10 kg, in heavier children, however, 6 suppositories cannot be exceeded.
04.3 Contraindications
Hypersensitivity to the active ingredient, to any of the excipients or other closely related substances from a chemical point of view; in particular towards other analgesics and antipyretics.
04.4 Special warnings and appropriate precautions for use
Children
Consult your doctor before giving this medicine to a child.
Teenagers (12-18 years) and adults
See your doctor if the cause of the pain or fever is in doubt.
To avoid toxicity even at therapeutic doses of paracetamol, the proposed dosages must be reduced in case of excessive consumption of alcohol, fasting or poor nutritional status. In such situations, it is advisable to consult your doctor.
High or prolonged doses of the product can cause a high-risk liver disease and alterations to the kidney and blood, even serious.
Paracetamol should be administered with caution to patients with renal insufficiency, mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency, acute hepatitis, concomitant treatment with drugs that impair liver function, glucose-6 deficiency -phosphate dehydrogenase, haemolytic anemia.
During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses.
Instruct the patient to contact the physician before associating any other medication. See also section 4.5.
During therapy with oral anticoagulants it is recommended to reduce the doses.
Do not take this medicine together with other analgesics, antipyretics or non-steroidal anti-inflammatory drugs.
In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted.
Do not administer for more than 3 consecutive days without consulting your doctor.
Warnings relating to excipients
Oral drops: Patients with rare hereditary problems of fructose intolerance should not take this medicine. Any browning of the solution does not affect in any way the efficacy and tolerability of the product.
Effervescent granules, syrup: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. The product contains sugar: this should be taken into account in the case of administration to diabetic subjects or in the course of low-calorie diets.
Syrup: contains para-hydroxybenzoates which can cause allergic reactions (even delayed).
04.5 Interactions with other medicinal products and other forms of interaction
Oral absorption of paracetamol is dependent on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (eg anticholinergics, opioids) or increase (eg prokinetics) the rate of gastric emptying may lead to a decrease, respectively. or an increase in the bioavailability of the product.
Concomitant administration of cholestyramine reduces the absorption of paracetamol. The concomitant intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of elevating its toxicity.
The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may induce slight variations in INR values. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its interruption.
The drug should be used with caution in patients receiving tranquilizers, antidepressants.
Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine) The same is true in cases of alcoholism and in patients treated with zidovudine.
The administration of paracetamol can interfere with the determination of uric acid (by the method of phospho-tungstic acid) and with that of blood glucose (by the method of glucose-oxidase-peroxidase).
Interactions with substances used as antidote and listed in section 4.9 are known.
04.6 Pregnancy and lactation
Although clinical studies in pregnant or lactating patients have not revealed particular contraindications to the use of paracetamol, nor caused unwanted effects affecting the mother or child, it is advisable to administer the product only in cases of real need and under the direct control of the doctor.
04.7 Effects on ability to drive and use machines
The medicine does not affect the ability to drive or use machines.
04.8 Undesirable effects
Skin reactions of various types and severities have been reported with the use of paracetamol including cases of erythema multiforme, Stevens Johnson syndrome and epidermal necrolysis.
Hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock have been reported. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness.
04.9 Overdose
Paracetamol in massive doses can cause hepatotoxicity so in cases of suspected accidental intake 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 towards massive and irreversible necrosis. Symptoms of overdose usually 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 it is 15 g or more. Children appear to be less sensitive than adults to the hepatotoxic effect of paracetamol.
The recommended treatment, in addition to common practices (gastric lavage or induced emesis), consists in the administration of acetylcysteine or methionine antidotes, at least within 10 hours of intake for best results. Acetylcysteine is administered by intravenous infusion in an initial dose of 150 mg / kg body weight, for 15 minutes followed by 50 mg / kg for 4 hours and 100 mg / kg for the first 16 hours. Alternatively, methionine 2.5 g can be administered orally every 4 hours for a total of 4 doses.
The determination of plasma concentrations of paracetamol reveals the degree of intoxication; with concentrations of 300 mcg / ml after 4 hours severe hepatic damage may develop; with plasma concentrations of 120 mcg / ml within 4 hours and 50 mcg / ml at 12 hours only mild liver damage may develop.
After the acute phase of toxicity, no structural or functional abnormalities of the liver remain.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: analgesics and antipyretics, anilides.
ATC code: N02BE01
Paracetamol or acetaminophen, active principle of Acetamol, is a synthesis product, with marked analgesic and antipyretic activity, clinically proven.
The analgesic activity of the drug is due to an increase in the pain threshold; the antipyretic effect is consequent to the action carried out on the hypothalamic center which regulates body temperature.
Being a non-salicylic drug, it is well tolerated in the stomach and can therefore be advantageously used in case of intolerance to salicylates.
05.2 "Pharmacokinetic properties
Paracetamol is absorbed rapidly and almost completely through the gastrointestinal tract: maximum plasma concentrations occur within 30 minutes - 2 hours after intake.
The drug is distributed evenly in all organs; its average plasma life is about 2-4 hours.
Acetamol is mainly metabolised by microsomal enzymes in the liver. Most of it conjugates with glucuronic acid (60%) and the remainder with sulphates (35%) or cysteine (3%).
The first of these three metabolic pathways is elective in the adult man, while the second prevails in children under 9 years of age, whose liver is said to have a lower glucuroconjugating capacity than phenolic derivatives.
In cases where glucuronic acid and sulfate deposits were limited, the excess paracetamol would be oxidized by mercapturic acid or cysteine.
When very high doses are administered, the drug is destroyed by N-hydroxylation followed by dehydration to the N-acetyl-p-benzoquinone form, the metabolite generally believed to be responsible for the hepatotoxicity found in these cases.
After both oral and rectal administration of therapeutic doses, 90-100% of the drug is recovered in the urine within the first day.
05.3 Preclinical safety data
Paracetamol, administered to common laboratory animals and by various routes (oral, i.p., subcutaneous) proved to be devoid of ulcerogenic properties, even after prolonged administration.
However, the toxicity of Paracetamol varies greatly depending on the animal species and the route of administration.
In rats by the oral route there is a decrease in LD50 of about 15-40% related to administration in a fed or fasted stomach.
LD50 in mice is 850 mg / kg / os.
LD50 in fasting rats is 3700 mg / kg / os, non-fasting is 4500 mg / kg / os; of 1200 mg / kg / e.p.
LD50 in rabbits is 3000 mg / kg / os and 1200 mg / kg / i.p.
Paracetamol was found to have no embryotoxic and teratogenic effects and was well tolerated even in specific carcinogenicity studies.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
ACETAMOL 300 mg effervescent granules: Citric acid, sodium bicarbonate, compressible sugar.
ACETAMOL adults 500 mg tablets: Potato starch, polyvinylpyrrolidone, magnesium stearate.
ACETAMOL early childhood 25 mg / mL syrup: Macrogol 6000, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, disodium phosphate dihydrate, monobasic sodium phosphate dihydrate, cream strawberry flavor, purified water.
ACETAMOL early childhood 100 mg / mL oral drops, solution: Macrogol 300, glycerol, diethylene glycol monoethyl ether, sorbitol, sodium saccharin, propyl gallate, orange flavor, lemon flavor, purified water.
ACETAMOL suppositories: Semi-synthetic glycerides, soy lecithin.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
ACETAMOL 300 mg effervescent granules: 4 years.
ACETAMOL adults 500 mg tablets: 3 years.
ACETAMOL early childhood 25 mg / mL syrup: 18 months.
ACETAMOL early childhood 100 mg / mL oral drops, solution: 3 years in unopened packaging. After first opening the bottle: 6 months.
ACETAMOL adults 1 g suppositories: 4 years.
ACETAMOL 500 mg and 250 mg suppositories: 42 months.
ACETAMOL early childhood 125 mg suppositories: 3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
ACETAMOL 300 mg effervescent granules: aluminum coupled sachets -10 sachets in carton.
ACETAMOL adults 500 mg tablets: 20 tablets -blister opaque milky white PVC / PVDC / AI.
ACETAMOL early childhood 25 mg / mL syrup: glass bottle -100 ml solution.
ACETAMOL early childhood 100 mg / mL oral drops, solution: glass bottle -30 ml solution.
ACETAMOL adults 1 g suppositories: valve - 10 suppositories.
ACETAMOL 500 mg suppositories: valve -10 suppositories.
ACETAMOL children 250 mg suppositories: valve -10 suppositories.
ACETAMOL early childhood 125 mg suppositories: valve -10 suppositories.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto -PISA.
08.0 MARKETING AUTHORIZATION NUMBER
ACETAMOL 300 mg effervescent granules -10 sachets
AIC 023475041
ACETAMOL adults 500 mg tablets -20 tablets
AIC 023475054
ACETAMOL early childhood 25 mg / mL syrup
AIC 023475092
ACETAMOL early childhood 100 mg / mL oral drops, solution
AIC 023475130
ACETAMOL adults 1 g suppositories -10 suppositories
AIC 023475066
ACETAMOL 500 mg suppositories -10 suppositories
AIC 023475078
ACETAMOL children 250 mg suppositories -10 suppositories
AIC 023475080
ACETAMOL early childhood 125 mg suppositories -10 suppositories
AIC 023475104
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
November 1976 / May 2005
ACETAMOL adults 500 mg tablets -20 tablets
July 1983 / May 2005
ACETAMOL early childhood 25 mg / mL syrup
July 1983 / May 2005
ACETAMOL early childhood 100 mg / mL oral drops, solution
May 2011
ACETAMOL adults 1 g suppositories -10 suppositories
July 1983 / May 2005
ACETAMOL 500 mg suppositories -10 suppositories
July 1983 / May 2005
ACETAMOL children 250 mg suppositories -10 suppositories
July 1983 / May 2005
ACETAMOL early childhood 125 mg suppositories -10 suppositories
November 2001 / May 2005
10.0 DATE OF REVISION OF THE TEXT
February 2013
