Acetamol 300mg

Early Childhood Drops

Composition:

ACETAMOL 300 mg effervescent granules One sachet contains: Active ingredient : paracetamol 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 100 ml of syrup contain: Active ingredient : paracetamol 2.5 g ACETAMOL early childhood 100 mg / mL oral drops, solution 30 ml of oral drops contain: Active ingredient : paracetamol 3 g One drop contains: Active ingredient : paracetamol 2.8 mg ACETAMOL adults 1 g suppositories One suppository contains: Active ingredient : paracetamol 1 g ACETAMOL 500 mg suppositories One suppository contains: Active ingredient : paracetamol 500 mg ACETAMOL children 250 mg suppositories One suppository contains: Active ingredient : paracetamol 250 mg ACETAMOL early childhood 125 mg suppositories One suppository contains: Active ingredient : paracetamol 125 mg

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.

Therapeutic indications

Symptomatic treatment of fever and mild to moderate pain.

Contraindications

Hypersensitivity to the active substance, to any of the excipients or other closely related substances from a chemical point of view; in particular towards other analgesics and antipyretics.

Dosage

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 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 dosing syringe for oral administration, graduated with 0 notches, 5 mL; 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 doses 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 a dose and 1). '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 drug 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. 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 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 another). The table contains some examples in relation to weight.

Children over 18 months and weighing more than 11 kg 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 another). The table contains some examples in relation to weight.

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 medicine 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. 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 500 mg suppository 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 The 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 children of 6–7 kg, 5 for those of 7–10 kg, in heavier children, however, 6 suppositories cannot be exceeded.

Warnings and Precautions

Children Consult your doctor before giving this medicine to a child. Adolescents (12–18 years) and adults See your doctor if the cause of the pain or fever is doubtful. 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 deficiency-6 –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 related 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 the efficacy and tolerability of the product in any way. 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).

Interactions

The oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous 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 the INR values. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its discontinuation. 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 uricaemia (by the phospho-tungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). Interactions with substances used as antidote and listed in section 4.9 are known.

Side 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, laryngeal 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.

Pregnancy and breastfeeding

Although clinical studies in pregnant or lactating patients have not revealed particular contraindications to the use of paracetamol, nor caused undesirable effects affecting the mother or child, it is recommended to administer the product only in cases of real need and under the direct control of the doctor.