TERMADEC FEVER AND DOL * 10CPR500

TERMADEC FEVER AND DOL * 10CPR500

Therapeutic indications

Symptomatic treatment of acute painful states (headache, neuralgia, toothache, menstrual pain) and of feverish states.

Dosage and method of use

The minimum amount of medicine necessary for the shortest possible treatment duration should be used to achieve clinical efficacy. After 3 consecutive days of treatment, a clinical evaluation is required. For children it is essential to respect the dosage defined according to their body weight. The dosing schedule of TERMADEC fever and pain in relation to body weight and route of administration is as follows (ages, approximated according to body weight, are indicated for information):- Children weighing between 26 and 40 kg (approximately between 8 and 12 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day.- Adolescents weighing more than 41 kg (approximately over 12 years old):1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day.- Adults: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6doses 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. In adults, the maximum daily oral dosage is 3000 mg (see section 4.9). It is necessary to respect the minimum interval of 4 hours between two doses. Children weighing less than 26 kg (age less than 7 years) : the medicine should not be given to this category of patients. Elderly patients: the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.

Contraindications

• Hypersensitivity to the active substance, or to other closely related substances from a chemical point of view, or to any of the excipients, listed in section 6.1. • Severe renal insufficiency. • Children weighing less than 26 kg (age less than 7 years).

Side effects

The following are the side effects of acetaminophen organized according to the MedDRA systemic and organic classification. Insufficient data are available to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders: Skin rash. Very rare cases of severe skin reactions have been reported, including erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis. Immune system disorders: Angioedema, larynx edema, anaphylactic shock, asthma. Disorders of the blood and lymphatic system: Thrombocytopenia, leukopenia, anemia, agranulocytosis. Hepatobiliary disorders: Changes in liver function and hepatitis. Renal and urinary disorders: Acute renal failure, interstitial nephritis, haematuria, anuria. Gastrointestinal disorders: Gastrointestinal reactions. Ear and labyrinth disorders: Dizziness. Respiratory, thoracic and mediastinal disorders: Bronchospasm in subjects sensitive to acetylsalicylic acid or other NSAIDs.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted. Do not take at the same time as other acetaminophen medicines. Concomitant use with other paracetamol-containing products may lead to an overdose. Overdose of acetaminophen can cause liver failure, which can lead to liver transplantation or death. Cases of liver dysfunction / failure have been reported in patients with low glutathione reserves, e.g. severe malnutrition, anorexia, bulimia or cachexia, low body mass index, excessive alcohol intake (3 or more alcoholic beverages per day) , chronic alcoholism, sepsis. Use with caution in case of dehydration or hypovolaemia. In patients with glutathione-depleted states, such as sepsis, the use of paracetamol may increase the risk of metabolic acidosis. Pre-existing liver disease increases the risk of acetaminophen-related liver damage. Patients with hepatic or renal insufficiency should undergo clinical evaluation before taking this medicinal product and be closely monitored. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency ( Child-Pugh> 9), acute hepatitis, concomitant treatment with drugs that impair liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anemia. High or prolonged doses of the product can cause high-risk liver disease and even serious changes in the kidney and blood. In case of prolonged use it is advisable to monitor liver and kidney function and blood count.Important information about some of the ingredients: This medicinal product contains parahydroxybenzoates (sodium Nipasept: sodium methyl parahydroxybenzoate E219, sodium ethyl parahydroxybenzoate E215 and sodium propyl parahydroxybenzoate E217) which may cause allergic reactions (possibly delayed). This medicinal product contains less than 1 mmol (23 mg) sodium per dose (1 tablet), i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

Clinical experience with the use of paracetamol during pregnancy and lactation is limited. Pregnancy:A large amount of data on pregnant women indicate neither malformative nor fetal / neonatal toxicity. Epidemiological studies of neurodevelopmental in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Feeding time:Paracetamol, at recommended doses, is excreted in breast milk in small quantities. Based on the available data, the administration of paracetamol is considered compatible with breastfeeding. However, caution should be exercised in administering paracetamol to breastfeeding women. The possibility of skin rash occurring in breast-fed babies has been reported in the literature.

Expiration and retention

Do not store above 30 ° C.

Interactions with other drugs

The use of the product is not recommended if the patient is being treated with anti-inflammatories. During therapy with oral anticoagulants it is recommended to reduce the doses of paracetamol. The anticoagulant effect of warfarin and other coumarin derivatives can be enhanced by the regular daily and prolonged use of paracetamol, with an increased risk of bleeding; occasional use has no significant effect. 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) . Drugs that slow down gastric emptying (eg propanteline) can reduce the absorption rate of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase the gastric emptying rate (eg metoclopramide, domperidone) lead to an increase in the rate of absorption. Concomitant administration of chloramphenicol and paracetamol can induce a prolongation of the half-life of chloramphenicol, with the risk of elevating its toxicity. The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). The concomitant administration of NSAIDs or opioids results in a reciprocal enhancement of the analgesic effect. Paracetamol increases the AUC of ethinylestradiol by 22%. Paracetamol can reduce the plasma concentration of lamotrigine.

Overdose

Clinical signs of hepatic injury from overdose usually onset within 24 to 48 hours, peaking after 4 to 6 days. In the event of an overdose, paracetamol can cause liver failure, which may require liver transplantation and / or lead to death. Cases of acute pancreatitis, usually associated with liver dysfunction and hepatotoxicity, have been reported. Overdose can also cause severe changes in the kidney and blood, which occur 12 to 48 hours after intake. Symptoms due to acute paracetamol intoxication: nausea, vomiting, anorexia, paleness, abdominal pain which generally appear during the first 24 hours. In the event of an overdose, immediate medical treatment is still required, even in the absence of symptoms. Emergency procedure: rapid elimination of the ingested product by gastric lavage, possibly forced diuresis and hemodialysis. Antidote: As timely as possible administration of N-acetylcysteine or methionine.

Active principles

Each tablet contains:Active principle:paracetamol 500 mg.Excipients with known effects:parahydroxybenzoates (sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) and sodium propyl parahydroxybenzoate (E217)) For the full list of excipients, see section 6.1.

Excipients

Pregelatinized starch, calcium carbonate, alginic acid, crospovidone type A, povidone (K-25), magnesium stearate, colloidal anhydrous silica, parahydroxybenzoates (sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) and sodium propyl parahydroxybenzoate (E217) , Opadry white (titanium dioxide, hypromellose 2910 3 cp, hypromellose 2910 6 cp, macrogol 400, polysorbate 80), carnauba wax, water.