TERMADEC FEBBRE AND DOL 10CPR500

TERMADEC FEBBRE AND DOLORE 500 MG COMPRESSE RIVESTITE WITH FILM - COMPRESSE OPTIZORB

active ingredients

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

Excellent

Pregelatinized starch, calcium carbonate, alginic acid, chrosopovidone type A, povidone (K-25), magnesium stearate, colloidal silica anidra, paraidroxybenzoati (sodium metil paraidroxybenzoato (E219), sodium etil paraidroxybenzoato (E215) and sodium propyl paraidroxybenzoate.

Therapeutic indications

Symptomatic treatment of acute painful states (headache, neuralgies, toothache, menstrual pain) and fever states.

Contraindications

• Hypersensitivity to the active ingredient, or other substances strictly related to the chemical point of view, or to any of the excipients listed in the paragraph 6.1. • Severe kidney failure. • Children weighing less than 26 kg (age less than 7 years).

Dosage

The minimum amount of medicine required for the shortest possible duration of treatment must be used to obtain clinical effectiveness. After 3 consecutive days of treatment, a clinical evaluation is required. For children it is essential to respect the defined dosage according to their body weight. The posological scheme of TERMADEC fever and pain in relation to body weight and the way of administration is the following (ages, approximated according to body weight, are indicated as 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 administrations per day. - Teenagers weighing more than 41 kg (approximately over 12 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 a 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 posology is 3000 mg (see paragraph 4.9). You must comply with the minimum interval of 4 hours between two doses. Children weighing less than 26 kg (age less than 7 years) : the medicinal product should not be administered to this category of patients. Senior Patients: posology must be carefully established by the doctor who will have to assess a possible reduction of the dosages indicated above.

Conservation

Do not store at temperature above 30°C.

Warnings

In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be established. Do not simultaneously take other medicines based on paracetamol. Concurrent use with other products containing paracetamol can lead to overdose. Paracetamol overdose can cause liver failure, which can lead to liver transplantation or death. Cases of liver dysfunction/insufficiency have been reported in patients with low glutathione reserves, such as severe malnutrition, anorexia, bulimia or cachesia, low body mass index, excessive alcohol intake (3 or more alcoholic beverages per day), chronic alcoholism, sepsis. Use carefully in case of dehydration or hypovolemia. In patients with glutathione depletion states, such as sepsis, the use of paracetamol can increase the risk of metabolic acidosis. Pre-existing liver disease increases the risk of damage to the paracetamol-related liver. Patients with liver or kidney failure must be subjected to clinical evaluation before taking this medicine and be carefully monitored. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure (Child-Pugh>9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose deficiency-6-phosphate dehydrogenase, hemolytic anemia. High or prolonged doses of the product may result in high-risk hepatopathy and alterations to the kidney and blood. In case of protracted use it is advisable to monitor the liver and renal function and the blood crasis. Important information about some excipients: This medicine contains parahydroxybenzoates (sodium Nipasept: sodium methyl parahydroxybenzoate E219, sodium ethyl parahydroxybenzoate E215 and propyl sodium E217) that can cause allergic reactions (also delayed). This medicine contains less than 1 mmole (23 mg) of sodium per dose (1 tablet), i.e. essentially ‘without sodium’.

Interactions

It is not recommended to use the product if the patient is in treatment with anti-inflammatory drugs. In the course of therapy with oral anticoagulants it is recommended to reduce the doses of paracetamol. The anticoagulant effect of warfarin and other cumarinic derivatives can be enhanced by the regular daily and prolonged use of paracetamol, with increased risk of bleeding; occasional intake has no significant effects. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). Drugs that slow gastric emptying (e.g. propantelin) can reduce the absorption rate of paracetamol, delaying the therapeutic effect; on the contrary, drugs that increase the rate of gastric emptying (e.g. metoclopramide, domperidone) involve an increase in the rate of absorption. Concurrent administration of chloramphenicol and paracetamol may lead to a prolongation of chloramphenicol half-life, with the risk of increasing its toxicity. Paracetamol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). The simultaneous administration of NSAIDs or opioids leads to a mutual strengthening of the analgesic effect. Paracetamol increases the AUC of Etinilestradiol by 22%. Paracetamol can reduce the plasma concentration of lamotrigine.

Effects

Below are the undesirable effects of the paracetamol organized according to the systemic and organic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Pathologies of skin and subcutaneous tissue: Skin Rash. Very rare cases of severe skin reactions have been reported, including multiform erythema, Stevens Johnson syndrome and toxic epidermal necrolysis. Immune system disorders: Angioedema, larynx edema, anaphylactic shock, asthma. Emolinfopoietic system pathologies: Trombocytopenia, leucopenia, anemia, agranulocytosis. Hepatobiliary diseases: Alterations of liver and hepatitis functionality. Kidney and urinary pathologies: Acute renal insufficiency, interstitial nephritis, hematuria, anuria. Gastrointestinal diseases: Gastrointestinal reactions. Ear and labyrinth pathologies: Vertigo. Respiratory, chest and mediastinic pathologies: Broncospasm in acetylsalicylic acid or other NSAIDs. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Clinical signs of hepatic overdose damage generally arise within 24-48 hours, reaching the peak after 4-6 days. In case of overdose the paracetamol may cause liver failure, which may require liver transplantation and/or lead to death. Acute pancreatitititititis cases were reported, usually associated with liver and hepatotoxicity dysfunctions. Overdose can also cause serious alterations to the kidney and blood, which occur from 12 to 48 hours after intake. Symptoms due to acute intoxication by paracetamol: nausea, vomiting, anorexia, pallor, abdominal pains that generally appear during the first 24 hours. In case of overdose, immediate medical treatment is necessary, even in the absence of symptoms. Emergency procedure: rapid elimination of the product ingested by gastric lavender, possibly forced diuresis and hemodilysis. Antidote: as early as possible administration of N-acetylcysteine or methionine.

The clinical experience with the use of paracetamol during pregnancy and nursing is limited.

Pregnancy

: A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible.

Food

: Paracetamol, at recommended doses, is excreted in breast milk in small quantities. On the basis of the available data, paracetamol administration is considered compatible with breast milk. It must, however, be used caution in administering the paracetamol to women breastfeeding. The possibility of skin rash on the breast milk was reported in the literature.

Source: Farmadati