EFFERALGAN 10SUPP 150MG

EFFERALGAN SUPPLY LATTERS

active ingredients

Efferalgan milking 8O mg suppositories A suppository contains Active ingredient: paracetamol 80 mg. Efferalgan early childhood 150 mg suppositories A suppository contains Active ingredient: 150 mg paracetamol. Efferalgan children 300 mg suppositories A suppository contains Active ingredient: paracetamol 300 mg.For the full list of excipients, see section 6.1.

Excellent

Semisynthetic glycerides, including lecithin derived from soy oil.

Therapeutic indications

Efferalgan infants 80 mg suppositories Syntomatic treatment of mild to moderate pain and fever conditions in infants. Efferalgan early childhood 150 mg suppositories Efferalgan children 300 mg suppositories Symptomatic treatment of mild to moderate pain and fever conditions in children.

Contraindications

Hypersensitivity to paracetamol or acetamol hydrochloride (paracetamol precursor) or any of the excipients listed in paragraph 6.1. This product contains lecithin derived from soy oil. In case of soy allergy or peanuts, the medicinal product is contraindicated.

Population

To avoid the risk of overdose, check that other medications administered (with or without a prescription) do not contain paracetamol (see paragraphs 4.4 and 4.5). An accidental overdose of paracetamol can cause severe liver damage and death (see paragraph 4.9). Population In children the posologic patterns must be respected according to body weight and consequently it is necessary to choose the suitable formulation. The correlation between age and weight is only orientation. Due to the risk of local toxicity, it is not advisable to take suppositories more than 4 times a day and the duration of treatment by rectal means must be as short as possible. Suppose administration is not recommended in case of diarrhea. Efferalgan infants 80 mg suppositories This formulation is reserved for body-weight infants between 4 kg and 7 kg (age between 1 and 6 months). The dosage is 1 suppository of 80 mg to be repeated, if necessary, after a range of at least 6 hours, without exceeding 3 suppositories per day for infants weighing less than 5 kg and the 4 suppositories per day for infants weighing equal to or greater than 5 kg. Efferalgan early childhood 150 mg suppositories This formulation is reserved for children weighing between 8 kg and 13 kg (age between 6 months and 2 years). The dosage is of 1 suppository of 150 mg, to be repeated, if necessary, after a interval of at least 6 hours, without exceeding the 3 assumptions per day for children weighing less than 10 kg and the 4 assumptions per day for children weighing equal to or greater than 10 kg. Efferalgan children 300 mg suppositories This formulation is reserved for children of body weight between 14 kg and 28 kg (age between 2 and 9 years). The dosage is 1 300 mg suppository to be repeated, if necessary, after a period of at least 6 hours, without exceeding 3 suppositories per day for children weighing less than 20 kg and 4 times a day for children weighing equal to or greater than 20 kg. Frequency of administration Regular administrations avoid the oscillation of pain or fever levels. In infants and children the interval between administrations must be regular, both day and night, and must be preferably at least 6 hours. Renal insufficiency In case of severe renal failure (creatiny clearance less than 10 ml/min), the interval between administrations must be at least 8 hours. Method of administration Rectal use.

Conservation

Store at temperature not exceeding 30°C.

Warnings

During treatment with paracetamol before prescribing any other medication, check that it does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medication (with or without a prescription) (see paragraph 4.5). In case of chronic treatment with drugs that can determine the induction of liver monooxidases or exposure to substances that may have such an effect, see paragraph 4.5. High or prolonged doses of the product may result in a high-risk hepatopathy and even serious 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. Paracetamol should be given with caution in the following cases: • patients with mild to moderate liver failure (including Gilbert syndrome), severe liver failure (Child-Pugh >9), acute hepatitis, in treatment with drugs that alter liver function, glucose-6-phosphate-dehydrogenase deficiency, hemolytic anemia; • patients with kidney failure; • chronic alcoholism, anorexia, bulimia or cachessia, chronic renalnutrition (low liver glutathione reserves), dehydration, hypovolemia. Alcohol consumption during therapy is not recommended. Prolonged (continuous or repeated) use of analgesics (>3 months) in patients with chronic headache can increase or worsen cephalea. The headache induced by excessive use of analgesics (MOH - Medication-Overuse Headache) should not be treated with an increase in dosage. In these cases, medical evaluation is necessary. Paracetamol can cause severe skin reactions such as generalized acute acute exantelosis, Stevens-Johnson syndrome and epidermal toxic necrolysis, which can be fatal. Patients should be informed about signs of severe skin reactions and the use of the drug should be stopped at the first appearance of skin rash or any other sign of hypersensitivity.

Interactions

Paracetamol may increase the possibility of undesirable effects if administered simultaneously to other drugs. Diagnostic examinations Paracetamol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Antiagulants Concurrent use of paracetamol with cumarinics, including warfarin, can lead to variations of INR values. In such cases, a more rigid monitoring of INR values must be carried out during concurrent use and after termination of treatment with paracetamol. Monooxidase inductors Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of liver monooxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutethymids, phenobarbital, carbamazepine). Fenitoin Concurrent administration of phenytoin may result in a decreased effectiveness of paracetamol and in an increased risk of hepatotoxicity. Patients in treatment with phenytoin should avoid high doses and/or paracetamol chronics. Patients must be monitored in case of evidence of hepatotoxicity. Probenecid The probenecid causes a reduction of at least twice of paracetamol clearance through the inhibition of its conjugation with glucuronic acid. A reduction in the dose of paracetamol should be considered if administered simultaneously to probenecid. Salicilamide Salicylamide can prolong elimination half-life (t_1/2Paracetamol. Flucloxacillin Precaution is required when paracetamol is administered in conjunction with flucloxacillin, due to increased risk of metabolic acidosis with high anionic gap (HAGMA), especially in patients with a risk factor for glutathione deficiency as severe kidney failure, sepsis, malnutrition and chronic alcoholism. Careful monitoring is recommended to detect the occurrence of acid-base balance disorders, especially HAGMA, including the search for 5-oxoproline urinary. Concurrent administration with chloramphenicol can induce an increase in the half-life of paracetamol, with the risk of increasing its toxicity. Drugs that slow gastric emptying (p.e. anticholinergics) can determine antral stasis by delaying the absorption of the paracetamol and therefore the onset of the analgesic effect. Use with extreme caution in patients treated with zidovudine.

Effects

The table below lists the adverse reactions associated with the administration of paracetamol, resulting from the surveillance after trade. Adverse reactions are listed according to the Classification for System and Organs, using the MedDRA terminology (inserting the PT). The frequency of adverse reactions shown below is not known.

Classification for Systems and Organs	Terms MedDRA
Emolinfopoietic system pathologies	Trombocytopenia, Neutropenia, Agranulocytosis, Leucopenia, Anemia
Gastrointestinal diseases	Diarrhea, abdominal pain, gastrointestinal reactions
Hepatobiliary diseases	Hepatic insufficiency, Hepatic Necrosis, Hepatitis, Alteration of liver function
Immune system disorders	Anaphylactic reaction, Anaphylactic Shock, Angioedema, Hypersensitivity, Larynx Edema
Diagnostic examinations	Abnormal INR (see paragraph 4.5), increased liver enzymes
Pathologies of skin and subcutaneous tissue	Orticaria, Eritema, Multiform Erythema, Prurito, Eruption of the skin, Acute Exantematic Pustolosis Generalized, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Porpora
Diseases of the nervous system	Cefa
Ear and labyrinth pathologies	Vertigo
Vascular diseases	Hypotension (especially as a result of anaphylaxis)
Kidney and urinary pathologies	Acute renal insufficiency, Interstitial Nephritis, Ematuria, Anuria

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 “https://www.aifa.gov.it/content/segnalazioni-reazioni-avv arose”.

Overdosing

There is a risk of intoxication, especially in patients with liver disease, in case of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inductors. In these cases overdose can be fatal. Symptoms generally appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor, malaise and diaphoresis. Overdose with acute ingestion of 7.5 g or more of paracetamol in adults and 140 mg/kg body weight in children causes liver cytolysis that can evolve towards complete and irreversible necrosis that involves hepatocellular insufficiency, metabolic acidosis and encephalopathy that can lead to coma and death. At the same time, increased levels of hepatic transaminasis (AST, ALT), of the dehydrogenase lactate and bilirubin are observed, along with a decrease in the value of the protrombine that can be shown from 12 to 48 hours after administration. Clinical symptoms of liver damage usually occur after one or two days, and reach the maximum after 3 to 4 days. Rare cases of acute pancreatis have been observed. Emergency measures • Immediate Ospedalization; • Before starting the treatment take a blood sample to determine the plasma levels of paracetamol as soon as possible, but not before 4 hours after overdose; • Quick removal of the paracetamol by gastric lavender; • Treatment following overdose includes the administration of antidote, N-acetylcysteine (NAC), intravenous or oral, if possible, within 8 hours of ingestion. The NAC can, however, give a certain degree of protection even after 16 hours; • Syntomatic treatment. Hepatic tests must be carried out at the beginning of the treatment, which will be repeated every 24 hours. In most cases, hepatic transaminers return to the norm in one or two weeks with a full resumption of liver function. In very serious cases, however, liver transplant may be necessary.

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 is excreted in small amounts in breast milk. It was reported rash in breast milk breast-feededed children. However, paracetamol administration is considered compatible with breast milk. It must, however, be used caution in administering paracetamol to nursing women.

Source: Farmadati