PARACETAMON MY 20BUST 500MG

PARACETAM MYLAN ITALY 500 MG FREE

active ingredients

Each bag contains: Active ingredient: 500 mg paracetamol. Excipients with known effects: sorbitol (E420), aspartame (E951). For the full list of excipients, see paragraph 6.1.

Excellent

Each bag contains: mannitolo, sorbitol (E420), aspartame (E951), citric acid, lemon aroma.

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 or any of the excipients listed in the paragraph 6.1. • Children weighing less than 26 kg (age less than 7 years). • Severe kidney failure. • Patients with manifest lack of glucose-6-phosphate dehydrogenase.

Population

Population The minimum amount of medicine required for the shortest possible duration of treatment must be used to obtain clinical effectiveness. The doctor must assess the need for treatments for over 3 consecutive days. 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. For children it is essential to respect the defined dosage according to their body weight. The Posological scheme of Paracetamolo Mylan Italia 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 bag at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Adolescents weighing between 41 and 50 kg (approximately between 12 and 15 years): 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. Teenagers weighing more than 50 kg (approximately over 15 years): 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. Adults: 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. In case of severe pain or high fever, 2 500 mg sachets to be repeated if necessary after not less than 4 hours. Pediatric population Paracetamol Mylan Italia is contraindicated in children weighing less than 26 kg (age less than 7 years). Senior Patients Posology must be carefully established by the doctor who will have to assess a possible reduction of the dosages mentioned above. Method of administration Just for oral use. Place the granulate directly on the tongue and swallow it without water.

Conservation

This medicine does not require any special condition of conservation.

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. During treatment with paracetamol, before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Paracetamol can determine hepatotoxic and nephrotoxic effects. 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 a 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. Invite the patient to contact the doctor before associating any other medication. See also paragraph 4.5. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. Paracetamolo Mylan Italia 500 mg granulate contains: • Sorbitol: this medicine contains 94,5 mg of sorbitol per dose (1 sachet). Patients with hereditary fructose intolerance should not be given this medicine. • Aspartame: this medicine contains 25 mg of aspartame per dose (1 sachet).

Interactions

The use of the product is not recommended 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 glutetimid, 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 cloramfenicle administration can lead to an extension of the half-life of the paracetamol, 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. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).

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. With the use of paracetamol, very rare cases of severe skin reactions such as multiform erythema, Stevens Johnson's syndrome, toxic epidermal necrolysis, generalized acute exantema. Immune system disorders: Angioedema, edema of larynx, anaphylactic shock, asthma have been reported. Emolinfopoietic system pathologies: Trombocytopenia, leucopenia, anemia, agranulocytosis. Hepatobiliary diseases: Abnormal liver function and hepatitis. Kidney and urinary pathologies: Acute renal traumatic injury, piping-interstitial nephritis, hematuria, watermelon. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms 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 can cause liver cytolysis (hepatic failure), which can evolve towards massive and irreversible necrosis and 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 afterassunzione.Sintomi due to acute intoxication by paracetamol: nausea, vomiting, anorexia, pallor, abdominal pains that generally appear during the first 24 hours. Treatment 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

Epidemiological data on the use of therapeutic doses of oral paracetamol indicate that there is no undesirable effects in pregnant women or on the health of fetus or infants. Reproductive studies with paracetamol have not evidenced any malformation or fetotoxic effects. 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. Paracetamol should be used during pregnancy only after careful assessment of the risk/benefit ratio.

Food

Paracetamol, at recommended doses, is excreted in small amounts in breast milk. The possibility of skin rash in breast-feededed children has been reported in literature. However, on the basis of the available data, paracetamol administration is considered compatible with breastfeeding. It must, however, be used caution in administering paracetamol to nursing women.

Source: Farmadati