SAND 20CPR 500MG

PARACETAM SANDOZ COMPRESITION

active ingredients

Each tablet contains 500 mg of excipient paracetamol with known effect: Each tablet contains up to 1,87 mg of sodium. Each tablet contains 1000 mg of excipient paracetamol with known effect: Each tablet contains up to 3.74 mg sodium For the full list of excipients, see paragraph 6.1.

Excellent

Povidone K-30 (E1201) Pre-gelatinized starch starch (type A) Stearic acid (E570)

Therapeutic indications

Mild to moderate pain and fever. Paracetamol Sandoz is suitable for adults, teenagers and children over 9 years of age. Mild to moderate pain associated with hip and knee osteoarthritis. Paracetamol Sandoz is indicated for adults and adolescents over 15 years of age.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population The lowest dose should be used. Do not exceed the recommended dose for the risk of severe liver damage (see paragraph 4.4 and 4.9) Adults and adolescents aged 15 or older (over 55 kg body weight) Start with 1 tablet (500 mg paracetamol), if necessary 2 tablets (1000 mg) at a time, up to a maximum of 6 tablets (3000 mg of paracetamol) in 24 hours. Pediatric population Teenagers between 12 and 15 years (40-55 kg body weight) 1 tablet at a time, maximum from 4 to 6 tablets in 24 hours.Children between 9 and 12 years (30-40 kg body weight) 1 tablet at a time, maximum from 3 to 4 tablets in 24 ore.Paracetamolo Sandoz is not recommended in children under 9 years of age. Repeated administration is permitted, depending on the recurring symptoms. The minimum dosage range must be 4 hours. Therefore, when the symptoms of pain or fever occur again, administration cannot be repeated before 4 hours have passed. Adults and adolescents aged 15 years (over 55 kg body weight) Start with half tablet (500 mg paracetamol) and, if necessary, take 1 tablet (1000 mg); the maximum daily dose is 4 tablets (4000 mg of paracetamol). Repeated administration is permitted, depending on the recurring symptoms. When using a half tablet, the administration interval must be at least 4 hours. When using a whole tablet, the administration interval must be at least 6 hours. Therefore, when the symptoms of pain occur again, administration cannot be repeated before 4 hours (middle compressed) or 6 hours (full compression). Pediatric population Paracetamol Sandoz is not recommended in children and adolescents under 15 years. Year In case of kidney failure, the dose must be reduced.

Glomerular Filtration Speed	Dose in mg of paracetamol/minimum administration interval
10 - 50 ml/min	500 mg/6 hours
	500 mg/8 hours

Epathetic Comprogation In patients with impairment of Gilbert's liver function or syndrome, the dose must be reduced or the interval between prolonged doses. The daily dose should not exceed 60 mg paracetamol/kg body/day loss (up to 2 g paracetamol/day) in the following cases: - adults weighing less than 50 kg - mild to moderate liver failure - Gilbert syndrome (non-hemolytic family property) - chronic alcoholism - dehydration - chronic malnutrition If the pain persists for more than 5 days or if the fever persists for more than 3 days, or if the symptoms worsen, the treatment must be stopped and a doctor must be consulted. Method of administration Oral use Tablets must be swallowed with a sufficient amount of water, or dissolved in an adequate amount of water, mix well and drink.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Prolonged or frequent use is not recommended. Prolonged use may be dangerous, if not under medical control. For adolescents treated with a dose of paracetamol of 60 mg/kg of body/day loss, the concomitant use of other antipyretics is not allowed, except in cases where a lack of effectiveness occurs. In case of high fever, symptoms of a secondary infection or if symptoms persist, a doctor must be consulted. Paracetamus is recommended when paracetamol is administered in patients with: - moderate to severe renal impairment - hepatic impairment (including Gilbert Syndrome) - acute hepatitis - glucose deficiency 6 - sulphate dehydrogenase - hemolytic anemia - chronic malnutrition - dehydration - concomitant use of drugs that affect liver function 4.5. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. The individual administration for several times of a higher dose than the maximum daily dose may severely harm the liver. In such cases no state of unconsciousness occurs; however, in case of overdose you should immediately consult a doctor, even if the patient feels well, due to the risk of severe liver damage, delayed and irreversible. Latent liver diseases increase the risk of liver damage related to paracetamol. Patients who have compromised liver or kidney function should consult a doctor before using this medicine. This medicine contains paracetamol. Patients should be advised not to take other medications containing paracetamol at the same time, including product associations, due to the risk of severe liver damage in case of overdose (see paragraph 4.9). The risk of overdose increases in patients with non cirrhotic acolic liver disease. In case of chronic alcoholism, caution is recommended. In these cases, the daily dose of paracetamol should not exceed 2 grams. During treatment with paracetamol alcohol should not be taken. Hepatic impairment or liver failure in patients with glutathione depletion, as in patients with: - severe malnutrition - anorexia - low body mass index - sepsis In patients with glutathione depletion, paracetamol use can increase the risk of metabolic acidosis (see paragraph 4.9). Caution is required in asthmatic patients sensitive to acetylsalicylic acid, since cases of mild bronchospasm occurred as a crusade reaction after the use of paracetamol. After prolonged use (> 3 months) with any type of analgesic taken on alternate days or more frequently, it may worsen or appear headaches. The headache that is caused by excessive use of analgesics (cephalea from excessive use of drugs) should not be treated by increasing the dose of analgesic. If this situation occurs or is suspected, the use of analgesics must be stopped and medical advice must be required. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “without sodium”.

Interactions

Paracetamol is metabolized in the liver, and therefore can interact with other active substances that follow the same metabolic pathways or which are able to inhibit or induce such ways. Hepatotoxicity of paracetamol could be enhanced by chronic or excessive intake of alcohol or by concomitant administration of drugs that affect the liver (see paragraph 4.4). The use of liver enzyme inductors, such as barbituric and antidepressants, can lead to an increase in the severity of paracetamol overdose due to increased and accelerated formation of toxic metabolites. In case of simultaneous induction of enzymatic inductors, caution should be given (see paragraph 4.9). The willow can extend the half-life of the paracetamol.Isoniazide can inhibit the metabolism of paracetamol, this can enhance the liver toxicity of paracetamol. You should pay attention 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). Paracetamol can significantly increase the half-life of chloramphenicol. Chronic simultaneous use of paracetamol and zidovudine increases the frequency of neutropenia, probably due to a reduction of zidovudine metabolism and due to the competitive prevention of conjugation. Therefore paracetamol and zidovudine should be administered simultaneously only on medical advice. The anticoagulant effect of warfarin and other cumarinics can be increased by prolonged regular use of paracetamol, with increased risk of bleeding. The occasional use of a dose of paracetamol has no significant effect. The absorption rate of the paracetamol can be increased by metoclopramide or domperidone and reduced by choleramine. The probenecid inhibits the conjugation of paracetamol with glucuronic acid and thus leads to a reduction of paracetamol clearance approximately 50%. In patients taking probenecid at the same time, the dose of paracetamol should be reduced. Concurrent intake of paracetamol and lamotrigine can reduce the bioavailability of lamotrigine, probably by induction of metabolism in the liver. The effectiveness of lamotrigine can be reduced. Interference with diagnostic tests The use of paracetamol can affect the determination of uric acid using phosphotungstic acid and the determination of glucose in the blood using oxidase-peroxidase glucose.

Effects

Few adverse reactions occur at therapeutic doses.Adverse drug reactions are listed below, classified by system organ class and frequency.Frequencies are defined as: very common (≥1/10), common (≥1/100, Standard Organ System Rare Very rare Frequency not known Emolinfopoietic system pathologies agranulocytosis (after prolonged use), thrombocytopenia, thrombocytopenic purple, leukopenia, hemolytic anemia Pancitope   Immune system disorders Allergic reactions (excluding angioedema) Hypersensitivity (including angioedema, , difficulty in breathing, , sweating, , nausea, , hypotension, , shock, , anaphylaxis   Disorders of metabolism and nutrition   Hypoglycemia   Psychiatric disorders Depression, , confusion, , hallucinations     Diseases of the nervous system Tremore, headache     Pathologies of the eye View disturbances     Heart disease Edema     Respiratory, chest and mediastinic pathologies   Broncospasm   Gastrointestinal diseases Blood, Abdominal Pain, Diarrhea, Nausea, vomiting     Hepatobiliary diseases Abnormal liver function, increased liver enzymes, liver failure, liver necrosis, jaundice   Hepatotoxicity Pathologies of skin and subcutaneous tissue Skin rash, itching, erythema, hives, hyperhydrosis Severe skin reactions, exantema Acute generalized hexanthomasis (AGEP), toxic epidermal necrolysis (TEN), drug-induced dermatosis, Stevens Johnson syndrome Kidney and urinary pathologies   Sterile feather (torbidden urine), severe renal compromise, interstitial nephritis**, hematuria, anuria   Systemic pathologies and conditions for administration Capogiri (excluding dizziness), malaise, pyrexia, sedation     ** Broncospasm in acetylicylic acid-sensitive patients or other NSAIDs (asthma analgesic) 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

Paracetamol can cause toxicity, especially in elderly patients, in small children, in patients with liver disease, in case of chronic alcoholism, in patients with chronic malnutrition, in patients in a state of glutathione depletion (see paragraph 4.4) and in patients with enzymatic inductors. A paracetamol overdose can cause liver failure, which may require a liver transplant or lead to death. Acute pancreatitis was also observed, mainly in association with liver impairment and liver toxicity (see also paragraph 5.2). Synonyms Symptoms of paracetaminous overdose are nausea, vomiting, anorexia, pallor and abdominal pain and usually occur within 24 hours after ingestion. Although other symptoms are absent or improve, abdominal pain may indicate liver damage. A single ingestion of 140 mg/kg or more of paracetamol may cause moderate liver cytolysis. Ingestion of 200 mg/kg or more can lead to complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. At the same time, along with the decrease in protrombine levels, increased levels of hepatic transaminasis (AST, ALT), dihydrogenase lactate and bilirubin have been reported, which can occur from 12 to 48 hours after ingestion. Clinical symptoms of liver damage typically occur after 2 days and reach a maximum after 4-6 days. Management

-	Immediately, even if there are no overdose symptoms.
-	Before the overdose treatment, immediately take a blood sample to measure the plasma concentration of paracetamol.
-	In case of important overdose, which can lead to severe intoxication, the absorption reduction therapy can be applied: gastric lavender if possible within 1 hour of ingestion and, active carbon administration.
-	The treatment includes the administration of N-acetylcysteine (NAC) or methionine, intravenously or by mouth (so do not administer activated carbon), if possible before 10 hours have passed since ingestion. However NAC can also improve prognosis up to 36 hours after taking if paracetamol concentrations are still detectable. A further treatment is symptomatic. At the beginning of the treatment should be carried out analysis of liver function, which should be repeated every 24 hours. In most cases hepatic transaminers will return to normal within 1 or 2 weeks, with full recovery of liver function. However in very rare cases the liver transplant will be necessary.

Pregnancy A large amount of data on pregnant women do not indicate either malformation or 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 as low frequency as possible. Food Paracetamol is excreted in small amounts in breast milk. No effect has been reported in breast-feededed babies. Paracetamol can be used during feeding, provided the recommended doses are not exceeded.

Source: Farmadati