Product description
Panadol is an analgesic that does not cause irritation of the stomach and intestinal mucosa. *Used to make it easier: Â
- headaches
- migraines
- toothache lower back
- pain sore throat
- muscle pain
- painful menstruation
“Panadol®” is also used for the symptomatic treatment of febrile syndrome (as an antipyretic); with elevated body temperature against the background of “colds” and flu*. * Instructions for medical use, RU N014409 / 01
Composition
1 tablet contains
Active ingredient
- paracetamol 500 mg;
Auxiliary substances:
corn
starch, pregelatinized starch,
potassium sorbate,
povidone,
talc,
stearic acid,
triacetin,
hypromellose.
Pharmacological action
Analgesic-antipyretic. It has analgesic and antipyretic effects. Blocks COX-1 and COX-2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. The anti-inflammatory effect is practically absent. Does not cause irritation of the gastric and intestinal mucosa. It has no effect on water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.
Clinical pharmacology
Absorption and distributiona Bsorption is high, Cmax is reached in 0.5-2 hours and is 5-20 mcg / ml. Binding to plasma proteins is 15%. Penetrates through the BBB. Less than 1% of the dose of paracetamol taken by a nursing mother passes into breast milk. A therapeutically effective plasma concentration of paracetamol is achieved when it is administered at a dose of 10-15 mg / kg. Metabolism and excretion is metabolized in the liver (90-95%): 80% enters conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites that conjugate with glutathione to form already inactive metabolites. When glutathione is deficient, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP 2E1. T1/2 isoenzyme is also involved in drug metabolism – 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. Pharmacokinetics in special clinical cases in elderly patients, drug clearance decreases and T1 / 2 increases.
Indications
Symptomatic therapy:
- pain syndrome: headache, migraine, toothache, sore throat, lower back pain, muscle pain, painful menstruation;
- febrile syndrome (as an antipyretic): increased body temperature on the background of colds and flu.
The drug is intended to reduce pain at the time of use and does not affect the progression of the disease.
Use during pregnancy and lactation
The drug should be used with caution and only under the supervision of a doctor during pregnancy and lactation.
Contraindications
Children under 6 years of age; hypersensitivity to the components of the drug. The drug should be used with caution in patients with renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, glucose-6-phosphate dehydrogenase deficiency, alcoholic liver damage, alcoholism, in the elderly, during pregnancy and lactation.
Side effects
At the recommended doses, the drug is usually well tolerated. Allergic reactions: sometimes – skin rashes, itching, angioedema. From the hematopoietic system: rarely-anemia, thrombocytopenia, methemoglobinemia. From the urinary system: with prolonged use in high doses – renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis.
Interaction
Long-term concomitant use of paracetamol and other NSAIDs increases the risk of developing” analgesic” nephropathy and renal papillary necrosis, the onset of end-stage renal failure. Concomitant long-term use of high-dose paracetamol and salicylates increases the risk of developing kidney or bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. The drug, when taken for a long time, increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone, and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects. Metoclopramide and domperidone increase, and colestyramine reduces the rate of absorption of paracetamol. Ethanol, when used concomitantly with paracetamol, contributes to the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs.
How to take, course of use and dosage
Adults (including the elderly) are prescribed 500 mg-1 g (1-2 tablets). up to 4 times / day, if necessary. The interval between doses is at least 4 hours, a single dose (2 tablets). you can take it no more than 4 times (8 tablets) within 24 hours. Children aged 6-9 years are prescribed 1/2 tab. 3-4 times / day, if necessary. The interval between doses is at least 4 hours. The maximum single dose for children 6-9 years old is 1/2 tab. (250 mg), the maximum daily dose is 2 tab. (1 g). Children aged 9-12 years are prescribed 1 tablet. up to 4 times/day, if necessary. The interval between doses is at least 4 hours, a single dose (1 tab. ) you can take it no more than 4 times (4 tablets) within 24 hours. The drug is not recommended to be used for more than 5 days as an analgesic and for more than 3 days as an antipyretic without a doctor’s prescription and supervision. Increasing the daily dose of the drug or the duration of treatment is possible only under the supervision of a doctor.
Overdose
The drug should be taken only in the recommended doses. If you exceed the recommended dose, you should immediately seek medical attention, even if you feel well, as there is a risk of delayed serious liver damage. Liver damage in adults is possible when taking ≥ 10 g of paracetamol. Taking ≥ 5 g of paracetamol may cause liver damage in patients with the following risk factors: : long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort preparations or other drugs that stimulate liver enzymes; regular alcohol consumption in excessive quantities; possibly having glutathione deficiency (with malnutrition, cystic fibrosis, HIV infection, fasting and exhaustion). Symptoms of acute paracetamol poisoning include nausea, vomiting, stomach pain, sweating, and pale skin. After 1-2 days, signs of liver damage are detected (pain in the liver, increased activity of liver enzymes). In severe cases of overdose, liver failure develops, acute renal failure with tubular necrosis (including in the absence of severe liver damage), arrhythmia, pancreatitis, encephalopathy and coma may develop. The hepatotoxic effect in adults is manifested when taking ≥ 10 g of paracetamol. Treatment: stop using the drug and immediately consult a doctor. Gastric lavage and use of enterosorbents (activated charcoal, polyphepan) are recommended; use of SH-group donors and glutathione – methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine – 12 hours after overdose. The need for additional therapeutic measures (further use of methionine, intravenous use of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it. Treatment of patients with severe hepatic impairment 24 hours after taking paracetamol should be carried out in conjunction with specialists of the toxicology center or specialized department of liver diseases.
Description
Tablets covered with a film-coated white color, capsule-shaped with a flat edge, on one side of the tablet is embossed with a sign in the form of a triangle, on the other side – a risk.
Special instructions
With prolonged use in high doses, monitoring of the blood picture is necessary. With caution and only under the supervision of a doctor, the drug should be used for liver or kidney diseases, while taking antiemetics (metoclopramide, domperidone), as well as drugs that lower blood cholesterol (colestyramine). In case of a daily need to take analgesics while taking anticoagulants, paracetamol can be taken occasionally. When performing tests to determine uric acid and blood glucose levels, you should warn your doctor about taking Panadol. In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by people who are prone to chronic alcohol consumption.
Product form
12 pcs. – blisters (1) – cardboard packs.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Shelf life
5 years
Active ingredient
Paracetamol
Dosage form
Tablets
Purpose
For adults, Children over 6 years of age, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor
Indications
Flu, Migraines, Myositis, Lumbago, Neuritis, Osteoarthritis, Colds, Sciatica, Sciatica, Arthrosis and Arthritis
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Side effects of Panadol antipyretic and analgesic, pills 500mg, 12pcs.
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