Panadol: instructions for use of tablets, syrup and suppositories. Panadol ® soluble tablets (Panadol soluble) Panadol 500 mg instructions for use for children

Trade patent name: PANADOL

International nonproprietary name:

Dosage form:

Composition of the drug (per 1 tablet)

Active substance: paracetamol 500 mg. Excipients: corn starch, pregelatinized starch, potassium sorbate, povidone, talc, stearic acid, triacetin, hypromellose.

Description
White capsule-shaped tablets with a flat edge.

PANADOL is embossed on one side of the tablet and a line mark on the other side.

Pharmacotherapeutic group:

ATX Code: N02BE01

Pharmacological properties
The drug has analgesic and antipyretic properties. Blocks COX1 and COX2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. The anti-inflammatory effect is practically absent. Does not cause irritation to the mucous membranes of the stomach and intestines. It has no effect on water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Pharmacokinetics
Absorption is high, TCmax is achieved after 0.5-2 hours; Cmax - 5-20 µg/ml. Plasma protein binding -15%. Penetrates through the BBB. Less than 1% of the dose of paracetamol taken by a nursing mother passes into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when administered at a dose of 10-15 mg/kg. Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form active metabolites, which conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in the metabolism of the drug. Half-life (T1/2) -1-4 hours. Excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases.

Indications
Symptomatic therapy:

1. pain syndrome: headache, migraine, toothache, sore throat, lower back pain, muscle pain, painful menstruation
2. febrile syndrome (as an antipyretic). With elevated body temperature against 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.

Contraindications

• hypersensitivity;
• children under 6 years of age.

Carefully
Use with caution in case of renal and liver failure, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, glucose-6-phosphate dehydrogenase deficiency, alcoholic liver damage, alcoholism, in old age, during pregnancy and lactation.

Directions for use and dosage:

Adults (including the elderly): 0.5 -1 g (1-2 tablets) up to 4 times a day, if necessary. The interval between doses is at least 4 hours, a single dose (2 tablets) can be taken no more than 4 times (8 tablets) within 24 hours.

Children (6-9 years): 1/2 tablet 3-4 times a 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 tablet (250 mg), the maximum daily dose is 2 tablets (1 g).

Children (9-12 years old): 1 tablet up to 4 times a day, if necessary. The interval between doses is at least 4 hours, a single dose (1 tablet) can be taken no more than 4 times (4 tablets) within 24 hours.

The drug is not recommended for use 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 physician.

Side effect
At recommended doses, the drug is usually well tolerated. Paracetamol rarely causes side effects. Sometimes an allergic reaction may occur in the form of skin rashes, itching, and Quincke's edema. Rarely - blood system disorders (anemia, thrombocytopenia, methemoglobinemia).

With long-term use in high doses, the likelihood of liver and kidney dysfunction increases (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) and monitoring of the blood picture is necessary.

Overdose
The drug should be taken only in recommended doses. If you exceed the recommended dose, seek medical attention immediately, even if you feel well, as there is a risk of delayed serious liver damage.

Liver damage in adults is possible when taking 10 grams or more of paracetamol. Taking 5 grams or more 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 consumption of alcohol in excess quantities;
• possibly having glutathione deficiency (those with malnutrition, cystic fibrosis, HIV infection, starving, malnourished)

Signs of acute paracetamol poisoning are nausea, vomiting, stomach pain, sweating, and pale skin. After 1-2 days, signs of liver damage are determined (pain in the liver area, 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 occurs when taking 10 g or more.

Treatment: Stop using the drug and consult a doctor immediately. It is recommended to lavage the stomach and take enterosorbents (activated carbon, polyphepane); administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine ​​- after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration. Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department.

Interaction with other drugs
Long-term combined use of paracetamol and other NSAIDs increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

Simultaneous long-term administration of paracetamol in high doses 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, enhances 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 hepatotoxicity in overdoses. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. Ethanol contributes to the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs.

special instructions
Before taking the drug, you should consult your doctor if:

• you have liver or kidney disease;
• You are taking anti-nausea and vomiting medications (metoclopramide, domperidone), as well as medications that lower blood cholesterol (cholestyramine);
• You are taking anticoagulants and need painkillers every day for a long time. Paracetamol in this case can be taken occasionally;
• you are pregnant or breastfeeding;

When conducting tests to determine uric acid and blood sugar levels, you should inform your doctor about taking the drug.

TO AVOID TOXIC DAMAGE TO THE LIVER, PARACETAMOL SHOULD NOT BE COMBINED WITH ALCOHOL BEVERAGES, AND SHOULD NOT BE TAKEN BY PERSONS PROMOTED TO CHRONIC ALCOHOL CONSUMPTION.

Release form
Film-coated tablets 500 mg.

PVC/aluminum blister containing 6 or 12 tablets.

1 or 2 blisters (6 or 12 tablets each) are packed in a cardboard box along with instructions for use.

Best before date
5 years.
Do not use after the expiration date stated on the package.

Storage conditions
Store at a temperature not exceeding 25°C.
Keep out of the reach of children.

Conditions for dispensing from pharmacies
Over the counter.

Manufactured GlaxoSmithKline Dungarvan Ltd, Ireland, Knockbrack, Dungarvan, County Waterford for GlaxoSmithKline Consumer Healthcare, UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS / GlaxoSmithKline Consumer Healthcare , United Kingdom, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Representative in the Russian Federation / Importer: GlaxoSmithKline Healthcare CJSC, Russia, 109180, Moscow, Yakimanskaya embankment, 2.

Instructions for medical use of the drug

PANADOL® JUNIOR

Tradename

PANADOL® JUNIOR

International nonproprietary name

Paracetamol

Dosage form

Soluble tablets 500 mg

One tablet contains

active substance - paracetamol 500 mg

excipients: sorbitol, sodium saccharin, sodium bicarbonate (extra thin), povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate, purified water.

Description

Flat white tablets with a beveled edge, smooth on one side and scored on the other.

Pharmacological group

Other analgesics-antipyretics. Anilides.

PBX code N02BE01

Pharmacological properties

Pharmacokinetics

Paracetamol is quickly and almost completely absorbed (96%) from the gastrointestinal tract. The maximum concentration in the blood is about 6 µg/ml, the time to reach the maximum concentration is 10-60 minutes. Protein binding less than 10%. Paracetamol is metabolized in the liver, most of it enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites and is excreted in the urine in the form of sulfate and glucuronic conjugates. The half-life is 1-4 hours.

Pharmacodynamics

Paracetamol is an analgesic-antipyretic. It has an analgesic and antipyretic effect by suppressing the synthesis of prostaglandins in the hypothalamus. Has weak anti-inflammatory activity.

The drug has analgesic and antipyretic properties. Does not cause irritation to the mucous membranes of the stomach and intestines. It does not affect water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Indications for use

Pain syndrome: headache, migraine, toothache, neuralgia, joint and muscle pain, lower back pain, sore throat with sore throat, painful menstruation

Feverish syndrome: fever and pain associated with colds and flu.

Directions for use and doses

Before oral administration, Panadol® Junior tablets should be dissolved in at least 100 ml (1/2 cup) of water.

Children (6-12 years old) - 1/2-1 tablet 3-4 times a day, if necessary. The interval between doses is at least 4 hours. The maximum single dose for children is 1 tablet (0.5 g), the maximum daily dose is 2 tablets. The dose for children is calculated based on the child’s body weight: the maximum single dose is 15 mg/kg body weight, the maximum daily dose is 60 mg/kg body weight.

Children (12-18 years): 1 tablet 3-4 times a day, if necessary. The interval between doses is at least 4 hours. The maximum single dose is 1 tablet (0.5 g), the maximum daily dose is 4 tablets (2 g).

Adults: usually 1-2 tablets 3-4 times a day, if necessary. The interval between doses is at least 4 hours. The maximum single dose for adults is 2 tablets (1g), the maximum daily dose is 8 tablets (4g).

The drug is not recommended for use for more than five days as a canalgesic and for more than three days as an antipyretic without prescription and medical supervision. Increasing the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician. Do not exceed the indicated dose.

In case of overdose, consult a doctor immediately, even if you feel well.

Side effects

Allergic skin rash, Quincke's edema

Rarely - blood system disorders (anemia, thrombocytopenia, methemoglobinemia)

With long-term use in high doses, the likelihood of liver and kidney dysfunction increases (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) and blood count monitoring is necessary.

If unusual symptoms occur, you should contact your doctor.

Contraindications

Hypersensitivity to paracetamol or any other

ingredient of the drug

Severe liver or kidney dysfunction

Genetic absence of glucose-6-phosphate dehydrogenase

Children under 6 years old

Drug interactions

When taken for a long time, the drug enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, St. John's wort, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in case of overdose. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxicity. Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. Ethanol promotes the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs.

Before taking the drug, you should consult a doctor if:

Chronic liver or kidney diseases

The use of metoclopramide, domperidone, as well as drugs that lower blood cholesterol (cholestyramine) or anticoagulants

Paracetamol is not recommended for long-term use as a pain reliever for the treatment of chronic pain. The drug should be used with caution in cases of fructose intolerance, since it contains sorbitol. The drug contains sodium (427 mg/tab). Persons who abuse alcohol should consult a doctor before taking the drug. If the recommended dose is exceeded, paracetamol may cause damage to the liver.

Pregnancy and lactation

Before taking the drug, consult your doctor

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There are no restrictions on driving a car or operating machinery.

Overdose

Symptoms: nausea, vomiting, stomach pain, sweating, pale skin. After 1-2 days, signs of liver damage are determined (pain in the liver area, increased activity of “liver” enzymes). In severe cases, liver failure, encephalopathy and coma develop.

Disease class

• Migraine
• Other and unspecified lesions of the oral mucosa
• Joint pain
• Sciatica
• Myalgia
• Neuralgia and neuritis, unspecified
• Fever of unknown origin
• Headache
• Pain not elsewhere classified
• Other constant pain

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antipyretic
• Analgesic (non-narcotic)

Pharmacological group

• Anilides

Effervescent tablets Panadol

Instructions for medical use of the drug

• Indications for use
• Release form
• Pharmacodynamics of the drug
• Pharmacokinetics of the drug
• Contraindications for use
• Side effects
• Directions for use and doses
• Overdose
• Special instructions for use
• Storage conditions
• Best before date

Indications for use

Pain of mild to moderate intensity (headache, migraine, back pain, arthralgia, myalgia, neuralgia, toothache, menalgia).

Feverish syndrome with colds.

Release form

Soluble tablets 500 mg; strip 2 cardboard pack 6;

Soluble tablets 500 mg; strip 4 cardboard pack 6;

Soluble tablets 500 mg; strip 2 pack cardboard 12;

Pharmacodynamics

A non-narcotic analgesic, it blocks COX1 and COX2 mainly in the central nervous system, affecting the centers of pain and thermoregulation.

In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of anti-inflammatory effect.

The absence of a blocking effect on the synthesis of Pg in peripheral tissues determines the absence of a negative effect on water-salt metabolism (retention of Na+ and water) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics

Quickly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma reaches a peak after 30–60 minutes, T1/2 of plasma - 1–4 hours.

Metabolized in the liver.

Excreted in the urine, mainly in the form of esters with glucuronic and sulfuric acids; less than 5% is excreted unchanged.

Use during pregnancy

Carefully.

Contraindications for use

Hypersensitivity, neonatal period (up to 1 month).

With caution.
Renal and liver failure, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, lactation, old age, early infancy (up to 3 months), glucose-6-phosphate dehydrogenase deficiency; diabetes.

Side effects

From the skin: itching, rash on the skin and mucous membranes (usually erythematous, urticaria), angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the side of the central nervous system (usually develops when taking high doses): dizziness, psychomotor agitation and disorientation.

From the digestive system: nausea, epigastric pain, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect). From the endocrine system: hypoglycemia, up to hypoglycemic coma.

From the hematopoietic organs: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency).

With long-term use in large doses - aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.

From the urinary system: (when taking large doses) - nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

Directions for use and doses

Inside, adults - 2 tablets. up to 4 times a day with an interval between doses of at least 4 hours (maximum daily dose - 8 tablets), children from 6 to 12 years old - 1/2–1 tablet. up to 4 times a day with an interval between doses of at least 4 hours (maximum daily dose - 4 tablets).

Soluble tablets are dissolved in 1/2 glass of water before use.

Overdose

Symptoms (acute overdose develops 6-14 hours after taking paracetamol, chronic - 2-4 days after exceeding the dose) of acute overdose: dysfunction of the gastrointestinal tract (diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or pain in stomach), increased sweating.

Symptoms of chronic overdose: a hepatotoxic effect develops, characterized by general symptoms (pain, weakness, adynamia, increased sweating) and specific ones characterizing liver damage.

As a result, hepatonecrosis may develop. The hepatotoxic effect of paracetamol may be complicated by the development of hepatic encephalopathy (thought disturbances, central nervous system depression, stupor), convulsions, respiratory depression, coma, cerebral edema, hypocoagulation, development of disseminated intravascular coagulation syndrome, hypoglycemia, metabolic acidosis, arrhythmia, collapse. Rarely, liver dysfunction develops suddenly and can be complicated by renal failure (renal tubular necrosis).

Treatment: administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine ​​- after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined in depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interactions with other drugs

Reduces the effectiveness of uricosuric drugs. Concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (decreased synthesis of procoagulant factors in the liver). Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications even with a small overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Ethanol contributes to the development of acute pancreatitis. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity.

Precautions for use

Caution should be exercised in severely impaired liver or kidney function. During treatment it is necessary to avoid drinking alcohol.

Special instructions for use

If the febrile syndrome continues during the use of paracetamol for more than 3 days and pain syndrome for more than 5 days, a doctor’s consultation is required.

The risk of developing liver damage increases in patients with alcoholic hepatosis.

Distorts laboratory test results in the quantitative determination of glucose and uric acid in plasma.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

Storage conditions

At a temperature not exceeding 25 °C.

Best before date

ATX classification:

N Nervous system

N02 Analgesics

N02B Analgesics and antipyretics

N02BE Anilides

Paracetamol*

ATX

N02BE01 Paracetamol

Pharmacological group

Composition and release form

pharmachologic effect

Pharmacological effects - analgesic, antipyretic.

Suppresses the synthesis of PG in the central nervous system, reduces the excitability of the hypothalamic thermoregulation center, and increases heat transfer.

Pharmacodynamics

Pharmacokinetics

Indications of the drug Panadol® soluble tablets

Contraindications

Side effects

Interaction

Directions for use and doses

Overdose

Precautionary measures

special instructions

Storage conditions for the drug Panadol® soluble tablets

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of Panadol® soluble tablets

Do not use after the expiration date stated on the package.