Panadol - instructions for use, doses, side effects, contraindications

Excipients: starch corn 21,4 mg, starch pregelatinized 50.0 mg, potassium sorbate 0.6 mg, povidone 2.0 mg, talc 15.0 mg, stearic acid 5.0 mg, triacetin 0.83 mg, hypromellose 4.17 mg.

Description:White tablets covered with a film sheath, capsular shaped with a flat edge. On one side of the tablet there is a triangular sign using the embossing method, on the other side - a risk.

Pharmacotherapeutic group:Analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:

The drug has analgesic and antipyretic properties. It 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 of the stomach and intestinal mucosa. 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 h; Cmax - 5-20 mcg / ml. Connection with plasma proteins - 15%. Penetrates through the BBB. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg.

Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life (T1 / 2) is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% in unchanged form. In elderly patients, the clearance of the drug decreases and the half-life increases.

Indications:"Panadol®" is used for relief of headache, migraine, toothache, sore throat, pain in the loin, pain in the muscles, painful menstruation.

"Panadol®" is also used for symptomatic treatment fever syndrome (as a antipyretics); at elevated body temperature at background of "colds" and influenza.

The drug is intended for reducing pain at the time of application and the progression of the disease is not affected.

Contraindications:

hypersensitivity;

- children's age till 6 years;

Carefully:Use with caution when renal and hepatic insufficiency, benign hyperbilirubinemia (incl. Gilbert syndrome), viral hepatitis, a deficiency of glucose-6-phosphate dehydrogenase, alcoholic liver damage, alcoholism, in old age.

Pregnancy and lactation:During pregnancy and during breastfeeding, use only at recommended doses after consultation with a doctor.

Paracetamol penetrates into breast milk in a small amount.

Dosing and Administration:Inside.

Adults (including seniors): 1-2 tablets (0.5-1 g) up to 4 times in day, if necessary.

The maximum single dose is 2 tablets (1 g).Maximum daily dose - 8 tablets (4 g). Interval between receptions - not less than 4 hours.

Children

The dose is calculated from the mass child's body: maximum single dose - 15 mg / kg body weight, the maximum daily dose is 60 mg / kg body weight

Children (6-9 years): 1/2 tablets (250 mg) up to 4 times a day, if necessary.
The maximum single dose - 1/2 tablets (250 mg). The maximum daily intake is 2 tablets (1 g). The interval between receptions is not less than 4 hours. Children (9-12 years):1 tablet (500 mg) up to 4 times a day, if necessary. The maximum single dose is 1 tablet (500 mg). The maximum daily dose is 4 tablets (2 g). The interval between receptions is not less than 4 hours.

In adults, the drug is not recommended for more than 5 days as an anesthetic and for more than 3 days as an antipyretic agent without prescribing and seeing a doctor.

In children, the drug is not recommended for more than 3 days without prescribing and monitoring the doctor.

Do not exceed the indicated dose. If the recommended dose is exceeded, consult a doctor immediately, even if you are feeling well, as there is a risk of delayed severe liver damage.

Increase in daily dose of the drug or duration of treatment are possible only under the supervision of a physician.

Side effects:

In recommended doses, the drug is usually well tolerated. The following secondary the effects were revealed spontaneously during the post-marketing use of the drug.

By-products Effects are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), infrequently (greater than or equal to 1/1000 and less than 1/100), rarely greater than or equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 and less than 1/10 000).

Allergic reactions:

Very rarely - in the form of rashes on the skin, itching, angioedema, Stevens-Johnson syndrome, anaphylaxis;

On the part of the system hematopoiesis:

Very rarely - thrombocytopenia, methemoglobinemia, hemolytic anemia;

From the respiratory system:

Very rarely - bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs);

From the hepatobiliary system:

Very rarely - a violation of the liver.

With prolonged use in high doses, the likelihood of impaired liver and kidney function (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) increases, a blood picture check is necessary.

If any of these side effects occur, stop taking the medication and consult a doctor immediately.

Overdose:Symptoms: During the first 24 hours after an overdose, nausea, vomiting, stomach pain, sweating, pallor skin, anorexia. After 1-2 days, signs of liver damage are determined (soreness in the liver, increased activity of "liver" enzymes). It is possible to develop a violation of carbohydrate metabolism and metabolic acidosis. In adults patients liver damage develops after taking more than 10 g of paracetamol. In the presence of factors that affect the toxicity paracetamol for the liver, (see "Interactions with other drugs", "Special instructions"), liver damage is possible after taking 5 or more grams of paracetamol.

In severe cases of overdose resulting from hepatic insufficiency may develop encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema, up to a lethal outcome. It is possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region,hematuria (an admixture of blood or erythrocytes in the urine), proteinuria (high protein in the urine), with severe liver damage may be absent. There were cases of heart rhythm disturbances, pancreatitis.

Treatment: If you suspect a overdose, even in the absence of pronounced first symptoms, it is necessary to stop using the drug and immediately seek medical help. Within 1 hour after overdose recommended gastric lavage and admission enterosorbents (Activated carbon, polyphepan). The level of paracetamol in the blood plasma should be determined, but not earlier than 4 hours after overdoses (earlier the results are unreliable). Introduction acetylcysteine within 24 hours after an overdose.

The maximum A protective action is provided in within the first 8 hours after overdose, over time antidote effectiveness dramatically falls. If necessary, enter acetylcysteine intravenously. When absence of vomiting before admission patient in hospital possible use of methionine. The need for additional therapeutic activities (further introduction methionine, iv administration acetylcysteine) is defined in depending on concentration paracetamol in the blood, as well as from time after reception. Treatment of patients with a serious violation of liver function 24 hours after taking paracetamol should be carried out in conjunction with specialists of the toxicology center or specialized department of liver diseases.

Interaction:Long-term joint application Paracetamol and NSAIDs increases risk of developing an "analgesic" Nephropathy and Renal papillary necrosis, onset terminal stage of renal insufficiency.

Simultaneous long-term application of paracetamol in high doses and salicylates increases the risk kidney or urinary cancer the bubble.

With regular admission during the long time drug enhances the effect of indirect anticoagulants (warfarin and others coumarins), which increases the risk bleeding. Episodic reception a single dose of the drug does not have significant impact on the action indirect anticoagulants.

Diflunisal increases plasma paracetamol concentration by 50%, which increases the risk of hepatotoxicity.

Barbiturates, carbamazepine, phenytoin, primidon, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, preparations of St. John's wort, tricyclic antidepressants and other inducers of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more). Inhibitors of microsomal liver enzymes (cimetidine) reduce the risk of hepatotoxic effects. Under the influence of paracetamol, the time of chloramphenicol elimination is increased by 5 times. Simultaneous reception of paracetamol and alcoholic beverages increases the risk of developing liver damage and acute pancreatitis.

Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. The drug may reduce the effectiveness of uricosuric drugs.

Special instructions:

Before taking the drug "Panadol®" is necessary consult with your doctor if you are taking any of the drugs listed in the "Interaction with other medicinal products ".

If you receive preparation no improvement in the condition or headache is becoming constant, you need to see a doctor.

Deficiency of glutathione due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion causes the possibility of developing severe liver damage with small overdoses paracetamol (5 g or more).

The drug should not be taken at the same time from other paracetamol-containing preparations.

When conducting analyzes for determination of uric acid and blood glucose inform the doctor about taking the drug.

TO AVOID TOXIC LIVER DISEASES PARACETAMOL DO NOT CONSTITUTE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TO TAKE PERSONS STRONG TO THE CHRONIC CONSUMPTION OF ALCOHOL

Form release / dosage:Film coated tablets 500 mg

Packaging:

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.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:П N014409 / 01

Date of registration:06.11.2008 / 26.05.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Dungarvan, Ltd. Ireland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp07.10.2015

Illustrated instructions

Instructions

Panadol® (Panadol®)