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

Excipients: sorbitol 50 mg, sodium saccharinate 10 mg, sodium hydrogen carbonate 1342 mg, povidone 1 mg, sodium lauryl sulfate 0.1 mg, dimethicone 1 mg, citric acid 925 mg, sodium carbonate 134.2 mg.

Description:

Flat white tablets with rounded edges, with risk on one side. The surface on both sides of the tablet may be slightly rough.

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 enzyme systems. hepatocytes and cause their necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life period (T1 / 2) is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% in unchanged form. U. in elderly patients reduces clearance of the drug and increases the half-life.

Indications:"Panadol®" is used to relieve headache, migraine, toothache, sore throat, back pain, muscle pain, painful menstruation. "Panadol®" is also used for the symptomatic treatment of febrile syndrome (as an antipyretic agent); at an elevated body temperature against the background of "colds" and flu. The drug is designed to reduce pain at the time of application and the progression of the disease is not affected.

Contraindications:

- hypersensitivity;

- children up to 6 years old

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

Pregnancy and lactation:According to epidemiological studies among pregnant women paracetamol does not have adverse effects when administered at recommended doses during pregnancy. However, use during pregnancy is only possible after consulting a doctor.

Paracetamol penetrates into breast milk in a small amount.According to the published data, use during breastfeeding is not contraindicated.

Dosing and Administration:

Inside.

"Panadol®", tablets are soluble, Before taking it, you should not dilute it. less than 100 ml (half a cup) water.

Adults (including seniors):

1-2 tablets (0.5-1 g) up to 4 times in day, as 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 of body weight.

Children (6-9 years): ½ tablets (250 mg) up to 4 times a day, as far as necessity. Maximum single dose - ½ tablets (250 mg). Maximum daily - 2 tablets (1 g). The interval between doses is not less than 4 hours.

Children (9-12 years): 1 tablet (500 mg) up to 4 times a day, as far as necessity. 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.

An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician.

Side effects:In recommended doses, the drug is usually well tolerated. The following side effects were revealed spontaneously during the post-marketing use of the drug.Side 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 1/10 000).

Allergic reactions:

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

On the part of the hematopoiesis system:

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, papillary necrosis), the control of a picture of a blood 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, pale skin integuments, anorexia. After 1-2 days signs of defeat are determined liver (soreness in the area liver, increased activity "hepatic" enzymes). maybe development of a disorder of carbohydrate metabolism and metabolic acidosis. In adult patients, defeat liver develops after taking more than 10 g of paracetamol. If there are factors contributing to the Effect on the toxicity of 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, as a result of liver failure, encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema can occur, 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 (blood or erythrocyte admixture 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 there is a suspicion of an overdose, even in the absence of severe first symptoms, it is necessary to stop using and immediately seek medical help. Within 1 hour after an overdose it is recommended to wash the stomach and receive enterosorbents (Activated carbon, polyphepan). It is necessary to determine the level of paracetamol in the blood plasma, but not earlier than 4 hours after an overdose (earlier results are not reliable).Introduction of acetylcysteine within 24 hours after an overdose. The maximum protective effect is achieved within the first 8 hours after an overdose, with time the effectiveness of the antidote drops sharply. If necessary, enter acetylcysteine intravenously. If there is no vomiting before the patient enters the hospital, methionine.

The need for additional therapeutic measures (further introduction of methionine, in / in introduction acetylcysteine) is determined depending on the concentration paracetamol in the blood, as well as from time that has elapsed since it was received. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

Interaction:Long-term combined use of paracetamol and NSAIDs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure. Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of developing kidney cancer orBladder.

With regular intake for a long time, the drug enhances the effect of indirect angiocy1amphibians (warfarin and other coumarins), which increases the risk of bleeding. Episodic reception a single dose of the drug has no significant effect on the effect of indirect anticoagulants. Diflunisal increases the plasma concentration of paracetamol 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 and 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. 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 Panadol®, you should consult your doctor if you are taking any of the drugs listed under "Interaction with other medicines".

If there is no improvement in the condition when the drug is taken or the headache becomes permanent, it is necessary to consult a doctor. Deficiency of glutathione due to eating disorders, dietary fibrosis, HIV infection, starvation, exhaustion causes the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more).

The drug should not be taken simultaneously with other paracetamol-containing preparations.

Patients who follow a salt-free or low-salt diet should take into account the sodium content of the tablet (427 mg) when calculating the daily intake of salt.

When analyzing the determination of uric acid and blood glucose levels, the doctor should be informed of the drug. The drug should be used with caution in cases of intolerance to fructose, since the drug contains sorbitol.

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

When consuming sodium bicarbonate in high doses, it is possible to develop disorders from the gastrointestinal tract, including eructations, nausea; it is also possible to develop hypernatremia, in which case it is necessary to monitor the water-electrolyte balance and apply appropriate tactics to the patient.

Form release / dosage:

Tablets are soluble, 500 mg.

Packaging:

2 or 4 tablets in a laminated strip (kraft-bleached paper / polyethylene / aluminum foil / polyethylene or glass-coated paper / polyethylene / aluminum foil / surlin). 6 strips of 2 tablets or 12 strips of 2 tablets or 6 strips of 4 tablets with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:П N014375 / 01

Date of registration:16.10.2008 / 26.05.2016

Expiration Date:Unlimited

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

Manufacturer: & nbsp

FAMAR, S.A. Greece

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp07.10.2015

Illustrated instructions

Instructions

Panadol® (Panadol®)