Instructions for Panadol Extra effervescent tablets strip No. 12
Composition
active ingredients: paracetamol, caffeine;
1 tablet contains 500 mg of paracetamol, 65 mg of caffeine;
excipients: sorbitol (E 420), sodium saccharin, sodium bicarbonate, povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate.
Dosage form
Effervescent tablets.
Main physicochemical properties: flat white tablets with beveled edges, smooth on one side and with a break line on the other.
Pharmacotherapeutic group
Analgesics and antipyretics. ATX code N02B E51.
Pharmacological properties
Pharmacodynamics
Paracetamol is an analgesic-antipyretic. The effect is based on the inhibition of prostaglandin synthesis in the central nervous system (CNS). The blockade of peripheral prostaglandin synthesis is insignificant, so paracetamol is partially suitable for patients for whom the blockade of peripheral prostaglandins is undesirable (for example, patients with a history of gastrointestinal bleeding).
Caffeine increases the effectiveness of analgesia due to its stimulating effect on the CNS, which can eliminate the depression that often accompanies pain.
Pharmacokinetics
Paracetamol and caffeine are rapidly and almost completely absorbed from the gastrointestinal tract. Paracetamol is evenly distributed throughout all body fluids, and its binding to plasma proteins is minimal when administered in therapeutic doses.
Paracetamol and caffeine are metabolized mainly in the liver and excreted in the urine as transformation products.
Indication
Moderate to severe pain (headache, migraine, musculoskeletal pain, muscle pain, toothache, pain after tooth extraction and dental procedures, sore throat, periodic pain during menstruation), fever and pain after vaccination, elevated body temperature.
Contraindication
Hypersensitivity to paracetamol, caffeine or any other component of the drug in history; severe liver and/or kidney dysfunction; congenital hyperbilirubinemia; glucose-6-phosphate dehydrogenase deficiency; alcoholism; blood diseases, severe anemia, leukopenia; states of increased excitement, sleep disorders, epilepsy; severe increased blood pressure, organic diseases of the cardiovascular system, including severe atherosclerosis, severe hypertension; decompensated heart failure, acute myocardial infarction, paroxysmal tachycardia, hyperthyroidism, acute pancreatitis, severe forms of diabetes mellitus, glaucoma; age over 60 years.
Do not use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks of discontinuing MAOIs.
Contraindicated in patients taking tricyclic antidepressants or beta-blockers.
Interaction with other medicinal products and other types of interactions
The rate of absorption of paracetamol may increase with metoclopramide and domperidone and decrease with cholestyramine. The anticoagulant effect of warfarin and other coumarins with an increased risk of bleeding may be enhanced by long-term regular use of paracetamol. Single doses do not have a significant effect. Barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of liver microsomal enzymes, may enhance the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites. With simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of drugs on the liver increases. Simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome. Paracetamol reduces the effectiveness of diuretics.
Do not use simultaneously with alcohol.
The simultaneous use of caffeine with MAO inhibitors can cause a dangerous increase in blood pressure. Caffeine enhances the effect (improves bioavailability) of analgesics-antipyretics, potentiates the effects of xanthine derivatives, alpha- and beta-adrenomimetics, and psychostimulants.
Cimetidine, hormonal contraceptives, and isoniazid enhance the effects of caffeine.
Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of anesthetics and other drugs that depress the central nervous system, a competitive antagonist of adenosine drugs, ATP. When caffeine is used simultaneously with ergotamine, the absorption of ergotamine from the digestive tract improves, and with thyroid-stimulating drugs, the thyroid effect increases.
Caffeine may increase the excretion of lithium from the body. Therefore, simultaneous use of the drug with lithium preparations is not recommended.
Application features
The product contains paracetamol, so it should not be used with other paracetamol-containing products used, for example, to reduce fever, treat pain, flu and cold symptoms or insomnia. Simultaneous use with other paracetamol-containing products may lead to overdose. Paracetamol overdose may cause liver failure, which may require a liver transplant or be fatal.
Cases of liver dysfunction/liver failure have been reported in patients with reduced glutathione levels, such as those with severe wasting, anorexia, low body mass index, chronic alcoholism, or sepsis.
Patients with low glutathione levels are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should seek immediate medical attention if you experience these symptoms.
If symptoms persist, you should consult a doctor.
During treatment with the drug, it is not recommended to consume excessive amounts of beverages containing caffeine (such as coffee, tea and some other drinks). This may lead to sleep problems, tremors, chest discomfort due to palpitations, tension, irritability.
In case of liver or kidney diseases, you should consult a doctor before using the drug. Restrictions on the use of the drug by such patients are primarily due to the content of paracetamol. It should be borne in mind that in patients with alcoholic non-cirrhotic liver damage, the risk of hepatotoxic effects of paracetamol in case of overdose increases. The drug may affect the results of laboratory tests for blood glucose and uric acid.
Patients who take analgesics every day for mild arthritis should consult a doctor.
1 tablet contains 427 mg of sodium. This should be taken into account by patients on a controlled sodium diet. The product contains sorbitol in an amount of 50 mg/tablet. Patients with rare hereditary forms of fructose intolerance should not take this medicine.
Keep the drug out of the sight and reach of children.
Use during pregnancy or breastfeeding
It is not recommended for use during pregnancy, as the risk of spontaneous miscarriage associated with caffeine use is increased.
It is not recommended to use the drug during breastfeeding. Paracetamol and caffeine pass into breast milk. Caffeine in breast milk may have a stimulating effect on infants during breastfeeding, but no significant toxicity has been observed.
Ability to influence reaction speed when driving vehicles or other mechanisms
The probability of impact is almost non-existent.
Method of administration and doses
The drug is intended for oral administration.
Do not exceed the recommended dose.
The lowest dose of the drug necessary to obtain a therapeutic effect should be used for the shortest period of time.
The interval between doses should be at least 4 hours.
Adults, the elderly and children over 16 years: 1-2 tablets should be dissolved in a total of half a glass of water. Take every 4-6 hours as needed. Do not take more than 8 tablets (4000 mg paracetamol/520 mg caffeine) in 24 hours.
Children aged 12 to 15 years: 1 tablet dissolved in half a glass of water. Take every 4–6 hours as needed (up to 4 times a day). Do not take more than 4 tablets (2000 mg paracetamol/260 mg caffeine) in 24 hours. Do not take for more than 3 days without consulting a doctor.
Children: Not recommended for use in children under 12 years of age.
Overdose
Paracetamol.
Paracetamol overdose can cause liver failure, which may require liver transplantation or be fatal. Acute pancreatitis has been reported, usually accompanied by liver dysfunction and hepatotoxicity. Liver damage is possible in adults who have taken 6–8 g or more of paracetamol, and in children who have taken more than 150 mg/kg of body weight. In patients with risk factors (long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia)), taking 5 g or more of paracetamol can lead to liver damage.
In case of overdose, urgent medical attention is required. Treatment should be started immediately. The patient should be taken to a hospital, even if there are no early symptoms of overdose.
Symptoms of overdose may not reflect the severity of the overdose or the risk of organ damage. Immediate medical attention is necessary in case of overdose, even if symptoms of overdose are not observed. If overdose is confirmed or only suspected, the patient should be taken to the nearest medical facility where emergency medical care and qualified treatment can be provided. This should be done even if symptoms of overdose are absent, because of the risk of delayed liver damage. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentration measurements are unreliable). Treatment with N-acetylcysteine can be used within 24 hours of paracetamol ingestion, but the maximum protective effect occurs when it is used within 8 hours of overdose. The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be given intravenous N-acetylcysteine at the recommended dosage. If vomiting is absent, oral methionine may be used as a suitable alternative in remote areas outside the hospital.
In severe poisoning, hepatic failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma, and death. Acute renal failure with acute tubular necrosis may present with severe lumbar pain, hematuria, and proteinuria, and may occur even in the absence of severe liver damage. Cardiac arrhythmias have also been reported.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic system. When taking large doses, dizziness, psychomotor agitation and disorientation are possible from the central nervous system; nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis) is possible from the urinary system.
Caffeine.
Caffeine overdose can cause epigastric pain, vomiting, diuresis, rapid breathing, tachycardia or cardiac arrhythmia, and affect the central nervous system (insomnia, restlessness, nervous excitement, agitation, anxiety, dizziness, irritability, affective state, tremor, convulsions). Clinically important symptoms of caffeine overdose are also associated with serious liver damage by paracetamol, which can occur when taking such an amount of the drug that causes a caffeine overdose. There is no specific antidote, but supportive measures, such as the use of beta-adrenoreceptor antagonists, can alleviate the cardiotoxic effect. Gastric lavage is necessary, oxygen therapy is recommended, and diazepam is recommended for convulsions. Symptomatic therapy.
Sodium bicarbonate.
High doses of sodium bicarbonate can cause gastrointestinal disturbances such as belching and nausea, and can also cause hypernatremia, so it is necessary to monitor electrolyte balance and provide patients with appropriate treatment.
Side effects
The following adverse reactions have been reported from post-marketing experience. They are reported voluntarily from a patient population of unknown size, therefore the frequency of these adverse reactions is unknown, but they are most likely to be rare (< 1/10,000).
Adverse reactions caused by paracetamol
From the blood and lymphatic system: thrombocytopenia, agranulocytosis.
Immune system disorders: anaphylaxis, hypersensitivity skin reactions including, but not limited to, skin rash, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Respiratory, thoracic and mediastinal disorders: bronchospasm in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
Hepatobiliary system: liver dysfunction.
Adverse reactions caused by caffeine
From the side of the central nervous system: dizziness, headache.
Cardiovascular system: palpitations.
Gastrointestinal: gastrointestinal disorder.
On the part of the psyche: insomnia, restlessness, anxiety and irritability, nervousness.
When the drug is taken at recommended doses with products containing caffeine, the increased dose of caffeine resulting in this way may increase caffeine-related side effects, such as insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disturbances, and rapid heartbeat.
Expiration date
4 years.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach and sight of children.
Packaging
2 tablets in a multilayer strip, 6 strips in a cardboard box; 4 tablets in a multilayer strip, 3 strips in a cardboard box.
Vacation category
Without a prescription.
Producer
Famar A.V.E. Anthoussa plant/Famar AVE Anthoussa plant.
GlaxoSmithKline Dungarvan Limited.
Address
Knockbrack, Dungarvan, Co. Waterford, Ireland.
