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Anadin Analgesic 20 Tablets is indicated to help with the relief of fever and moderate pain brought on by headache, toothache, muscular pain, dysmenorrhoea, arthralgia and pain associated with flu and colds.
Anadin Analgesic Tablets 20
Each tablet contains: Aspirin 400.0 mg. Caffeine anhydrous 22.7. Pfizer. Marketed by: Pfizer Consumer Healthcare. Tel: 011 320 6000. Scheduling status: SO. Proprietary name and dosage form: Anadin® tablets. Composition: Each tablet contains: Aspirin 400.00 mg. Caffeine anhydrous 22.70 mg. Pharmacological Classification: A 2.8 analgesic combinations. Pharmacological action: pharmacodynamic properties: Acetylsalicylic acid (aspirin) has analgesic, anti-inflammatory and antipyretic actions. It is an inhibitor of the enzyme cyclo-oxygenase, which results in the inhibition of the biosynthesis of prostaglandins. Caffeine is a central nervous system (CNS) stimulant. Indications: Anadin tablets are indicated for the relief of fever and mild to moderate pain such as headache, toothache, dysmenorrhoea, arthralgia, muscular pain and pain associated with colds and flu. Presentation: The tablets are available in: Paper sachets containing 2 tablets. White securitainers containing 50 or 100 tablets. Clear PVC/silver aluminium foil blistered tablets packed in cartons containing 10 or 20 tablets. Date of publication of this package insert: 14 September 2012. Manufactured by: Specpharm Holdings (Pty) Ltd. 15th Road, Halfway House, Midrand, 1685, South Africa. Patient information leaflet: This leaflet tells you about Anadin tablets. Please read this leaflet carefully before you take Anadin tablets, as it contains important information for you. Anadin tablets are available without a doctor's prescription, for you to treat a mild illness. Nevertheless, you still need to use Anadin tablets carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice. Do not use continuously for pain for more than 10 days or for fever for more than 3 days, unless directed by a doctor. If the pain or fever persists or gets worse, or if new symptoms occur, consult a doctor. Scheduling status of Anadin tablets: The medicine is a schedule 0 (SO) medicine. The name of Anadin tablets: The name of this medicine is Anadin tablets, and it is available as a tablet. What Anadin tablets contain: Each tablet contains 400 mg of the active ingredient aspirin and 22.70 mg of the active ingredient caffeine. In addition the tablets contain the inactive ingredient maize starch. What Anadin tablets are used for: Aspirin, AS in Anadin tablets, is an analgesic (reduces pain), anti-inflammatory (reduces inflammation) and anti-pyretic (reduces fever) agent. Anadin tablets are used for the relief of fever and mild to moderate pain such as headache, toothache, period pain, joint pain, muscle pain and pain associated with colds and flu.
Quantity in pack:
Anadin®. 20 analgesic tablets. Stronger than pain.
Dosage and direction for use: use the lowest effective dose. Children: Anadin tablets should not be given to children under 12 years of age. A medical practitioner should be consulted before giving Anadin tablets to children between the ages of 12 and 16 years. Dosage and directions for use: see enclosed insert for full details.
Storage and disposing of Anadin tablets: Store in a cool, dry place (at or below 25 degrees C). Protect from light. Keep securitainer tightly closed.
Contra-indications: do not use Anadin tablets in patients with: Dyspepsia; peptic ulcers; haemophilia, thrombocytopenia or other haemorrhagic disorders. A history of gastrointestinal bleeding, ulceration or perforation related to previous Anadin tablets, aspirin or non-steroidal anti-inflammatory drugs (NSAID) therapy. Active or history of recurrent peptic ulcer, haemorrhage or perforations. Intolerance (hypersensitivity) to Anadin tablets, aspirin or other NSAIDs, hypersensitivity to caffeine or other xanthenes, or any of the ingredients of Anadin tablets (see special precautions). Gout. Severe renal or hepatic function impairment. Heart failure. Patients receiving oral anticoagulant therapy (see interactions and side effects and special precautions). Do not use continuously for pain for more than 10 days or for fever for more than 3 days, unless directed by a medical practitioner. If the pain or fever persists or gets worse, or if new symptoms occur, a medical practitioner should be consulted. Regular use of NSAID's during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased. The use of Anadin tablets during pregnancy is not advised (see "pregnancy and lactation"). Anadin tablets should not be taken for at least one week prior to surgical procedures, in order to reduce the risk of bleeding. The aspirin component in Anadin tablets has been implicated in Reye's Syndrome, a rare but serious illness in children and teenagers, with chicken pox and influenza. Therefore, Anadin tablets should not be given to children under 12 years of age. A medical practitioner should be consulted before giving Anadin tablets to children between the ages of 12 and 16 years. Anadin tablets should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, crohn's disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated. When gastrointestinal bleeding, perforation or ulceration occurs in patients receiving Anadin tablets, treatment with Anadin tablets should be stopped. The risk of gastrointestinal bleeding or perforation is higher with increasing doses of Anadin tablets, in patients with a history of ulcers, and the elderly. Continuous prolonged use of Anadin tablets should be avoided in the elderly because of the risk of gastrointestinal bleeding. The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. In view of Anadin tablets' inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients. Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with Anadin tablets therapy. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolyis have been reported. Anadin tablets should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Patients sensitive to tartrazine may be sensitive to aspirin (as contained in Anadin tablets). Interactions: aspirin: aspirin, as in Anadin tablets, may enhance the activity of anticoagulants (such as warfarin), oral antidiabetic preparations, insulin, sulphonamides, zafirlukast, montelukast, methotrexate and phenytoin. Aspirin, as in Anadin tablets, diminishes the effect of uricosurics such as probenecid and sulphinpyrazone barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity. Some of the effects of aspirin, as in Anadin tablets, on the gastrointestinal tract are enhanced by alcohol. Use of aspirin, as in Anadin tablets, with dipyridamole may result in an increase in plasma-salicylate concentrations. Concomitant administration of medicines such as metoclopramide in patients with migraine headache results in earlier absorption of aspirin and higher peak plasma-salicylate concentrations. Metoprolol may increase peak plasma-salicylate concentrations. Risk of gastrointestinal bleeding and ulceration associated with aspirin, as in Anadin tablets, is increased when used with corticosteroids, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIS). Concurrent use with valproic acid may lead to valproic toxicity. Concurrent use of vancomycin with Anadin tablets should be avoided as the potential for ototoxicity may be increased. Concurrent use of platelet aggregation inhibitors with Anadin tablets increases the risk of bleeding. The concomitant use of Anadin tablets and other NSAIDs should be avoided because of the increased risk of adverse effects. Aspirin, as in Anadin tablets, can cause increased plasma concentrations of lithium. Caffeine: caffeine, as in Anadin tablets, increases the urinary excretion of lithium, thereby possibly reducing its therapeutic effect. Monitoring of serum lithium concentrations is imperative, as adjustments of lithium dose may be necessary (see interactions, aspirin). Concurrent use of monoamine oxidase (MAO) inhibitors and caffeine, as in Anadin tablets, may produce dangerous cardiac dysrhythmias or severe hypertension because of the sympathomimetic side effects of caffeine. Concurrent use with even small amounts of caffeine may produce tachycardia and an increase in blood pressure. Concurrent use of caffeine, as in Anadin tablets, and CNS stimulation-producing medications may result in excessive CNS stimulation. Pregnancy and lactation: Anadin tablets should not be used in pregnancy. The use of aspirin, as in Anadin tablets, during pregnancy may be associated with delayed onset and prolongation of labour and is associated with premature closure of the ductus arteriosus and pulmonary hypertension in the newborn. Anadin tablets should not be used during lactation as aspirin and caffeine pass into breastmilk. Side effects and special precautions: Side effects: The following side effects have been reported. Aspirin, as in Anadin tablets: Blood and the lymphatic system disorders: Frequency unknown: Anadin tablets increases bleeding time, decreases platelet adhesiveness and in large doses may cause hypoprothrombinaemia. It may cause other blood disorders including thrombocytopenia. Immune system disorders: Less frequent: patients especially those with asthma, chronic urticaria, or chronic rhinitis exhibit notable sensitivity to aspirin which may provoke various hypersensitivity reactions which may include urticaria and other skin eruptions, angioedema, rhinitis and severe or even fatal paroxysmal bronchospasm and dyspnoea. Patients sensitive to aspirin may exhibit cross-sensitivity to other NSAIDs. Cardiac disorders: Frequency unknown: oedema, hypertension and cardiac failure. Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Frequent: nausea, vomiting, dyspepsia. Less frequent: abdominal pain, melaena, peptic ulcers, perforation or gastrointestinal bleeding, which may be fatal. Frequency unknown: diarrhoea, flatulence, constipation, haematemesis, ulcerative stomatitis, exacerbation of colitis and crohn's disease, gastritis. Hepato-biliary disorders: Frequency unknown: Anadin tablets may cause hepatotoxicity particularly in patients with juvenile idiopathic arthritis or other connective tissue disorders. Skin and subcutaneous tissue disorders: Less frequent: bullous reaction including Stevens-Johnson syndrome and toxic epidermal necrolysis. Caffeine, as in Anadin tablets: Endocrine disorders: Frequent: hyperglycaemia. Nervous system disorders: Frequent: anxiety, dizziness, restlessness. Frequency unknown: insomnia, headache, tremor. Cardiac disorders: Frequent: palpitations. Gastrointestinal disorders: Frequent: gastrointestinal irritation including nausea, vomiting. Less frequent: diarrhoea and gastrointestinal bleeding. Frequency unknown: abdominal pain. Special precautions: Anadin tablets should be used with caution in patients with asthma or allergic disorders. It should not be given to patients with a history of hypersensitivity reactions to aspirin or other NSAIDs, including those in whom attacks of asthma, angioedema, urticaria, or rhinitis have been precipitated by such medicines (see contraindications). Caution is necessary when renal or hepatic function is impaired; Anadin tablets is contraindicated in severe renal or hepatic impairment (see contraindications). Anadin tablets should be used cautiously in dehydrated patients and in the presence of uncontrolled hypertension. High doses of Anadin tablets may precipitate acute haemolytic anaemia in patients with G6PD deficiency. Anadin tablets may interfere with insulin and glucagon control in diabetes. Aspirin, as in Anadin tablets, and other salicylates can interfere with thyroid function tests. Known symptoms of overdosage and particulars of its treatment: In the event of an overdose, a medical practitioner or pharmacist should be consulted. If neither is available, contact the nearest hospital or poison control centre. Aspirin: symptoms of mild chronic aspirin intoxication include dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache, mental confusion and may be controlled by reducing the dosage. Symptoms of more severe intoxication or acute poisoning following overdosage include hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma, cardiovascular collapse, respiratory failure and death. In children: drowsiness and metabolic acidosis commonly occur, hypoglycaemia may be severe, serious signs of overdosage may develop rapidly. Treatment: in acute aspirin overdosage the stomach should be emptied by gastric lavage. Aspirin remaining in the stomach may be adsorbed by activated charcoal. Fluid and electrolyte management is the mainstay treatment with the immediate aim being correction of acidosis, hyperpyrexia, hypokalemia and dehydration. Alkaline diuresis, haemodialysis, or haemoperfusion are effective methods of removing aspirin from the plasma. Caffeine: severe overdosage or idiosyncrasy may also lead to maniacal behaviour, dieresis and repeated vomiting with extreme thirst, tremor, delirium, hyperthermia, tachycardia, tachypnoea, electrolyte disturbances, convulsions and death. Severe toxicity may not be preceded by milder symptoms. Treatment: treatment is supportive and symptomatic. Identification: A white, biconvex tablet with the Anadin shield (a distinctive arrow) on each side. Keep out of reach of children. Do not use continuously for pain for more than 10 days or for fever for more than 3 days, unless directed by a medical practitioner. Before taking Anadin tablets: Do not take anadin tablets if you: Suffer from heartburn or stomach ulcers. Suffer from any blood disorder (such as haemophilia which is a condition where your blood does not clot well). Have a history of stomach or intestinal bleeding or perforation due to previous Anadin, aspirin or non-steroidal anti-inflammatory (medicines that reduce inflammation and pain) treatment. Suffer from or have suffered from a recurring ulcer, bleeding or perforation of the stomach or intestines. Have an allergy to Anadin tablets, to the ingredient aspirin or caffeine or any other xanthine medicine; or an allergy to any non-steroidal anti-inflammatory medicine (medicines that reduce pain and inflammation). Have an allergy to any other ingredient listed in this leaflet. Have gout. Have a severe kidney or liver function problem. Are taking blood thinners such as warfarin. Ask your medical doctor or pharmacist for advice before taking Anadin tablets if you: Are older than 65 years of age. Suffer with asthma or other allergic problems. Suffer from a kidney or liver function problem. Have lost a lot of body fluid. Suffer from uncontrolled hypertension (high blood pressure). Have a glucose-6-phosphate dehydrogenase (G6PD) deficiency (a condition leading to low red blood cell counts). Are a diabetic. Are to undergo a thyroid function test. Are to undergo a surgical procedure within a week of taking Anadin tablets. Have a history of stomach or intestinal disease, as the conditions may worsen. Suffer from or have suffered from heart failure. Stop taking Anadin tablets immediately and contact your medical doctor if you experience bloody or black tarry stools. The aspirin component in Anadin tablets has been implicated in Reye's Syndrome, a rare but serious illness in children and teenagers, with chicken pox and flu. Therefore, do not give to children under 12 years of age and consult a medical doctor before giving to children between the ages of 12 and 16 years. Taking other medicines with Anadin tablets: If you are taking other medicines on a regular basis, such as prescription medicines or other medicines available without a prescription or complementary medicines or traditional medicines, the use of Anadin tablets with these medicines may cause undesirable interactions. Please consult your medical doctor, pharmacist or other healthcare professional, for advice. Examples of medicines that may cause an undesirable interaction are as follows (caution and consultation with your doctor or pharmacist is advised): Blood thinners such as warfarin. Oral antidiabetic medicines (medicine you take by mouth for the treatment of diabetes). Insulin (medicine you inject for the treatment of diabetes). Sulphonamides (medicine used to treat infection). Zafirlukast and montelukast: used for asthma. Methotrexate: used in cancer patients. Phenytoin and valproic acid (medicine used in epilepsy). Alcohol. Vancomycin (medicine used to treat infection). Other non-steroidal anti-inflammatory drugs (medicine used to reduce inflammation, i.e. Reduces pain and swelling). Platelet aggregation inhibitors (medicine used to help prevent the platelets in the blood from clumping together). Metoprolol (medicine used to treat high blood pressure). Metoclopramide (medicine used for nausea and vomiting.) Dipyridamole (medicine used to treat heart or blood conditions). Uricosurics (medicine used in the treatment of gout). Barbiturates and sedatives (medicine used to induce sleep). Corticosteroids. Selective serotonin re-uptake inhibitors (medicine used to treat depression). Lithium (medicine used to treat bipolar mood disorders). Monoamine oxidase inhibitors (medicines used to treat depression). Medicines increasing mental alertness. Pregnancy and breastfeeding: Anadin tablets should not be used during pregnancy and breastfeeding. Consult your medical doctor or pharmacist for further advice. How to take Anadin tablets: adults: take two tablets with water and repeat every six hours, if necessary (do not take more than 8 tablets within any 24-hour period). Children: do not give to children under 12 years of age and consult a medical doctor before giving to children between the ages of 12 and 16 years. If you have taken more Anadin tablets than recommended: if you have exceeded the recommended dosage, immediately consult your medical doctor or pharmacist. If neither is available, immediately seek help at the nearest hospital or poison control centre. Take any remaining tablets with you to show the doctor. If you forget to take Anadin tablets: do not double the dose. Continue taking Anadin tablets as directed. Contact your healthcare professional for further advice. Possible side effects: not all side effects reported for Anadin tablets are included in this leaflet. If you notice any other effects or if your general state of health worsens while taking Anadin tablets, please consult your medical doctor or pharmacist. If you experience any of these effects then stop taking Anadin tablets immediately and contact your doctor or pharmacist: Stomach ulceration or perforation: symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black stools. Severe allergic reactions: symptoms could include difficulty breathing, skin rash or swollen facial features. Breathing problems: wheezing and breathing difficulties may be triggered in patients suffering from or with a previous history of asthma. Other possible side effects: If any of the following side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. Occasionally, the blood does not clot well which may result in easy bruising or bleeding. Rarely, a severe reduction in the number of white blood cells, which makes infections more likely. High caffeine intake can result in tremor (shaking) and palpitations (uncomfortable feeling in the chest caused by fluttering heartbeat). Aspirin may trigger gout in people prone to it. Other side effects include indigestion, heartburn, feeling of being sick, changes in skin colour, shortness of breath and a runny nose. Storage and disposing of Anadin tablets: Keep out of the reach of children. Do not use after the expiry date shown on the carton, securitainer or sachet. Store all medicines out of reach and sight of children. For presentation, identification, registration no. And registration certificate holder details please refer to the package insert above.