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| Drug class description : | Analgesic, Antipyretic and mild Anti-Inflammatory |
| Generic Name : | Paracetamol, Caffeine and Codeine Phosphate |
| Drug description : | Film-coated tablet. White, capsule-shaped tablet with dimensions of 17.55 mm x 7.5 mm and debossed on one face to read PCC. |
| Presentation : | Paracetamol 500 mg per tablet Caffeine 30 mg per tablet Codeine Phosphate 8 mg per tablet |
| Indications : | For the treatment of mild to moderate pain. Suitable for migraine, headache, rheumatic pain, period pain, toothache, neuralgia, sore throats and feverishness and the symptomatic relief of colds and influenza. |
| Adult Dosage : | For oral administration only. Adults 2 tablets taken with water every 4-6 hours No more than 8 tablets in 24 hours Do not take for more than 3 days without consulting a doctor. |
| Child Dosage : | Children over 12 years of age: 2 tablets taken with water every 4-6 hours No more than 8 tablets in 24 hours Do not give to children under 12 years of age. Do not take for more than 3 days without consulting a doctor |
| Elderly Dosage : | See Adult Dosage |
| Contra Indications : | Hypersensitivity to paracetamol, caffeine, codeine or any of the other constituents. Conditions where morphine and opioids are contraindicated, eg acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure and following biliary tract surgery. |
| Special Precautions : | Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Care should be taken in administering the product to any patient whose condition may be exacerbated by opioids, particularly the elderly, in whom there is increased sensitivity to the central and gastro-intestinal effects, those on concurrent treatment with other CNS depressant drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders. Patients should be advised not to exceed the recommended dose. Patients should be advised not to take other paracetamol-containing products concurrently. If symptoms persist, patients should consult a doctor. Keep out of the reach and sight of children. |
| Interactions : | The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. Occasional doses have no significant effect. The use of drugs which induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptive steroids, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate. Drugs which induce hepatic microsomal enzymes, such as alcohol and barbiturates, may increase the hepatotoxicity of paracetamol, particularly after overdose. CNS depression or excitation may occur if codeine is given to patients receiving monoamine oxidase inhibitors, or within two weeks of stopping treatment with them. The effects of CNS depressants (including alcohol) may be potentiated by codeine. Concurrent use of codeine with antidiarrhoeal and antiperistaltic agents may increase the risk of severe constipation. Concomitant use of antimuscarinics or medications with antimuscarinic action may result in an increased risk of severe constipation, which may lead to paralytic ileus and/or urinary retention. Quinidine can inhibit the analgesic effect of codeine. Codeine may delay the absorption of mexiletine and thus reduce the antiarrhythmic effect of the latter. Codeine may antagonise the gastrointestinal effects of metoclopramide and domperidone. Cimetidine inhibits the metabolism of opioid analgesics resulting in increased plasma concentrations. Naltrexone blocks the therapeutic effect of opioids. Pregnancy and lactation There is inadequate evidence on the use of codeine in human pregnancy. Codeine crosses the placenta and should be used with caution in pregnancy. Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol and caffeine use in the recommended dosage, but patients should follow medical advice regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Insignificant amounts of codeine also pass into breast milk. Available published data do not contraindicate breast-feeding. |
| Adverse Reactions : | Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Codeine can produce constipation and drowsiness. Occasional effects are nausea, vomiting, sweating, facial flushing, dry mouth, blurred or double vision, dizziness, postural hypotension, headache, vertigo, palpitations, allergic reactions (itch, skin rash, facial oedema), and difficulties in micturition (dysuria, increased frequency, decrease in amount). Side-effects which occur rarely include hallucinations, nightmares, restlessness and stomach cramps. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity and are unlikely at this dosage. Tolerance and dependency can occur, especially with prolonged high doses of codeine. High doses of caffeine may produce headache, tremor, nervousness and irritability. |
| Manufacturer : | Chefaro UK Ltd |
| Drug Availability : | (POM) |
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