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PARACETAMOL CODEINE AND CAFFEINE is a brand name for Caffeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine is indicated in patients older than 12 years of age for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This medicine is recommended for the relief of migraine, headache, backache, rheumatic pain, period pain, dental pain, strains and sprains…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults 1 to 2 tablets every 4-6 hours, up to 4 times a day. The minimum dosing interval is 4 hours. No more than 8 tablets in 24-hours.
Paediatric population:
Adolescents aged 16-18 years: 1-2 tablets every 6 hours up to 4 times a day. The minimum dosing interval is 6 hours. No more than 4 doses (8 tablets) should be given in 24 hours. Adolescents aged 12-15 years: 1 tablet every 6 hours up to 4 times a day.
The minimum dosing interval is 6 hours. No more than 4 doses (4 tablets) should be given in 24 hours. 4).
Elderly patients:
Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing.
Renal impairment:
Patients who have been diagnose with kidney impairment must seek medical advice before taking this medication. It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum interval between each interval to at least 6 hours.
4).
Hepatic impairment:
Patients who have been diagnosed with hepatic impairment or Gilbert’s Syndrome must seek medical advice before taking this medication. 4). 9). Method of Administration This medicine is for oral administration only. This medicine should be dissolved in at least half a tumbler of water.
Treatment goals and discontinuation Before initiating treatment with Codasolve, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed.
When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. 4). Duration of treatment The duration of treatment should be as short as possible and limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional.
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system.
The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, 363 <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).
Paracetamol Body System Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Not Known Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Not Known Not Known Allergies (not including angioedema) Rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Not Known Hepatobiliary disorders Hepatic dysfunction Not Known Skin and subcutaneous tissue disorders Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema Very rare cases of serious skin reactions have been reported Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), druginduced dermatitis, acute generalized exanthematous pustulosis (AGEP) Very rare Very rare Renal and urinary disorders Sterile pyuria (cloudy urine) Very rare Metabolism and nutrition disorders High anion gap metabolic acidosis** Not Known Description of selected adverse reactions * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
**High anion gap metabolic acidosis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Caffeine Body System Undesirable effect Frequency Central nervous system Nervousness Dizziness Not known When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
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. Paracetamol should be administered only with particular caution under the following circumstances: • Hepatocellular insufficiency • Chronic alcoholism • Renal failure (GFR ≤ 50 ml/min) • Gilbert’s Syndrome (familial non-haemolytic jaundice) • Concomitant treatment with medicinal products affecting hepatic function • Glucose-6-phosphatase dehydrogenase deficiency • Haemolytic anaemia • Glutathione deficiency • Dehydration • Chronic malnutrition • The elderly, adults and adolescents weighing less than 50 kg Do not exceed the stated dose.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued. The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Patients should be advised not to take other paracetamol or codeine containing products concurrently. 9). If symptoms persist for more than 3 days, consult your doctor. Keep out of the sight and reach of children. Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.
Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Hypersensitivity to paracetamol, codeine, caffeine, opioid analgesics or any of the other constituents. 6) In respiratory depression, chronic constipation In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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9). Minimum dosing interval: 4 hours for adults and 6 hours for adolescents.
Codeine Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known. 4) Not Known Gastrointestinal disorder Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis Not Known Nervous system disorder Dizziness, worsening of headache with prolonged use, Hyperalgesia drowsiness.
Not Known General disorders and administration Drug withdrawal syndrome Uncommon Renal and urinary disorders Difficulty with micturition Not Known Skin and subcutaneous tissue disorder Pruritus, sweating Not Known Hepatobiliary disorders Sphincter of Oddi dysfunction Not Known Drug dependence Repeated use of co-codamol can lead to drug dependence, even at therapeutic doses.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Care should be observed in administering the product to any patient, whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy, hypothyroidism and those with inflammatory or obstructive bowel disorders, Addison's disease or myasthenia gravis.
Care should also be observed if prolonged therapy is contemplated. Precaution should be observed in patients with asthma who are sensitive to acetylsalicylic acid since mild bronchospasms are reported in association with paracetamol (cross reaction).
g. 2% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 161% of the WHO recommended maximum daily intake for sodium. Paracetamol, Codeine and Caffeine Tablets are considered high in sodium.
This should be particularly taken into account for those on a low salt diet. The tablets also contain aspartame (a source of phenylalanine) and so should not be taken by people with phenylketonuria. Patients should be advised not to take other paracetamol or codeine- containing products concurrently.
9). 5) should not take this product. Codeine, as with other opioids should be used with caution in patients with hypotension, hypothyroidism, head injury or raised intracranial pressure. CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite.
If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. 3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with […]