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CO-CODAMOL PLUS CAFFEINE is a brand name for Codeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. Suitable for migraine, headache, rheumatic pain, period pain, toothache and neuralgia. Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration only Adults (including the elderly) 2 tablets every 4 to 6 hours up to four times daily. Maximum 8 tablets in 24 hours. The dose should not be repeated more frequently than every 4 hours.
Paediatric population:
Children aged 16 to 18 years: 1-2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours. Children aged 12 to 15 years: 1 tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours Do not take for more than 3 days continuously without medical review.
If no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. 3. Contra-indications Hypersensitivity to paracetamol, caffeine, codeine or any of the other constituents. g. acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure, paralytic ileus and following biliary tract surgery.
6) In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
Adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as:
Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to<1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data) Paracetamol Blood and lymphatic system disorders Not known: blood dyscrasias* (blood disorder), thrombocytopenia* (thrombocytopenia), agranulocytosis* (agranulocytosis) Immune system disorders Not known: hypersensitivity (hypersensitivity) Skin and subcutaneous tissue disorders Not known: skin rash (rash) Very rare cases of serious skin reactions have been reported.
Metabolism and nutrition disorders Not known (frequency cannot be estimated from the available data: high anion gap metabolic acidosis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
*not necessarily causally related to paracetamol Caffeine High doses of caffeine may produce Psychiatric disorders Not known: nervousness (nervousness) Nervous system disorders Not known: headache (headache), tremor (tremor) General disorders and administration site conditions Not known: irritability Codeine Immune system disorders Not known: allergic reactions (hypersensitivity) Psychiatric disorders Not known: dysphoria (dysphoria), hallucinations (hallucination), mood changes (mood altered), confusion (confusional state), decreased libido (libido decreased), nightmares (nightmare), restlessness (restlessness) Nervous system disorders Not known: dizziness (dizziness), light-headedness (dizziness), drowsiness (somnolence) Eye disorders Not known: miosis (miosis), blurred vision (vision blurred), double vision (diplopia) Ear and labyrinth disorders Not known: vertigo (vertigo) Cardiac disorders Not known: bradycardia (bradycardia), palpitations (palpitations), tachycardia (tachycardia) Vascular disorders Not known: postural hypotension (orthostatic hypotension), hypotension (hypotension), facial flushing (flushing) Respiratory, thoracic and mediastinal disorders Not known: respiratory depression (respiratory depression) Gastrointestinal disorders Not known: constipation (constipation), nausea (nausea), vomiting (vomiting), dry mouth (dry mouth), stomach cramps (abdominal pain upper) Hepatobiliary disorders Not known: biliary spasm (biliary spasm) Skin and subcutaneous tissue disorders Not known: pruritus (pruritus), sweating (hyperhidrosis), urticaria (urticaria), rash (rash) Musculoskeletal and connective tissue disorders Not known: muscle rigidity (muscle rigidity) Renal and urinary disorders Not known: urinary retention (urinary retention), uretic (ureteral spasm), difficulties in micturition (dysuria), dysuria (dysuria), increased frequency (polyuria) Reproductive system and breast disorders Not known: decreased potency (erectile dysfunction) General disorders and administration site conditions Not known: hypothermia (hypothermia), facial oedema (face oedema) Investigations Not known: decrease in amount (urine output decreased) The frequency and severity are determined by dosage, duration of treatment and individual sensitivity, and are unlikely at this dosage.
4. Special Warnings and Special Precautions for Use 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.
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. 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. Debilitated patients should discuss their treatment prior to taking this medicine, as well as patients suffering from hypotension and hypothyroidism. Patients should be advised not to exceed the recommended dose as taking a painkiller for headaches too often or for too long can make them worse.
Dependence, abuse and misuse This medicine contains codeine whose regular or prolonged use may produce psychological and physical dependence. , major depression). 9). Patients should be advised that they should not take this product for more than 3 days continuously without consulting a doctor.
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. Codeine is partially metabolised by CYP2D6 into morphine, its active metabolite.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Codeine in United Kingdom.
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Tolerance and dependency can occur, especially with prolonged high doses of codeine. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.
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.
If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. 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 low doses.
These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, shallow breathing, small pupils, nausea, vomiting, constipation, lack of appetite and somnolence.
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 compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. The leaflet will state in the “Pregnancy and breast-feeding” subsection of section 2 “Before taking your medicine”: Usually it is safe to take this medicine while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems.
However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
1 of the SmPC • If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist • This medicine contains codeine which can cause addiction if you take it continuously for more than three days.
If you take this medicine for headaches for more than three days it can make them worse • Keep out of the sight and reach of children.
The leaflet will state:
Headlines section (to be prominently displayed) • For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. • You should only take this product for a maximum of three days at a time.
If you need to take it for longer than three days you should see your doctor or […]