1. Name Of The Medicinal Product
Paracetamol and Codeine Caplets or Paracetamol and Codeine Tablets
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone such as: headache, period pains, neuralgia, toothache and rheumatic pains.
For oral administration.
4.2 Posology And Method Of Administration
Adults and children over 12 years: 1 to 2 tablets
Children 6 to 12 years: half to 1 tablet
This dose may be taken with water every four to six hours if required, up to a maximum of four doses in 24 hours.
Children under 6 years: not to be given without medical advice.
Elderly: The normal dose is considered appropriate in elderly patients.
Do not take for more than 3 days continuously without medical review.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Severe liver disease.
4.4 Special Warnings And Precautions For Use
Should be taken with caution by patients with impaired kidney or liver function. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not give to children under 6 years without medical advice.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
Do not take with any other paracetamol-containing products.
The label will state:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Front of pack
• Can cause addiction
• For three days use only
Back of pack
• List of indications as agreed in 4.1 of the SPC
• If you need to take this medicine continuously for more than 3 days you should see your doctor or pharmacist
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse
The leaflet (or combined label/leaflet) will state:
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
'Headlines' section (to be prominently displayed)
• This medicine can only be used for.....(indications)
• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take this medicine for headaches for more than 3 days it can make them worse
'What this medicine is for' section
• Succinct description of the indications from 4.1 of the SPC
'Before you take this medicine' section
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take a painkiller for headaches for more than 3 days it can make them worse
'How to take this medicine' section
• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist
• This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms
'Possible side effects' section
• Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy
'How do I know if I am addicted?' section
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to you doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended amount
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulation 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.
Codeine may delay the absorption of mexiletine and thus reduce the antiarrhythmic effect of the latter. The depressant effects of codeine are enhanced by depressants of the central nervous system such as hypnotics, sedatives tricyclic antidepressants and phenothiazines. Codeine may antagonise the gastrointestinal effects of metoclopramide and domperidone.
4.6 Pregnancy And Lactation
The safety of paracetamol and codeine tablets during pregnancy has not been established and in view of the possible association of codeine with respiratory depression and heart malformations, use during this period should be avoided. Codeine passes into breast milk in very small amounts which are probably insignificant and considered to be compatible with breast feeding.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
The most common side effects are nausea, vomiting, constipation, dry mouth, sweating, skin rashes and other allergic reactions. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors:
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
or
b) Regularly consumes ethanol in excess of recommended amounts.
or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Codeine
The effects of codeine in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotention and tachycardia are possible but unlikely.
Management should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350mg or a child more than 5mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least 4 hours after ingestion.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol is a peripherally acting analgesic with antipyretic activity.
Codeine phosphate is an opioid analgesic which acts via the central nervous system.
5.2 Pharmacokinetic Properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent.
Codeine phosphate is absorbed from the gastrointestinal tract and peak plasma concentrations occur after about one hour. Codeine is metabolised by O- and N-Demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. The plasma half life has been reported to be between 3 and 4 hours.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Pregelatinised maize starch BP
Maize starch pdr BP
Microcrystalline cellulose Ph Eur
Purified water Ph Eur
Dried maize starch pdr BP
Magnesium stearate Ph Eur
Sodium metabisulphite BP
6.2 Incompatibilities
None stated.
6.3 Shelf Life
60 months in glass bottle
36 months in HDPE bottle
18 months in blister
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
Amber glass bottle fitted with a child resistant polythene/polypropylene cap fitted with a waxed aluminium faced pulpboard liner or with a tamper evident lectraseal liner of surlyn/ aluminium/polythene/bleached kraft paper/melinex coated carton board.
Pack sizes: 25/30/32
or a white HDPE bottle with a polypropylene cap fitted with an induction heat seal membrane.
Pack sizes: 25/30/32
or a child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.
Pack sizes: 6/8/10/12/16/18/20/24/25/30/32
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
England
ML 0014/01
8. Marketing Authorisation Number(S)
PL 00014/0251
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 9 July 1981
Renewal of the authorisation: 17 September 1996
10. Date Of Revision Of The Text
September 2009
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