BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 306
Fax: +44 (0)1159 592 565

Summary of Product Characteristics last updated on the eMC: 22/12/2006
SPC Paracetamol and Codeine Caplets (Boots Company plc)

The MHRA have issued updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC). This affects all OTC solid dose medicines containing codeine or DHC. The MHRA states that changes to the marketing authorisations need to take place by 31 December 2009, and that packs with the new information should be available within 3-6 months.

Further information can be found on the MHRA website.



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1. NAME OF THE MEDICINAL PRODUCT

Paracetamol and Codeine Caplets or Paracetamol and Codeine Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

mg/tablet

Paracetamol pdr Ph Eur

500.0

 

Codeine phosphate Ph Eur

8.00


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3. PHARMACEUTICAL FORM

Tablet


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of mild to moderate pain such as: headache, period pains, neuralgia, toothache, rheumatic pains and symptoms of cold and influenza.

For oral administration.


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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.


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4.3 Contraindications

Hypersensitivity to any of the ingredients. Severe liver disease.


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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.

(To be displayed prominently on outer pack – not boxed):

• If you need to use this medicine for more than three days at a time, see your doctor or pharmacist. Taking codeine regularly for a long time can lead to addiction.

• Taking a painkiller for headaches too often or for too long 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.

In a prominent position in the 'before taking' section:

• If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional.

• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

• Taking a painkiller for headaches too often or for too long can make them worse.


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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.


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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.


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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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.


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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.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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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.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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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


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

60 months in glass bottle

36 months in HDPE bottle

18 months in blister


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6.4 Special precautions for storage

None


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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: 25/30/32/36/50/100

or glass bottle fitted with a tinplate or polythene cap fitted with a waxed aluminium faced pulpboard liner.

Pack size: 1000

or a white HDPE bottle with a polypropylene cap fitted with an induction heat seal membrane.

Pack sizes: 25/30/32/36/50/100/1000

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: 6/8/10/12/16/18/20/24/25/30/32/36/48/96


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

England

ML 0014/01


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/0251


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 9 July 1981

Renewal of the authorisation: 17 September 1996


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10. DATE OF REVISION OF THE TEXT

August 2005



More information about this product

Link to this document from your website: http://emc.medicines.org.uk/medicine/7899/SPC/Paracetamol and Codeine Caplets (Boots Company plc)/

Active Ingredients/Generics

 
   paracetamol
   codeine phosphate


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