GlaxoSmithKline Consumer Healthcare

980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)208 0475 000
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Summary of Product Characteristics last updated on the eMC: 15/06/2007
SPC Panadol Ultra

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

Panadol Ultra


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Paracetamol Ph Eur 500 mg, Codeine phosphate hemihydrate Ph Eur 12.8 mg


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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. For example headache including migraine, sinusitis, dental pain, arthritic and rheumatic pain, sciatica and lumbago, strains and sprains and dysmenorrhoea. Also to reduce the pain and febrile symptoms of colds, sore throats and influenza. Panadol Ultra is especially suitable for pain which requires stronger analgesia than paracetamol or aspirin alone.


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4.2 Posology and method of administration

Adults (including the elderly)

Two tablets up to 4 times a day. This dose should not be repeated at more than 4 hour intervals, and not more than 4 doses should be given in any 24 hour period. Do not take for more than 3 days without consulting a doctor.

Children

Not recommended for children under 12 years of age.

For oral adminstration only.


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4.3 Contraindications

Hypersensitivity to paracetamol, codeine or any of the other constituents.


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4.4 Special warnings and 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.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach of children.

The leaflet will state 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 health care 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.

The label will state (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.


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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 colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Opioid analgesics should be given with care to patients receiving monoamine oxidase inhibitors. The effect of CNS depressants (including alcohol) may be potentiated by codeine; these interactions are unlikely to be significant at the dosage involved.


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4.6 Pregnancy and lactation

There is inadequate evidence for the safety of codeine in human pregnancy, but epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage. Patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Insignificant levels of codeine also pass into breast milk. Available published data do not contraindicate breast feeding.


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4.7 Effects on ability to drive and use machines

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.


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4.8 Undesirable effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Codeine may cause constipation, nausea, dizziness and drowsiness according to dosage and individual susceptibility.

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

Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms of restlessness and irritability may result when treatment is stopped.

Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

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. Hypotension and tachycardia are possible but unlikely.

Management

This 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 350 mg or a child more than 5 mg/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 four hours after ingestion, or eight hours if a sustained release preparation has been taken.

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose 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 overdose. 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). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. 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. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Paracetamol is an analgesic and antipyretic. Codeine phosphate is a moderate analgesic and has weak cough suppressant activity.


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5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Concentration in plasma reaches a peak in 30-60 minutes. Plasma half-life is 1-4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma protein binding is variable.

Codeine phosphate is well absorbed after oral administration and is widely distributed. About 86% is excreted in the urine in 24 hours, 40-70% is free or conjugated codeine, 5-15% is free or conjugated morphine and 10-20% is free or conjugated norcodeine.


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5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

starch, pre-gelatinised

povidone

potassium sorbate

maize starch

talc

magnesium stearate

stearic acid

microcrystalline cellulose

croscarmellose sodium

lactose monohydrate

hypromellose

macrogol

quinoline yellow (E104)

erthyrosine (E127)

titanium dioxide (E171)


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6.2 Incompatibilities

None.


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6.3 Shelf life

48 months.


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6.4 Special precautions for storage

None.


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6.5 Nature and contents of container

PVC 250µm / aluminium foil 30µm blisters in outer cartons, containing 6, 10, 12, 16, 20, 24, 30 or 32 tablets.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00071/0233


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18.04.84


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10. DATE OF REVISION OF THE TEXT

January 2006



More information about this product

Link to this document from your website: http://emc.medicines.org.uk/medicine/16070/SPC/Panadol Ultra/

Active Ingredients/Generics

 
   paracetamol
   codeine phosphate hemihydrate


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