PANADOL EXTRA TABLETS

Active substance: PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Panadol Extra Tablets.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol Ph. Eur. 500.0 mg and Caffeine Ph. Eur.
65.0 mg.

3

PHARMACEUTICAL FORM
Tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Panadol Extra is a mild analgesic and antipyretic formulated to give extra pain
relief. The tablets are recommended for the treatment of most painful and
febrile conditions, for example, headache, including migraine, backache,
toothache, rheumatic pain and dysmenorrhoea, and the relief of the symptoms
of colds, influenza and sore throat.

4.2.

Posology and Method of Administration
Adults:
Two tablets up to four times daily. The dose should not be repeated more
frequently than every 4 hours. Do not exceed 8 tablets in 24 hours.
Elderly:
As for adults.
Children:

Not recommended for children under 12 years.
For oral administration only.

4.3

Contraindications
Hypersensitivity to paracetamol, caffeine or any of the other constituents.

4.4

Special Warnings and Precautions for Use
Care is advised in the administration of paracetamol to patients with renal or hepatic
impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic
liver disease.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be
avoided while taking this product.
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 and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you
feel well. Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
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.

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.

4.6

Pregnancy and Lactation
Paracetamol-caffeine is not recommended for use during pregnancy due to the
possible increased risk of lower birth weight and spontaneous abortion
associated with caffeine consumption.

Caffeine in breast milk may potentially have a stimulating effect on breast fed
infants.
Due to the caffeine content of this product it should not be used if you are
pregnant or breast feeding.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable Effects
Adverse events from historical clinical trial data are both infrequent and from
small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labelled dose and considered attributable
are tabulated below by system class. Due to limited clinical trial data, the
frequency of these adverse events is not known (cannot be estimated from
available data), but post-marketing experience indicates that adverse reactions
to paracetamol are rare and serious reactions are very rare.
Post marketing data
Body System

Undesirable effect

Blood and lymphatic system
disorders

Thrombocytopenia
Agranulocytosis

Immune system disorders

Anaphylaxis
Cutaneous hypersensitivity reactions
including skin rashes, angiodema and
Stevens Johnson syndrome/toxic
epidermal necrolysis

Respiratory, thoracic and
mediastinal disorders

Bronchospasm*

Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are
more likely in asthmatics sensitive to aspirin or other NSAIDs.
Caffeine
Central Nervous system

Nervousness
Dizziness

When the recommended paracetamol-caffeine 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.

4.9

Overdose
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 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 Nacetylcysteine 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.

Caffeine
Symptoms
Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or
cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation,
jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur
with this product, the amount ingested would be associated with serious paracetamolrelated toxicity.
Management
Patients should receive general supportive care (e.g. hydration and maintenance of
vital signs). The administration of activated charcoal may be beneficial when
performed within one hour of the overdose, but can be considered for up to four hours
after the overdose. The CNS effects of overdose may be treated with intravenous
sedatives.
Summary
Treatment of overdose with Panadol Extra Tablets requires assessment of plasma
paracetamol levels for antidote treatment, with signs and symptoms of caffeine
toxicity being managed symptomatically.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The combination of paracetamol and caffeine is a well established analgesic
combination.

5.2

Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is relatively uniformly distributed throughout most body
fluids and exhibits variable protein binding. Excretion is almost exclusively
renal, in the form of conjugated metabolites. Caffeine is absorbed readily after
oral administration. Maximal plasma concentrations are achieved within one
hour and the plasma half-life is about 3.5 hours. 65 - 80% of administered
caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate,
purified talc, stearic acid, croscarmellose sodium, water, hypromellose
(6CPS), triacetin.

6.2

Incompatibilities
None.

6.3

Shelf life
60 months.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
PVC 250µm / aluminium foil 30µm blister packs in an outer cardboard carton,
containing 4, 6, 8, 12, 16, 24, 30 or 32 tablets, or PVC 300µm/aluminium foil
30µm blister packs in a cardboard/PVC wallet containing 16 tablets.

6.6

Special precautions for disposal
None.

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,
U.K.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00071/0306

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/05/1988 / 20/05/2004

10

DATE OF REVISION OF THE TEXT
14/04/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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