PANADOL EXTRA ADVANCE 500 MG/65 MG TABLETS

Active substance: PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Panadol Extra Advance 500 mg/65 mg Tablets
Panadol Period Pain 500 mg/65 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
For full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Tablet.
White to off-white, oval shaped, film-coated tablets debossed with ’xPx’, with the P
enclosed within a circle on one side and plain on the other side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
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
Oral use.
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.

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.
Sodium methyl-, sodium ethyl- and sodium propyl- parahydroxybenzoates (E 219, E 215 and
E 217) may cause allergic reactions (possibly delayed).
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 post-marketing 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 postmarketing 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, angioedema and Stevens Johnson
syndrome/toxic epidermal necrolysis

Respiratory, thoracic and mediastinal
disorders

Bromchospasm*

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
If the patient

factors

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 paracetamol-related 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 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
ATC code: N02B E51
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 gastro-intestinal
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 1methyluric acid and 1-methylxanthine.

Panadol Extra Advance 500 mg/65 mg Tablets contain a disintegrant system which
accelerates tablet dissolution compared to standard parcetamol and caffeine tablets.
Human pharmacokinetic data demonstrate that the time taken to reach plasma
paracetamol threshold (4-7 mcg/ml) is at least 44% faster with Panadol Extra
Advance 500 mg/65 mg Tablets compared with standard paracetamol and caffeine
tablets.
Total extent of absorption of paracetamol and caffeine from Panadol Extra Advance
500 mg/65 mg Tablets is equivalent to that from standard paracetamol and caffeine
tablets.

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
Tablet core:
Starch pregelatinised,
Povidone k-25,
Calcium carbonate,
Crospovidone,
Alginic acid,
Magnesium stearate,
Sodium methyl (E 219), Sodium ethyl (E 215) and Sodium propyl (E 217)
parahydroxybenzoates.
Film coat and polish:
Titanium dioxide (E 171),
Hypromellose,
Macrogol,
Polysorbate 80,
Carnauba wax

6.2

Incompatibilities
None.

6.3

Shelf-life
24 months.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
PVC 250 µm or 300 µm aluminium foil 30 µm blister packs in an outer cardboard carton,
containing 4, 6, 8, 12, 14 or 16 tablets, or PVC/aluminium foil blister packs in a
carboard/PVC wallet containing 14 or 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 00071/0660

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/02/2010

10

DATE OF REVISION OF THE TEXT
30/03/2012

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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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