PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

PL 00071/0659

UKPAR

TABLE OF CONTENTS
Lay Summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 13

Steps taken after authorisation summary

Page 14

Summary of Product Characteristics

Page 15

Patient Information Leaflet

Page 20

Labelling

Page 23

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PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

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LAY SUMMARY
The Medicines Healthcare products Regulatory Agency granted SmithKline Beecham
(SWG) Limited, trading as GlaxoSmithKline Consumer Healthcare a Marketing
Authorisation (licence) for the medicinal product Paracetamol and Caffeine 500mg/65mg
Tablets (PL 00071/0659) 19th May 2010. This is a pharmacy-only medicine (P) used to for
the relief of headache, migraine, backache, rheumatic pain, toothpain and period pain. It
also relieves discomfort in colds, flu and sore throat and helps reduce temperature.
The tablets contain two active ingredients, paracetamol and caffeine, this combination has
been widely available for many years. Paracetamol is a painkiller and reduces your
temperature when you have a fever. Caffeine acts to further help the effectiveness of
paracetamol.
This application is similar to the already granted and currently marketed medicine Panadol
Extra tablets (PL 00071/0306).
The proposed product contains an established combination of paracetamol and caffeine,
and this combination is widely available.
No new or unexpected safety concerns arose from this application and it was, therefore,
judged that the benefits of taking Paracetamol and Caffeine 500mg/65mg Tablets outweigh
the risks; hence a Marketing Authorisation has been granted.

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PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

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SCIENTIFIC DISCUSSION

TABLE OF CONTENTS
Introduction

Page 4

Pharmaceutical assessment

Page 5

Preclinical assessment

Page 8

Clinical assessment

Page 9

Overall conclusions and risk benefit assessment

Page 12

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INTRODUCTION
The UK granted Marketing Authorisations for the medicinal products Paracetamol and
Caffeine 500mg/65mg Tablets (PL 00071/0659) to SmithKline Beecham (SWG) Limited,
trading as GlaxoSmithKline Consumer Healthcare on 19th May 2010. This product is a
pharmacy-only medicine.
The product contains the active ingredients paracetamol and caffeine. The active
ingredients exert their effect by unrelated pharmacological mechanisms. Paracetamol is a
centrally acting analgesic (a pain killer that acts on pain centres on the brain), which is used
to relieve mild to moderate pain in the body and also acts as an antipyretic to help reduce
body temperature; caffeine is a mild stimulant.
This application was submitted as a national abridged application according to Article 8.3
of Directive 2001/83/EC. The aim of this application was to update the formulation of the
currently marketed Panadol Extra Tablets (PL 00071/0306) changing the tablet shape, film
coat and incorporating printing ink on the tablet.

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PHARMACEUTICAL ASSESSMENT
DRUG SUBSTANCE (1)
Paracetamol
INN/ BAN

Paracetamol

Chemical name:

N-(4-hydroxyphenyl)acetamide

Structure

Molecular formula:
Molecular weight:

C8H9NO2
151.2

General Properties
Description:
Paraectamol is a white, crystalline powder. It is sparingly
soluble in water, free soluble in alcohol and very slightly soluble in dichloromethane.
Manufacture
All aspects of the manufacture and control of the active substance paracetamol are covered
by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability.
DRUG SUBSTANCE (2)
Caffeine
INN/ BAN

Caffeine

Chemical name:
1,3,7-trimethylxanthine.

1,3,7-trimethyl-1,3-dihydro-1H-purine-2,5-dione,

or

Structure

Molecular formula:
Molecular weight:

C8H10N4O2
194.2

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General Properties
Caffeine is a white or almost white, crystalline powder. It is sparingly soluble in
water, freely soluble in boiling water, and slightly soluble in ethanol.
Manufacture
All aspects of the manufacture and control of the active substance paracetamol are covered
by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability.
DRUG PRODUCT
Other ingredients
Other ingredients consist of pharmaceutical excipients, namely starch pregelatinised, maize
starch, purified talc, croscarmellose sodium, stearic acid, povidone, potassium sorbate,
hypromellose and triacetin. All the ingredients within the tablet comply with relevant Ph.
Eur monographs.
The printing ink consists of: propylene glycol, shellac, brilliant blue FCF (E133), sodium
lactate and dimethylpolysiloxane. The composition of the printing ink is from nonpharmacopoieal grade material; this is satisfactory considering that these ingredients are
used in such small quantities.
Appropriate justification for the inclusion of each excipient has been provided.
Satisfactory Certificates of Analysis have been provided for all the excipients.
None of the excipients used contains material of animal or human origin.
There were no novel excipients used and no overages.
Pharmaceutical Development
Suitable pharmaceutical development data have been provided for this application.
The pharmaceutical development was aimed at updating the current Panadol Extra Tablets
(PL 00071/0306) changing the debossing of the tablet to printing onto the tablet.
Manufacture
A description and flow-chart of the manufacturing method have been provided. In-process
controls are satisfactory based on process validation data and controls on the finished
product. Process validation has been carried out on batches of the product. The results
appear satisfactory.
Finished product specification
The finished product specification is satisfactory. Test methods have been described and
adequately validated, as appropriate. Batch data have been provided and comply with the
release specification. Certificates of analysis have been provided for any working standards
used.
Container Closure System
The finished product is packed in a blister pack composed of polyvinylchloride/aluminium
(PVC/Al) and then packed with the patient information leaflet (PIL) into an outer
cardboard carton. Pack sizes are 4, 6, 8, 10, 12, 16, 20, 24, 30, 32 tablets.
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The marketing authorisation holder has stated that not all pack sizes may be marketed. The
Marketing Authorisation Holder (MAH) has committed to submitting mock-ups for all
packaging for assessment before those pack sizes are commercially marketed.
Specifications and Certificates of Analysis for all packaging materials have been provided.
These are satisfactory. All primary product packaging complies with EU legislation
regarding contact with food.
Stability
Finished product stability studies have been conducted in accordance with current
guidelines and in the packaging proposed for marketing.
Based on the results, a shelf-life of 60 months has been set with the following storage
precaution Do not store above 25oC.
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL),
Labels
The SPC, PIL and labelling are pharmaceutically acceptable.
MAA form
The MAA form is pharmaceutically satisfactory.
Expert Report
The pharmaceutical expert report has been written by an appropriately qualified person and is a
suitable summary of the pharmaceutical dossier.
Conclusion
It is recommended that a Marketing Authorisation is granted for this application.

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PRECLINICAL ASSESSMENT
No new preclinical data have been supplied with this application and none are required for
an application of this type. A preclinical expert report has been written by a suitably
qualified person and is satisfactory.
The marketing authorisation holder has provided adequate justification for not submitting
an Environmental Risk Assessment (ERA). These were applications for generic products
and there is no reason to conclude that marketing of these products will change the overall
use pattern of the existing market. The marketing authorisation holder has provided
adequate justification for not submitting a Risk Management Plan (RMP).

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CLINICAL ASSESSMENT
INTRODUCTION
Clinical Background
Paracetamol has been widely available as an over-the-counter analgesic since the 1950s.
Paracetamol tablets (500 mg) were first marketed in the UK in 1956. The maximum
recommended adult dose is 1.0 g every 4-6 hr up to a maximum of 4 g in 24 hours.
The proposed product contains an established combination of paracetamol and caffeine,
and this combination is widely available.
Caffeine acts as an analgesic adjuvant which enhances the clinical efficacy of paracetamol.
GlaxoSmithKline data on file and published data support the efficacy and safety profile of
products containing this combination.
The Clinical Overview has adequately reviewed all the relevant clinical documentation
relevant to this application. In view of the widespread use of paracetamol and the nature of
the paracetamol and caffeine formulation, the data presented here are considered adequate
in support of this application.
Indications
Paracetamol and Caffeine 500 mg / 65 mg Tablets are a mild to moderate analgesic and
antipyretic. The tablets are recommended for the treatment of most painful and febrile
conditions, for example, headache, including migraine, backache, toothache, pain of
osteoarthritis, and dysmenorrhoea, and for relieving the fever, aches and pains of colds and
flu, and sore throat.
Dose and Dose Regimen
Each tablet contains 500 mg paracetamol and 65 mg caffeine. The maximum recommended
dose of paracetamol and caffeine is two tablets (500 mg paracetamol, 65 mg caffeine in
each tablet) every 4-6 hours, up to a maximum of 8 tablets in 24 hours.
Legal Status
The proposed legal Status is P not subject to medical prescription; supply through
pharmacies only. This type of combination tablet formulation has been available in the EU
without prescription for many years.
CLINICAL PHARMACOLOGY
Pharmacokinetics
Overview
A confirmatory pharmacokinetic study has demonstrated that paracetamol and caffeine is
bioequivalent to PANADOL (also known as PANODIL Tablets) for the paracetamol
component. Results from a supportive pharmacokinetic study are consistent with the
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confirmatory study. Data from the studies indicate that there is no pharmacokinetic
interaction between paracetamol and caffeine. Further details regarding this study are
contained in the Clinical overview.
The pharmacokinetics of both paracetamol and caffeine, alone and in combination, is well
established and has been adequately reviewed by the Clinical Expert.
It has been established that no pharmacokinetic interaction occurs between paracetamol and
caffeine.
Assessors overall conclusions on pharmacokinetics
The pharmacokinetics of this combination is well-established and adequately reviewed in
this dossier.
Bioequivalence
There are no important issues related to bioavailability that might affect efficacy or safety
of Paracetamol and Caffeine 500 mg / 65 mg Tablets. A confirmatory pharmacokinetic
study has demonstrated that paracetamol and caffeine is bioequivalent to PANADOL (also
known as PANODIL Tablets) for the paracetamol component. Results from a supportive
pharmacokinetic study are consistent with the confirmatory study. Data from the studies
indicate that there is no pharmacokinetic interaction between paracetamol and caffeine. No
new studies have been conducted with the proposed formulation and none are required for
this type of application.

Pharmacodynamics
Pharmacodynamics and mechanism of action
The primary pharmacodynamics of paracetamol and caffeine alone and in combination is
well described and has been adequately reviewed by the Clinical Expert.
CLINICAL EFFICACY
The superior analgesic efficacy of paracetamol 500 mg/caffeine 65 mg compared to the
single actives and placebo has previously been demonstrated in clinical studies. This has
been adequately reviewed in the Clinical Overview. Caffeine acts as an analgesic adjuvant
which enhances the efficacy of paracetamol.
Paracetamol
The antipyretic activity of paracetamol is thought to be mediated by central prostaglandin
synthetase inhibition. This may also play a role in the analgesic effect though the precise
mechanism remains unclear. Paracetamol does not have an anti-inflammatory effect and,
unlike NSAIDs, does not inhibit peripheral prostaglandin sysnthesis and serious gastrointestinal adverse events are not associated with this active.
Caffeine
Caffeine is a methylxanthine and has a mild stimulant effect. The specific mechanism by
which it acts as an analgesic adjuvant remains unclear, but may be mediated via adenosine
antagonism (adenosine being one of the kinins released in association with pain), inhibition
of COX-2 synthesis or by affecting the emotional response to pain.

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CLINICAL SAFETY
The overall safety profile of products containing paracetamol and caffeine is wellestablished with extensive safety monitoring conducted on all currently marketed
formulations. The safety profile of this combination has been adequately reviewed in the
Clinical Overview. There are currently no safety concerns regarding this combination.
Pharmacovigilance & Risk Management Plans
An overview of GlaxoSmithKline's organisation and processes for conducting
pharmacovigilance activities has been provided and is consistent with regulatory
requirements. The MHRA agrees that a formal Risk-Management Plan is not required for
this product.

EXPERT REPORTS
The Clinical Expert Report has been written by a suitably qualified person.

PRODUCT LITERATURE
SmPC
This is satisfactory.
Patient Information Leaflet
This is satisfactory.
User Testing: A Bridging Report Summary is provided
According to The Medicines (Marketing Authorisations and Miscellaneous Amendments)
Regulations 2004 [SI 2004/3224] this report considers the legibility, clarity and ease of use
of the Patient Information provided with Paracetamol and Caffeine 500 mg / 65 mg
Tablets. By referring to the Patient Information provided with similar products which have
been successfully user tested, it is appropriate to consider that the Patient Information
provided with Paracetamol and Caffeine 500 mg / 65 mg Tablets is legible, clear and easy
to use by consumers.
Assessor's comment: this approach is considered to be satisfactory, and no further user
testing is required.

Label
This is considered to be satisfactory.
Application Form
Satisfactory

CONCLUSION
From a Clinical perspective and the Benefit-Risk evaluation is considered to be favourable,
and MA is recommended.

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OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY
The important quality characteristics of Paracetamol and Caffeine 500mg/65mg Tablets are
well-defined and controlled. The specifications and batch analytical results indicate
consistency from batch to batch. There are no outstanding quality issues that would have a
negative impact on the benefit/risk balance.
PRECLINICAL
No new preclinical data were submitted and none are required for an application of this
type.

EFFICACY
The superior analgesic efficacy of paracetamol 500mg/caffeine 65mg compared to the
single actives and placebo has previously been demonstrated in clinical studies. The use of
this combination has been widely available for many years.
No new or unexpected safety concerns arise from this application.
The SPC, PIL and labelling are satisfactory and consistent with those for the innovator
product.
RISK BENEFIT ASSESSMENT
The quality of the product is acceptable and no new preclinical or clinical safety concerns
have been identified. Extensive clinical experience with paracetamol and caffeine is
considered to have demonstrated the therapeutic value of the compound. The risk benefit is,
therefore, considered to be positive.

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PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

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STEPS TAKEN FOR ASSESMENT

1

The MHRA received the marketing authorisation application on 20th May 2009.

Following standard checks and communication with the applicant the MHRA
considered the application valid on 9th June 2009.

Following assessment of the applications the MHRA requested further

information relating to the quality dossiers on 24th August 2009 and 17th
February 2010.

The applicant responded to the MHRAs requests, providing further information

on the quality dossier on 20th October 2009 and 26th April 2010.

The application was determined on 19th May 2010.

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PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

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STEPS TAKEN AFTER AUTHORISATION - SUMMARY

Date
Application
submitted type

Scope

Outcome

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PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT

Paracetamol and Caffeine 500 mg / 65 mg Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 500mg paracetamol and 65mg caffeine.
For full list of excipients, see section 6.1

PHARMACEUTICAL FORM
Film-coated tablet.
White capsule-shaped, film-coated tablets printed on one side.

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
Paracetamol and Caffeine 500 mg / 65 mg Tablets are a mild to moderate analgesic and antipyretic.
The tablets are recommended for the treatment of most painful and febrile conditions, for example,
headache, including migraine, backache, toothache, pain of osteoarthritis, and dysmenorrhoea, and
for relieving the fever, aches and pains of colds and flu, 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 and/or any of the other constituents.

4.4

Special warnings and precautions for use

Medical consultation 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 containing 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.

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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.

4.6

Pregnancy and lactation

Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased
risk of spontaneous abortion associated with caffeine consumption.
Caffeine in breast milk may potentially have a stimulating effect in breast fed infants but significant
toxicity has not been observed.

4.7

Effects on ability to drive and use machines

None.

4.8

Undesirable effects
Paracetamol
Body System
Blood
and
Lymphatic
system disorders
Immune System disorders

Respiratory, thoracic and

mediastinal disorders
Hepatobiliary disorders

Undesirable effect
Thrombocytopenia

Frequency
Very rare (<1/10,000)

Anaphylaxis

Very rare (<1/10,000)

Cutaneous hypersensitivity
reactions including skin
rashes, angiodema and
Stevens Johnson Syndrome
Bronchospasm in patients
sensitive to aspirin and other
NSAIDs
Hepatic dysfunction

Very rare (<1/10,000)

Very rare (1/10,000)

Caffeine
Body System
Central Nervous System

Undesirable effect
Nervousness
Dizziness

Frequency
Not Known
Not Known

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 Johns Wort or other drugs that induce liver enzymes.
Or
b,

Regularly

consumes

ethanol

in

excess

of

recommended

amounts.

Or
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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 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 National Poisons Information Service (NPIS) or a liver unit.
Caffeine
Symptoms
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac
arrhythmia, or 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 liver 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
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Anilides
ATC code: N02B E01
The combination of paracetamol and caffeine is a well established analgesic combination.
Paracetamol is an antipyretic and analgesic. Its mechanism of action is believed to include inhibition
of prostaglandin synthesis, primarily within the central nervous system. The lack of peripheral
prostaglandin inhibition confers important pharmacological properties such as the maintenance of
the protective prostaglandins within the gastrointestinal tract. Paracetamol is, therefore, particularly

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suitable for patients with a history of disease or on concomitant medication where peripheral
prostaglandin inhibition would be undesirable (such as, for example, those with a history of GI
bleeding or the elderly).
Clinical data has demonstrated that the combination of paracetamol and caffeine gives better
efficacy than paracetamol alone.
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 rapidly absorbed from the gastrointestinal tract and is widely distributed throughout the
body. It is almost completely metabolized in the liver by oxidation and demethylation to various
xanthine derivatives, which are excreted in the urine. The mean plasma half life is about 4.9 hours

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
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Starch pregelatinised
Maize starch
Purified Talc
Croscarmellose sodium
Stearic acid
Povidone
Potassium sorbate
Hypromellose
Triacetin
Printing Ink:
Propylene glycol
Shellac
Brilliant Blue FCF (E133)
Sodium Lactate
Dimethylpolysiloxane

6.2

Incompatibilities
None.

6.3

Shelf life
60 months.

6.4

Special precautions for storage

Do not store above 25C.

6.5

Nature and contents of container

PVC 250 or 300m / aluminium foil 20m blister packs in an outer cardboard carton, containing 4,
6, 8, 10, 12, 16, 20, 24, 30, 32 tablets.
Not all pack sizes may be marketed

6.6

Special precautions for disposal

None.

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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.

MARKETING AUTHORISATION NUMBER(S)

PL 00071/0659

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

19/05/2010

10

DATE OF REVISION OF THE TEXT

19/05/2010

AUTHORISATION

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PATIENT INFORMATION LEAFLET

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PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

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