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MAX STRENGTH COLD & FLU CAPSULES, HARD
(PARACETAMOL, CAFFEINE, PHENYLEPHRINE HYDROCHLORIDE)

PL 12063/0066
MAX STRENGTH SINUS RELIEF CAPSULES, HARD
PL 12063/0067
UKPAR
TABLE OF CONTENTS
Lay Summary
Page 2
Scientific discussion
Page 3
Steps taken for assessment
Page 21
Steps taken after authorisation summary
Page 22
Summary of Product Characteristics
Page 23
Product Information Leaflet
Page 39
Labelling
Page 43
MHRA PAR Max Strength Cold & Flu Capsules, hard PL 12063/0066
Max Strength Sinus Relief Capsules, hard PL 12063/0067
-1

PL 12063/0066
PL 12063/0067
LAY SUMMARY
The MHRA granted Wrafton Laboratories Limited Marketing Authorisations (licences) for the
medicinal products Max Strength Cold & Flu Capsules, hard (PL 12063/0066) and Max
Strength Sinus Relief Capsules, hard (PL 12063/0067) on 9th June 2006. These General Sales
List medicines (GSL) are used for the relief of the symptoms of sinusitis, colds and flu,
including blocked nose, aches and pains, sore throat, headache, fatigue, drowsiness and fever.
Max Strength Cold & Flu Capsules and Max Strength Sinus Relief Capsules contain the active
ingredients:
- paracetamol, which is a pain reliever and reduces temperature/fever
- caffeine, which increases the pain relief effect
- phenylephrine hydrochloride, which is a decongestant
The data presented to the MHRA, pre licensing, demonstrated that Max Strength Cold & Flu
Capsule and Max Strength Sinus Relief Capsules are equivalent to the approved product,
Beechams Powders Capsules but with a higher strength of paracetamol and phenylephrine
hydrochloride. These capsules can therefore be used instead of Beechams Powders capsules,
when a higher dose is required.
No new or unexpected safety concerns arose from these applications. It was, therefore, judged
that the benefits of taking Max Strength Cold & Flu Capsules and Max Strength Sinus Relief
Capsules outweigh the risks. Hence, Marketing Authorisations have been granted.
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PL 12063/0066
PL 12063/0067
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction
Page 4
Pharmaceutical assessment
Page 5
Preclinical assessment
Page 17
Clinical assessment
Page 18
Overall conclusions and risk benefit assessment
Page 20
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INTRODUCTION
Based on the review of the data on quality, safety and efficacy the UK granted marketing
authorisations for the medicinal products Max Strength Cold & Flu Capsules, hard (PL
12063/0066) and Max Strength Sinus Relief Capsules, hard (PL 12063/0067) to Wrafton
Laboratories Limited on 9th June 2006. The products are General Sales List (GSL) medicines.
The applications were submitted as abridged applications according to article 10.1 [formerly
article 10.1(a)(iii)] of Directive 2001/83/EC, claiming essential similarity to the original
product Beechams Powders Capsules. The applicants products contain higher strength
paracetamol and phenylephrine hydrochloride than the original product and, as such, the
applicant has also referenced Lemsip Max Strength Capsules which have the same quantitative
composition of paracetamol, caffeine and phenylephrine hydrochloride.
The products contain the active ingredients paracetamol (an analgesic and antipyretic), caffeine
(an analgesia adjunct) and phenylephrine (a decongestant). The products are indicated for the
relief of symptoms of the common cold, influenza and sinusitis, including relief of aches and
pains, headache, nasal congestion, headaches, sore throat, fatigue, drowsiness and lowering of
temperature.
These applications for Max Strength Cold & Flu Capsules and Max Strength Sinus Relief
Capsules were assessed concurrently. Consequently, all sections of this Scientific Discussion
refer to both products.
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PHARMACEUTICAL ASSESSMENT
1. INTRODUCTION
These are abridged applications for Marketing Authorisations in the UK submitted under
Article 10.1 [formerly article 10.1 (a)(iii)] of Directive 2001/83 (as amended) with the
difference compared to the original product listed as a different strength.
The original product is listed as Beechams Powders Capsules, PL 00079/0205 granted 1st July
1982. The original product contains lower strengths of paracetamol and phenylephrine
hydrochloride. The reference products are listed as Lemsip Max Strength Cold and Flu
Capsules, PL 00063/0104 granted 9th October 1998 and Lemsip Max Strength Sinus Relief
Capsules, PL 0063/0120 granted 12th March 2002.
2. ACTIVE SUBSTANCE
2.1 PARACETAMOL
2.1.1 General information
The active substance supplier has been named.
A valid Certificate of Suitability has been supplied. The re-test date on the certificate of
suitability is 5 years if stored in either LDPE bags in cardboard drums or flexible containers
lined with polyethylene.
Structure:
Description:
White odourless crystalline powder
Chemical name:
N-(4-hydroxyphenyl)acetamide
Molecular formula:
C8H9NO2
Relative molecular mass:
151.2
2.1.2 Manufacture
2.1.2.1 Manufacturing process
The manufacturing process is referenced to the certificate of suitability.
-5
2.1.2.2 Impurities
The impurities are controlled by the levels in the European Pharmacopoeia monograph and
certificates of suitability. Residual solvents used during the process are controlled in the active
substance specification with the loss on drying test.
2.1.3 Control of active substance
2.1.3.1 Specification
The specification used by the active substance manufacturer is that in the European
Pharmacopoeia as covered by the certificate of suitability, with an additional in-house test.
The finished product manufacturer specification provided for the active substance is in
compliance with the European Pharmacopoeia monograph with additional in-house tests.
2.1.3.2 Analytical test methods
The test methods used are those described in the pharmacopoeia. Consequently, no validation
data has been presented for the pharmacopoeia methods.
2.1.3.3 Batch analyses
Certificates of analysis for several batches, by the active substance manufacturer, demonstrate
compliance to the specifications and inter-batch conformity. The impurity levels in the batches
are well below specification. The raw material analysis reports from the finished product
manufacturer have been provided.
2.1.3.4 Reference standards
The certificate of suitability has been referenced for the reference standards.
2.1.3.5 Container closure system
The certificate of suitability has been referenced for the container closure system.
2.1.3.6 Stability
The certificate of suitability has been referenced for the stability of the active substance.
2.2 CAFFEINE
The active substance manufacturer has supplied a valid, current Certificate of Suitability with a
re-test period of 4 years if stored in a container consisting of fibre drums or big bags lined with
a low density polyethylene bag.
-6
Structure:
Description:
Odourless silky, white crystals, usually matted together, or a white

crystalline powder.
Chemical name:
1,3,7-Trimethylpurine-2,6 (3H,1H)-dione
Molecular formula:
C8H10N4O2
194.2
2.2.2 Manufacture
2.2.2.2 Impurities
certificate of suitability.
Pharmacopoeia as covered by the certificate of suitability with an additional in-house test.
compliance with the European Pharmacopoeia monograph with an additional in-house test.
data has been presented for the pharmacopoeia methods. Particle size is determined by air jet
sieving which does not require validation data.
compliance to the specifications and inter-batch conformity. The raw material analysis reports
from the finished product manufacturer have been provided.
-7
2.2.3.6 Stability
The certificate of suitability has been referenced for the stability of the active substance. The
certificate of suitability has a re-test date of 4 years if stored in a container consisting of fibre
drums or big bags lined with a low density polyethylene bag.
2.3 PHENYLEPHRINE HYDROCHLORIDE

The active substance is to be supplied by a named supplier.
A valid, current certificate of suitability has been supplied. The re-test period for the active
substance is 3 years if stored at room temperature not exceeding 25C in a container consisting
of two polyethylene bags placed in a fibre drum or in a polyethylene bottle.
Structure:
Description:
White or almost white crystalline powder
Chemical name:
(S)-1-(3-Hydroxyphenyl)-2-methylaminoethanol hydrochloride
Molecular formula:
C9H14ClNO2
203.7
2.3.2 Manufacture
2.3.2.2 Impurities
certificates of suitability. The certificates of suitability include additional tests for related
substances and residual solvents
Pharmacopoeia as covered by the certificate of suitability with an additional in-house test.
-8
compliance with the European Pharmacopoeia monograph with an additional in-house test.
data has been presented for the pharmacopoeia methods.
compliance to the specifications and inter-batch conformity. The raw material analysis reports
have been provided from the finished product manufacturer.
2.3.3.6 Stability
The certificate of suitability has been referenced for the stability of the active substance. The
re-test period for the active substance is 3 years if stored at room temperature not exceeding
25C in a container consisting of two polyethylene bags placed in a fibre drum or in a
polyethylene bottle.
It has been confirmed that the finished product manufacturer stores the active substance in a
controlled environment with the temperature not exceeding 25C as specified in the certificate
of suitability.
3. DRUG PRODUCT
3.1 Composition
The composition of the products are summarised in table 1. The products are red capped,
yellow bodied (PL 12063/0066) or red capped/blue bodied (PL 12063/0067) hard gelatin
capsules containing the drug product, an off-white powder.
The products are packed in blisters comprising white opaque PVC lidded with aluminium foil.
The pack has been approved as BS8404 compliant in line with current child resistant closure
regulations.
Table 1
Name
Paracetamol
Phenylephrine hydrochloride
Reference
Ph. Eur. & in house
Ph. Eur. & in house
-9
Caffeine
Maize starch
Croscarmellose sodium
Sodium laurilsulfate
Magnesium stearate
Purified talc
Gelatin
Erythrosine
Titanium dioxide
Quinoline yellow
Patent blue V
Indigo carmine E132*
* Only in PL 12063/0067
Ph. Eur. & in house

Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur
95/45/EC
Ph. Eur.
95/45/EC
95/45/EC
95/45/EC
3.2 Pharmaceutical Development

3.2.1 Formulation development
The qualitative and quantitative composition of the finished product has been designed to be
equivalent to Lemsip Max Strength Cold & Flu capsules (PL 00063/0104) for PL 12063/0066
and Lemsip Max Strength Sinus Relief Capsules (PL 00063/0120) for PL 12063/0067.
The formulation was based on Wrafton Laboratories Cold Relief capsules, a product containing
Paracetamol (300mg), Phenylephrine hydrochloride (5mg) and caffeine (25mg) with maize
starch, croscarmellose sodium, sodium laurilsulfate and magnesium stearate.
Full details on the formulations manufactured with a quantitative assessment of the quality that
determined the development of the product and the final proposed formulation have been
provided. The quantitative data of the parameters assessed has been provided and demonstrates
the development of the formulation.
It has been stated that dissolution analyses were performed and showed equivalence to the
Wrafton Cold Relief capsules. Single point data has been provided at 15 minutes
demonstrating complete release of all the actives. Only a single point has been provided on the
basis that more than 85% was released in 15 minutes in line with the guidelines.
The dissolution parameters are stated as being standard parameters as specified in the European
Pharmacopoeia. It has been stated that the discriminatory nature of the method has been
demonstrated with the stability batches with the samples at accelerated conditions having a
marginally lower value than those at long-term conditions.
3.2.2 Clinical trial formula
No clinical studies have been performed.
3.2.4 Physicochemical and biological properties
The finished product has been developed to ensure rapid dissolution.
3.2.5 Manufacturing development
The development of the proposed manufacturing process has been adequately described.
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3.2.6 Container closure system

The packaging materials are opaque white PVC and aluminium foil. The combination complies
with BS8404, the child resistant packaging regulations covering paracetamol containing
products in blister packs.
3.3 Manufacture
3.3.1 Manufacturer
A valid Manufacturers Licence and Wholesale Dealers Licence has been provided for the
finished product manufacturer.
3.3.2
Batch formula
The batch formula has been presented for the pilot scale batch and the maximum proposed fullscale production batch. It has been stated that other suitably validated batch sizes will be used
up to the proposed maximum batch size.
3.3.3
Manufacturing process and process controls
A flow diagram detailing the manufacturing process and in-process control testing has been
provided. A written summary of the process has been included.
The mixing and processing times for full-scale manufacture will be defined during full scale
manufacturing trials.
It has been confirmed that the equipment intended to be used for full-scale manufacture will
utilise the equivalent mixing process to the stability batches and process evaluation batches
presented.
For the pilot scale batches the manufacturing process times have been stated and have been
shown to be acceptable on the basis of the initial and subsequent stability data.
The estimated time lines for the production scale batches have been stated and the suitability of
these parameters will be assessed as part of the process validation on the production scale
batches. This is acceptable.
It has been confirmed that the hold time for the validation of the main blend for one month will
be demonstrated by full testing after manufacture and then prior to encapsulation to justify this
time period. This is acceptable.
It has been confirmed that the shelf-life will be set from the beginning of the manufacturing
process with the preparation of the materials.
3.3.4 Reprocessing
No reprocessing will be undertaken.
3.3.5
Control of critical steps (in-process controls)
- 11
The in-process controls are limited.

The manufacturing process is considered by the applicant to be suitably validated on a pilot
scale. It is assumed that this is the justification for having minimal in-process controls.
3.3.6
Process validation or evaluation
Three batches have been manufactured, at batch sizes representing more than 10% of the
proposed maximum batch size.
Satisfactory details of process validation and evaluation have been provided.
Samples from each batch tested to the finished product specification demonstrated compliance
to the specification with reasonable comparability.
The validation protocol has been provided for the full-scale manufacture of the finished
product, which is basically the same as that used for the pilot scale batches. It has been stated
that the equipment to be used does not have specific validation documents, with its suitability
based on its use for the manufacture of other products.
The scale-up protocol has been provided and will cover the robustness of the process to
compensate for the absence of formal validation documents for the equipment being used in
the manufacture of the finished product. This is acceptable.
3.4 Control of excipients
3.4.1 Specification
Maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and purified
talc have monographs in the European Pharmacopoeia. Certificates of analysis have been
provided for these excipients, from the excipient manufacturers, accompanied by raw material
analysis sheets from the finished product manufacturer.
Identification and appearance tests are performed on the excipients upon receipt. Reduced
testing is also performed on a rolling basis when supplied with a certificate of analysis from the
excipient manufacturer so that all tests on the certificate of analysis are performed over 10
batches.
Gelatin and titanium dioxide present in the capsule shell have monographs in the European
Pharmacopoeia. The colours erythrosine, quinoline yellow, patent blue V and indigo carmine
comply with commission directive 95/45/EC. Relevant certificates of conformance have been
provided from the capsule manufacturer.
Certificates of suitability have been provided from gelatin suppliers. The validity of the
certificates of suitability for the gelatin as a consequence of the re-classification of countries
listed as origin of source materials has been provided.
The only product used derived from human or animal sources in the finished product is gelatin,
which has been covered by the certificates of suitability. Relevant certification has been
provided covering the TSE status and residual solvents for all the other materials present in the
finished product.
- 12
The analytical methods used to test the excipients are those provided in the European
Pharmacopoeia. Consequently no validation data has been supplied.
3.5 Control of drug product
3.5.1 Specification
All physical and chemical parameters have been shown to comply with the relevant
legislations.
The limits of unknown impurities have been set on the basis of the limits accepted for the
active substances which are in compliance with the certificates of suitability.
The applicant has justified the inclusion of uniformity of weight and content uniformity tests,
rather than uniformity of dosage unit tests. It has been stated that the products are well known
active substances with good safety profiles and there are no anticipated safety issues associated
with the proposed tests. In line with the European Pharmacopoeia this is considered reasonable.
3.5.2
Analytical procedures
All the details have been provided for the pharmacopoeia and non-pharmacopoeia methods.
The assay methods and related substances methods for the active substances are all HPLC
methods.
3.5.3
Validation
The methods for dissolution, assay of the active substances and related substances have been
adequately validated.
Relevant validation data has been supplied for the microbiology methods in line with the
European Pharmacopoeia.
3.5.4
Reference standards
Suitable information on the reference standards for the active ingredients and related
substances has been provided. The assay value of the reference standards used has been
provided.
Relevant data has been provided in relation to the standardisation of the reference standards
against relevant pharmacopoeia monographs.
3.5.5
Batch analyses
Batch analyses have been provided for the pilot scale validation batches. These are all within
specification and show a reasonable degree of comparability. The certificates of analysis have
been supplied.
3.5.6
Characterisation of impurities
- 13
The impurities in the active substances are stated as being covered by the certificates of
suitability. The potential impurities of the finished product have been identified in relation to
each of the active substances used and are suitably controlled.
3.6
Container closure system
The packaging consists of opaque white PVC blisters lidded with aluminium foil.
Relevant specifications have been supplied accompanied by certificates of conformity from the
packaging material manufacturers. Adequate testing is performed on the packaging
components, when received by the finished product manufacturer.
Relevant certification of compliance to the EU directives on food contact materials has been
provided from the suppliers of the PVC and the aluminium foil.
The packaging material is in compliance with the child resistant closure regulations. Relevant
confirmation has been supplied that the aluminium foil is listed as being compliant with the
German standard DIN 55559 (B.Anz No./Date: 117, 01/07/81). To be compliant with BS8404
(for non-re-closable containers) additional testing is required to demonstrate adult accessibility.
Acceptable testing has been supplied for a senior adult panel test section of BS 8404.
3.7 Stability
Stability data has been presented for the validation batches. The active substances used in the
batches are from different lots. The capsules were packed in the proposed commercial
packaging. The storage conditions are long-term and accelerated ICH conditions.
Stability tests performed are based on those in the finished product specification.
Data has been presented for samples stored at both long-term and accelerated conditions. All
samples remain in specification with the exception of appearance under accelerated conditions
and show a reasonable degree of conformity across the batches. There were differences seen in
appearance on storage under accelerated conditions, the powder showed evidence of
agglomeration though broke up easily to form a free flowing powder and the capsule was softer
to touch with a slightly greasy feel and there was some pitting on the capsule body.
The current stability study will continue to 36 months. The first three production batches will
be placed on to stability. This is a reasonable post approval stability commitment. A
commitment has been made to put one batch a year on to stability there after.
The applicant is proposing a shelf life of 24 months when stored below 25C. This is
acceptable on the basis of the data presented.
3.8 Other information
3.8.1
Clinical work
No clinical work has been conducted. See medical assessment for further comment.
3.8.2
Essential similarity
- 14
Comparative dissolution has been conducted with the original product rather than the reference
product. Samples were analysed and shown to be comparable for the active substances. The
dissolution profiles have not been provided due to the rapid release, in line with the guidelines.
Comparative impurity profiles of the finished product with the reference product have been
provided.
4.
PRODUCT LITERATURE
4.1 SPC
Satisfactory
4.2 PIL
Satisfactory
4.3 LABEL
Satisfactory
5.
ADMINISTRATIVE
5.1 MAA form

The MAA forms are in compliance with the SPC and current guidelines.
5.2 Quality Overall Summary
The summary has been done by a suitably qualified person. The report is a summary of the
module.
6. CONCLUSIONS AND ADVICE
Marketing authorisations can be granted.
- 15
PRECLINICAL ASSESSMENT
No new preclinical data have been supplied with these applications and none are required for
applications of this type.
- 16
CLINICAL ASSESSMENT
The applications have been submitted under Article 10.1 [formerly article 10.1(a)(iii)] of
Directive 2001/83, (application for a product referring to a so-called original product) with
the difference compared to the original product listed as a different strength. The applicant has
also referred to a reference medicinal product for each to justify the change in strength.
1.
Introduction
The three active ingredients are well known and have been approved singly or in combination
for the indications claimed.
An excellent 16-page Clinical Overview and Clinical Summary covering the rationale of
product development, biopharmaceutics, clinical pharmacology, efficacy, safety and
risk/benefit analysis in respect of both the products has been provided, by a suitably qualified
person.
2.
Assessment
The following assessment of the SPCs of the two products is based on SPCs of other
authorised similar products rather than on any one reference SPC.
The assessment also taken into account the Agency guidance on individual active ingredients
for GSL use
2.1.
Therapeutic indications
Satisfactory and acceptable.

2.2.
Posology and method of administration

2.3.
Contraindications

2.4.
Special warnings and precautions for use

2.5.
Interactions with other medicinal products and other forms of interaction

2.6.
Pregnancy and lactation
- 17

2.7.
Effects on ability to drive and use machines

2.8.
Undesirable effects

2.9.
Overdose

2.10.
Pharmacodynamic properties

2.11
Pharmacokinetic properties
3.
Bioequivalence
The applications have been submitted under Article 10.1 [formerly article 10.1(a)(iii)] of
Directive 2001/83, (application for a product referring to a so-called original product) with
the difference compared to the original product listed as a different strength. The applicant has
also referred to a reference medicinal product for each to justify the change in strength.
The applicant submitted a justification for not performing bioequivalence studies.
This has been discussed extensively within the Agency for its legal validity as well as scientific
and safety merits. The Agency is content that the applicant has justified exemption from the
need to demonstrate bioequivalence by referring to, and meeting, the inclusion and exemption
criteria in the bioequivalence guideline.
4.
Carton
Clinically, these are satisfactory in terms of safety information.
5.
Recommendations
There are no clinical public health issues and the recommendation is to grant marketing
authorisations for these preparations.
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OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT
QUALITY
The important quality characteristics of Max Strength Cold & Flu Capsules and Max Strength
Sinus Relief Capsules 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 have been supplied with these applications and none are required for
applications of this type.
EFFICACY
Paracetamol, caffeine and phenylephrine are well-known drugs and have been used in the
treatment of the common cold, influenza and sinusitis for many years. It has been
demonstrated that the applicants products are comparable to the originator product, Beechams
Powders Capsules and the reference product, Lemsip Max Strength Capsules.
No new or unexpected safety concerns arise from these applications.
The SPC, PIL and labelling are satisfactory.
RISK BENEFIT ASSESSMENT

The quality of the products is acceptable and no new preclinical or clinical safety concerns
have been identified. The data supplied supports the claim that the applicants products and the
innovator products are interchangeable, with the applicants products containing a higher dose
of paracetamol and phenylephrine hydrochloride. Clinical experience with paracetamol,
caffeine and phenylephrine hydrochloride is considered to have demonstrated the therapeutic
value of the compounds. The risk benefit is therefore considered to be positive.
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PL 12063/0066
PL 12063/0067
STEPS TAKEN FOR ASSESSMENT
The MHRA received the marketing authorisation applications on 20/10/2004

and 16/11/2004
Following standard checks and communication with the applicant the MHRA
considered the application valid on 10/11/2004 and 18/11/2004.
Following assessment of the application the MHRA requested further

information relating to the dossier on 10/06/2005, 28/11/2005, 07/12/2005,
12/01/2006 and 15/03/2006.
The applicant responded to the MHRAs requests, providing further information

relating to the dossier on 28/11/2005, 07/12/2005, 01/03/2006 and 27/04/2006
and 23/05/2006.
The application was determined on 09/06/2006
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PL 12063/0066
PL 12063/0067
STEPS TAKEN AFTER ASSESSMENT

Date
Application
submitted type
Scope
Outcome
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PL 12063/0066
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT

Asda Max Strength Cold & Flu Capsules, hard
Benylin Cold & Flu Max Strength Capsules, hard
Boots Max Strength Cold & Flu Capsules, hard
Lloydspharmacy Max Strength Cold & Flu Capsules, hard
Morrisons Max Strength Cold & Flu Capsules, hard
Sainsburys Max Strength Cold & Flu Capsules, hard
Superdrug Max Strength Cold & Flu Capsules, hard
Tesco Max Strength Cold & Flu Capsules, hard
Wilko Max Strength Cold & Flu Capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient
Mg/Capsule
Paracetamol
Caffeine
Phenylephrine Hydrochloride
500
25
6.1
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Red/yellow hard gelatin capsules containing the drug product, an off-white powder.
4.
CLINICAL PARTICULARS
4.1.
For the relief of symptoms associated with the common cold and influenza, including
relief of aches and pains, sore throat, headaches, fatigue and drowsiness, nasal
congestion and lowering of temperature.
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4.2.

For oral use.
Swallow whole with water. Do not chew.
Adults and Children over 12 years
2 capsules every 4 hours as required to a maximum of four doses in any 24 hours.
Do not exceed eight capsules in any 24 hours.
Children 6-12 years
1 capsule every 4 hours as required to a maximum of four doses in any 24 hours.
Do not exceed four capsules in any 24 hours.
Not recommended for children under 6 years of age.
4.3.
Contraindications
Paracetamol:
Caffeine:
Phenylephrine Hydrochloride:
4.4.
Hypersensitivity to paracetamol or any of the

other constituents.
Should be given with care to patients with a
history of peptic ulcer.
Severe coronary heart disease and cardiovascular
disorders. Hypertension. Hyperthyroidism.
Contraindicated in patients currently receiving or
within two weeks of stopping therapy with
monoamine oxidase inhibitors.

Care is advised in the administration of paracetamol to patients with severe renal or
severe hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.
Use with caution in patients with Raynauds Phenomenon and diabetes mellitus.
The following warnings will appear on the pack:CONTAINS PARACETAMOL
-
If symptoms persist consult your doctor.

Do not exceed the stated dose.
Keep all medicines out of the reach and sight of children.
Do not take with any other paracetamol-containing products.
The Label shall say:
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Immediate medical advice should be sought in the event of an overdose, even if you
feel well.
The Leaflet shall say:
feel well, because of the risk of delayed, serious liver damage.
If you are pregnant or being prescribed medicine by your doctor, seek your doctors
advice before taking this product.
4.5.

Paracetamol
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 use of paracetamol with increased risk of bleeding; occasional doses
have no significant effect.
Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates,
monoamine oxidase inhibitors and tricyclic antidepressants, may increase the
hepatotoxicity of paracetamol, particularly after overdosage. Contraindicated in patients
currently receiving or within two weeks of stopping therapy with monoamine oxidase
inhibitors because of a risk of hypertensive crisis.
Phenylephrine may adversely interact with other sympathomimetics, vasodilators and
beta blockers.
4.6.

Paracetamol
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommended dosage, but patients should follow the advice of
their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant amount.
Available published data do not contraindicate breast feeding.
Caffeine
Taken during pregnancy, it appears that the half-life of caffeine is prolonged. This is a
possible contributing factor in hyperemesis gravidarum (morning sickness).
Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have
been reported.
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Due to the vasoconstrictive properties of phenylephrine the product should be used with
caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental
perfusion and the product should be used in pregnancy only if the benefits outweigh
this risk. There is no information on use in lactation.
4.7.

None known.
4.8.
Undesirable effects
Paracetamol
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may
occur.
There have been reports of blood dyscrasias including thrombocytopenia and
agranulocytosis, but these were not necessarily causally related to paracetamol.
Caffeine
Nausea and insomnia have been noted.
Phenylephrine hydrochloride may elevate blood pressure with headache, vomiting and
rarely palpitations; tachycardia or reflex bradycardia; tingling and coolness of the skin.
There have been rare reports of allergic reactions.
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 Johns 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.
- 25
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 British National
Formulary (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
24 hours from ingestion should be discussed with the National Poisons Information
Service (NPIS) or a liver unit.
Caffeine
Doses over 1g are probably necessary to induce toxicity, 2-5g to produce severe
toxicity and 5-10g is likely to be lethal.
Symptoms include: epigastric pain, vomiting, diuresis, tachycardia. CNS stimulation
(insomnia, restlessness, excitement, agitation, jitteriness, tremors, convulsions).
No specific antidote is available, reduce or stop dosage and avoid excessive intake of
coffee or tea.
Severe overdosage may produce hypertension and associated reflex bradycardia.
Treatment measures include early gastric lavage and symptomatic and supportive
measures. The hypertensive effects may be treated with an alpha-receptor blocking
agent (such as phentolamine mesylate 6-10mg) given intravenously, and the
bradycardia treated with atropine, preferably only after the pressure has been controlled.
- 26
5.
PHARMACOLOGICAL PROPERTIES
5.1.
Pharmacotherapeutic Group:
ATC code:
Other analgesics and antipyretics &

Other cold combination preparations
N02BE51
PARACETAMOL
Analgesic:
The mechanism of analgesic action has not been fully determined. Paracetamol may act
predominantly by inhibiting a prostaglandin synthesis in the central nervous system
(CNS) and to a lesser extent through a peripheral action by blocking pain-impulse
generation. The peripheral action may also be due to inhibition of prostaglandin
synthesis or to inhibition of the synthesis or actions of other substances that sensitise
pain receptors to mechanical or chemical stimulation.
Antipyretic:
Paracetamol probably produces antipyresis by acting on the hypothalamic heatregulating centre to produce peripheral vasodilation resulting in increased blood flow
through the skin, sweating and heat loss. The central action probably involves
inhibition of prostaglandin synthesis in the hypothalamus.
CAFFEINE
Central nervous system stimulant Caffeine stimulates all levels of the CNS, although
its cortical effects are milder and of shorter duration than those of amfetamines.
Analgesia Adjunct:
Caffeine constricts cerebral vasculature with an accompanying decrease in cerebral
blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to
relieve headaches by providing a more rapid onset of action and/or enhanced pain relief
with lower doses of analgesic. Recent studies with ergotamine indicate that the
enhancement of effect by the addition of caffeine may also be due to improved
gastrointestinal absorption of ergotamine when administered with caffeine.
PHENYLEPHRINE HYDROCHLORIDE
Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of
the respiratory tract to produce vasoconstriction, which temporarily reduces the
swelling associated with inflammation of the mucous membranes lining the nasal and
sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses.
In addition to reducing mucosal lining swelling, decongestants also suppress the
production of mucus, therefore preventing a build up of fluid within the cavities which
could otherwise lead to pressure and pain.
5.2.
PARACETAMOL
- 27
Absorption and Fate

Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma
concentrations occurring between 10 and 120 minutes after oral administration. It is
metabolised in the liver and excreted in the urine mainly as the glucuronide and
sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The
elimination half-life varies from about 1 to 4 hours.
Plasma-protein binding is negligible at usual therapeutic concentrations but increases
with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by
mixed-function oxidases in the liver and which is usually detoxified by conjugation
with liver glutathione may accumulate following paracetamol overdose and cause liver
damage.
CAFFEINE
Absorption and Fate
Caffeine is absorbed readily after oral administration and is widely distributed
throughout the body. Caffeine is metabolised almost completely via oxidation,
demethylation, and acetylation, and is excreted in the urine as 1-methyluric acid, 1methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine), 5acetylamino-6-formylamino-3-methyluracil (AFMU), and other metabolites with only
about 1% unchanged.
Absorption and Fate
Phenylephrine has reduced bioavailability from the gastro-intestinal tract owing to
irregular absorption and first-pass metabolism by monoamine oxidase in the gut and
liver.
5.3.
Preclinical safety data

There are no preclinical data of relevance to the prescriber additional to that already
covered in other sections of the SPC.
6.
PHARMACEUTICAL PARTICULARS
6.1.
List of excipients
Maize Starch
Croscarmellose Sodium
Sodium Laurilsulfate
Magnesium Stearate
Talc
- 28
Gelatin
Titanium Dioxide E171
Quinoline Yellow E104
Patent Blue V E131
Erythrosine E127
6.2.
Incompatibilities
None known.
6.3.
Shelf life
2 years.
6.4.
Special precautions for storage

Do not store above 25C.
6.5.
Nature and contents of container

250 micron white opaque PVC/30 micron hard temper pyramidal aluminium foil, heatseal coated, contained in an outer cardboard carton.
Pack size: 8 or 16 capsules.
6.6
Special precautions for disposal

None
7.
MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL
8.
MARKETING AUTHORISATION NUMBER

PL 12063/0066
- 29
DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
09/06/2006
10
DATE OF REVISION OF THE TEXT

09/06/2006
- 30

PL 12063/0067
SUMMARY OF PRODUCT CHARACTERISTICS

1.
NAME OF THE MEDICINAL PRODUCT

Asda Max Strength Sinus Relief Capsules, Hard
Boots Max Strength Sinus Relief Capsules, Hard
Superdrug Max Strength Sinus Relief Capsules, Hard
Wilko Max Strength Sinus Relief Capsules, Hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient
Paracetamol
Caffeine
mg/Capsule
500
25
6.1
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsule.
Red/blue hard gelatin capsules containing the drug product, an off-white powder.
4.
CLINICAL PARTICULARS
4.1.
For the relief of symptoms associated with the pain and congestion of sinusitis,
including relief of aches and pains, headache, nasal congestion and lowering of
temperature.
4.2.

For oral use.
Swallow whole with water. Do not chew.
- 31
Adults and Children over 12 years

2 capsules every 4 hours as required to a maximum of four doses in any 24 hours.
Do not exceed eight capsules in any 24 hours.
Children 6 12 years
1 capsule every 4 hours as required to a maximum of four doses in any 24 hours.
Do not exceed four capsules in any 24 hours.
Not recommended for children under 6 years of age.
4.3.
Contraindications
Paracetamol: Hypersensitivity to paracetamol or any of the other constituents.
Caffeine: Should be given with care to patients with a history of
peptic ulcer.
Phenylephrine Hydrochloride: Severe coronary heart disease and cardiovascular
disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently
receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.
4.4.

Care is advised in the administration of paracetamol to patients with severe renal or
severe hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.
Use with caution in patients with Raynauds Phenomenon and diabetes mellitus.
The following warnings will appear on the pack:CONTAINS PARACETAMOL
- If symptoms persist consult your doctor.
- Do not exceed the stated dose.
- Keep all medicines out of the reach and sight of children.
Do not take with any other paracetamol-containing products.
The Label shall say:
feel well.
The Leaflet shall say:
- 32
feel well, because of the risk of delayed, serious liver damage.
If you are pregnant or being prescribed medicine by your doctor, seek your doctors
advice before taking this product.
4.5.

Paracetamol
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 use of paracetamol with increased risk of bleeding; occasional doses
have no significant effect.
Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates,
monoamine oxidase inhibitors and tricyclic antidepressants, may increase the
hepatotoxicity of paracetamol, particularly after overdosage. Contraindicated in
patients currently receiving or within two weeks of stopping therapy with monoamine
oxidase inhibitors because of a risk of hypertensive crisis.
Phenylephrine may adversely interact with other sympathomimetics, vasodilators and
beta blockers.
4.6.

Paracetamol
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommended dosage, but patients should follow the advice of
their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant amount.
Available published data do not contraindicate breast feeding.
Caffeine
Taken during pregnancy, it appears that the half-life of caffeine is prolonged. This is a
possible contributing factor in hyperemesis gravidarum (morning sickness).
Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have
been reported.
Due to the vasoconstrictive properties of phenylephrine the product should be used with
caution in patients with a history of pre-eclampsia. Phenylephrine may reduce
placental perfusion and the product should be used in pregnancy only if the benefits
outweigh this risk. There is no information on use in lactation.
- 33
4.7.

None known
4.8.
Undesirable effects
Paracetamol
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may
occur.
There have been reports of blood dyscrasias including thrombocytopenia and
agranulocytosis, but these were not necessarily causally related to paracetamol.
Caffeine
Nausea and insomnia have been noted.
Phenylephrine hydrochloride may elevate blood pressure with headache, vomiting and
rarely palpitations; tachycardia or reflex bradycardia; tingling and coolness of the skin.
There have been rare reports of allergic reactions.
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 Johns 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
- 34
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 British National
Formulary (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
24 hours from ingestion should be discussed with the National Poisons Information
Service (NPIS) or a liver unit.
Caffeine
Doses over 1g are probably necessary to induce toxicity, 2 5g to produce severe
toxicity and 5 10g is likely to be lethal.
Symptoms include: epigastric pain, vomiting, diuresis, tachycardia, CNS stimulation
(insomnia, restlessness, excitement, agitation, jitteriness, tremors, convulsions).
No specific antidote is available, reduce or stop dosage and avoid excessive intake of
coffee or tea.
Severe overdosage may produce hypertension and associated reflex bradycardia.
Treatment measures include early gastric lavage and symptomatic and supportive
measures. The hypertensive effects may be treated with an alpha-receptor blocking
agent (such as phentolamine mesylate 6 10 mg) given intravenously, and the
bradycardia treated with atropine, preferably only after the pressure has been
controlled.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic Group:
Other analgesics and antipyretics &

Other cold combination preparations
- 35
ATC code:
5.1.
N02BE51
PARACETAMOL
Analgesic:
The mechanism of analgesic action has not been fully determined. Paracetamol may
act predominantly by inhibiting a prostaglandin synthesis in the central nervous system
(CNS) and to a lesser extent through a peripheral action by blocking pain-impulse
generation. The peripheral action may also be due to inhibition of prostaglandin
synthesis or to inhibition of the synthesis or actions of other substances that sensitise
pain receptors to mechanical or chemical stimulation.
Antipyretic:
Paracetamol probably produces antipyresis by acting on the hypothalamic heatregulating centre to produce peripheral vasodilation resulting in increased blood flow
through the skin, sweating and heat loss. The central action probably involves
inhibition of prostaglandin synthesis in the hypothalamus.
CAFFEINE
Central nervous system stimulant Caffeine stimulates all levels of the CNS, although
its cortical effects are milder and of shorter duration than those of amfetamines.
Analgesia Adjunct:
Caffeine constricts cerebral vasculature with an accompanying decrease in cerebral
blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to
relieve headache by providing a more rapid onset of action and/or enhanced pain relief
with lower doses of analgesic. Recent studies with ergotamine indicate that the
enhancement of effect by the addition of caffeine may also be due to improved
gastrointestinal absorption of ergotamine when administered with caffeine.
Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of
the respiratory tract to produce vasoconstriction, which temporarily reduces the
swelling associated with inflammation of the mucous membranes lining the nasal and
sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses.
In addition to reducing mucosal lining swelling, decongestants also suppress the
production of mucus, therefore preventing a build up of fluid within the cavities which
could otherwise lead to pressure and pain.
5.2.
PARACETAMOL
Absorption and Fate
- 36
Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma
concentrations occurring between 10 and 120 minutes after oral administration. It is
metabolised in the liver and excreted in the urine mainly as the glucuronide and
sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The
elimination half-life varies from about 1 to 4 hours.
Plasma-protein binding is negligible at usual therapeutic concentrations but increases
with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by
mixed-function oxidases in the liver and which is usually detoxified by conjugation
with liver glutathione may accumulate following paracetamol overdose and cause liver
damage.
CAFFEINE
Absorption and Fate
Caffeine is absorbed readily after oral administration and is widely distributed
throughout the body. Caffeine is metabolised almost completely via oxidation,
demethylation, and acetylation, and is excreted in the urine as 1-methyluric acid, 1methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine), 5acetylamino-6-formylamino-3-methyluracil (AFMU), and other metabolites with only
about 1% unchanged.
Absorption and Fate
Phenylephrine has reduced bioavailability from the gastro-intestinal tract owing to
irregular absorption and first-pass metabolism by monoamine oxidase in the gut and
liver.
5.3.
Preclinical safety data

There are no preclinical data of relevance to the prescriber additional to that already
covered in other sections of the SPC.
6.
PHARMACEUTICAL PARTICULARS
6.1.
List of excipients
Maize Starch
Croscarmellose Sodium
Sodium Laurilsulfate
Magnesium Stearate
Talc
Gelatin
Titanium Dioxide E171
Quinoline Yellow E104
- 37
Patent Blue V E131

Erythrosine E127
Indigo Carmine E132
6.2.
Incompatibilities
None known.
6.3.
Shelf life
2 years
6.4.
Special precautions for storage

Do not store above 25C.
6.5.
Nature and contents of container

250 micron white opaque PVC/30 micron hard temper pyramidal aluminium foil, heatseal coated, contained in an outer cardboard carton.
Pack sizes: 16 capsules.
6.6
Special precautions for disposal

None
7.
MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited
Wrafton
Braunton
North Devon EX33 2DL
8.
MARKETING AUTHORISATION NUMBER

PL 12063/0067
DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
- 38
09/06/2006
10
DATE OF REVISION OF THE TEXT

09/06/2006
- 39

PL 12063/0066
PRODUCT INFORMATION LEAFLET
Please note that the leaflet and labelling below is representative of that produced by the
individual distributors of these products. The content will be the same although the
layout is different.
- 40
- 41

PL 12063/0067
PRODUCT INFORMATION LEAFLET
- 42
- 43

PL 12063/0066
LABELLING
CARTON
- 44
FOIL
- 45

PL 12063/0067
LABELLING
CARTON
FOIL
- 46

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MAX STRENGTH COLD & FLU CAPSULES, HARD

(PARACETAMOL, CAFFEINE, PHENYLEPHRINE HYDROCHLORIDE)

Steps taken for assessment

Steps taken after authorisation summary

Summary of Product Characteristics

Product Information Leaflet

MAX STRENGTH COLD & FLU CAPSULES, HARD

MAX STRENGTH COLD & FLU CAPSULES, HARD

Overall conclusions and risk benefit assessment

White odourless crystalline powder

Relative molecular mass:

Odourless silky, white crystals, usually matted together, or a white

Relative molecular mass:

2.3 PHENYLEPHRINE HYDROCHLORIDE

White or almost white crystalline powder

Relative molecular mass:

Ph. Eur. & in house

3.2 Pharmaceutical Development

3.2.6 Container closure system

Manufacturing process and process controls

Control of critical steps (in-process controls)

The in-process controls are limited.

Process validation or evaluation

Container closure system

5.1 MAA form

Satisfactory and acceptable.

Posology and method of administration

Satisfactory and acceptable.

Satisfactory and acceptable.

Special warnings and precautions for use

Satisfactory and acceptable.

Interactions with other medicinal products and other forms of interaction

Satisfactory and acceptable.

Pregnancy and lactation

Satisfactory and acceptable.

Effects on ability to drive and use machines

Satisfactory and acceptable.

Satisfactory and acceptable.

Satisfactory and acceptable.

Satisfactory and acceptable.

Satisfactory and acceptable.

Clinically, these are satisfactory in terms of safety information.

OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

RISK BENEFIT ASSESSMENT

MAX STRENGTH COLD & FLU CAPSULES, HARD

STEPS TAKEN FOR ASSESSMENT

The MHRA received the marketing authorisation applications on 20/10/2004

Following assessment of the application the MHRA requested further

The applicant responded to the MHRAs requests, providing further information

The application was determined on 09/06/2006

MAX STRENGTH COLD & FLU CAPSULES, HARD

STEPS TAKEN AFTER ASSESSMENT

MAX STRENGTH COLD & FLU CAPSULES, HARD

NAME OF THE MEDICINAL PRODUCT

QUALITATIVE AND QUANTITATIVE COMPOSITION

For a full list of excipients, see section 6.1.

Posology and method of administration

Hypersensitivity to paracetamol or any of the

Special warnings and precautions for use

If symptoms persist consult your doctor.

The Label shall say:

Interactions with other medicinal products and other forms of interaction

Pregnancy and lactation