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NUROFEN MAXIMUM STRENGTH 10 % GEL

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Ibuprofen 10% w/w gel
Nurofen Maximum Strength 10 % Gel
Boots Max Strength Ibuprofen 10% Gel

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 10% w/w
“For the full list of excipients, see section 6.1”

3

PHARMACEUTICAL FORM
Gel.
For cutaneous use.
Clear or slightly opalescent, colourless or almost colourless gel with Isopropanol
odour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of pain and inflammation associated with backache, rheumatic pain,
muscular aches, pains or swellings such as sprains, strains and sports injuries.

4.2

Posology and method of administration

Posology
Adults, the elderly, and children over 12 years: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches)
of gel (50mg to 125 mg ibuprofen) from the tube and lightly rub into the affected area
until absorbed. Use up to four times daily with individual doses administered at least
4 hours apart. Patients should not apply more than 500mg ibuprofen (approximately
5g gel) in any 24 hour period.

Wash hands after each application. Review treatment after 2 weeks, especially if the
symptoms worsen or persist.
Children under 12 years: Do not use on children 12 years of age, except on the advice
of a doctor.
Method of administration.
For cutaneous use.

4.3

Contraindications
Not to be used if allergic to any of the ingredients, or in cases of hypersensitivity to
aspirin, ibuprofen or related painkillers (including when taken by mouth), especially
where associated with a history of asthma, rhinitis or urticaria.

Not to be used on broken or damaged skin.

4.4

Special warnings and precautions for use
Apply with gentle massage only.
Discontinue if rash develops.
Hands should be washed immediately after use.
Not for use with occlusive dressings.
Keep away from the eyes and mucous membranes.
Oral NSAIDs, including ibuprofen, can sometimes be associated with renal
impairment, aggravation of active peptic ulcers, and can induce allergic bronchial
reactions in susceptible asthmatic patients.
Although systemic absorption of topically applied ibuprofen is less than for oral
dosage forms, these complications can occur in rare cases. For these reasons, patients
with an active peptic ulcer, a history of kidney problems, asthma or intolerance to
aspirin or ibuprofen taken orally should seek medical advice before using the gel as
should patients already taking other painkillers.

The label should include the following warnings:
• Do not apply more of this medicine than the label tells you to.
• Not recommended for children under 12 years.
• Use this medicine only on your skin.
• Not to be used during pregnancy or breastfeeding.
• Do not use if you are allergic to any of the ingredients or have experienced
problems
with aspirin, ibuprofen or related painkillers (including when taken by
mouth).
• If symptoms do not get better after 2 weeks or if they worsen, consult your
doctor or pharmacist.

• Keep out of the sight and reach of children.
• Patients with asthma, an active peptic ulcer or history of kidney problems
should consult their doctor before use, as should patients already taking
aspirin or other painkillers.

Patients should be advised against excessive exposure to sunlight of area
treated in order to avoid possibility of photosensitivity.

4.5

Interaction with other medicinal products and other forms of interaction
Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering
drugs, and may possibly enhance the effects of anticoagulants, although the chance of
either of these occurring with a topically administered preparation is extremely
remote.
Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in
mind that these may increase the incidence of undesirable effects.

4.6

Fertility, Pregnancy and lactation
Not to be used during pregnancy or lactation.
Pregnancy:
Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during
pregnancy. The onset of labour may be delayed and the duration of labour increased.
Lactation:
Ibuprofen appears in breast milk in very low concentrations but is unlikely to affect breast fed
infants adversely.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
Very rarely, susceptible patients may experience the following side effects with ibuprofen, but
these are extremely uncommon when ibuprofen is administered topically. If they occur,
treatment should be discontinued:Hypersensitivity: Hypersensitivity reactions have been reported following treatment with
ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis (b)
respiratory tract reactivity comprising of asthma, aggravated asthma, brochospasm or
dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria,
purpura, angioedema and less commonly, bullous dermatoses (including epidermal necrolysis
and erythema multiforme).
Gastro-intestinal: Side effects such as abdominal pain and dyspepsia have been reported.
Renal: Renal impairment can occur in patients with a history of kidney problems.

4.9

Overdose

Overdosage with a topical presentation of ibuprofen is extremely unlikely.
Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion)
include headache, vomiting, drowsiness and hypotension. Correction of severe
electrolyte abnormalities should be considered.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: M02AA13, Anti-inflammatory preparations, non-steroids for topical use.
Ibuprofen 10% w/w Gel is a topical preparation which has anti-inflammatory and
analgesic properties. It contains the active ingredient, ibuprofen, which exerts its
effects directly in inflamed tissues underlying the site of application, mainly by
inhibiting prostaglandin biosynthesis.
Because it is formulated in an aqueous/alcoholic gel, the preparation also exerts a
soothing and cooling effect when applied to the affected area.

5.2

Pharmacokinetic properties
Specially formulated for external application, the active ingredient penetrates through the skin
rapidly and extensively (approximately 22% of a finite dose within 48 hours), achieving high,
therapeutically relevant local concentrations in underlying soft tissues, joints and the synovial
fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic
side-effects, other than in rare individuals who are hypersensitive to ibuprofen. Furthermore,
there do not appear to be any appreciable differences between the oral and topical routes of
administration regarding metabolism or excretion.

5.3

Preclinical safety data
No special information.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Hydroxyethyl cellulose E1525
Sodium Hydroxide E524
Benzyl alcohol E1519
Isopropyl alcohol
Purified water

6.2

Incompatibilities
None known

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 25°C.
Keep the tube in the outer carton in order to protect from light.

6.5

Nature and contents of container
Collapsible aluminium tubes with internal protective lacquer with polypropylene
screw caps.
Pack Sizes: 30g and 40g.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
Mercury Pharma Group Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 10972/0089

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/07/2012

10

DATE OF REVISION OF THE TEXT
29/01/2014

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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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