A Fi Sau Nu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deep Relief
Deep Relief Pain Relief Gel
Deep Relief Anti-Inflammatory Gel
5% w/w / 3% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 50 mg (5%) ibuprofen and 30 mg (3%) levomenthol.
Excipient with known effect: propylene glycol.

For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Gel for cutaneous administration.
Clear, colourless gel with the odour of menthol.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This product is indicated in adults and children aged over 12 years.
Relief of rheumatic pain, muscular aches, pains and swellings such as strains,
sprains and sports injuries.
4.2 Posology and method of administration
Posology
For adults, the elderly and children over 12 years
Method of administration
Apply the gel over the affected area and massage gently until absorbed. Repeat
as necessary, up to a maximum of three times a day. Not to be repeated more
frequently than every four hours.
For each application use about 10 to 40mm (½ to 1½ inches) if using the 20,
30 or 50g sizes and use 40 to 100mm (1½ to 4 inches) (containing 50-125mg
Ibuprofen) if using the 15g size.
If no improvement is seen after two weeks, consult your doctor.
For external use only.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in

section 6.1
Those patients known to be hypersensitive to ibuprofen, levomenthol, or any
of the ingredients or sensitive to aspirin, or other NSAIDS including when
taken by mouth, or asthmatic patients in whom aspirin or non-steroidal anti-
inflammatories are known to precipitate asthmatic attacks, rhinitis or urticaria.
Use on broken skin or denuded skin. Simultaneous use on the same site with
any other topical medicine. Use in the presence of local infection. Use in the
last trimester of pregnancy.
4.4 Special warnings and precautions for use
Paediatric population
Not recommended for children under 12 years of age.
The gel should not be used on or near mucous membranes, nor near the eyes.
Avoid contact with inflamed or broken skin. Discontinue use if rash or

irritation develops. Not for use with occlusive dressings.
Always try on a small area first.
As it is known that oral Ibuprofen may worsen an existing renal impairment,

or aggravate an active peptic ulcer, patients with a history of renal problems or
with an active peptic ulcer should seek medical advice before using topical
Ibuprofen products.
The hands should be washed after applying the product, unless they are being
treated.
Undesirable effects may be reduced by using the minimum effective dose for
the shortest possible duration.
If anyone swallows the gel he or she should contact his or her doctor or nearest
casualty department.
If anyone experiences any unwanted effects, if there is no improvement, or the

condition is aggravated, he or she should consult his or her doctor.
By extrapolation from other routes of administration:

Although this is less likely with NSAIDs intended for topical use compared to
oral drugs, the use of this product, as with any drug known to inhibit cyclo-
oxygenase/prostaglandin synthesis, may impair fertility. In women who have
difficulty conceiving or who are undergoing investigation of infertility,
withdrawal of this product should be considered.
Keep all medicines out of the sight and reach of children.
For external use only.
Do not store above 25°C
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concurrent use of aspirin or other NSAIDS may result in an increased

incidence of adverse reactions. Due to the low systemic absorption in normal
conditions, interactions described for NSAIDS administered orally are
unexpected.
Paediatric population
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
The safety of ibuprofen in pregnancy has not been sufficiently documented in

humans. Animal studies with oral treatment did not show teratogenic effects.
In case of sufficient systemic concentrations an inhibition of spontaneous
labour, premature closure of the ductus arteriousus botalli, increased bleeding
complications in the mother and neonate and increased risk of oedema in the
mother can be expected.
Topical ibuprofen is not recommended during the first six months of
pregnancy and is contraindicated in the last trimester of pregnancy.
Ibuprofen and metabolites are excreted into breast milk so this product is not
recommended during nursing.
4.7 Effects on ability to drive and use machines
This product has no influence on the ability to drive and use machines.
No effects are known with topical Ibuprofen.
4.8 Undesirable effects
Skin disorders are most frequently reported: Application site reactions such as,
rashes, pruritus and urticaria, drying, reddening, burning sensation, contact
dermatitis.
Other systemic undesirable effects of NSAIDs depend on the quantity of gel

applied, the treated area, the integrity of the skin, the duration of treatment, the
use of occlusive dressings: although extremely uncommon when administered
topically side effects such as abdominal pain, dyspepsia and renal impairment
are possible.
Hypersensitivity reactions have been reported following treatment with

ibuprofen. These may consist of:
(a) Non-specific allergic reactions and anaphylaxis.
(b) Respiratory tract reactivity comprising of asthma, aggravated asthma,
dyspnoea and bronchospasm may be precipitated in patients suffering from
or with a previous history of bronchial asthma or allergic disease (see
section 4.3).
(c) Assorted skin disorders, including rashes of various types, pruritus,
urticaria, purpura, angioedema and, less commonly, bullous dermatoses
(including epidermal necrolysis and erythema multiforme).
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdosage is unlikely to occur with topical application.

Symptoms of Ibuprofen overdose include headache, vomiting, drowsiness and
hypotension.
Severe electrolyte abnormalities should be corrected.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other topical products for joint and muscular
pain. ATC Code M02AX
Ibuprofen, a phenylpropionic acid derivative, is a prostaglandin synthetase

inhibitor, with analgesic and anti-inflammatory activities when applied
topically.
Levomenthol, when applied to the skin, constricts the blood vessels causing a
sensation of coldness followed by an analgesic effect. The action of menthol is
exerted at the nerve endings of the skin producing mild counter-irritation
which is comforting in painful lesions of the muscles, tendons and joints.
Because it is formulated in an aqueous/alcoholic gel, the preparation itself also

exerts a soothing and rapid cooling effect when applied to the skin.
5.2. Pharmacokinetic properties
Ibuprofen is applied topically for percutaneous absorption. When applied

topically, absorption through the skin has been shown to be about 5% of that
taken orally. Systemic concentration reaches a maximum of about 0.6
micrograms per ml some two hours after application.
Levomenthol absorbed through the skin is transported to the liver. Some Phase
I metabolism may occur in the skin but most occurs in the liver. The menthol
is hydroxylated and then conjugated with glucuronide prior to circulation to
the kidneys for excretion in the urine.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional

studies of safety pharmacology, ibuprofen and menthol were devoid of
mutgenic activity in vitro and in vivo.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene glycol
Diisopropanolamine
Carbomer
Denatured Ethanol
Purified water
6.2 Incompatibilities
Not applicable to a topical formulation.

6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Collapsible aluminium tube with epoxy resin lining and high density
polyethylene cap filled to an average weight of 15, 20, 30 or 50g. The tube is
enclosed by a cardboard carton containing a package insert.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
The Mentholatum Company Limited

1 Redwood Avenue
Peel Park Campus
East Kilbride G74 5PE, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00189/0027
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
15/02/2009
10 DATE OF REVISION OF THE TEXT
01/08/2016

A Fi Sau Nu

Uploaded by

Copyright:

Available Formats

A Fi Sau Nu

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

A Fi Sau Nu

Uploaded by

Copyright:

Available Formats

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g of gel contains 50 mg (5%) ibuprofen and 30 mg (3%) levomenthol.

Excipient with known effect: propylene glycol.

Gel for cutaneous administration.

Clear, colourless gel with the odour of menthol.

4.1 Therapeutic indications

This product is indicated in adults and children aged over 12 years.

4.2 Posology and method of administration

For adults, the elderly and children over 12 years

If no improvement is seen after two weeks, consult your doctor.

For external use only.

Hypersensitivity to the active substances or to any of the excipients listed in

4.4 Special warnings and precautions for use

Avoid contact with inflamed or broken skin. Discontinue use if rash or

Always try on a small area first.

As it is known that oral Ibuprofen may worsen an existing renal impairment,

If anyone experiences any unwanted effects, if there is no improvement, or the

By extrapolation from other routes of administration:

Keep all medicines out of the sight and reach of children.

For external use only.

Do not store above 25°C

No interaction studies have been performed.

Concurrent use of aspirin or other NSAIDS may result in an increased

4.6 Fertility, pregnancy and lactation

The safety of ibuprofen in pregnancy has not been sufficiently documented in

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Other systemic undesirable effects of NSAIDs depend on the quantity of gel

Hypersensitivity reactions have been reported following treatment with

Reporting of suspected adverse reactions

Overdosage is unlikely to occur with topical application.

5.1 Pharmacodynamic properties

Ibuprofen, a phenylpropionic acid derivative, is a prostaglandin synthetase

Because it is formulated in an aqueous/alcoholic gel, the preparation itself also

Ibuprofen is applied topically for percutaneous absorption. When applied

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional

6.1 List of excipients

Not applicable to a topical formulation.

6.4 Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

7 MARKETING AUTHORISATION HOLDER

The Mentholatum Company Limited

8 MARKETING AUTHORISATION NUMBER(S)

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

You might also like