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IBUTOP GEL

Active substance(s): IBUPROFEN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ibutop ® Gel

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: ibuprofen 5 % w/w
For excipients, see section 6.1

3

PHARMACEUTICAL FORM
Gel, for topical application.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Symptomatic relief of rheumatic pains, lumbago and muscular aches, pains and
swellings such as strains, sprains and sports injuries

4.2

Posology and method of administration
Adults, including the elderly, and children over 12 years should apply the gel to
affected areas 3 - 4 times daily. Approximately 4-10cm (1.5-4 inches) should be
expressed from the tube and rubbed gently into the skin. A 4 cm strip of gel is
equivalent to about 80 mg ibuprofen.
The product should not be used by children under 12 years of age.

The dose should not be repeated more frequently than every four hours and no more
than 4 times in any 24-hour period.

4.3

Contraindications
Hypersensitivity to ibuprofen or to any of the other constituents.
Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs including
patients predisposed to asthma, rhinitis or urticaria.

4.4

Special warnings and precautions for use
Apply with gentle massage, avoid contact with eyes, mucous membranes and
inflamed or broken skin. Discontinue use if a rash develops. Not to be used under an
occlusive dressing. Wash hands immediately after use.

4.5

Interaction with other medicinal products and other forms of interaction
If used concurrently with aspirin or other NSAIDs, there may be an increased
incidence of adverse reactions.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. However, the limitations of
these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical
situation imply that no firm conclusions can be made for regular ibuprofen use, and
no clinically relevant effect is considered to be likely for occasional ibuprofen use
(see section 5.1).

4.6

Pregnancy and lactation
Pregnancy: Whilst no terratogenic effects have been observed in animal experiments,
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 concentration and is unlikely
to affect the breast-fed infant adversely.

4.7

Effects on ability to drive and use machines
No effects are known.

4.8

Undesirable effects
Gastro-intestinal effects such as abdominal pain and dyspepsia may occur. Following
application on large skin areas or long-term treatment other systemic side effects may
occur like renal disorders and in very rare cases even renal failure.
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, bronchospasm
or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis,
urticaria, purpura, angiodema and, less commonly, bullous dermatoses (including
epidermal necrolysis and erythema multiforme).
Respiratory: Bronchospasm may be precipitated in patients suffering from or with a
previous history of bronchial asthma or allergic disease.

4.9

Overdose
Overdosage with topical ibuprofen is unlikely to occur. Symptoms of ibuprofen
overdose include headache, vomiting, drowsiness and hypotension. Correction of
severe electrolyte abnormalities should be considered.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The active constituent is a phenylproprionic acid derivative possessing analgesic,
anti-inflammatory and anti-pyretic properties.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. In one study, when a single
dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after
immediate release aspirin dosing (81mg), a decreased effect of aspirin on the
formation of thromboxane or platelet aggregation occurred. However, the limitations

of these data and the uncertainties regarding extrapolation of ex vivo data to the
clinical situation imply that no firm conclusions can be made for regular ibuprofen
use, and no clinically relevant effect is considered to be like for occasional ibuprofen
use.

5.2

Pharmacokinetic properties
Percutaneous absorption amounts to about 5 % of that which occurs after oral dosing
with ibuprofen.

5.3

Preclinical safety data
There is no relevant information additional to that contained elsewhere in this SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Isopropyl alcohol
Solketal
Poloxamer 407
Miglyol 812
Water
Lavender oil
Neroli oil.

6.2

Incompatibilities
None known

6.3

Shelf life
3 years

6.4

Special precautions for storage
Store below 25ºC.

6.5

Nature and contents of container
Aluminium tubes, with a tamper-evident diaphragm, hold 100 grams of gel.
Tube interior surfaces coated with protective varnish.

6.6

Special precautions for disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
Dolorgiet Arzneimittel GmbH & Co. KG.
Trading as: Dolorgiet Pharmaceuticals
Otto-von-Guericke-Strasse 1
53754 St. Augstin/Bonn
Germany

8

MARKETING AUTHORISATION NUMBER(S)
PL 04315/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24 March 1997

10

DATE OF REVISION OF THE TEXT
17/12/2008

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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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