Ibutop Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany

ATC code:

M02AA13

INN (International Name):

IBUPROFEN 5 % (W/W)

Pharmaceutical form:

GEL

Composition:

IBUPROFEN 5 % (W/W)

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Withdrawn

Authorization date:

2006-11-24

Patient Information leaflet

PACKAGE INSERT 

IBUTOP® GEL 

Active ingredient: Ibuprofen 

COMPOSITION: 
100 g of Ibutop Gel contain: _Active ingredient_: ibuprofen 5 g 

_Excipients_: 2-propanol,
2,2-dimethyl-4-hydroxymethyl-1,3-dioxolane, poloxamer, medium-
chain triglycerides, water, lavender oil, neroli oil 

PHARMACOTHERAPEUTIC GROUP: Pain-relieving and
anti-inflammatory substance for topical 
application. 

INDICATIONS 
Topical or supporting treatment in cases of muscular rheumatism,
painful degenerative 
articular affections (arthrosis), inflammatory rheumatic affections
of the joints and of the  
vertebral column, swelling or inflammation of the soft
tissues adjacent to the joints (e. g.  
bursae, tendines, tendon sheaths, ligaments
and articular capsules), shoulder stiffness,  
myalgia, lumbago, sports and accident-related injuries such as
contusions, sprains, strains. 

CONTRAINDICATIONS 
Hypersensitivity to ibuprofen or other drugs having the
same mode of action. 
Allergic diathesis. 
Ibutop Gel must not be applied to open wounds or mucosae. 
The present data are not sufficient in order to assess
the security of the use in humans during 
pregnancy.  
During the last third of pregnancy Ibutop Gel should not
be applied for a prolonged time and 
to large skin areas. Due to the mode of action tocolysis,
obstruction of Botallo´s duct before 
term, increased hemorrhagic diathesis in mother and child and
increased proneness to edemas 
in the mother might occur. Though so far no teratogenic effects
(malformations) have been 
observed, Ibutop Gel should not be applied to large skin areas
for a prolonged period during 
the first six months of pregnancy. 
Small amounts of ibuprofen penetrate into the breast milk. An
application to large skin areas 
or for a prolonged period during lactation should be avoided. In
order to avoid the infant´s 
contact with Ibutop Gel, this preparation should n

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibutop® Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of gel contain 5 g of ibuprofen
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
100 g of gel contain 5 g of ibuprofen
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For topical, supporting treatment in cases of
-
acute strains, sprains or contusions of the limbs caused by blunt
trauma, e. g. sports
injuries
-
muscular rheumatism
-
painful degenerative articular affections (arthrosis), inflammatory
rheumatic
affections of the joints and of the vertebral column, swelling or
inflammation of the
soft tissues adjacent to the joints (e. g. bursae, tendines, tendon
sheaths, ligaments
and articular capsules), shoulder stiffness, low back pain, lumbago.
A physician should be contacted if the discomforts persist for more
than 3 days
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ibutop® Gel is applied 3 – 4 times daily. According to the size of
the affected aching area a 4
- 10 cm long strip of gel, corresponding to 2 – 5 g of gel
(corresponding to 100 – 250 mg of
ibuprofen) is necessary. The maximum daily dosage amounts to 12 g of
gel (corresponding to
600 mg of ibuprofen).
Apply only externally! Not for oral use!
Ibutop® Gel is applied thinly to the affected part of the body and
rubbed in lightly.
Ibutop® Gel should dry on the skin for some minutes before a dressing
is put on. Ibutop® Gel
should not be applied under an occlusive dressing.
Page 2 of 6
The penetration of the active ingredient through the skin can be
intensified by iontophoresis (a
special form of electrotherapy). Ibutop® Gel is to be applied under
the cathode (negative
pole). The current intensity should be 0.1 – 0.5 mA per 5 cm² of
electrode surface, the
duration of treatment up to approx.15 minutes.
The duration of treatment is determined by the physician. In most
cases an application over 1
– 2 weeks is sufficient.
There are no data available concerning a therapeutic app