Traumon Gel 10%

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETOFENAMATE

Available from:

Viatris Healthcare GmbH Lutticher Strasse 5 53842 Troisdorf, Germany

ATC code:

M02AA06

INN (International Name):

ETOFENAMATE 100 mg/g

Pharmaceutical form:

GEL

Composition:

ETOFENAMATE 100 mg/g

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Authorised

Authorization date:

2008-01-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAUMON GEL 10%
Etofenamate
For use by adults
CAREFULLY READ THROUGH THE ENTIRE PACKAGE INSERT BEFORE YOU USE THIS
MEDICINE. THE
PACKAGE INSERT CONTAINS IMPORTANT INFORMATION.
Always use this medicine exactly as described in this leaflet or as
directed by your doctor or
pharmacist.
•
Retain this package leaflet. You might want to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you experience any side effects, talk to your doctor or pharmacist.
This also
applies to side effects that are not specified in this leaflet. See
section 4.
•
If you do not feel better or your condition deteriorates after 2 weeks
(for blunt
injuries) or after 3-4 weeks (for rheumatic diseases), contact your
doctor.
WHAT IS IN THIS LEAFLET:
1.
What is
_Traumon Gel 10%_
, and what is it used for?
2.
What should you watch out for before using
_Traumon Gel 10%_
?
3.
How to use
_Traumon Gel 10%_
4.
What are the possible side effects?
5.
How to store
_Traumon Gel 10%_
6.
Contents of the package and other information.
1. WHAT IS _TRAUMON GEL 10%_ AND WHAT IS IT USED FOR?
_Traumon Gel 10%_
is a medicine for external, topical use.
The active ingredient etofenamate belongs to the group of
non-steroidal (cortisone-free) anti-
inflammatory drugs (rheumatic agents) and has anti-inflammatory and
analgesic properties.
SCOPE OF USE
For the external symptomatic treatment of pain;
•
in cases of acute strains, sprains or bruises in the limbs due to
blunt traumas, e.g. sports
injuries;
•
soft tissues close to joints (e.g. bursas, tendons, ligaments and
joint capsules), for
osteoarthritis of the knee joint.
_ _
If you do not feel better or your condition deteriorates after 2 weeks
(for blunt injuries) or after
3-4 weeks (for rheumatic diseases), contact your doctor.
2. WHAT SHOULD YOU BEAR IN MIND BEFORE USING _TRAUMON GEL 10%_?
2
_TRAUMON GEL 10%_ MUST NOT BE USED,
–
if you are allergic to etofenamate, the main metabolite flufenamic
acid, or any of the other
ingredients

Summary of Product characteristics

Page
1
of
7
1.
NAME OF THE MEDICATION
_Traumon Gel 10% _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Traumon Gel 10% _
1 g of gel contains 100 mg Etofenamate.
Other components with known effects
Propylene glycol (E1520): 1 g of Traumon Gel 10% contains 30 mg
Propylene glycol.
For a complete list of other components, see section 6.1.
3.
DOSAGE FORMS
_Traumon Gel 10%: _
Gel
_ _
Clear to slightly opalescent, colourless to slightly yellowish gel
4.
CLINICAL INFORMATION
4.1.
SCOPE OF USE
For the external symptomatic treatment of pain;
▫
in cases of acute strains, sprains or bruises in the limbs due to
blunt traumas, e.g. sports
injuries;
▫
soft
tissues
close
to
joints
(e.g.
bursas,
tendons,
ligaments
and
joint
capsules),
for
osteoarthritis of the knee joint.
4.2.
DOSAGE AND APPLICATION
_Traumon Gel 10% _
Three times daily, thinly apply a 10 cm long line of
_Traumon Gel 10%_
(approx. 3.3 g per
application) to the affected parts of the body and lightly rub it.
4.3.
CONTRAINDICATIONS
Do not use the
_Traumon Gel 10% _
Page
2
of
7
-
if you are hypersensitive to the active substance etofenamate, the
main metabolite
flufenamic acid or any of the other ingredients listed in section 6.1;
-
if you have a history of hypersensitivity reactions (e.g. asthma,
bronchospasms, rhinitis,
angioedema or urticaria) after taking acetylsalicylic acid or other
non-steroidal anti-
inflammatory drugs/anti-inflammatory drugs (NSAIDs);
-
on open injuries, inflammation or skin infections, as well as on
eczema;
-
on eyes, lips or mucous membranes;
-
in the last trimester of pregnancy;
-
for children and adolescents.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Traumon Gel 10% _
may only be used under certain precautionary measures and under direct
medical supervision if:
-
Patients suffering from asthma, hay fever, swelling of the nasal
mucosa (so-called nasal
polyps)
or
chronic
obstructive
respiratory
diseases
or
chronic
respiratory
infections
(especially coupled with hay fever-like symptoms). When using
_Traumon Gel 10% / _
these
patients