Traumon Gel 10%

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETOFENAMATE

Available from:

MEDA Manufacturing GmBH

ATC code:

M02AA06

INN (International Name):

ETOFENAMATE

Pharmaceutical form:

GEL

Composition:

ETOFENAMATE 100 milligram(s)/gram

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Authorised

Authorization date:

2008-01-18

Patient Information leaflet

Package leaflet – Traumon Gel 10%
1
Translation from the German Language
PACKAGE LEAFLET: INFORMATION FOR THE USER
_TRAUMON_
_®_
_ GEL 10%_
_ _
_Traumon® Gel 10%_, 1 g of gel contains 100 mg of etofenamate.
Active substance: Etofenamate
For use in adults.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO USE
_TRAUMON GEL 10%_ CAREFULLY TO GET THE BEST RESULTS FROM IT.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4

You must contact a doctor if your symptoms worsen or do not improve
after two
weeks (blunt injuries) and/or after 3-4 weeks in case of rheumatic
disorders.
What is in this leaflet:
1.
What _Traumon Gel 10%_ is and what it is used for
2.
What you need to know before you use _Traumon Gel 10%_
3.
How to use _Traumon Gel 10%_
4.
Possible side effects
5.
How to store _Traumon Gel 10% _
6.
Contents of the pack and other information.
1. WHAT _TRAUMON GEL 10%_ IS AND WHAT IT IS USED FOR
_Traumon Gel 10% _is a medicinal product for external, local
application.
Etofenamate, the active substance in _Traumon Gel 10%_, belongs to the
group of the
non-steroidal (cortisone-free) anti-rheumatics (rheumatism cure) and
has anti-inflammatory
(antiphlogistic) and pain-relieving (analgesic) properties
.
Package leaflet – Traumon Gel 10%
2
USES
▫
For the external supportive symptomatic treatment of pain:
▫
caused by acute strains, sprains or bruises in the limbs after blunt
injuries such as
sports injuries;
▫
in soft tissue near a joint (e.g. bursa, tendon, cord and joint
capsule) in cases of
arthrosis of the knee.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE _TRAUMON GEL 10%_
DO NOT USE_ TRAUMON GEL 10%_,
–
if you are allergic (hypersensitive) to etofenamate, flufenamic acid,
other non-steroidal
a

Summary of Product characteristics

SPC – EN - Traumon Gel 10%
1
01 November 2017
Translation from the German Language
_TRAUMON_
_®_
_ GEL 10% _
EXPERT INFORMATION
(German Summary of Product Characteristics (SmPC))
1.
NAME OF THE MEDICINAL PRODUCTS
_Traumon Gel 10% _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of gel contains 100 mg of etofenamate
Excipient with known effect
Propylene glycol (E1520): 1g Traumon Gel 10% contains 30mg propylene
glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORMS
Clear to slightly opalescent, colourless to slightly yellowish gel
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the external supportive symptomatic treatment of pain:
▫
caused by acute strains, sprains or bruises in the extremities after
blunt trauma
such as sports injuries;
▫
in soft tissue near a joint (e.g. bursa, tendon, cord and joint
capsule) in cases of
gonarthrosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply an about 10 cm long ribbon of
_ Traumon Gel 10%_
(equivalent to about 3.3 g per
administration) three times a day in a thin layer on the affected
parts of the body and gently
rub into the skin.
For topical use only. Do not ingest.
Before applying a dressing,
_Traumon Gel 10%_
should be left for a few minutes to dry on
the skin. The application of an occlusive dressing is not recommended.
SPC – EN - Traumon Gel 10%
2
01 November 2017
In case of blunt injury (e.g. sports injury) usually treatment for one
week is sufficient.
Therapeutic benefit of a longer use has not been verified.
For rheumatic disorders therapy lasting 3-4 weeks is sufficient in
most cases. If symptoms
persist a doctor should be consulted to determine whether further
treatment is required.
4.3
CONTRAINDICATIONS
_Traumon Gel 10%_
must not be used in the following cases:
-
Hypersensitivity to the active substance etofenamate, the main
metabolite flufenamic
acid or to any other of the excipients listed in section 6.1;
-
History of hypersensitivity reactions (e.g. asthma, bronchospasm,
rhinitis, angioedema
or urticaria) occ