Traxam 3% w/w Gel

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Felbinac

Beschikbaar vanaf:

Imbat Limited

ATC-code:

M02AA; M02AA08

INN (Algemene Internationale Benaming):

Felbinac

Dosering:

3 percent weight/weight

farmaceutische vorm:

Gel

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Antiinflammatory preparations, non-steroids for topical use; felbinac

Autorisatie-status:

Authorised

Autorisatie datum:

2008-09-26

Bijsluiter

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAXAM
® 3% W/W GEL
(felbinac)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Traxam Gel is and what it is used for
2.
What you need to know before you use Traxam Gel
3.
How to use Traxam Gel
4.
Possible side effects
5.
How to store Traxam Gel
6.
Contents of the pack and further information
1.
WHAT TRAXAM GEL IS AND WHAT IT IS
USED FOR
Traxam Gel contains felbinac and belongs to a group of
medicines called non-steroid anti-inflammatory drugs (NSAIDs).
These medicines reduce pain and inflammation.
Traxam Gel is used for the relief of pain in the joints and muscles
caused by injury or inflammation. It is used for the treatment of
the following conditions: sprains, strains, bruising, rheumatic or
arthritic conditions, frozen shoulder, tennis elbow or other joint
injuries.
Traxam Gel is applied to the skin and may be used to treat these
conditions in adults and elderly patients.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE TRAXAM GEL
DO NOT USE TRAXAM GEL IF:

You are allergic to felbinac, aspirin or any other NSAID
painkiller, or any of the other ingredients in this gel (listed in
Section 6)

You have had a reaction such as asthma, hay-fever like
symptoms or itchy rash with aspirin or other NSAIDs

You are pregnant or breast feeding

You have stomach ulcer

You are using any other topical preparation (ie. cream, gel or
ointment applied to the skin) on the same site

You have an infection (redness on the skin) where you want
to apply the gel.
This medicine should only be used on healthy unbroken sk

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Traxam 3% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains felbinac 3% w/w as the active ingredient.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
_Product imported from UK:_
A clear, smooth, non-greasy, non-staining topical gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with painful inflammatory
conditions of the musculo-skeletal system such as:
Soft tissue traumas (sprains, strains and contusions).
Extra-articular rheumatic or inflammatory conditions including
bursitis, capsulitis, frozen shoulder, myalgia, tendonitis,
tenosynovitis and tennis elbow.
For the relief of pain and stiffness of rheumatic or non-serious
arthritic conditions (i.e. common arthritis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical to affected area
ADULTS:
Rub 1g of Traxam 3%w/w Gel (approximately 1 inch (2.5cm) of gel)
lightly into the affected area 2 to 4 times a day. If
symptoms do not resolve, the patient should be reviewed to assess
whether continued treatment is appropriate. The total
dose should not exceed 25g a day, regardless of the number of affected
areas. Treatment should not be extended
beyond 6 weeks.
ELDERLY
No special dosage recommendations are made for elderly patients;
however, NSAIDs should be used with particular
caution in elderly patients who are more prone to adverse events. The
lowest dose compatible with adequate safe
clinical control should be employed. See also Section 4.4.
Paediatric Patient
There is insufficient information regarding the safety and efficacy of
this medicine in children. It is not recommended
for children under 18 yrs.
Hands should be washed following application of Traxam 3%w/w Gel,
unless they are the treatment sites.
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