Rheumon

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Etofenamate 50 mg/g;  ;  

Available from:

Viatris Limited

INN (International Name):

Etofenamate 50 mg/g

Dosage:

5% w/w

Pharmaceutical form:

Topical gel

Composition:

Active: Etofenamate 50 mg/g     Excipient: Carbomer Ethanol Isopropyl alcohol Macrogol 400 Purified water Sodium hydroxide

Units in package:

Tube, 50 g

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Duke-Chem S A

Therapeutic indications:

For the external supportive symptomatic treatment of pain: · caused by active strains, sprains or bruises in the extremities after blunt trauma such as sport injuries · in soft tissue near a joint (e.g.bursa, tendon, cord and joint capsule) in cases of gonarthrosis

Product summary:

Package - Contents - Shelf Life: Tube, - 50 g - 60 months from date of manufacture stored at or below 30°C

Authorization date:

1995-03-08

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
RHEUMON
®
GEL
1 g of gel contains 50 mg of 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
RHEUMON GEL 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.

You must contact a doctor if your symptoms worsen or do not improve
after three
days.

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 Rheumon Gel is and what it is used for
2. Before you use Rheumon Gel
3. How to use Rheumon Gel
4. Possible side effects
5. How to store Rheumon Gel
6.
Further information
1. WHAT RHEUMON GEL IS AND WHAT IT IS USED FOR
Rheumon Gel is a medicine for external, local application.
Etofenamate, the active substance in Rheumon Gel, belongs to the group
of the non-
steroidal (cortisone-free) anti-rheumatics (rheumatism cure) and has
anti-inflammatory
(antiphlogistic) and pain-relieving (analgesic) properties.
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.
DO NOT USE RHEUMON GEL FOR LONGER THAN 3 DAYS WITHOUT CHECKING WITH
YOUR
DOCTOR.
2. BEFORE YOU USE RHEUMON GEL
DO NOT USE RHEUMON GEL,

if you are allergic (hypersensitive) to etofenamate, flufenamic acid,
any of the other
ingredients of Rheumon Gel or to any other pain reliever or rheumatic
cure (non-
steroidal anti-inflammatory agents);

on open injuries, inflammations or infections of the skin as well as
on skin eczema or
on mucous membranes.

in the last trimester of pregnancy.

in children and adolescents.
TAKE SPECIAL CARE WITH R

Summary of Product characteristics

Page 1 of 7
NEW ZEALAND DATA SHEET
RHEUMON
1. PRODUCT NAME
Rheumon, 5% w/w, topical gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of topical gel contains 50 mg of etofenamate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nearly transparent yellowish gel for topical application.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
For the external supportive symptomatic treatment of pain in adults:

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.
If symptoms persist for longer than 3 days, a doctor must be
consulted.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
Apply Rheumon Gel three times a day. Depending on the size of the
painful areas, an about 5 to
10 cm long ribbon (equivalent to about 1.7 to 3.3 g of gel and 75 to
150 mg of etofenamate) will be
required.
For treatment of blunt trauma, the maximum daily dose is 9 g of gel,
equivalent to 450 mg of
etofenamate.
METHOD OF ADMINISTRATION
Only for external application to the skin. Do not ingest.
Apply Rheumon Gel in a thin layer on the affected parts of the body
and gently rub into the skin.
Before applying a dressing, Rheumon Gel should be left for a few
minutes to dry on the skin. The
application of an occlusive dressing is not recommended.
Page 2 of 7
Usually, treatment for one week is sufficient. Therapeutic benefit of
a longer use has not been
verified.
_4.3_
_CONTRAINDICATIONS_
Rheumon Gel should not be used in the following cases:

Hypersensitivity
to
etofenamate, flufenamic
acid,
other
non-steroidal
anti-inflammatory
drugs or to any of the excipients listed in section 6.1.

On open injuries, inflammations or infections of the skin as well as
on skin eczema or on
mucous membranes.

Third trimester of pregnancy.

Children and adolescents, as clinical experience is limited.
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
Rheumon Gel should not