Fenbid Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom

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Withdrawn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:

2006-03-20

Patient Information leaflet

pharmacode read direction
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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 recommended 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 is Fenbid Gel and what it is used for
2. Before you use Fenbid Gel
3. How to use Fenbid Gel
4. Possible side effects
5. How to store Fenbid Gel
6. Further information
1. WHAT IS FENBID GEL AND
WHAT IT IS USED FOR
Fenbid Gel contains ibuprofen and belongs to a
group of medicines called non-steroid anti-
inflammatory drugs (NSAID’s). These medicines
reduce pain and inflammation, and bring down
a high temperature.
Fenbid Gel is used to treat a number of painful
conditions affecting the joints and muscles,
such as backache, rheumatic and muscular
pain, sprains, strains and sports injuries. It is
also
used
to
treat
pain
from
non-serious
arthritic conditions and nerve pain (neuralgia).
2. BEFORE YOU USE FENBID GEL
DO NOT USE FENBID GEL:
• If you are allergic to ibuprofen, aspirin or
similar medicines (e.g NSAIDs) or any of the
other ingredients in this gel (listed at the end
of this leaflet)
• If you are asthmatic, or suffer from rhinitis
(allergic runny nose) or urticaria (hives)
•
On broken, damaged, infected or diseased skin.
TAKE SPECIAL CARE WITH FENBID GEL:
• Protect treated areas from direct sunlight to
avoid any sensitivity reaction, e.g. a rash
• If you suffer from bronchial asthma or any
allergic disease
•
If you have had an ulcer or some other problem
affecting your stomach or intestines in the past
• If you have asthma or wheezing attacks (or if
you have had asthma in the past)
• If you have any kidney problems
• If you develop a rash after using the gel stop
using it any furthe

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fenbid gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
5% w/w Ibuprofen Phur.
3
PHARMACEUTICAL FORM
Gel for topical application.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Pharmacy Only Indications_:_ _
Topical analgesic and anti-inflammatory for backache, pain of
non-serious
arthritic
conditions,
muscular
pain,
sprains,
strains,
sports
injuries
and
neuralgia.
_General Sales List Indications_:_ _
Topical
analgesic
and
anti-inflammatory
for
backache,
rheumatic
and
muscular pain, sprains, strains and sports injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Strength 5% maximum
METHOD OF ADMINISTRATION
For topical application to the skin.
DOSAGE
_Adults, the elderly and children over 12_ years:_ _ Squeeze 50 to
125mg (4 to
10cm) of the gel from the tube and lightly rub into the affected area
until
absorbed. The dose should not be repeated more frequently than every
four
hours and no more than 4 times in any 24 hour period. Wash hands after
each
application. Do not exceed the stated dose. Review treatment after 2
weeks,
especially if the symptoms worsen or persist.
Page 2 of 6
_ _
_Children under _12 _years:_ Do not use on children under 12 years of
age except
on the advice of a doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the constituents. Hypersensitivity to
aspirin, or
other non-steroidal anti-inflammatory drugs, asthma, rhinitis or
urticaria.
Not to be used on broken or damaged skin.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Apply with gentle massage only. Avoid contact with eyes, mucous
membranes
and inflamed or broken skin.
Discontinue if rash develops.
Hands should be washed immediately after use.
Not for use with occlusive dressings.
The label will state:
Do not exceed stated dose
Keep out of reach of children
For external use only.
If symptoms persist consult your doctor or pharmacist
Do not use if you are allergic to Ibuprofen or any of the ingredients,
aspirin, or
any other painkillers.
Consult your docto