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Package leaflet: Information for the patient

Feldene® 5mg/g Gel

Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.
• 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 only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours.
• 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.

What is in this leaflet
1. What Feldene Gel is and what it is used for
2. What you need to know before you use
Feldene Gel
3. How to use Feldene Gel
4. Possible side effects
5. How to store Feldene Gel
6. Contents of the pack and other information

1. What Feldene Gel is and what
it is used for
Feldene Gel is one of a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). This means it will help to relieve
pain and reduce swelling affecting joints and
muscles when rubbed into the skin over the
affected area.
Feldene Gel is for the treatment of rheumatism,
sprains, strains and mild osteoarthritis of joints
(knees, wrists, ankles etc).

2. What you need to know before
you use Feldene Gel
Do not use Feldene Gel

• If you are allergic to piroxicam or any of
the other ingredients of this medicine
(listed in section 6), any other form of
piroxicam, aspirin or any other medicines
used to treat painful joints and muscles.
This may have been itching, reddening of
the skin or difficulty in breathing.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Feldene Gel. Medicines are not always
suitable for everyone. Your doctor needs to
know before you use Feldene Gel if you suffer
from or have suffered in the past from any of
the following conditions:

• liver disease.
• kidney disease.





Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use
of piroxicam, appearing initially as reddish
target-like spots or circular patches often
with central blisters on the trunk.
Additional signs to look for include ulcers
in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes
are often accompanied by flu-like symptoms.
The rash may progress to widespread
blistering or peeling of the skin.
The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson
syndrome or toxic epidermal necrolysis with
the use of piroxicam, you must not be
re-started on piroxicam at any time.
If you develop a rash or these skin symptoms,
seek immediate advice from a doctor and tell
them that you are taking this medicine.
NSAIDs, including Feldene Gel, may cause
kidney damage or kidney failure.
Children and adolescents
Feldene Gel is not recommended for use in
children under 12 years of age.

Other medicines and Feldene Gel

Feldene Gel is not known to interact with
any other medicines. Tell your doctor or
pharmacist if you are taking, have recently
taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are trying to become pregnant or
being investigated for infertility, withdrawal of
Feldene Gel should be considered. Feldene
Gel may increase the risk of miscarriage in
early pregnancy.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.

Driving and using machines

Feldene Gel is not expected to affect your
ability to drive or use machines.

Feldene Gel contains propylene glycol

Feldene Gel contains propylene glycol which
may cause skin irritation.

3. How to use Feldene Gel
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
Feldene Gel is for external use on the skin only.
Pierce the tube by reversing the cap and
screwing down to break the seal on the tube.
Apply 3cm (1 ¼” approximately) of the Gel on
the affected area. Use the scale below as a
guide. Rub the Gel into the skin until the Gel
disappears. Do this three or four times a day.
You will find more about FELDENE GEL
on the back of this leaflet

If there is no improvement in your symptoms,
tell your doctor. If the gel is not rubbed in
completely, mild but temporary staining of the
skin and staining of clothing may occur.
3 cm
Do not use Feldene Gel for more than four
weeks without telling your pharmacist or doctor.
Do not rub your medication into damaged
skin, for example wounds, scratches,
infections or dermatitis. Do not apply near
eyes, nose, mouth, genital or anal (bottom)
areas. If the Gel does come into contact with
these areas, rinse away with water.
Do not cover the area where Feldene Gel has
been rubbed in with dressings or bandages.

After using Feldene Gel

1. Always replace the cap
2. Wash your hands

If you use too much or accidentally
swallow Feldene Gel

If you accidentally use too much Feldene Gel
this is unlikely to cause any side effects.
If a large amount of your medication is
swallowed accidentally, tell your doctor
immediately, or contact your nearest hospital
casualty department.

If you forget to use Feldene Gel

If you forget to use Feldene Gel, use it as
soon as you remember unless it is time for
your next application. Do not use double the
amount to make up for a missed application.

If you stop using Feldene Gel

Your pain may return if you stop using
Feldene Gel.
If you have any further questions on how to take
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately and stop
using Feldene Gel if you experience any of
the following symptoms after applying this
medicine. Although they are very rare, these
symptoms can be serious:

These effects should disappear if you
stop using Feldene Gel. If the discomfort
continues tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Feldene Gel

• potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported
very rarely (see section 2).
Other side effects that Feldene Gel may
cause are:

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stamped on the tube and carton. The
expiry date refers to the last day of that month.
Do not store above 30oC.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

• Redness, rash and/or itching of the
skin where Feldene Gel was rubbed in
(for example eczema, contact dermatitis)
• Reaction of the skin to sunlight

6. Contents of the pack and other
What Feldene Gel contains

• sudden wheeziness, difficulty in breathing,
fever, swelling of eyelids, face or lips, rash
or itching affecting the whole body

Uncommon side effects are:
• Nausea (feeling sick)
• Indigestion
• Stomach discomfort





The active substance is piroxicam. Each
gram of Feldene Gel contains 5mg piroxicam.
The other ingredients are benzyl alcohol,
carbopol 980, di-isopropanolamine, ethyl

alcohol, hydroxy-ethyl cellulose, propylene
glycol and purified water.

What Feldene Gel looks like and
contents of the pack

Feldene Gel is clear, pale yellow and smells of
alcohol. Each tube of Feldene Gel contains
either 60g or 112g of Gel. Not all pack sizes
may be marketed.

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, United Kingdom.


Farmasierra Manufacturing S.L.,
Carretera de Irun, Km 26.200
E-28700 San Sebastian de los Reyes, Spain.

Company Contact Address

For further information on your medicine
please contact Medical Information at the
following address: Pfizer Ltd, Walton Oaks,
Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone: 01304 616161.
The leaflet was last revised in 06/2015
Ref: FE 13_0


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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.