FELDENE 0.5% W/W GEL

Active substance: PIROXICAM

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Package leaflet: Information for
the patient

Feldene® 0.5% w/w
Gel
(piroxicam)
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.
Your medicine is known by the above
name, but will be referred to as
Feldene Gel throughout this leaflet.
This medicine is also available as
Feldene Gel 112 g tube.
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 antiinflammatory 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 flulike 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 StevensJohnson 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 sure.
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.
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
SCALE:
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.

4. Possible side effects

5. How to store Feldene Gel

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

 Do not store above 30°C.
 Keep out of the sight and reach of
children.
 Do not use Feldene Gel after the
expiry date which is stated on the
tube and carton after ‘EXP.’ The
expiry date refers to the last day of
that month.
 Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.
 If your medicine have become
discoloured or show any other signs
of deterioration, consult your doctor
or pharmacist who will tell you what
to do.

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

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

Your pain may return if you stop using
Feldene Gel.

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

If you have any further questions on
how to take this medicine, ask your
doctor or pharmacist.

Reporting of side effects

If you stop using Feldene Gel

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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety
of this medicine.

6. Contents of the pack and
other information
What Feldene Gel contains
 Each gram corresponding to 3 cm
contains 5 mg of piroxicam.
 Also contains: carbopol, propylene
glycol, ethyl alcohol, benzyl alcohol,
di-isopropanolamine,
hydroxylethylcellulose, purified
water.

What Feldene Gel looks like and
contents of the pack
Feldene is a clear pale yellow gel.
Each tube of gel contains 60g of
Feldene Gel.

Manufactured by: Farmasierra
Manufacturing, S.L., Carretera de Irun,
Km 26.200, E-28700 San Sebastian
de los Reyes, Spain.
Procured from within the EU &
repackaged by PL holder:
Kosei Pharma UK Ltd.,
956 Buckingham Avenue, Slough,
SL1 4NL.
Feldene® Gel is a registered trademark
of Pfizer Products Inc.
POM
Feldene® 0.5% w/w Gel
PL 39352/0279
Leaflet date: 24.10.2014

Package leaflet: Information for
the patient

Piroxicam 0.5% w/w
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.
Your medicine is known by the above
name, but will be referred to as
Piroxicam throughout this leaflet. This
medicine is also available as
Piroxicam 112 g tube.
What is in this leaflet:
1. What Piroxicam is and what it is
used for
2. What you need to know before you
use Piroxicam
3. How to use Piroxicam
4. Possible side effects
5. How to store Piroxicam
6. Further information

1. What Piroxicam is and what
it is used for
Piroxicam is one of a group of
medicines called non-steroidal antiinflammatory 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.
Piroxicam 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 Piroxicam
Do not use Piroxicam
 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

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 flulike 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 StevensJohnson 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 Piroxicam, may
cause kidney damage or kidney
failure.
Children and adolescents
Piroxicam is not recommended for use
in children under 12 years of age.

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

Other medicines and Piroxicam

 liver disease
 kidney disease

Pregnancy, breast-feeding and
fertility

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.

Piroxicam 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.

If you are trying to become pregnant or
being investigated for infertility,
withdrawal of Piroxicam should be
considered. Piroxicam 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
Piroxicam is not expected to affect
your ability to drive or use machines.

Piroxicam contains propylene
glycol
Piroxicam contains propylene glycol
which may cause skin irritation.

3. How to use Piroxicam
Always use this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
Piroxicam 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.
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
SCALE:
Do not use Piroxicam 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
Piroxicam has been rubbed in with
dressings or bandages.

After using Piroxicam
1. Always replace the cap
2. Wash your hands

If you use too much or
accidentally swallow Piroxicam
If you accidentally use too much
Piroxicam 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 Piroxicam
If you forget to use Piroxicam, 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 Piroxicam
Your pain may return if you stop using
Piroxicam.
If you have any further questions on
how to take this medicine, ask your
doctor or pharmacist.

4. Possible side effects

5. How to store Piroxicam

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

 Do not store above 30°C.
 Keep out of the sight and reach of
children.
 Do not use Piroxicam after the
expiry date which is stated on the
tube and carton after ‘EXP.’ The
expiry date refers to the last day of
that month.
 Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.
 If your medicine have become
discoloured or show any other signs
of deterioration, consult your doctor
or pharmacist who will tell you what
to do.

Tell your doctor immediately and
stop using Piroxicam if you
experience any of the following
symptoms after applying this medicine.
Although they are very rare, these
symptoms can be serious:
 sudden wheeziness, difficulty in
breathing, fever, swelling of eyelids,
face or lips, rash or itching affecting
the whole body
 potentially life-threatening skin
rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis) have
been reported very rarely (see
section 2)
Other side effects that Piroxicam may
cause are:
 Redness, rash and/or itching of the
skin where Piroxicam was rubbed in
(for example eczema, contact
dermatitis)
 Reaction of the skin to sunlight

Uncommon side effects are:
 Nausea (feeling sick)
 Indigestion
 Stomach discomfort
These effects should disappear if you
stop using Piroxicam. 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety
of this medicine.

6. Contents of the pack and
other information
What Piroxicam contains
 Each gram corresponding to 3 cm
contains 5 mg of piroxicam.
 Also contains: carbopol, propylene
glycol, ethyl alcohol, benzyl alcohol,
di-isopropanolamine,
hydroxylethylcellulose, purified
water.

What Piroxicam looks like and
contents of the pack
Feldene is a clear pale yellow gel.
Each tube of gel contains 60g of
Piroxicam.

Manufactured by: Farmasierra
Manufacturing, S.L., Carretera de Irun,
Km 26.200, E-28700 San Sebastian
de los Reyes, Spain.
Procured from within the EU &
repackaged by PL holder:
Kosei Pharma UK Ltd.,
956 Buckingham Avenue, Slough,
SL1 4NL.
POM
Piroxicam 0.5% w/w Gel
PL 39352/0279
Leaflet date: 24.10.2014

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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.

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