PIROXICAM 0.5% W/W GEL

Active substance: PIROXICAM

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PATIENT INFORMATION LEAFLET
®

FELDENE GEL
(piroxicam)
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 Feldene Gel is and what it is used
for
2 Before you use Feldene Gel
3 How to use Feldene Gel
4 Possible side effects
5 How to store Feldene Gel
6 Further 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. Before you use Feldene Gel
Do not use Feldene Gel:
• If you have ever had an allergic reaction to
Feldene Gel, 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.

Use Feldene Gel with special care
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 restarted 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.
Feldene Gel is not recommended for use in
children under 12 years of age.

Taking other medicines
Feldene Gel is not known to interact with any
other medicines. However, you should still tell
your doctor about any other medicines you
are taking or applying or have recently taken
or applied including medicines you bought
yourself without a prescription.

Pregnancy and Breast-feeding
If you are pregnant or breast-feeding tell your
doctor before you use Feldene Gel.
Ask your doctor or pharmacist for advice
before taking any medicine.

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

Important information about some of
the ingredients of Feldene Gel
Feldene Gel contains propylene glycol which
may cause skin irritation.

3. How to use Feldene Gel
Always use Feldene Gel exactly as your
doctor has told you. You should 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 (1¼” 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.

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.
2.

Always replace the cap
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
use this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Feldene Gel 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:
• 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
These effects should disappear if you stop
using Feldene Gel. If the discomfort continues
tell your doctor or pharmacist.

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

Manufactured by: Farmasierra
manufacturing S.L., Ctra. N-I, km.26, 20028700, San Sebastian de los Reyes, Madrid,
Spain

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.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK

5. How to store Feldene Gel

Feldene Gel PL 18799/2198

Keep Feldene Gel out of the sight and reach
of children. Do not store above 30°C.

Leaflet date: 25.02.2013

Do not use Feldene Gel after the expiry date
which is stamped on the tube. 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.

6. Further information
What Feldene Gel contains
Each gram of Feldene Gel contains 5mg
piroxicam as the active substance. Other
ingredients are benzyl alcohol, carbopol 980,
di-isopropanolamine, ethyl alcohol, hydroxyethyl cellulose, propylene glycol and purified
water.

POM

Feldene is a registered trademark of Pfizer.

PATIENT INFORMATION LEAFLET

Piroxicam 0.5% w/w Gel
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 Piroxicam Gel is and what it is
used for
2 Before you use Piroxicam Gel
3
4
5
6

How to use Piroxicam Gel
Possible side effects
How to store Piroxicam Gel
Further information

The name of your medicine is Piroxicam 0.5%
w/w Gel but it will be used as Piroxicam Gel
throughout this leaflet.

1. What Piroxicam Gel is and
what It is used for
Piroxicam 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.

Piroxicam Gel is for the treatment of
rheumatism, sprains, strains and mild
osteoarthritis of joints (knees, wrists, ankles
etc).

2. Before you use Piroxicam
Gel
Do not use Piroxicam Gel:
• If you have ever had an allergic reaction to
Piroxicam Gel, 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.

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 restarted 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.
Piroxicam Gel is not recommended for use in
children under 12 years of age.

Taking other medicines
Use Piroxicam Gel with special care
Medicines are not always suitable for
everyone. Your doctor needs to know before
you use Piroxicam 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.

Piroxicam Gel is not known to interact with
any other medicines. However, you should
still tell your doctor about any other medicines
you are taking or applying or have recently
taken or applied including medicines you
bought yourself without a prescription.

3. How to use Piroxicam Gel
Always use Piroxicam Gel exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Piroxicam 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 (1¼” 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.

Pregnancy and Breast-feeding
If you are pregnant or breast-feeding tell your
doctor before you use Piroxicam Gel.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Piroxicam Gel is not expected to affect your
ability to drive or use machines.

Important information about some of
the ingredients of Piroxicam Gel
Piroxicam Gel contains propylene glycol
which may cause skin irritation.

Do not use Piroxicam 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 Piroxicam Gel
has been rubbed in with dressings or
bandages.

After using Piroxicam Gel
1.
2.

Always replace the cap
Wash your hands

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

4. Possible side effects
Like all medicines, Piroxicam Gel can cause
side effects, although not everybody gets
them.
Tell your doctor immediately and stop
using Piroxicam 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 Piroxicam Gel may
cause are:

What Piroxicam Gel looks like and
contents of the pack

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

Piroxicam Gel is clear, pale yellow and smells
of alcohol. Each tube of Piroxicamcontains
60g PiroxicamGel.

Uncommon side effects are:
• Nausea (feeling sick)
• Indigestion
• Stomach discomfort
These effects should disappear if you stop
using Piroxicam Gel. If the discomfort
continues tell your doctor or pharmacist.
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.

5. How to store Piroxicam Gel
Keep Piroxicam Gel out of the sight and reach
of children. Do not store above 30°C.
Do not use Piroxicam Gel after the expiry date
which is stamped on the tube. 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.

6. Further information
What Piroxicam Gel contains
Each gram of Piroxicam Gel contains 5mg
piroxicam as the active substance. Other
ingredients are benzyl alcohol, carbopol 980,
di-isopropanolamine, ethyl alcohol, hydroxyethyl cellulose, propylene glycol and purified
water.

Manufactured by: Farmasierra
manufacturing S.L., Ctra. N-I, km.26, 20028700, San Sebastian de los Reyes, Madrid,
Spain
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK
Piroxicam Gel PL 18799/2198
Leaflet date: 25.02.2013

POM

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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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