FELDENE 0.5% GEL

Active substance: PIROXICAM

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

FELDENE 0.5% GEL
PIROXICAM 0.5% GEL
(piroxicam)
Patient Information Leaflet

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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).

WARNING!

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.

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.

Q.A.
APPROVED:

DATE:

DT

20/08/14

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.

ARTWORKER:

DATE OF PROOF:

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.

UK PIL GRANTED DECEMBER 2013
REPORTING OF SIDE EFFECTS

6464/0341A

TVT CHECKED

Children and adolescents
Feldene Gel is not recommended for use in children under 12 years of age.

CODE:

CUSTOMER: Waymade
PRODUCT: Feldene Gel

PRE-PRESS NO.:

05-0440

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.

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.

SCALE:

3cm
Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

This product is known as the above names but will be referred to as Feldene Gel throughout this leaflet.
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.

PROOF HISTORY:
v.1 - waymade -20/08/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Do not use Feldene Gel for more than four weeks without telling your pharmacist or doctor.

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

WARNING!

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

DATE:

CUSTOMER
APPROVED:

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.

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

5. HOW TO STORE FELDENE GEL
• Feldene 0.5% Gel/Piroxicam 0.5% Gel should not be stored above 30°C
• Do not use after the expiry date printed on the carton or tube label. The expiry date refers to the last day
of that month.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using the gel, please take it back to the pharmacist for safe disposal. Only
keep the Gel if your doctor tells you to.
• If the gel becomes discoloured or shows any other signs of deterioration, you should seek the advice of
your pharmacist before using it.
• 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.

UK PIL GRANTED DECEMBER 2013
REPORTING OF SIDE EFFECTS

6464/0341A

DATE OF PROOF:

TVT CHECKED

20/08/14
CODE:

DT
ARTWORKER:

DATE:

05-0440

CUSTOMER: Waymade
PRODUCT: Feldene Gel

PRE-PRESS NO.:

Q.A.
APPROVED:

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Feldene 0.5% Gel/Piroxicam 0.5% Gel. Each gram of gel contains 5mg of
piroxicam.
Feldene 0.5% Gel/Piroxicam 0.5% Gel is a clear, pale yellow gel.
Feldene 0.5% Gel/Piroxicam 0.5% Gel also contains the following:
benzyl alcohol, carbopol 940, di-isopropanolamine, ethanol, hydroxyethylcellulose, propylene glycol and
purified water.
Feldene 0.5% Gel / Piroxicam 0.5% Gel is available as a tube of 60g.
POM

PL No: 6464/0341

This product is manufactured by Farmasierra Manufacturing S.L. Ctra. N-I, Km 26,200 – 28700 San
Sebastian de los Reyes, Madrid, Spain and is procured from within the EU by the Product Licence holder
who is:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 20.08.2014
Feldene is a registered trademark of Pfizer Limited

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

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

PROOF HISTORY:
v.1 - waymade -20/08/14

Leaflet Flat Size = 148 x 317

Do not cover the area where Feldene Gel has been rubbed in with dressings or bandages.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

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.

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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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