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FELDENE GEL 60G

Active substance(s): PIROXICAM

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By symonsp
at 9:50 pm, Aug 24, 2015
PACKAGE LEAFLET: INFORMATION FOR THE USER
FELDENE™ GEL 60G
(piroxicam)

Your medicine is available using the name Feldene Gel 60g
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.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Feldene Gel is and what it is used for
What you need to know before you use Feldene Gel
How to use Feldene Gel
Possible side effects
How to store Feldene Gel
Contents of the pack and other information

1. What Feldene Gel is and what it is used for

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Potentially
life-threatening skin rashes (Stevens-Johnson
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statement
syndrome, toxic epidermal necrolysis) have been reported
of active
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with the
use of piroxicam,
appearing initially as reddish
target-like spots or circular patches often with central blisters
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the trunk.
approved
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.

NSAIDs, including Feldene Gel, may cause kidney damage or
kidney failure.

Children and adolescents

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

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.

2. What you need to know before you use
Feldene Gel

Pregnancy, breast-feeding and fertility



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

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 (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.

SCALE:

3cm

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 one of a group of medicines called nonsteroidal 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.

Do not use Feldene Gel

Feldene Gel contains propylene glycol

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

Other medicines and Feldene Gel

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.

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.
Page 1 of 2

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

If your doctor decides to stop the treatment, return any
leftover gel to the pharmacist. Only keep it 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.

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

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.

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:

6. Contents of the pack and other
information





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.

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.

5. How to store Feldene Gel
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton or
tube.
The expiry date refers to the last day of that month. The
expiry date refers to the last day of that month.

What Feldene Gel contains

Your medicine is called Feldene Gel.
The active ingredient is piroxicam.
Each gram of gel corresponding to 3cm (approximately 1¼
inches) contains 5mg piroxicam.
Feldene Gel also contains the following inactive ingredients:
propylene glycol, carbomer, ethyl alcohol, benzyl alcohol,
di-isopropanolamine, hydroxyethyl cellulose and purified
water.

What Feldene Gel looks like and contents of the
pack

Tubes are supplied in an aluminium blind-ended tube
incorporating epoxy-phenol internal lacquer with a white vinyl
pressure sensitive polyethylene end seal, fitted with a
polypropylene cap containing 60g of Feldene Gel.

Manufacturer

This product is manufactured by:
Farmasierra Manufacturing S.L., Ctra. N-I Km. 26,200,
San Sebastián de los Reyes, Madrid, Spain.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0273

POM

Feldene™ is a trademark of Pfizer Ltd.
Leaflet revision date: 04.08.15

Do not store above 30°C.

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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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