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PIROXICAM 0.5% GEL

Active substance(s): PIROXICAM / PIROXICAM / PIROXICAM

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0154 Feldene gel 20160622

PACKAGE LEAFLET: INFORMATION FOR THE USER

FELDENE 0.5% GEL
PIROXICAM 0.5% GEL

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

Your medicine is known by above names but will be referred to as
Feldene Gel throughout the following leaflet.

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.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

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.



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.

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

What is in this leaflet

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

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

Feldene Gel is for external use on the skin only.

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

Pierce the tube by reversing the cap and screwing down to break
the seal on the tube.

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

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.

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).

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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FELDENE
GEL

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 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.

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

Warnings and precautions

If you use too much or accidentally swallow Feldene Gel

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:

If you accidentally use too much Feldene Gel this is unlikely to
cause any side effects.



liver disease.

If a large amount of your medication is swallowed accidentally, tell
your doctor immediately, or contact your nearest hospital casualty
department.



kidney disease.

If you forget to use Feldene Gel

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.

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.

Additional signs to look for include ulcers in the mouth, throat, nose,
genitals and conjunctivitis (red and swollen eyes).

Your pain may return if you stop using Feldene Gel.

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.

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:


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:

6. CONTENTS OF THE PACK AND OTHER INFORMATION



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

What Feldene gel contains



Reaction of the skin to sunlight



Feldene Gel contains the active ingredient, Piroxicam 0.5%
(5mg per g).



Feldene gel also contains the following: benzyl alcohol,
carbopol 940, di-isopropanolamine, ethyl alcohol,
hydroxyethylcellulose, propylene glycol and water.

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 a clear, pale yellow gel.



Feldene gel is available in a tube of 60g.

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

Product Licence Holder:
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex HA0 1DX, England.
Manufacturer:
This product is manufactured by Farmasierra Manufacturing, S.L.,
28700 San Sebastian de los Reyes, Madrid, Spain.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.

POM PL: 08747/0154



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.

Leaflet revision date: 22 June 2016



Do not use after the expiry date printed on the carton or tube
label.

Feldene is a registered trade mark of Pfizer Inc, USA.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

0154 Feldene gel 20160622

Expand Transcript

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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