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Active substance(s): PIROXICAM

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Manxiflex 0.5%w/w Gel

Read all of this leaflet carefully before you start using this
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
In this leaflet
1. What Piroxicam is and what it is used for
2. Before using 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
Manxiflex 0.5%w/w Gel (hereinafter referred to as Piroxicam) is
a gel containing the active ingredient Piroxicam. Piroxicam
helps to relieve inflammation, pain and stiffness.
Piroxicam belongs to a group of medicines called topical
non-steroidal anti-inflammatory drugs (often shortened to
NSAIDs) which are applied to the skin to reduce inflammation
(swelling) and pain.
Piroxicam works by blocking the production of chemicals
(prostaglandins) which the body produces in response to injury
or certain diseases. These prostaglandins would otherwise go
on to cause swelling and pain.
Piroxicam can be used to treat:
muscle or joint pain caused by rheumatism or injury
pain from arthritis (knee)
pain or swelling from a sprain, back strain or bruise
tennis elbow.

2. Before using Piroxicam
Do not use Piroxicam if you have or have had:
an allergic (hypersensitive) reaction to piroxicam or any of
the other ingredients of Piroxicam Gel (see section 6 for
other ingredients).
asthma that is made worse by aspirin or other painkilling
an allergic reaction to aspirin or any other anti-inflammatory
painkiller (for example if you had an itchy red rash, hay-fever
like symptoms or asthma after taking these medicines).
Special warnings
Do not get this medicine in your eyes, nose or mouth. If the gel
does accidentally go in your eyes or mouth wash it out
immediately, then contact your doctor. If you accidentally
swallow some of the gel, contact your doctor immediately.
Avoid contact with inflamed or broken skin. Do not put a plaster,
bandage or another topical medicine on the area you have
applied the gel to because it may affect the way the gel works.

The gel can sometimes make your skin more sensitive to
sunlight. To prevent this happening you should try to keep the
treated area out of the sun.
Speak to your doctor or pharmacist if you have:
a history of serious allergic drug reactions, especially of the
suffered a skin reaction before, however severe, to
Piroxicam taken by mouth, to other anti-inflammatory
medicines (NSAIDs) or to any other medicines
liver problems
kidney problems.
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 occurrance 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 using this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
You must tell your doctor or pharmacist if you are already
taking any of the following medicines:
other painkillers
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
Do not use Piroxicam if you are pregnant, think you might be
pregnant or are breast-feeding.
Driving and using machines
Piroxicam should not have an effect on your ability to drive or
use machinery.
Important information about some of the ingredients of
Piroxicam Gel
This gel contains propylene glycol, which can cause allergic
reactions in some people. If you have been told by your doctor
that you are allergic to propylene glycol contact your doctor
before using this medicine.

3. How to use Piroxicam
Always use Piroxicam exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not
Apply the gel three or four times a day as required.

(continued overleaf)

BOH Approval Date
Saved as

Manxiflex Gel PIL - Side 1
210 x 158mm
21 April 2016
14196-01 PIL
1 Colour - Black


There is a seal on the nozzle of this tube. Break this seal by
pushing the pointed end of the cap onto the nozzle. If the seal is
already broken when you receive the gel, return it to your
Wash your hands before using the gel. Also, wash your
hands when you have finished using the gel unless your
hands are the area being treated.
Squeeze about one and a quarter inches (3cm) of the gel onto
your finger or hand and gently massage it onto the skin around
the injury. If you have more than one injury, repeat on each
Do not use the gel for more than 4 weeks. Speak to your doctor
if you still have symptoms after this time.
Piroxicam is not suitable for children under 12 years of age.
If you use more Piroxicam than you should:
Talk to your doctor or pharmacist.
Do not use more than 25g of the gel in one day (this would be
about 25 applications).
Applying large amounts of Piroxicam may increase the chance
of side effects.
If you forget to use Piroxicam
Apply as soon as you remember. If it is close to your next
application miss the forgotten application and apply as normal.
Do not double the amount to make up for a forgotten
If you have any further questions on the use of this product ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Piroxicam can cause side effects, although
not everybody gets them.
If you experience any of the following side effects stop using
the gel and speak to your doctor immediately:
rash, bruising or blistering of the skin
potentially life-threatening skin rashes (Stevens Johnson
syndrome, toxic epidermal necrolysis) have been reported
very rarely (see section 2)
Other side effects may include:
skin becoming red, sore, itchy, painful, numb or tingly
(contact dermatitis)
itchy rash (scale-like) caused by sunlight
Rare side effects include:
feeling sick
upset stomach
These side effects should disappear when you stop using the
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 sides effects directly via the Yellow
Card Scheme at: By reporting
side effects, you can help provide more information on the
safety of this medicine.

5. How to store Piroxicam
Keep medicines out of the sight and reach of children.
This product should not be used after the expiry date which
appears at the end of the tube.
Do not store above 25ºC.

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 contains
This medicine contains piroxicam 0.5%w/w in a gel. It also
contains propylene glycol, isopropyl alcohol, macrogol 7
glyceryl cocoate, hypromellose, sodium hydroxide, sodium
metabisulphite, potassium dihydrogen phosphate and purified
What Piroxicam looks like and contents of the pack
This gel is available in 60g, 100g or 112g tubes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane,
Warwick, CV34 5YA, United Kingdom.
C.P.M. ContractPharma GmbH & Co KG
Frühlingstrasse 7, 83620 Feldkirchen, Westerham, Germany.
Other Formats
To request a copy of this leaflet in braille, large print or audio
please call 01926 482511.
This leaflet was last revised in April 2016

General information on treating and preventing
muscular and soft tissue injuries
What can I do to help recover from injury?
Rest the area to prevent further tissue damage.
Ice may be used to reduce swelling (a bag of frozen peas
makes a convenient ice pack). Place a wet towel on the skin
and apply only for short, ten minute periods.
Compress injuries carefully with a bandage for support. (Wash
off any Manxiflex 0.5%w/w Gel first).
Elevate the injury slightly above the rest of the body to reduce
Don't massage or apply heat to an acute injury within the first 48
Gently start to mobilise the injury as soon as possible without
causing pain.
Return to normal activity gradually.
If symptoms are severe or persist, always seek the advice of an
experienced physiotherapist or your doctor.
How can I reduce the risk of injury?
Before you play sport or exercise, always warm up first
(15 minutes minimum) and warm down gently afterwards (5
minutes minimum).
Don't attempt heavy or awkward movements at work or in the
Get assistance and use appropriate tools and equipment.
Don't play sport competitively if you are tired or in pain.
Don't ignore the first signs of injurystop the activity and rest.
WIP URN: 210416-XXXX-PIL-01

BOH Approval Date
Saved as

Manxiflex Gel PIL - Side 2
210 x 158mm
21 April 2016
14196-01 PIL
1 Colour - Black


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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.