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TRAXAM PAIN RELIEF 3% W/W GEL

Active substance(s): FELBINAC

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PATIENT INFORMATION LEAFLET

Traxam® Pain Relief 3% w/w Gel
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Pharma code

Felbinac
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again. Always take this medicine exactly as described in this leaflet
or as your pharmacist has told you.
Ask your pharmacist if you need more information or advice.
This medicine is available without prescription to treat minor conditions. However you still need to use it
carefully.
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. You must talk to a doctor if your symptoms do not improve or if you feel worse.
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this leaflet:
What is Traxam Gel and what it is used for
Before you use Traxam Gel
How to use Traxam Gel
Possible side effects
How to store Traxam Gel
Further information
1. WHAT IS TRAXAM GEL AND WHAT IT IS USED FOR

Traxam Gel is a medicine for rubbing into the skin. It contains felbinac and belongs to a group of medicines
called non-steroid anti-inflammatory drugs (NSAID’s). These medicines reduce pain and inflammation.
Traxam Gel is used for the relief of pain in the joints and muscles caused by injury or inflammation.
2. BEFORE YOU USE TRAXAM GEL
DO NOT use Traxam Gel if:
• You are allergic to Felbinac, aspirin or similar medicines or any of the other ingredients in this Gel (listed at
the end of this leaflet)
• Aspirin or similar medicines have given you asthma, itchy rash or hayfever-like symptoms
• In children under 12 years of age.
Take special care with Traxam Gel
• When applying the gel to the skin, be careful to avoid the eyes, lips and mouth, nose, genital areas and any
damaged skin.
• Protect treated areas from direct sunlight to avoid any sensitivity reaction, e.g. a rash
TRAXAM GEL IS FOR EXTERNAL USE ONLY
Taking/Using other medicines
Please tell your pharmacist if you are taking or having recently taken any other medicines, including medicines
obtained without a prescription. Specifically tell your pharmacist if you are taking:
• Any other NSAID (for painful or inflammatory conditions e.g. aspirin)
Do not use Traxam Gel with other skin medicines/preparations.
Pregnancy and breast feeding
The effect of Traxam Gel in pregnancy is unknown. It is therefore not recommended for use during pregnancy
or breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Traxam Gel should not affect the ability to drive or use machines.
3. HOW TO USE TRAXAM GEL
Traxam Gel is designed for topical (on the skin) application only. If you do accidentally swallow some
of the gel, speak to your doctor or go to your local hospital as soon as possible.
Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. You should
check with your pharmacist if you are not sure.

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Pharma code

The usual dose is about one gram (which is approximately 1 inch or 2.5 cm) of gel rubbed into the affected area
two to four times a day.
Do not use more than 25g of Traxam Gel in one day. Do not use the gel for longer than 7 days.
Hands should be washed after applying Traxam Gel, unless they are the site of treatment.
It may take a couple of days before you feel the full benefit of using Traxam.
Traxam Gel should only be used on healthy, unbroken skin. Do not use it on or near cuts or grazes or under
dressings such as plasters.
Do not let any Gel come in contact with your eyes. If it does, rinse your eyes with cold water and consult your
doctor.
Children: Traxam Gel is not recommended for use in children under 12 years of age.
If you use more than you should:
If you accidentally use too much Traxam Gel this is unlikely to cause any side effects.
If you accidentally swallow any Traxam Gel, contact your doctor, or nearest hospital, as soon as possible.
If you forget to use your Traxam Gel:
If you miss a dose, just carry on with the next dose as normal. Do not apply double the dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Traxam Gel can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop using Traxam Gel if you experience any of the following symptoms
after taking this medicine:
• sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching affecting the
whole body
If you suffer from asthma Traxam Gel may make this worse. If you notice any deterioration of your condition
please contact your doctor as soon as possible.
Other side effects that Traxam Gel may cause are:
• Redness, tingling, prickling, numbness, rash and/or itching of the skin where Traxam Gel was rubbed in
• Reaction of the skin to sunlight
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.
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.
United Kingdom
Yellow Card Scheme
Freephone: 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays)
Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE TRAXAM GEL
Keep this medicine out of the sight and reach of children.
Do not use Traxam Gel after the expiry date which is stated on the package. The expiry date refers to the last
day of that month. It should be stored in a cool, dry place, below 25˚C. Do not refrigerate. Return any remaining
Traxam Gel to your pharmacist or dispose of it safely.
6. FURTHER INFORMATION
What Traxam Gel contains
The active substance is felbinac. The other ingredients are carbomer, diisopropanolamine, ethanol and purified
water.
What Traxam Gel looks like and contents of the pack
Traxam Gel is non greasy and quickly breaks down to a readily absorbed liquid.
Traxam Pain Relief 3% w/w Gel is available in packs of 7.5g, 25g and 30g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd, No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
Manufacturer
Lusomedicamenta-Sociedade Tecnica Farmaceutica SA, Estrada Consiglieri Pedroso, 69B, Queluz de Baixo,
2730-055, Barcarena, Portugal.
This leaflet was last revised in September 2013.
TRAXAM is a registered trade mark of Mercury Pharma Group Ltd
100085/LF/3, 100086/LF/3

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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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