What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0486.


Traxam Pain Relief 3% w/w Gel

PATIENT INFORMATION LEAFLET

Traxam® Pain Relief 3% w/w Gel

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.

In this leaflet:

1. What is Traxam Gel and what it is used for
2. Before you use Traxam Gel
3. How to use Traxam Gel
4. Possible side effects
5. How to store Traxam Gel
6. 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
  • Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

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.

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.

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 carboxyvinyl polymer, diisopropanolamine, ethanol and 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.
Capital House
85 King William Street
London
EC4N 7BL
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 2019.

TRAXAM is a registered trade mark of Mercury Pharma Group Ltd

LF-118874-01

1604420C