Patient leaflet - Traxam Pain Relief 3% w/w gel
1. WHAT TRAXAM GEL IS 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. WHAT YOU NEED TO KNOW BEFORE YOU USE TRAXAM GEL
Do not use Traxam Gel
- If you are allergic to Felbinac or any of the other ingredients in this medicine (listed in section 6).
- If Aspirin or other NSAIDs have given you asthma, itchy rash or hayfever-like symptoms.
- In children under 12 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 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
Children and adolescents
Not recommended for use in children under 12 years of age.
Other medicines and Traxam Gel
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Specifically tell your pharmacist if you are taking:
- Any other NSAIDs (for painful or inflammatory conditions e.g. aspirin).
Do not use Traxam Gel with other skin medicines/preparations.
Pregnancy, breast-feeding and fertility
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 using this medicine.
The effect of Traxam Gel in pregnancy is unknown. It is therefore not recommended for use during pregnancy or breast feeding. Driving and using machines
Traxam Gel should not affect the ability to drive or use machines.
Traxam Gel contains Ethanol
This medicine contains 300 mg of alcohol (ethanol) in each 1 g which is equivalent to 300 mg/g (30%w/w). It may cause burning sensation on damaged skin.
3. HOW TO USE TRAXAM GEL
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.
The recommended 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.
Package leaflet: Information for the Patient Traxam® Pain Relief 3% w/w Gel
felbinac 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. Use in children and adolescents
Traxam Gel is not recommended for use in children under 12 years of age.
If you use more Traxam Gel 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 Traxam Gel
If you miss a dose, just carry on with the next dose as normal.
Do not apply a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
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 Traxam Gel if you experience any of the following symptoms after taking this medicine:
- serious skin reactions (Fluid filled blisters may be associated with itching and pain)
- 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:
Common: may affect up to 1 in 10 people
- Redness, tingling, prickling, numbness, rash and/or itching of the skin.
Rare: may affect up to 1 in 1,000 people
- Symptoms of stomach pain, heartburn, diarrhea, constipation, nausea, and vomiting.
Not known: frequency cannot be estimated from the available data
- Reaction of the skin to sunlight
- Respiratory reactivity comprising asthma, aggravated asthma or shortness of breath
- Red or purple discolored spots on the skin.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TRAXAM GEL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after Expiry Date:. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the tube in the outer carton in order to protect from light. Keep the tube tightly closed. Do not refrigerate.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6. CONTENTS OF THE PACK AND OTHER 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, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK Manufacturer
Lusomedicamenta-Sociedade Tecnica Farmaceutica SA, Estrada Consiglieri Pedroso, 69B, Queluz de Baixo, 2730-055, Barcarena, Portugal.
This leaflet was last revised in November 2023.
TRAXAM is a registered trade mark of Mercury Pharma Group Ltd
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