Felbinac 3% W/W Gel
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Traxam® 3% w/w Gel
Felbinac
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Read all of this leaflet carefully before you start using 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
i. 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. It is also used as a coupling agent for ultrasound therapy (used to relieve pain and inflammation in inflamed joints and for soft tissue injuries).
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.
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 doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription. Specifically tell your doctor 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 Traxam Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is about one gram (which is approximately 1 inch or 2.5cm) 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. If the symptoms do not resolve within 14 days please speak to your doctor.
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.
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.
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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.
Remember:
This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.
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 3%w/w Gel is available in packs of 50g and 100g.
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 December 2013.
TRAXAM is a registered trade mark of Mercury Pharma Group Ltd.
100088/LF/3