FELDENE GEL
Active substance: PIROXICAM
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300 mm
Patient Information Leaflet
UNITED KINGDOM
Feldene 5mg/g Gel
piroxicam
In this leaflet: 1 What Feldene Gel is and what it is used for 2 Before you use Feldene Gel 3 How to use Feldene Gel 4 Possible side effects 5 How to store Feldene Gel 6 Further information
Use Feldene Gel with special care
Medicines are not always suitable for everyone. Your doctor needs to know before you use Feldene Gel if you suffer from or have suffered in the past from any of the following conditions: liver disease. kidney disease. 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 occurrence 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 taking this medicine.
Feldene Gel is not recommended for use in children under 12 years of age.
Taking other medicines
Feldene Gel is not known to interact with any other medicines. However, you should still tell your doctor about any other medicines you are taking or applying or have recently taken or applied including medicines you bought yourself without a prescription.
1. What Feldene Gel is and what it is used for
Feldene Gel is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints and muscles when rubbed into the skin over the affected area. Feldene Gel is for the treatment of rheumatism, sprains, strains and mild osteoarthritis of joints (knees, wrists, ankles etc).
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding tell your doctor before you use Feldene Gel. Ask your doctor or pharmacist for advice before taking any medicine.
145 mm
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.
25 mm 25 mm
MEDIDA FINAL PLEGADO
Driving and using machines
Feldene Gel is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Feldene Gel
Feldene Gel contains propylene glycol which may cause skin irritation.
2. Before you use Feldene Gel Do not use Feldene Gel
If you have ever had an allergic reaction to
Feldene Gel, any other form of piroxicam, aspirin or any other medicines used to treat painful joints and muscles. This may have been itching, reddening of the skin or difficulty in breathing.
3. How to use Feldene Gel
Always use Feldene Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You will find more about FELDENE GEL on the back of this leaflet
300 mm
Feldene Gel is for external use on the skin only. Pierce the tube by reversing the cap and screwing down to break the seal on the tube. Apply 3cm (1 approximately) of the Gel on the affected area. Use the scale below as a guide. Rub the Gel into the skin until the Gel disappears. Do this three or four times a day. If there is no improvement in your symptoms, tell your doctor. If the gel is not rubbed in completely, mild but temporary staining of the skin and staining of clothing may occur. SCALE: 3 cm
If a large amount of your medication is swallowed accidentally, tell your doctor immediately, or contact your nearest hospital casualty department.
If you forget to use Feldene Gel
If you forget to use Feldene Gel, use it as soon as you remember unless it is time for your next application. Do not use double the amount to make up for a missed application.
Other side effects that Feldene Gel may cause are: Redness, rash and/or itching of the skin where Feldene Gel was rubbed in (for example eczema, contact dermatitis) Reaction of the skin to sunlight
6. Further information What Feldene Gel contains
Each gram of Feldene Gel contains 5mg piroxicam as the active substance. Other ingredients are benzyl alcohol, carbopol 980, di-isopropanolamine, ethyl alcohol, hydroxy-ethyl cellulose, propylene glycol and water.
Uncommon side effects are:
Nausea (feeling sick) Indigestion Stomach discomfort
These effects should disappear if you stop using Feldene Gel. If the discomfort continues tell your doctor or pharmacist. 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.
If you stop using Feldene Gel
Your pain may return if you stop using Feldene Gel. If you have any further questions on how to use this product, ask your doctor or pharmacist.
What Feldene Gel looks like and contents of the pack
Feldene Gel is clear, pale yellow and smells of alcohol. Each tube of Feldene contains either 60g or 112g of Feldene Gel.
145 mm
Do not use Feldene Gel for more than four weeks without telling your pharmacist or doctor. Do not rub your medication into damaged skin, for example wounds, scratches, infections or dermatitis. Do not apply near eyes, nose, mouth, genital or anal (bottom) areas. If the Gel does come into contact with these areas, rinse away with water. Do not cover the area where Feldene Gel has been rubbed in with dressings or bandages.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
4. Possible side effects
Like all medicines, Feldene Gel can cause side effects, although not everybody gets them. Tell your doctor immediately and stop using Feldene Gel if you experience any of the following symptoms after applying this medicine. Although they are very rare, these symptoms can be serious: sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching affecting the whole body Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely (see section 2).
5. How to store Feldene Gel
Keep Feldene Gel out of the reach and sight of children. Do not store above 30C. Do not use Feldene Gel after the expiry date which is stamped on the tube. The expiry date refers to the last day of that month. 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.
Manufacturer
Farmasierra Manufacturing S.L., Carretera de Irun, Km 26.200, E-28700 San Sebastian de los Reyes, Spain.
Company Contact Address
For further information on your medicine please contact Medical Information at the following address: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone: 01304 616161.
After using Feldene Gel
1. Always replace the cap 2. Wash your hands
If you use too much or accidentally swallow Feldene Gel
If you accidentally use too much Feldene Gel this is unlikely to cause any side effects.
This leaflet was last revised in 08/2012. Pfizer Limited Ref: FE 8_1 13042/3
Patient Information Leaflet
UNITED KINGDOM
Feldene 5mg/g Gel
piroxicam
In this leaflet: 1 What Feldene Gel is and what it is used for 2 Before you use Feldene Gel 3 How to use Feldene Gel 4 Possible side effects 5 How to store Feldene Gel 6 Further information
Use Feldene Gel with special care
Medicines are not always suitable for everyone. Your doctor needs to know before you use Feldene Gel if you suffer from or have suffered in the past from any of the following conditions: liver disease. kidney disease. 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 occurrence 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 taking this medicine.
Feldene Gel is not recommended for use in children under 12 years of age.
Taking other medicines
Feldene Gel is not known to interact with any other medicines. However, you should still tell your doctor about any other medicines you are taking or applying or have recently taken or applied including medicines you bought yourself without a prescription.
1. What Feldene Gel is and what it is used for
Feldene Gel is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints and muscles when rubbed into the skin over the affected area. Feldene Gel is for the treatment of rheumatism, sprains, strains and mild osteoarthritis of joints (knees, wrists, ankles etc).
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding tell your doctor before you use Feldene Gel. Ask your doctor or pharmacist for advice before taking any medicine.
145 mm
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.
25 mm 25 mm
MEDIDA FINAL PLEGADO
Driving and using machines
Feldene Gel is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Feldene Gel
Feldene Gel contains propylene glycol which may cause skin irritation.
2. Before you use Feldene Gel Do not use Feldene Gel
If you have ever had an allergic reaction to
Feldene Gel, any other form of piroxicam, aspirin or any other medicines used to treat painful joints and muscles. This may have been itching, reddening of the skin or difficulty in breathing.
3. How to use Feldene Gel
Always use Feldene Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You will find more about FELDENE GEL on the back of this leaflet
300 mm
Feldene Gel is for external use on the skin only. Pierce the tube by reversing the cap and screwing down to break the seal on the tube. Apply 3cm (1 approximately) of the Gel on the affected area. Use the scale below as a guide. Rub the Gel into the skin until the Gel disappears. Do this three or four times a day. If there is no improvement in your symptoms, tell your doctor. If the gel is not rubbed in completely, mild but temporary staining of the skin and staining of clothing may occur. SCALE: 3 cm
If a large amount of your medication is swallowed accidentally, tell your doctor immediately, or contact your nearest hospital casualty department.
If you forget to use Feldene Gel
If you forget to use Feldene Gel, use it as soon as you remember unless it is time for your next application. Do not use double the amount to make up for a missed application.
Other side effects that Feldene Gel may cause are: Redness, rash and/or itching of the skin where Feldene Gel was rubbed in (for example eczema, contact dermatitis) Reaction of the skin to sunlight
6. Further information What Feldene Gel contains
Each gram of Feldene Gel contains 5mg piroxicam as the active substance. Other ingredients are benzyl alcohol, carbopol 980, di-isopropanolamine, ethyl alcohol, hydroxy-ethyl cellulose, propylene glycol and water.
Uncommon side effects are:
Nausea (feeling sick) Indigestion Stomach discomfort
These effects should disappear if you stop using Feldene Gel. If the discomfort continues tell your doctor or pharmacist. 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.
If you stop using Feldene Gel
Your pain may return if you stop using Feldene Gel. If you have any further questions on how to use this product, ask your doctor or pharmacist.
What Feldene Gel looks like and contents of the pack
Feldene Gel is clear, pale yellow and smells of alcohol. Each tube of Feldene contains either 60g or 112g of Feldene Gel.
145 mm
Do not use Feldene Gel for more than four weeks without telling your pharmacist or doctor. Do not rub your medication into damaged skin, for example wounds, scratches, infections or dermatitis. Do not apply near eyes, nose, mouth, genital or anal (bottom) areas. If the Gel does come into contact with these areas, rinse away with water. Do not cover the area where Feldene Gel has been rubbed in with dressings or bandages.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
4. Possible side effects
Like all medicines, Feldene Gel can cause side effects, although not everybody gets them. Tell your doctor immediately and stop using Feldene Gel if you experience any of the following symptoms after applying this medicine. Although they are very rare, these symptoms can be serious: sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching affecting the whole body Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely (see section 2).
5. How to store Feldene Gel
Keep Feldene Gel out of the reach and sight of children. Do not store above 30C. Do not use Feldene Gel after the expiry date which is stamped on the tube. The expiry date refers to the last day of that month. 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.
Manufacturer
Farmasierra Manufacturing S.L., Carretera de Irun, Km 26.200, E-28700 San Sebastian de los Reyes, Spain.
Company Contact Address
For further information on your medicine please contact Medical Information at the following address: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone: 01304 616161.
After using Feldene Gel
1. Always replace the cap 2. Wash your hands
If you use too much or accidentally swallow Feldene Gel
If you accidentally use too much Feldene Gel this is unlikely to cause any side effects.
This leaflet was last revised in 08/2012. Pfizer Limited Ref: FE 8_1 13042/3
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
