Piroxicam 0.5% Gel
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Patient Information Leaflet
PIROXICAM 0.5% GEL
Piroxicam
Read all of this leaflet carefully before you start taking this medicine.
Please keep this leaflet. You may need to read it again.
If you have any further questions, please 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
in this leaflet:
1. What Piroxicam 0.5% Gel is and what is it used for.
2. Before you use Piroxicam 0.5% Gel.
. How to use Piroxicam 0.5% Gel.
4. Possible side effects.
5. How to store Piroxicam 0.5% Gel.
6. Further information.
1. WHAT PIROXICAM 0.5% GEL IS AND WHAT I IS IT USED FOR
The name of your medicine is Piroxicam 0.5% Gel.
The active ingredient in this medicine is piroxicam. Piroxicam is one of a group of medicines called non-steroidal anti-inflammatory drugs. Piroxicam gel will help to relieve pain and reduce swelling affecting joints and muscles when rubbed into the skin over the affected area. It is used for the treatment of rheumatism (pain or inflammation in or around the bones, muscles or joints), sprains, strains and mild osteoarthritis of joints (knees, wrists, ankles etc).
2. BEFORE YOU USE PIROXICAM 0.5% GEL Do not use this medicine if:
• You had an allergic reaction to aspirin or other anti-inflammatory medicines used to treat painful joints and muscles
• You ever had an allergic reaction to Piroxicam, any of the other ingredients or any other form of Piroxicam. (Allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).
• You are under 12 years of age
Liking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
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Other special warnings
If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking or using.
Talk to your doctor before taking Piroxicam Gel. Your doctor needs to know before you use Piroxicam Gel if you suffer from or have suffered in the past from any of the following condition(s):
- 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 re-started 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.
NSAIDs, including Piroxicam Gel, may cause kidney damage or kidney failure.
Pregnancy and breast-feeding
If you are trying to become pregnant or being investigated for infertility, withdrawal of Piroxicam Gel should be considered. Piroxicam Gel may increase the risk of miscarriage in early pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
3. HOW TO USE PIROXICAM 0.5% GEL
• Always use your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. He or she will tell you how your medicine should be used.
• To apply Piroxicam 0.5% Gel, pierce the tube by reversing the cap and screwing down to break the seal on the tube. Apply 3cm(1 1/4" approximately) of the gel on the affected area.
Rub the gel into the skin until the gel disappears. Do this three or four times a day.
For musclessprains andltrains you should start to feel better within one week. If the pain has not got any less after a week, tell your pharmacist or doctor.
Do not use Piroxicam 0.5% 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 areas. If the gel does come into contact with these areas, rinse away with water.
Avoid excessive exposure to sunlight of area treated in order to prevent possible allergic type reaction with light (photosensitivity).
Do not cover the area where Piroxicam 0.5% Gel has been rubbed in with dressings or bandages. Piroxicam 0.5% Gel is for external use only.
|Afler using Piroxicam 0.5% Gel
1. Always replace the cap.
2. Wash your hands, unless it is the hands that are being treated.
If you accidentally swallow Piroxicam |D.5% Gel
If a large amount of your medication is swallowed accidentally, tell your doctor immediately, or contact your nearest hospital casualty department.
4. POSSIBLE SIDE EFFECTS
Like all medicines Piroxicam 0.5% Gel can cause unwanted side effects in some people, although it is generally well tolerated. You are unlikely to get any of the following, but if you do, tell your doctor immediately:
• Redness and itching of the skin where the gel was rubbed in;
• Wheeziness, difficulty breathing or tightness in the chest;
• Swelling of eyelids, face or lips;
• Life-threatening skin reactions (progressive skin rash often with blisters or mucosal lesions)
These symptoms could be the signs of an allergic reaction or photosensitivity.
Other side effects may include:
• Nausea
• Indigestion
• Stomach discomfort
These effects should disappear if you stop using Piroxicam 0.5% Gel. If the discomfort continues, tell your doctor or pharmacist.
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please doctor or pharmacist immediately
If you become unwell or have any discomfort that you do not understand while you are using Piroxicam 0.5% Gel, tell your doctor or pharmacist.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.
5. HOW TO STORE PIROXICAM 0.5% GEL
Do not store above 25°C. Keep the tube tightly closed. Do not use after the expiry date that is stated on the carton.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION What Piroxicam 0.5% Gel contains
Each gram of Piroxicam 0.5% Gel contains 5 mg of piroxicam. It also contains the following inactive ingredients: propylene glycol, isopropyl alcohol, macrogol 7 glyceryl cocoate, hypromellose, sodium hydroxide, sodium metabisulphite, potassium dihydrogen phosphate and water.
What Piroxicam 05% Gel looks like and the contents of the pack
Aluminium tube with inner protective lacquer and polypropylene screw cap. A tube contains 60 g or 112 g of Piroxicam gel.
Marketing Authorisation Holden
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.
Mamrlacluien
Tiofarma B.V., Benjamin Franklinstraat 9,
3261 LW Oud-Beijereland, The Netherlands.
This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. The information in this leaflet applies only to Piroxicam 0.5% Gel
This leaflet was last approved in: November 2014
A1000425/2
Auden Mckenzie
A1000425_2 V2 Piroxicam 0.5% Gel.indd 2 06/11/2014 09:07