Piroxicam 0.5% Gel
Package leaflet: Information for the patient Piroxicam 0.5% Gel
(Piroxicam Gel)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Piroxicam Gel is and what it is used for
2. What you need to know before you use Piroxicam Gel
3. How to use Piroxicam Gel
4. Possible side effects
5. How to store Piroxicam Gel
6. Contents of the pack and other information
1. What Piroxicam Gel is and what it is used for
Piroxicam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which help to fight pain and inflammation. When applied to the skin, it penetrates into the affected area bringing direct relief.
Piroxicam Gel is for the relief of osteoarthritis of joints such as the knee and shoulder, painful and stiff muscles and tendons, and other sports injury such as tennis elbow.
2. What you need to know before you use Piroxicam Gel Do not use Piroxicam Gel
• If you are allergic (hypersensitive) to active substance or to any of the other ingredients of this medicine (listed in section 6),any other non-steroidal anti-inflammatory drugs (including aspirin or ibuprofen)
• If you have allergic type reactions (including asthma, blocked nose, itching, reddening of the skin, difficulty in breathing, swelling, e.g. of the eyes and lips, or nettle rash) to aspirin or other NSAIDs (including those taken by mouth) or any other medicines used to treat painful joints and muscles
Warnings and precautions
Talk to your doctor or pharmacist 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 conditions:
• If you have a liver or kidney disorder.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the systemic use of piroxicam. These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be excluded.The skin rashes 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 , may cause kidney damage or kidney failure. There have also been reports of kidney damage or kidney failure with topical piroxicam, although the causal relationship to treatment with topical piroxicam has not been established. As a result, the possibility that these events may be related to the use of topical piroxicam cannot be ruled out.
Children and adolescents
Piroxicam Gel is not recommended.
Other medicines and Piroxicam Gel
Piroxicam Gel is not known to interact with any other medicines.Tell your doctor or pharmacist if you are using, have recently taken or might take any other medicines.
Pregnancy,breast-feeding and fertility
Do not use Piroxicam Gel while pregnant or while breast-feeding unless your doctor tells you to.
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 taking this medicine.
Driving and using machines
Piroxicam Gel is not expected to affect your ability to drive or use machines.
Piroxicam Gel contains propylene glycol
Piroxicam Gel contains propylene glycol, which may cause skin irritation.
3. How to use Piroxicam Gel
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Piroxicam Gel is for external use only.
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.
Adults and the elderly
Apply 1g of gel (about 3cm or 1% inches) and rub into the affected area until the gel completely disappears. Apply up to three or four times a day. If the condition has not improved within four weeks, contact your doctor. Do not use Piroxicam Gel for more than four weeks without telling your pharmacist or doctor.
After application do not cover the affected area with plasters or any other type of dressing. You can, however, cover the skin with your clothes.
If you forget to use Piroxicam Gel
If you forget an application of Piroxicam Gel, use it as soon as you remember and carry on as usual afterwards. Do not use a double dose to make up for a forgotten application.
If you use more Piroxicam Gel than you should
If you accidentally use too much Piroxicam Gel this is unlikely to cause any side effects.
Piroxicam Gel is for external use only and should not be used in the mouth. If it is accidentally swallowed you should consult a doctor immediately, or contact your nearest hospital casualty department.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, fever, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely (see section 2).
The following side effects have been reported:
• redness,rash and / or itching of the skin, dermatitis (for example: eczema, contact dermatitis ) may occur where Piroxicam Gel was rubbed in
• skin may be more sensitive to sunlight (avoid exposure)
Uncommon: may affect up to 1 in 100 people
• nausea
• indigestion
• stomach discomfort.
Rare: may affect up to 1 in 1,000 people
• tummy pain and gastritis (inflammation of the stomach).
Very rare: may affect up to 1 in 10,000 people
• bronchospasm (asthma-like symptoms) and dyspnoea (breathlessness).
Not known: frequency cannot be estimated from the available data
• Sensitisation rash.
These effects should disappear if you stop using Piroxicam Gel. If the discomfort continues 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.
By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Piroxicam Gel
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton.The expiry date refers to the last day of that month.
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 Piroxicam Gel contains
• The active substance is Piroxicam 0.5% w/w.
• The other ingredients are propylene glycol, isopropyl alcohol, macrogol 7 glyceryl cocoate, hypromellose, sodium hydroxide, sodium metabisulphite, potassium dihydrogen phosphate, purified water.
What Piroxicam Gel looks like and contents of the pack
Aluminium tubes containing 50g, 60g, 100g, or 112g of Piroxicam 0.5% Gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
PLIVA Pharma Ltd, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX
Manufacturer:
C.P.M. ContractPharma GmbH & Co. KG, Fruhlingstrasse 7, 83620 Feldkirchen-Westerham, Germany