Piroxicam 0.5% Gel
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Piroxicam 0.5% Gel
(Piroxicam Gel)
Read all of this leaflet carefully before you start taking 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 Piroxicam Gel is and what it is used for
2. Before you use Piroxicam Gel
3. How to use Piroxicam Gel
4. Possible side effects
5. How to store Piroxicam Gel
6. Further 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. Before you use Piroxicam Gel Do not use Piroxicam Gel
• If you are allergic (hypersensitive) to Piroxicam or to any of the other ingredients of Piroxicam Gel or 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 or any other medicines used to treat painful joints and muscles
Take special care with Piroxicam Gel and tell your doctor
• If you get a skin reaction following application of Piroxicam Gel. Stop the treatment if that happens.
• If you have a liver or kidney disorder.
Children
Piroxicam Gel is not recommended.
Using other medicines
Piroxicam 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.
Pregnancy and breast-feeding
Do not use Piroxicam Gel while pregnant or while breast-feeding unless your doctor tells you to. Ask your doctor for advice before taking any medicine.
Driving and using machines
Piroxicam Gel is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Piroxicam Gel
Piroxicam Gel contains propylene glycol, which may cause skin irritation.
3. How to use Piroxicam Gel Dosage
Piroxicam Gel is for external use only.
Always use Piroxicam Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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 too much or accidentally swallow Piroxicam Gel
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Piroxicam Gel 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).
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 side effects are:
• nausea
• indigestion
• stomach discomfort
Rarely Piroxicam Gel can cause:
• tummy pain and gastritis (inflammation of the stomach).
There have been very rare reports of:
• bronchospasm (asthma-like symptoms) and dyspnoea (breathlessness).
These effects should disappear if you stop using Piroxicam 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.
5. How to store Piroxicam Gel
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Piroxicam Gel after the expiry date which is stated on the carton and the end of 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.
6. Further 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, Vision House, Bedford Road, Petersfield, Hampshire GU32 3QB Manufacturer:
C.P.M. ContractPharma GmbH & Co. KG, Fruhlingstrasse 7, 83620 Feldkirchen-Westerham, Germany
This leaflet was last revised in June 2012