Patient leaflet - PIROXICAM 0.5% GEL
PIROXICAM 0.5% GEL
Piroxicam
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Please 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 0.5% Gel is and what it is used for
2. What you need to know before you use Piroxicam 0.5% Gel
3. How to use Piroxicam 0.5% Gel
4. Possible side effects
5. How to store Piroxicam 0.5% Gel
6. Contents of the pack and other information
1. what piroxicam 0.5% gel is and what it is 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. what you need to know before you use
PIROXICAM 0.5% GEL
Do not use this medicine if:
- you had an allergic reaction to aspirin or other antiinflammatory medicines used to treat painful joints and muscles.
- you are allergic to Piroxicam or any of the other ingredients of this medicine (listed in section 6). 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.
Warnings and precautions
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 using 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, including DRESS syndrome, Stevens-Johnson syndrome and 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, and genitals or 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, I cODe you must not be re-started on piroxicam at any time.
Treatment should be discontinued at the first appearance of skin rash, blistering and peeling of the skin, mucosal lesions, or any other sign of hypersensitivity. If you develop a rash or skin symptoms, you should stop using piroxicam immediately, seek prompt medical advice and tell your doctor that you are using this medicine. These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be ruled out. Reported cases of DRESS syndrome following piroxicam use have been present only after systemic treatment, and the likelihood of DRESS syndrome following topical treatment is currently unknown.
NSAIDs, including Piroxicam Gel, may cause kidney damage or kidney failure.
Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Children and adolescents
Piroxicam Gel is not recommended for use in children under 12 years of age.
Other medicines and Piroxicam Gel
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Pregnancy, breast-feeding and fertility
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 using this medicine.
Driving and using machines
Piroxicam 0.5% Gel is not expected to affect your ability to drive or use machines.
Piroxicam 0.5% Gel contains propylene glycol
This medicinal product contains 150mg propylene glycol per gram. Propylene glycol may cause skin irritation. Do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
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 onto the affected area.
- Rub the gel into the skin until the gel disappears. Do this three or four times a day. If the gel is not rubbed in completely, mild but temporary staining of the skin and staining of clothing may occur.
- For muscle sprains and strains 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 broken or 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 the area treated in order to prevent a 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.
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1. Always replace the cap.
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2. Wash your hands, unless it is your hands that are being treated.
If you accidently swallow Piroxicam 0.5% 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, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop using Piroxicam 0.5% 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).
Other side effects that Piroxicam 0.5% Gel may cause are:
- redness, rash and/or itching of the skin where Piroxicam 0.5% Gel was rubbed in (for example eczema, contact dermatitis)
- Fixed drug eruption (may look like round or oval patches of redness and swelling of the skin), blistering (hives), itching (the frequency of this reaction is unknown).
- reaction of skin to sunlight (photosensitivity).
- Nausea (feeling sick)
- Indigestion
- Stomach discomfort
5. how to store piroxicam 0.5% gel
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the tube tightly closed.
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 otherinformationwhat piroxicam 0.5% gel contains
Each gram of Piroxicam 0.5% Gel contains 5 mg of piroxicam. The other ingredients are: propylene glycol, isopropyl alcohol, macrogol 7 glyceryl cocoate, hypromellose, sodium hydroxide, sodium metabisulphite, potassium dihydrogen phosphate and water.
What Piroxicam 0.5% 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 Holder:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturers:
Tiofarma B.V., Benjamin Franklinstraat 5–10, 3261 LW Oud-Beijerland, The Netherlands
Tiofarma B.V., Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, 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 revised in February 2022
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