Patient leaflet - Piroxicam 0.5% w/w gel
1. WHAT PIROXICAM GEL IS AND WHAT IT IS USED FOR
The name of your medicine is Piroxicam 0.5% w/w Gel (referred to as Piroxicam Gel). Piroxicam belongs to a group of medicines known as 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.
Piroxicam Gel is used to treat:
- Rheumatism; painful (muscle or joint) conditions involving inflammation or stiffness
- Mild osteoarthritis of joints (such as the knees, elbows, wrists or ankles etc)
- sprains, strains and inflammation of tendons
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PIROXICAM GEL
DO NOT use Piroxicam Gel
- if you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6), 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.
- If you are in the last 3 months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Piroxicam Gel. Medicines are not always suitable for everyone. 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:
- liver disease
- kidney disease
- stomach ulcers or inflammatory bowel disorders (e.g. Crohn’s 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, 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.
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 taking piroxicam immediately, seek prompt medical advice and tell your doctor that you are taking 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.
Before prescribing Piroxicam Gel your doctor will assess the benefits this medicine may give you against your risk of developing side effects. Your doctor may need to give you check-ups and will tell you how often you need to be checked during treatment with Piroxicam Gel. This may be more frequent if you are elderly.
Whilst using Piroxicam Gel, it may take longer than usual for the bleeding to stop if you cut or injure yourself. You may also bruise more easily.
NSAIDs, including Piroxicam Gel, may cause kidney damage or kidney failure.
Children and adolescents
Piroxicam Gel is not recommended for use in children under 12 years of age. Other medicines and Piroxicam Gel
Piroxicam Gel is not known to interact with any other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are taking
anticoagulants, e.g. warfarin, to prevent blood clots, or aspirin.
Pregnancy, breast-feeding and fertility
Piroxicam Gel belongs to a group of medicines, NSAIDs, which may impair fertility in women. This effect is reversible upon stopping the medicine. It is unlikely that Piroxicam Gel used occasionally, will affect your chances of becoming pregnant, however tell your doctor before using this medicine if you have problems becoming pregnant or are trying to become pregnant. 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.
Oral forms (e.g., tablets) of piroxicam can cause adverse effects in your unborn baby. It is not known if the same risk applies to Piroxicam Gel.
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. Do not use Piroxicam Gel if you are in the last 3 months of pregnancy. You should not use Piroxicam Gel during the first 6 months of pregnancy unless clearly necessary and
advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should be used.
Driving and using machines
Piroxicam Gel is not expected to affect your ability to drive or use medicines.
Piroxicam Gel contains propylene glycol
Piroxicam Gel contains propylene glycol which may cause skin irritation. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.
3. HOW TO USE PIROXICAM GEL
Always use Piroxicam Gel 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 on the skin only.
The usual dose is to apply 1 g of gel (approximately about 3 cm or 1¼ inches) on the affected area 3 or 4 times a day. Rub it onto the affected area until the gel completely disappears. For muscle sprains and strains you should start to feel better within one week. 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. The usual duration of treatment is up to four weeks. You should not use Piroxicam Gel for longer than this without telling your doctor or pharmacist.
Elderly patients should apply the smallest amount of gel which provides adequate relief.
Attention:
- Do not use the gel on broken, damaged skin or open wounds, scratches, infections, dermatitis or rashes. Do not apply near eyes, nose, mouth, genital or anal (bottom) areas. If the gel does come in contact with these areas, rinse away with water.
- Do not cover the area where Piroxicam Gel has been rubbed in with dressings or bandages.
If you have the impression that the effect of Piroxicam Gel is too strong or too weak, talk to your doctor or pharmacist.
After using Piroxicam Gel
- Always replace the cap
- Wash your hands.
If you use too much or accidentally swallow Piroxicam Gel
If you accidently use too much Piroxicam Gel this is unlikely to cause any side effects. This product is for external use only. Do not swallow it!
If you or someone else accidentally swallows the gel, tell your doctor immediately or contact your nearest hospital casualty department.
If you forget to use Piroxicam Gel
If you forget to use Piroxicam Gel, use it as soon as you remember unless it is time for your next application. Do not use a double the amount to make up for a missed application. Continue to use the gel at the usual time for the next application If you stop using Piroxicam Gel
Your pain may return if you stop using Piroxicam Gel. Tell your doctor or pharmacist if you want to stop your treatment.
If you have any further questions on how to take 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.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely (see section 2).
Side effects that Piroxicam Gel may cause are:
- Redness, rash and/or itching of the skin where Piroxicam Gel was rubbed in (for example eczema, contact dermatitis)
- Reaction of the skin to sunlight
- 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.
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. or search for MHRA Yellow Card in Google Play or Apple App Store. 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 25ºC. Do not use Piroxicam Gel after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Use this product within 6 months of opening.
Do not throw away any medicines 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Piroxicam Gel contains
The active substance is piroxicam. Each gram of Piroxicam Gel contains 5 mg of piroxicam. The other ingredients are propylene glycol, isopropyl alcohol, macrogol 7 glycerol cocoate, hypromellose, sodium hydroxide, sodium metabisulphite, potassium dihydrogen phosphate, purified water.
What Piroxicam Gel looks like and contents of the pack
Piroxicam is a transparent light-yellow Gel. The gel is available in an aluminium tube with a polypropylene cap in cartons of 50g, 60g, 100g or 112g.
Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd, 3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom. This leaflet was last revised in 10/2025