Piroxicam 0.5% W/W Gel
Date: 23.07.15
Pharma code: Front - 88 std.
Back - 89 std.
INDOCO REMEDIES LTD.
Packaging Development Department Packaging Material Specification
Item: Leaflet
A/W Code No.: G1PHCLL01AESAB Open Size: 240 x 130 mm
Folding Pattern: H-Unfolded:240 mm Folded: 30 mm W-Unfolded: 130 mm Folded: 130 mm GSM/Paper: 40 gsm ITC superfine Paper Colour: Black Approved by:
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Reason for Preparation: New Development
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130 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Piroxicam 0.5% w/w Gel
Piroxicam
Read all of this leaflet carefully before you start using 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.
- Ifyou 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
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) Piroxicam Gel is used to treat:
• painful (muscle or joint) conditions involving inflammation or stiffness
• osteoarthritis of joints such as the knees, elbows or wrists
• 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 (hypersensitive) to piroxicam or any of the other ingredients of Piroxicam Gel (listed in section 6).This includes ifyou are allergic to piroxicam in other types of medicine e.g. capsules.
• if you are sensitive to aspirin or other non-steroidal anti-inflammatory drugs.
Warnings and precautions Potentially life-threatening skin rashes
have been reported when piroxicam has
been taken internally. Although these rashes have not been associated with piroxicam gel, it is possible that they could occur and you should look out for any signs. They appear 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). The rash is often accompanied by flu-like symptoms and may progress to widespread blistering or peeling of the skin. Ifyou develop a rash or any of these skin symptoms stop using this medicine and tell your doctor immediately or contact your nearest hospital casualty department.Tell them that you have been using this medicine.
There is a higher risk of developing a serious skin rash within the first weeks of treatment.
Do not use this medicine ifyou have ever had a serious skin reaction after using piroxicam.
NSAIDs, including Piroxicam Gel, may cause kidney damage or kidney failure.
Talk to your doctor or pharmacist before using Piroxicam Gel ifyou have kidney or liver problems
Children and adolescents
Piroxicam Gel is not recommended for use in children under 12 years of age.
Other medicines and Piroxicam Gel Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
Ifyou 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 you use
Piroxicam Gel. Piroxicam Gel could temporarily affect your fertility and it is not recommended for use during pregnancy or breast-feeding.
Driving and using machines
Piroxicam Gel is not expected to affect your ability to drive or use machines.
Piroxicam Gel contains propylene glycol,
which may cause skin irritation.
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 ifyou are not sure.
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Piroxicam Gel is for external use on the skin only.
The recommended dose is to apply 1 g of gel (approximately 3 cm or 1V4 inches) 3 or 4 times a day. Rub it onto the affected area until the gel completely disappears.
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.
Attention:
• Do not use the gel on broken skin or open wounds, scratches, infections or rashes. Do not apply near the eyes, nose, mouth, genitals or back-passage (anus).
• Do not cover the area where Piroxicam Gel has been rubbed in with dressings or bandages.
Replace the cap on the tube after use and wash your hands.
Ifyou have the impression that the effect of Piroxicam Gel is too strong or too weak, talk to your doctor or pharmacist.
If you accidentally swallow Piroxicam Gel
This product is for external use only. Do not swallow it!
Ifyou 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 Do not use a double dose to make up for a forgotten individual dose. Continue to use the gel at the usual time.
Ifyou stop using Piroxicam Gel
Your pain may return ifyou stop using Piroxicam Gel.Tell your doctor or pharmacist ifyou want to stop your treatment.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Piroxicam Gel can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop using Piroxicam Gel ifyou experience any of the following symptoms after using 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
• signs of a potentially life-threatening skin rash (see section 2)
Stop using Piroxicam Gel and ask your doctor for advice ifyou get any of the following side-effects:
• 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
Uncommon side effects are:
• Nausea (feeling sick)
• Indigestion
• Stomach discomfort
These effects should disappear ifyou stop using Piroxicam Gel. If the discomfort continues tell your doctor or pharmacist.
Reporting of side effects
Ifyou 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 Piroxicam Gel after the expiry date which is stated on the carton and tube. 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 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. Each gram of 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, containing 50g, 60g, 10Og or 112g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aptil Pharma Limited, Unit4,Charlwood Court, County Oak Way, Crawley, West Sussex, RH11 7XA, United Kingdom.
Manufacturer
Torrent Pharma (UK) Limited, Unit 4, Charlwood Court, County Oak Way, Crawley, West Sussex, RH11 7XA, United Kingdom.
This leaflet was last revised in 07/2015.
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