Feldene™ 10mg and 20mg Capsules
1. What Feldene is and what it is used for
Feldene is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints.
Feldene is used to relieve some symptoms caused by osteoarthritis (joint disease), rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.
Your doctor will only prescribe Feldene to you when you have had unsatisfactory relief of symptoms with other NSAIDs.
2. Before you take Feldene
Do not take Feldene:
• If you have previously had or currently have a stomach or intestinal ulcer, bleeding or perforation.
• If you have, or have previously had disorders of the stomach or intestines such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis (inflamed or infected pouches/pockets in the colon).
• If you are taking other NSAIDs such as ibuprofen, celecoxib or acetylsalicylic acid (aspirin), a substance present in many medicines used to relieve pain and lower fever.
• If you are taking anticoagulants, such as warfarin, to prevent blood clots.
• If you previously had an allergic reaction to piroxicam, (the active ingredient in this medicine) or any of the other ingredients, other NSAIDs or any other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), Stevens-Johnson syndrome (symptoms are a rash, blistering or peeling of the skin, mouth, eyes or genitals) or toxic epidermal necrolysis (a disease with blistering and peeling of the top layer of skin).
• If you have severe heart failure.
• If you are in the last three months of pregnancy.
If any of the above applies to you, tell your doctor immediately and do not take Feldene.
Take special care with Feldene:
Before prescribing Feldene (piroxicam), 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 Feldene.
Medicines such as Feldene may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment or if you are a smoker. Do not exceed the recommended dose or duration of treatment.
Tell your doctor before you take Feldene if you suffer from or have suffered in the past from any of the following conditions:
• liver disease
• kidney disease
• high blood pressure, heart problems or stroke
• high cholesterol or hardening of the arteries
If you have or had any other medical problems or any allergies or if you are not sure as to whether you can use Feldene tell your doctor before taking this medicine.
You should stop taking Feldene immediately and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing
Take special care with Feldene as like all NSAIDs, Feldene can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation.
You should stop taking Feldene immediately and tell your doctor if you have stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood.
Your doctor may prescribe Feldene together with another medicine to protect your stomach and intestines from side effects, particularly if you are over 70 years old, or you are taking other medicines like corticosteroids (medicines given to treat a variety of conditions such as allergies and hormone imbalances), certain medicines for depression called selective serotonin reuptake inhibitors (SSRIs) or low dose acetylsalicylic acid (aspirin) to help prevent heart attacks or stroke.
Feldene may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Patients over 70 years of age:
If you are over 70 years old, your doctor may wish to minimise the length of your treatment and to see you more often while you are taking Feldene.
You should not take this medicine if you are over 80 years of age.
Taking other medicines:
Tell your doctor about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription. Medicines can sometimes interfere with each other. Your doctor may limit your use of Feldene or other medicines, or you may need to take a different medicine.
The following medicines must not be taken with Feldene:
• aspirin or other non-steroidal anti-inflammatory drugs for pain relief
• anticoagulants such as warfarin to prevent blood clots
Tell your doctor before you take Feldene if you are taking any of the following medicines:
• corticosteroids, which are medicines given to treat a variety of conditions such as allergies and
• low dose aspirin (75 mg) to help prevent heart attack or stroke
• certain medicines used to treat heart conditions known as cardiac glycosides, such as digoxin
• certain medicines for depression such as lithium or selective serotonin re-uptake inhibitors (SSRIs)
• antihypertensives to treat high blood pressure
• methotrexate, which can be given to treat various conditions such as cancers, psoriasis and rheumatoid arthritis
• ciclosporin or tacrolimus, which are given to help prevent rejection of transplanted organs
• quinolone antibiotics e.g.ciprofloxacin, which are used to treat various infections
• mifepristone, a medicine used to terminate pregnancy
• diuretics such as hydrochlorothiazide to treat high blood pressure or kidney problems
Taking Feldene with food and drink:
Feldene should be taken with or after food.
Pregnancy and breast-feeding:
If you are pregnant, planning pregnancy or breast-feeding tell your doctor before you take Feldene. Do not take Feldene if you are in the last three months of pregnancy. It is not usually recommended at other stages of pregnancy, but you may be able to take it if your doctor advises that it is necessary for you.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machinery:
These capsules can cause some people to feel dizzy, drowsy, tired or have problems with their vision. If you are affected, do not drive or operate machinery.
Important information about some of the ingredients of Feldene:
Feldene contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking Feldene.
3. How to take Feldene
Always take Feldene exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Feldene. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms. Under no circumstances should you change your dose without first speaking to your doctor.
Swallow your capsules whole with a glass of water. It is best to take your capsules at the same time each day with food or soon after eating.
The maximum daily dose of Feldene is 20 milligrams taken as one single daily dose.
If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.
If you feel that the medicine is not very effective, always talk to your doctor. Do not increase the dose.
If you take more Feldene than you should:
If you accidentally take too much Feldene contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Feldene left or not.
If you forget to take Feldene:
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Feldene can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Feldene if you experience any of the following symptoms after taking this medicine:
• any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood
• sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
• a rash, blistering or peeling of the skin, mouth, eyes or genitals
• yellowing of the skin and the whites of your eyes (jaundice) which may be a sign of hepatitis or other liver problems
The most commonly reported side effects with Feldene are:
• diarrhoea or constipation, wind
• feeling sick (nausea), vomiting, loss of appetite
• sore mouth and/or lips
• stomach ache, indigestion, abdominal pain/discomfort
• stomach (peptic) ulcers
Other side effects that have been reported include:
•Effects on your heart and circulation: fast or pounding heartbeat, high blood pressure, swollen ankles and/or feet (oedema). Medicines such as Feldene may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
•Effects on your nervous system: dizziness, vertigo (a spinning sensation), headache, changes in sleep patterns, depression, nervousness, hallucinations, mood alterations, mental confusion, pins and needles.
•Effects on your skin: rashes, itching, redness, tenderness, thickening or scaling of skin, loosening or splitting of fingernails, hair loss and increased sensitivity of the skin to sunlight.
•Effects on your kidneys: kidney inflammation, kidney failure or kidney damage. If you notice any change in your urine output or appearance, possibly accompanied by kidney pain, or pain in your abdomen or back contact your doctor.
•Effects on blood and medical tests: abnormalities in blood and other biochemical tests. These effects may result in unusual bruising or bleeding or increased risk of infection. Changes in blood sugar levels may also occur.
•Effects on your eyes and ears: hearing impairment; ringing in ears, swollen eyes, blurred vision, eye irritation.
•Other effects: fever, nosebleeds, weight increase or decrease, inflamed pancreas (which may lead to severe pain in the upper abdomen or back), feeling unwell, unusual weakness or tiredness without any other symptoms.
If any of the side effects gets serious, or if you notice any side effects not listed in this post, please tell your doctor or pharmacist.
5. How to store Feldene
Keep all medicines out of the reach and sight of children
Store below 30°C.
Do not use Feldene after the expiry date which is stamped on the carton and the bottle label. 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 Feldene contains
The active substance in Feldene capsules is piroxicam. Feldene comes in two strengths; 10 mg or 20 mg.
The other ingredients are: lactose, corn starch, vegetable magnesium stearate and sodium lauryl sulphate.
The lOmg capsule shells contain gelatin, red iron oxide (E172), indigotin (E132) and titanium dioxide (E171).
The 20mg capsule shells contain gelatin and titanium dioxide (El 71).
What Feldene looks like and contents of the pack
Feldene 10 mg capsules are blue and red. Feldene 20 mg capsules are white.
The10 mg capsules come in containers of 30 and 20mg capsules come in containers of 30.