patient information leaflet feldene capsules

PATIENT INFORMATION LEAFLET

Please read this leaflet

This leaflet tells you about Feldene. Please read it before you start to take your medicine. It will help you. If you do not understand or you want to know more, ask your doctor or pharmacist (chemist). Keep this leaflet, you may want to read it again.

The name of this medicine is Feldene. The active ingredient is piroxicam.

What is in your medicine

Feldene capsules come in two strengths. The blue and red capsules contain 10mg piroxicam. The white capsules contain 20mg piroxicam. Inactive ingredients: lactose, corn starch, vegetable magnesium stearate and sodium lauryl sulphate.

The blue and red 10mg capsule shells contain gelatin, red iron oxide (E172), indigotin (E132) and titanium dioxide (E171).

The white 20mg capsule shells contain gelatin and titanium dioxide (E171).

The 10mg capsules come in containers of 56 and 20mg capsules come in containers of 28.

What type of medicine is Feldene?

Piroxicam 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 and muscles.

What is your medicine for?

Feldene is used to relieve some symptoms caused by rheumatoid arthritis, osteoarthritis and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness and joint pain. It does not cure arthritis and will help you only as long as you continue to take it.

Feldene is also used to relieve other kinds of pain and to treat other painful conditions such as:- acute attacks of gout, muscle sprains and muscle strains and pain following dental, orthopaedic and minor surgery.

Before taking your medicine

Have you had an allergic reaction to aspirin or other medications used to treat painful joints and muscles? This may have been itching, reddening of the skin or difficulty in breathing.
Have you ever had an allergic reaction to Feldene capsules or any other form of Feldene?
Are you under 16 years of age?
Have you got or ever had peptic (eg stomach) ulcers or other inflammatory bowel disorders (eg Crohn's Disease)?
Have you got severe heart failure?

If the answer to any of these questions is YES - DO NOT TAKE Feldene.

Are you pregnant or trying to become pregnant?
Are you breast feeding?
Do you have kidney disease?
Do you have liver disease?
Do you have high blood pressure or another heart condition?
Do you suffer from asthma or have you in the past?
Are you taking any of the following medicines?
- anticoagulants such as warfarin to prevent blood clots
- antihypertensives to treat high blood pressure
- methotrexate, which can be given to treat various conditions such as cancers, psoriasis and rheumatoid arthritis
- corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances
- cyclosporin, which is given to help prevent rejection of transplanted organs
- quinolone antibiotics, which are used to treat various infections
- mifepristone, which is used to medically terminate pregnancies
- aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- lithium to treat depression
- diuretics such as hydrochlorothiazide to treat high blood pressure or kidney problems

If the answer to any of these questions is YES - ask your doctor or pharmacist before taking 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. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, previous stroke or think you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Remember to tell the doctor that you are taking Feldene if you have a blood test or other test or are to have surgery as Feldene may affect the result.

If you are over 65 years old your doctor may wish to see you regularly.

How to take Feldene

Feldene capsules should only be taken by mouth.

The usual doses of this medicine are given below. Check with your doctor if you are not sure why you have been prescribed this medicine.

For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

20mg each day.This dose may be decreased to 10mg each day (especially for elderly patients) or increased to 30mg each day. See the label on the pack to find out what dose you should take.

As your medicine helps to relieve the painful symptoms of arthritis it is usual for it to be taken for long periods of time. (Doses above 20mg daily for more than several days carry an increased risk of effects on the digestive system).

For acute attacks of gout

40mg each day for 5 to 7 days.

For muscle sprains and strains

40mg each day on the first and second day then 20mg each day for the next 5 to 12 days.

For pain following dental and minor surgery

20mg each day. Doses of 40mg on each of the first and second days, then 20mg for the duration of the treatment period may provide a more rapid onset of action.

For pain following orthopaedic surgery

40mg on each of the first and second days, then 20mg each day for the duration of the treatment period.

These are the usual doses.Your doctor may prescribe different doses to these.The label on the bottle will tell you what dose you should take and for how long.If you are still not sure ask your doctor or pharmacist.

Swallow your capsules with a glass of water.

It is best to take your capsules at the same time each day and with food.

What if you take too many capsules?

Too many capsules at once may make you unwell.Contact your doctor or your nearest casualty department at once.

What if you miss a dose?

Do not worry. Take the missed dose as soon as you remember. However, if it is almost time for your next dose, leave out the missed dose and take your next dose at the right time.

YOU WILL FIND MORE ABOUT THIS MEDICINE BELOW

Does this medicine cause undesirable effects?

Feldene may cause undesirable effects. These generally do not cause a problem, however, if any of them are severe you should contact your doctor immediately.

Most common undesirable effects

Effects on digestive system including:

diarrhoea or constipation, wind.
nausea, vomiting, loss of appetite.
sore mouth and/or lips.
stomach ache, indigestion, abdominal pain/discomfort.
stomach (peptic) ulcers.

Since there have been reports of gastro-intestinal bleeding with Feldene it is important that vomiting of blood, black or bloodstained bowel movements are reported to your doctor immediately.

Medicines such as Feldene may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

The above undesirable effects are more likely to occur if you are taking doses greater than 20mg daily of Feldene for more than several days duration.

Other undesirable effects are rare and include:-

swollen ankles and/or feet. These effects may be associated with other medical conditions. See your doctor if these effects occur.
central nervous system effects:- dizziness (vertigo), headache, changes in sleep patterns, depression, nervousness, hallucinations, mood alterations, mental confusion, pins and needles.
serious skin effects (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's Disease)) have rarely been reported with Feldene. See your doctor if you have blistering, peeling or burning of the skin.
other skin effects are usually mild: skin rashes; itching, redness, tenderness, thickening or scaling of skin, loosening or splitting of fingernails; hairloss; increased sensitivity of the skin to sunlight; unusual bruising or bleeding; yellow skin or eyes.
effects on the liver, which may include jaundice (yellowing of the skin and/or eyes).
abnormalities in blood and other biochemical tests. These effects may result in unusual bruising or bleeding.
changes in kidney function rarely, including interstitial nephritis, nephrotic syndrome, renal failure and renal papillary necrosis.
other rare undesirable effects: fever; nosebleeds; hearing impairment; ringing in ears; weight increase or decrease; swollen eyes, blurred vision; eye irritation; shortness of breath; fast or pounding heartbeat; feeling unwell; unusual weakness or tiredness without any other symptoms.

These undesirable effects are usually mild but if they cause you discomfort or are long lasting, check with your doctor or pharmacist.

Allergic reactions

A few patients are allergic to medicines. An allergic reaction may be sudden wheeziness and/or difficulty in breathing after taking the medicine. Also skin rash, reddening of the skin, itching all over the body or fever. If you think you are allergic to Feldene check with your doctor immediately.

Check with your doctor or pharmacist if you become unwell or have any other discomfort you do not understand.

Look after your medicine

This treatment is for YOU. Do not give it to others. It may not suit them.

Do not take this medicine after the date stamped on the pack.

Where to keep your medicine

Store below 30°C.
Keep all medicines out of the reach of children

Medicine: feldene capsules