PATIENT INFORMATION LEAFLET

What is in your medicine?

Feldene Dispersible Tablets come in two strengths containing either 10mg or 20mg piroxicam. Inactive ingredients: lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium stearyl fumarate.

The 10mg tablets come in containers of 56. The 20mg tablets 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?

This medicine 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 is also used to treat children with juvenile chronic arthritis (Still's disease). Feldene does not cure arthritis and will help you or your child only as long as you or your child 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 you take Feldene

• 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 Dispersible Tablets or any other form of Feldene?
• Have you got or ever had peptic (eg stomach) ulcers or other inflammatory bowel disorders (eg Crohn's Disease)?

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 if YES - ask your doctor or pharmacist before taking Feldene.

Remember to tell the doctor that you are taking Feldene Dispersible Tablets 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.

Use of Feldene Dispersible Tablets in children

Feldene Dispersible Tablets may be given to children aged 6 years or over but only for the treatment of juvenile chronic arthritis (Still's disease).

Ask your doctor or pharmacist if you are not sure why your child has been prescribed Feldene.

Dosing instructions

Feldene Dispersible Tablets 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. (Doses above 20mg daily for more than several days carry an increased risk of effects on the digestive system).

For juvenile chronic arthritis (Still's disease)

• Child's body weight (kg) less than 15
• Once daily dose - 5 mg

• Child's body weight (kg) 16-25
• Once daily dose - 10 mg

• Child's body weight (kg) 26-45
• Once daily dose - 15 mg

• Child's body weight (kg) 46 and above
• Once daily dose - 20 mg

See the label on the pack to find what dose you or your child 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.

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 each day 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 pack will tell you what dose you or your child should take and for how long. If you are still not sure ask your doctor or pharmacist.

How to take Feldene Dispersible Tablets

The tablets can be placed in a glass of water, allowed to disperse and then swallowed. If you prefer, you could swallow your tablet whole with a glass of water.

It is best to take your tablet(s) at the same time each day and with food.

Does this medicine cause undesirable effects?

Feldene Dispersible Tablets 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.

These effects may sometimes result in bleeding into the digestive system. If you vomit any blood or pass any black or blood stained bowel motions, you should inform your doctor immediately.

The above undesirable effects are more likely to occur if you are taking doses of Feldene Dispersible tablets greater than 20mg daily 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.
• changes in kidney function rarely, including interstitial nephritis, nephrotic syndrome, renal failure and renal papillary necrosis.
• 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.
• 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 Dispersible 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.