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Package Leaflet: Information for the User

49 Feldene®

10mg and 20mg Capsules

piroxicam

In this leaflet:

1.    What Feldene is and what it is used for

2.    Before you take Feldene

3.    How to take Feldene

4.    Possible side effects

5.    How to store Feldene

6.    Further information

1. What Feldene is and what it is used for

Feldene is one of a group of medicines called nonsteroidal 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.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, 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.

If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

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

•    asthma

•    diabetes

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.

Continued overleaf

Before your take Feldene continued...

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 hormone imbalances

•    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.

If you are trying to become pregnant or being investigated for infertility, withdrawal of Feldene should be considered. Feldene may increase the risk of miscarriage in early pregnancy.

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.

Adults:

The maximum daily dose of Feldene is 20 milligrams taken as one single daily dose.

Elderly:

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.

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4. Possible side effects

Like all medicines, this medicine 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

Common: may affect up to 1 in 10 people

•    Changes in the red blood cells which may result in unusual bruising or bleeding

•    Changes in the white blood cells which may result in increased risk of infection

•    Anorexia

•    Increase in blood sugar levels

•    Dizziness

•    Headache

•    Vertigo (a spinning sensation)

•    Drowsiness

•    Ringing in ears (tinnitus)

•    Abdominal pain/discomfort

•    Constipation

•    Diarrhoea

•    Wind

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Indigestion

•    Itching

•    Skin rash

•    Swelling of the feet, hands or other parts of the body (oedema)

•    Weight increase

Uncommon: may affect up to 1 in 100 people

•    Blurred vision

•    Fast or pounding heartbeat

•    Sore mouth and/or lips

•    Decreased/low blood sugar level Rare: may affect up to 1 in 1,000 people

•    Kidney inflammation

•    Kidney failure

•    Kidney damage

•    Change in urine output or appearance

•    Kidney pain or pain in abdomen

Very rare: may affect up to 1 in 10,000 people

•    Potentially life-threatening skin rashes including peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or extensive peeling of the skin (toxic epidermal necrolysis) (see section 2)

Not known: frequency cannot be estimated from the available data

•    Abnormalities in the blood e.g. decreased haemoglobin

•    Fluid retention

•    Sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)

•    Depression

•    Dream abnormalities

•    Hallucinations

•    Changes in sleep patterns

•    Mental confusion

•    Mood alterations

•    Nervousness

•    Pins and needles

•    Eye irritations

•    Swollen eyes

•    Hearing impairment

•    High blood pressure Inflammation of the blood vessels Shortness of breath

Constriction of the muscles lining the airways of lungs (bronchial)

Nose bleeds

Inflammation of the stomach lining (gastritis) Gastrointestinal bleeding including vomiting of blood and black, tarry stools

Inflamed pancreas (which may lead to severe pain in the upper abdomen or back)

Stomach (peptic) ulcers Upset stomach Hair loss

Allergic reaction involving purple spots on the skin, joint pain, abdominal pain and kidney dysfunction (Henoch-Schoenlein purpura)

Rashes, blistering, peeling, itching, redness, tenderness, thickening or scaling of skin Loosening or splitting of fingernails Increased sensitivity of the skin to sunlight Decreased fertility

Feeling unwell, general aches and pains Weight decrease

Yellowing of the skin and the whites of your eyes (jaundice)

Inflammation of the liver (hepatitis)

Increased risk of heart attack (myocardial infarction) Increased risk of stroke

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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; lOmg or 20mg.

The other ingredients are: lactose, corn starch, vegetable magnesium stearate and sodium lauryl sulphate.

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

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

What Feldene looks like and contents of the pack

Feldene 10mg capsules are blue and red.

Feldene 20mg capsules are white.

The 10mg capsules come in containers of 30 and 20mg capsules come in containers of 30.

Marketing Authorisation Holder

Pfizer Limited Ramsgate Road Sandwich Kent

CT13 9NJ

Manufacturer

Fareva Amboise Zone Industrielle 29 route des Industries 37530 Poce-sur-Cisse France

This leaflet was last revised in 01/2015.

©Pfizer Limited Ref: FE 18_0

For supplier use only (glued or folded area)