6092

PACKAGE LEAFLET: INFORMATION FOR THE USER

PIROXICAM CAPSULES 10 mg & 20 mg

[Piroxicam]

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, health care provider or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What are Piroxicam Capsules and what are they used for

2.    Before you take Piroxicam Capsules

3.    How to take Piroxicam Capsules

4.    Possible side effects

5.    How to store Piroxicam Capsules

6.    Further information

1.    What are Piroxicam Capsules and what are they used for

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.

Piroxicam is used to relieve some symptoms caused by rheumatoid arthritis, osteoarthritis (joint disease) 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.

Your doctor will only prescribe Piroxicam Capsules to you when you have had unsatisfactory relief of symptoms with other NSAIDS.

2.    Before you take Piroxicam Capsules

Do not take Piroxicam Capsules and tell your doctor if you:

■    Have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach.

•    Have a history or stomach bleeding of perforation which may be related to the use of NSAIDs (naproxen, ibuprofon, diclofenac) or aspirin.

•    Have a history of hypersensitive (allergic) reaction to Piroxicam Capsules or any of the other ingredients in this medicine (see Section 6. Further information).

•    Have a history of skin hypersensitive (allergic) reactions such as exfoliative dermatitis (reddening of skin), Stevens Johnson syndrome (a rash, blistering and peeling of skin) or toxic epidermal necrolysis (blistering and peeling of the top layer of skin).

•    Have a history of allergy to aspirin, ibuprofon or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose.

■    Have a history of, or active 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).

•    Have severe heart failure.

•    Have severe liver or kidney failure

•    Are taking other non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofon, naproxen, diclofenac or acetylsalicylic acid (aspirin).

•    Are taking anticoagulants, such as warfarin, to prevent blood clots.

•    Are in the last three months of pregnancy.

If any of the above applies to you, tell your doctor immediately and do not take Piroxicam Capsules.

Take special care with Piroxicam Capsules

Your doctor will minimise the risk of you developing side effects by prescribing the lowest effective dose for the shortest duration necessary to control your symptoms.

Tell your doctor if you:

•    Suffer from asthma

•    Are elderly. Your doctor may prescribe another medicine to protect your stomach and intestines from side effects, particularly if you are over 70 years old or are taking other medication.

•    Have Systemic Lupus Erythmatosus (SLE) which causes inflammation in various parts of the body or mixed connective tissue disorders (MCTD) as there may be an increased risk of aseptic meningitis (an illness characterized by headache, fever and inflammation of the lining of the brain).

•    Suffer from kidney disease.

•    Suffer from liver disease.

•    Have diabetes.

•    Are a poor CYP2C9 metaboliser

Medicines such as Piroxicam Capsules may be associated with a small 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 may 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.

Piroxicam Capsules 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines must not be taken with Piroxicam:

Aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief e.g. naproxen, diclofenac

Anticoagulants such as warfarin to prevent blood clots.

Tell your doctor before you take Piroxicam if you are taking any of the following medicines:

Low dose aspirin (75mg) to help prevent heart attack or stroke Corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances

Certain medicines used to treat heart conditions known as cardiac glycosides such as digoxin

Certain medicines for depression such as lithium

Selective serotonin re-uptake inhibitors (SSRIs) used to treat depression, as these can increase the risk of gastro-intestinal bleeding e.g. Fluoxetine, paroxetine, citalopram

Antihypertensives to treat high blood pressure

Methotrexate which can be given to treat various conditions such as cancers, psoriasis and rheumatoid arthritis

Cyclosporin, which is given to help prevent rejection of transplanted organs can increase the risk of kidney problems when used with Piroxicam Quinolone antibiotics, which are used to treat various infections Mifepristone which is used to medically terminate pregnancies as NSAIDS can reduce the effects of mifepristone and so should not be used for 8-12 days after mifepristone

Diuretics such as hydrochlorothiazide to treat high blood pressure or kidney problems (water tablets) can increase the risk of kidney problems when used with Piroxicam

Anti-platelet agents (used to prevent blood clots from forming that can lead to heart attack or stroke) e.g. aspirin, clopidogrel, ticlopidine, dipyridamole Tacrolimus which is used to suppress the immune system after organ transplant can increase the risk of kidney problems when used with Piroxicam Zidovudine which is used in the treatment of AIDS and HIV infection Cimetidine, used in the treatment of heartburn and peptic ulcers.

Taking Piroxicam with food and drink

Piroxicam Capsules should only be taken by mouth and can be taken preferably with or after food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning on becoming pregnant or are breast-feeding. Do not take Piroxicam 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.

Driving and using machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, do not drive or operate machinery.

Important information about some of the ingredients

Piroxicam Capsules contain lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking Piroxicam Capsules.

3. How to take Piroxicam Capsules

Always take Piroxicam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Only specialist consultants and specializing GPs should start new patients on Piroxicam Capsules.

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 Piroxicam is 20mg. Side effects may be minimized by using the lowest effective dose for the shortest duration necessary to control your symptoms. Your doctor will decide if you need to continue with treatment after 14 days and frequently thereafter. If continued treatment is considered necessary, your doctor will continue to monitor you at frequent intervals.

For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis:

The maximum daily dose is 20mg.

6092

200 x 300 mm

Front Side

ARTWORK DETAIL LABEL

Elderly

If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.

If you are older than 80 years you may be given other medication to protect your stomach such as misoprostol.

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

If you take more Piroxicam Capsules than you should

If you accidentally take too many Piroxicam Capsules, tell your doctor at once. If you can’t do this, go to the nearest casualty department. Take along any capsules that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take Piroxicam Capsules

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 forgotten dose.

If you stop taking Piroxicam Capsules

Continue to take the capsules for as long as your doctor tells you to. Talk to your doctor if you have any concerns.

4. Possible side effects

Like all medicines, Piroxicam Capsules can cause side effects, although not everybody gets them.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Sudden life-threatening allergic reactions. Symptoms include sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

■    Pass blood in your faeces (stools/motions).

•    Pass black tarry stools.

•    Vomit any blood or dark particles that look like coffee grounds.

STOP TAKING the medicine and tell your doctor if you experience:

■    Indigestion or heartburn.

•    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

•    A severe condition of the skin that may affect the mouth and other parts of the body. This may progress to a severe skin reaction which starts with painful red areas, then large blisters and ends up with peeling of layers of skin, mouth, nose, eyes or genitals. This may be accompanied by fever and chills, aching muscles and generally feeling unwell.

•    Yellowing of the skin and the whites of your eyes (jaundice) which may be a sign of hepatitis or other liver problems.

•    Very rarely pancreatitis with symptoms of stomach pain, feeling sick and being sick. The most commonly reported side effects with Piroxicam Capsules 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.

•    Mouth ulcers.

Other side effects that have been reported include:

Effects on the lungs:

■    Worsening of asthma for patients who already have a history of asthma.

Effects on your heart and circulation:

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

•    Fast or pounding heartbeat.

•    High blood pressure.

•    Swollen ankles and/or feet (oedema).

Effects on the stomach and intestines:

•    Worsening of colitis and Crohn’s disease.

•    Inflamed pancreas (which may lead to severe pain in the upper abdomen or back). If you have any problems with your stomach contact your doctor.

Effects on your nervous system:

•    Dizziness.

•    Vertigo (a spinning sensation).

•    Headache, changes in sleep patterns abnormal dreams.

•    Depression, nervousness, hallucinations, mood alterations, mental confusion.

•    Pins and needles.

•    There are reports of aseptic meningitis (especially with patients with existing autoimmune disorders such as systemic lupus erythematosus SLE) with symptoms of stiff neck, headache, nausea, vomiting and fever.

•    Loss of appetite and eating disorders.

•    Feeling sleepy and falling asleep.

Effects on your skin:

•    Rashes, itching, redness, tenderness, thickening or scaling of skin contact your doctor.

•    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, fever, severe chills, sore throat or mouth ulcers.

•    Abnormal liver function blood tests taken by your doctor.

•    Changes in blood sugar levels may also occur.

•    Anaemia (a condition in which there is a decrease in the number of red blood cells). Symptoms include tiredness, headaches, being short of breath when exercising, dizziness and looking pale.

Effects on your eyes and ears:

•    Hearing impairment, ringing in ears, vertigo.

•    Swollen eyes, blurred vision, eye irritation contact your doctor.

Other rare side effects:

•    Fever.

•    Nosebleeds.

•    Weight increase or decrease.

•    Feeling unwell.

•    Unusual weakness or tiredness without any other symptoms.

Reporting of side effects

If you 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 Capsules

Keep out of the reach and sight of children.

Keep the capsules in a dry place at normal room temperature (below 30°C) in the packaging they come in.

Do not use Piroxicam Capsules 10 mg and 20 mg after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Piroxicam Capsules 10 mg and 20 mg if you notice visible signs of deterioration.

Medicines should not be disposed of via waste water 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 Piroxicam Capsules contain

The active substance is Piroxicam BP/Ph.Eur.

The other ingredients are: Lactose / Lactose Monohydrate Maize Starch Sodium lauryl sulphate Crospovidone

Magnesium Stearate (vegetable)

What Piroxicam Capsules look like and contents of the pack

Description:

Piroxicam Capsules 10 mg: A white powder encapsulated within a Size “3” Hard Gelatin Capsule with a violet body and turquoise cap, printed “CX45” both on body and cap in white.

Piroxicam Capsules 20 mg: A white powder encapsulated within a Size “3" Hard Gelatin Capsule with a maroon body and cap, printed “CX46” both on body and cap in white. Contents of pack: Blister pack.

Piroxicam Capsules 10 mg: Each blister contains 14 capsules and 4 such blisters packed in a carton.

Piroxicam Capsules 20 mg: Each blister contains 14 capsules and 2 such blisters packed in a carton.

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Marketing Authorisation Holder and Manufacturer

Co-Pharma Limited

Unit 4, Metro Centre,    5

Tolpits Lane, Watford, Herts.    SB

UK, WD 18 9SS    °

Tel: 01923 255580 Fax: 01923255581

This leaflet was last revised 03/2015.

6093

200 x 300 mm

6093

Back Side

ARTWORK DETAIL LABEL