Tenoxicam 20 mg Tablets

Patient Information Leaflet

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

•    Please keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor 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 becomes severe, of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Tenoxicam Tablets are and what they are used for

2.    Before you take Tenoxicam Tablets

3.    How to take Tenoxicam Tablets

4.    Possible side effects

5.    How to Store Tenoxicam Tablets

6.    Further information

1.    WHAT TENOXICAM TABLETS ARE AND WHAT THEY ARE USED FOR

Tenoxicam belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles and also reduce a fever.

Tenoxicam Tablets are used to treat:

•    osteoarthritis and rheumatoid arthritis;

•    short-term injuries such as sprains and strains and other soft-tissue injuries.

2.    BEFORE YOU TAKE TENOXICAM TABLETS Do not take this medicine if:

•    you are allergic to tenoxicam or any of the other ingredients;

•    you have previously taken another NSAID (e.g. ibuprofen) or aspirin and had an allergic reaction. This reaction may have been signs of asthma (e.g. wheeziness), runny nose, swelling of the skin or itching;

•    you have, or have ever had an ulcer of the stomach or duodenum (gut);

•    you have ever suffered from bleeding in the stomach or intestines (gastrointestinal bleeding) or bleeding in the brain (cerebrovascular bleeding) or you have a bleeding disorder;

•    you are taking a medication to prevent the blood clotting (e.g. warfarin);

•    you have severe liver, kidney or heart failure;

•    you are pregnant or planning to become pregnant, or are you breastfeeding;

•    your doctor tells you that you currently have a blood disorder known as thrombocytopenia.

Tell your doctor or pharmacist if you are not sure if any of the conditions above apply to you.

Tenoxicam Tablets are not recommended for children.

Take special care and tell your doctor or pharmacist before taking this medicine if:

•    you have a history of stomach or bowel problems e.g. inflammation of the stomach (gastritis) or gullet (oesophagitis), ulcerative colitis, Crohn’s disease;

•    you are elderly;

•    you have any liver, kidney or heart problems including high blood pressure: your doctor may want to keep a check on these before and during treatment;

•    you have, or have had, asthma;

•    you are going to have any surgery or have recently had surgery (as these tablets can affect the clotting of the blood);

•    you suffer from or have a history of blood abnormalities;

•    you suffer from rare conditions known as systemic lupus erythematosus (SLE) or mixed connective tissue disorder;

•    you are at risk of heart attack or stroke (e.g. if you have diabetes, high cholesterol or are a smoker). NSAIDs like Tenoxicam may be associated with an increased risk of heart attack or stroke, so your doctor will want to discuss this with you. Taking Tenoxicam in high doses or for a long time will increase this risk.

Tell your doctor or pharmacist if you think any of these apply to you, or you are not sure.

Tell the doctor if you are due to have a liver function test. This is important because taking Tenoxicam can affect the results.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any of the following medicines:

•    other non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, ibuprofen or naproxen;

•    any medicine used to treat heart problems or high blood pressure e.g. "water tablets” such as bendroflumethiazide, furosemide or acetazolamide, beta-blockers such as atenolol;

•    medicines which prevent blood clotting such as warfarin;

•    lithium, used to treat depression;

•    medicines for diabetes (e.g. glibenclamide);

•    ciclosporin, tacrolimus, used to prevent and treat the rejection of an organ transplant and also used in immune diseases;

•    methotrexate, used to treat some types of cancer, or for psoriasis or rheumatoid arthritis;

•    corticosteroids (such as cortisol or cortisone) used to treat inflammation;

•    quinolone antibiotics to treat infections such as ciprofloxacin;

•    mifepristone (taken within the last 12 days) which is usually prescribed through hospitals and is used to cause an abortion;

•    selective serotonin reuptake inhibitors (medicines used to treat depression) such as paroxetine;

•    zidovudine (a medicine used to treat the Human Immunodeficiency Virus (HIV));

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including any medicines that you have bought yourself without a prescription.

Pregnancy and breast-feeding

DO NOT take Tenoxicam if you are pregnant or breast-feeding. Tell your doctor IMMEDIATELY if you are being treated with Tenoxicam Tablets and think you may be pregnant. If you are trying to become pregnant, Tenoxicam may make it more difficult to become pregnant.

Driving and operating machinery:

You can drive while taking Tenoxicam but do not drive until you know how the tablets affect you. They may make you feel light headed, dizzy or drowsy, and may cause blurred vision. If they affect you in this way DO nOt drive or operate machinery.

3. HOW TO TAKE TENOXICAM TABLETS

Always take Tenoxicam exactly as your doctor has told you. Check with your doctor or the pharmacist if you are not sure.

Tenoxicam tablets should be taken by mouth, with a drink of water or other liquid and with food.

Adults:

The usual daily dose is 20 mg, taken as a single tablet at the same time each day.

DO NOT take more Tenoxicam than you have been told by your doctor. Short-term injuries:

Treatment should not normally be longer than 7 days, but in severe cases, it may be continued up to a maximum of 14 days.

Elderly patients:

The doctor will use as low dose as possible and will keep a check on you for any side effects.

Children:

Not suitable for children.

If you take more tablets than you should

Contact your nearest hospital casualty department immediately if you have taken more tablets than you should, or if someone else has swallowed any. Remember to take this leaflet and the pack with you to show the doctor, whether or not there are any tablets left.

If you forget to take your medicine

If you forget to take your tablets, take your recommended dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for one you have missed.

4. Possible side effects

As with all medicines, Tenoxicam Tablets can cause side effects although not everybody gets them.

If you notice:

•    swelling of the face, lips, tongue or throat;

•    itching or skin rashes;

•    difficulty breathing, cough or wheeziness.

Stop the tablets and seek medical advice immediately. These may be signs of an allergic reaction.

If you notice:

•    Indigestion or heartburn;

•    Constipation;

•    Wind;

•    Loss of appetite (anorexia);

•    Passing of black stools (faeces)

•    Passing of blood;

•    Stomach pain or discomfort;

•    Diarrhoea;

•    Feeling or being sick (especially vomiting blood or dark particles that look like coffee grounds);

•    Stomach ulcer.

Stop the tablets and tell your doctor immediately. These may be signs of stomach problems.

Other problems may include:

•    Build up of fluid in the body, including the legs, which causes swelling;

•    Changes in the blood e.g. reduction in red or white blood cells (which can make you feel tired or breathless and may make you more likely to get an infection) or other symptoms which may include sore throats, bruising or bleeding, mouth ulcers, fever, or malaise (agranulocytosis), if these symptoms occur please consult your doctor;

•    Headaches and dizziness, vertigo;

•    Generally feeling unwell;

•    Ringing in the ears (tinnitus);

•    Inflammation of the kidney, other kidney problems or kidney failure;

•    Skin rashes or itching;

•    Blistering of the skin;

•    Bruising;

•    Inflammation of the blood vessels (vasculitis);

•    Swollen eyes, blurred vision, eye irritation.

Rarely, the following side effects may occur:

•    Sleepiness;

•    Inability to sleep (insomnia);

•    Abnormal dreams;

•    Tingling in hands or feet (pins and needles);

•    Depression, nervousness or confusion;

•    Hallucinations;

•    Disturbances in memory or changes in sensation (including alterations to taste)

•    Nail disorders;

•    The skin may be more sensitive to sunlight;

•    Blisters of the eye, mouth, anus, genitals, skin or urethra; peeling of the skin, usually with a high fever and general weakness (Stevens-Johnson Syndrome);

•    Hair loss (alopecia);

•    Nail disorders;

•    Nose bleeds;

•    Inflammation of the liver (hepatitis) and changes in liver enzymes;

•    Yellowing of the skin or whites of the eyes (jaundice);

•    Changes in the blood e.g. increased calcium or agranulocytosis, which may cause fever, with ulceration of the mouth and throat;

•    Fast heart beat, high blood pressure, heart failure;

•    Difficulty breathing;

•    Weight gain or weight loss.

NSAID use has also been associated with inflammation of the stomach. Inflammation of the pancreas has also been reported (pancreatitis).

Medicines such as tenoxicam 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.

NSAID use has been associated with a range of blood disorders.

If you experience sore throats, bruising or bleeding, mouth ulcers, fever, or malaise, stop taking the NSAID and seek medical advice immediately. Your doctor may decide to perform blood cell counts to determine if there are problems with your blood.

There have been isolated cases of aseptic meningitis, especially in patients who have reduced immune function. This may lead to symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.

If any of the side effects becomes severe, or you experience any other side effect not mentioned above, tell your doctor or pharmacist.

5.    HOW TO STORE TENOXICAM TABLETS

Do not use your medicine after the expiry date printed on the carton. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the tablets in the original packaging.

KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

6.    FURTHER INFORMATION What Tenoxicam tablets contain

Each tablet contains 20 mg of the active ingredient tenoxicam.

The inactive ingredients are: lactose, maize starch, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), and yellow iron oxide (E172).

What Tenoxicam tablets look like and the contents of the pack

Tenoxicam 20 mg Tablets are round, yellowish and film-coated.

They are available in packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Waymade Plc t/a Sovereign Medical,

Sovereign House,

Miles Gray Road,

Basildon,

Essex,

SS14 3FR.

Date of preparation: February 2009