Mobic® 7,5 mg/15 mg Tablets

MOBIC is used in patients aged 12 years and older to relieve symptoms of arthritis such as joint pain and inflammation. It is also used for the symptomatic relief of acute episodes of sciatica (pain in the hip nerve) and ankylosing spondylitis (an inflammatory disease that can cause some of the vertebrae in your spine to fuse together). Meloxicam belongs to a class of medicines called non-steroidal anti-inflammatories. These medicines are usually used to treat inflammation, swelling, stiffness, pain and fever.

Do not take MOBIC tablets:

• if you are allergic to meloxicam or any of the other ingredients of MOBIC tablets
• if you are allergic to aspirin or other anti-inflammatory medicines
• if you have ever suffered from wheezing (asthma), nasal polyps (nasal obstruction due to swellings in the lining of your nose) along with a runny nose, swelling of the skin or urticaria (nettle rash) when taking aspirin or any other anti-inflammatory medicines
• if you have, or have had a recurring gastrointestinal ulcer (ulcer of the stomach or intestines), perforation or bleeding
• if you have active inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• if you have severe liver disease
• if you have severe kidney disease and are not undergoing dialysis
• if you have any kind of established general bleeding disorder or gastrointestinal bleeding (bleeding in the stomach or intestines) or recent cerebrovascular bleeding (bleeding in the brain)
• if you have heart failure (i.e. when your heart inadequately pumps blood through the body)
• if you have ever suffered from gastrointestinal bleeding (bleeding in the stomach or intestines), ulceration or perforation after taking aspirin or any other anti-inflammatory medicines, including MOBIC
• if you are under the age of 12 years
• if you are pregnant, planning to become pregnant or if you are breastfeeding (see Pregnancy and breastfeeding)
• if you have had coronary artery bypass graft (CABG) surgery, since MOBIC should not be used to treat pain after such an operation
• if you have been told by your doctor that you have an intolerance to some sugars, as MOBIC contains lactose (as monohydrate) (see Important information about some of the ingredients of MOBIC)

Take special care with MOBIC tablets and tell your healthcare provider:

• If you are elderly, side effects may happen more often, especially bleeding in the stomach and intestines, ulceration or perforation (which may be fatal), and you should discuss this with your doctor
• Gastrointestinal bleeding or ulcer can occur at any time during treatment with MOBIC, with or without warning symptoms. Tell your doctor if you have ever suffered from oesophagitis (inflammation of the gullet) or gastritis (inflammation of the stomach) or any other gastrointestinal disease e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastroesophageal reflux disease or angiodysplasia (a small malformation of some blood vessels in the gut)
• Tell your doctor if you are taking anticoagulant medicines (to prevent blood clotting)
• Tell your doctor if you develop any skin rash, sores on the linings of nose, mouth, etc., or other signs of allergy like swollen lymph glands or fever
• Tell your doctor if you have heart disease, high blood pressure, diabetes, high cholesterol or if you are a smoker as these may increase the risk of heart attack or stroke
• Tell your doctor if you have liver or kidney disease
• You should tell your doctor if you have hypovolaemia (reduced blood volume) which may occur if you have serious blood loss or burns, surgery or low fluid intake, or if you are taking diuretics (water tablets) or certain medications used to treat high blood pressure
• Tell your doctor if you have ever been diagnosed with high sodium or potassium levels in the blood, or if you are retaining water (swollen hands or feet)
• MOBIC may reduce the contraceptive effectiveness of the intrauterine device (IUD) (see Taking other medicines with MOBIC tablets), and you should take additional precautions to avoid falling pregnant
• MOBIC may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke. The risk is more likely with prolonged treatment. Do not exceed the recommended dose or duration of treatment
• If you have heart problems, have had a 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 if you are a smoker) you should discuss your treatment with your doctor or pharmacist
• The regular use of MOBIC in the last three months of pregnancy may cause abnormally high blood pressure in the blood vessels of the baby’s lungs which makes it harder to pump blood into the lungs, and it may delay or lengthen labour in the mother
• MOBIC may mask the symptoms of an infection.

Do not share medicines prescribed for you with any other person. Always take MOBIC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual recommended doses are:

Rheumatoid arthritis:

15 mg (one x 15 mg tablet or two x 7,5 mg tablets) once per day. Your doctor may reduce this to 7,5 mg (one x 7,5 mg tablet) once per day, depending on the response.

Painful osteoarthritis:

7,5 mg (one x 7,5 mg tablet) once per day. Your doctor may increase this to 15 mg (one x 15 mg tablet or two x 7,5 mg tablets) once per day, if necessary.

Ankylosing spondylitis:

15 mg (one x 15 mg tablet or two x 7,5 mg tablets) once per day. Your doctor may reduce this to 7,5 mg (one x 7,5 mg tablet) once per day, depending on the response.

Episodes of acute sciatica:

7,5 mg (one x 7,5 mg tablet) once per day. Your doctor may increase this to 15 mg (one x 15 mg tablet or two x 7,5 mg tablets) once per day, if no improvement is seen.

Swallow the tablets with water or another drink, during a meal. If you need to take two x 7,5 mg tablets, you should take them together as one single dose. The total daily dosage of MOBIC administered as tablets and injections should not exceed 15 mg. Do not exceed the recommended maximum dose of 15 mg meloxicam per day. It is important to tell your doctor if you suffer from kidney problems, have a history of gastrointestinal disease or risk factors for heart disease (e.g. high blood pressure, diabetes, high cholesterol or if you are a smoker), as you should receive the lower dose of 7,5 mg MOBIC per day. See “Take special care with MOBIC tablets and tell your healthcare provider”. Your doctor will tell you how long your treatment with MOBIC will last. If you have the impression that the effect of MOBIC tablets is too strong or too weak, tell your doctor or pharmacist. If after several days you do not feel any improvement in your condition then you should talk to your doctor or pharmacist.

If you take more MOBIC tablets than you should: In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison control center. If you forget to take MOBIC tablets: Take your dose when you remember. Do not take a double dose to make up for the missed dose.

MOBIC tablets can have side effects. If you experience any of the following very serious side effects, stop taking MOBIC and tell your doctor immediately or go to the casualty department at your nearest hospital.

• sudden, life-threatening or severe allergic reactions which may include fainting, shortness of breath, skin reactions, swollen lymph glands and fever.
• MOBIC may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke. Symptoms may include chest pain, shortness of breath, weakness and slurring of speech.

If the following side effects occur, they also need medical attention. Contact your doctor as soon as possible or go to the casualty department at your nearest hospital if you notice:

• asthma (difficulty in breathing) - seen in people who are allergic to aspirin or other non-steroidal anti-inflammatory medicines
• stomach or intestinal ulcer
• inflammation of the large bowel (diarrhoea usually with bloody or black-coloured stools and mucous, stomach pain and fever)
• soreness of the gullet
• vomiting blood or material that looks like coffee grounds
• severe, persistent abdominal pain
• severe skin reaction which may be associated with painful red areas, large blisters and peeling of layers of skin with fever and chills, aching muscles and generally feeling unwell, or severe blistering and bleeding in mucous membranes (lips, eyes, mouth, nose and genitals), urticaria (nettle rash)
• cardiac failure (disease of the heart with shortness of breath and swelling of face, feet or lower legs due to fluid build-up
• unusual fast or irregular heartbeat or palpitations
• abnormality of white blood cell or platelet numbers, unusual bleeding or bruising, sore throat, fever and chills
• liver disease (with nausea, vomiting, loss of appetite, generally feeling unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine)
• kidney disease where you pass little or no urine – other symptoms include drowsiness, nausea, vomiting and breathlessness
• confusion and disorientation, mood changes

The following side effects have been reported, which may be related to the use of MOBIC.

Frequent:

• gastrointestinal symptoms such as indigestion, nausea (feeling sick) or vomiting (being sick), abdominal pain or diarrhoea
• headache

Less frequent:

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• asthma (difficulty in breathing) in persons allergic to aspirin or other non-steroidal anti-inflammatory medicines
• constipation, flatulence (wind), gastritis (a stomach problem which may result in pain, nausea, vomiting, vomiting blood, and blood in the bowel motions), burping
• gastrointestinal bleeding (causing offensive, tar-coloured stools or vomiting blood)
• inflammation or soreness of the mouth or gullet, stomach or intestinal ulcer, colitis (inflammation of the colon or Crohn’s disease), which may be worsened
• bleeding
• anaemia, changes in blood count test results (including low white cell count), unusual bleeding or bruising, sore throat, fever and chills
• skin reactions which may be severe, skin rash, itching, which may be accompanied by yellowing of the whites of the eyes and skin and darkened urine
• palpitations, heart failure
• general oedema (swelling of face, feet or lower legs)
• increase in blood pressure (high blood pressure)
• flushing
• abnormalities in tests of liver function
• abnormalities in tests of kidney function, any changes in urination
• vertigo (dizziness or spinning sensation), tinnitus (noises in the ear)
• dizziness, somnolence (sleepiness or drowsiness), insomnia (sleeplessness), nightmares
• altered mood, confusion and disorientation
• visual disturbances including blurred vision, conjunctivitis (discharge with itching of the eyes)
• increased sun sensitivity
• delayed ovulation and infertility in females

If any of these side effects continue, are severe or bother you, tell your doctor or pharmacist. Not all side effects reported for MOBIC are included in this leaflet. Should your general health worsen of if you experience any untoward effects while taking MOBIC, please consult your doctor, pharmacist, or other healthcare professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 30 °C. Keep all medicines out of the reach and sight of children. Do not take this medicine after the expiry date stated on the blister strips and carton. Return unused or expired medicines to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).