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MOBIC TABLETS 7.5mg

Active substance: meloxicam

Patient Information Leaflet

Your medicine is marketed using the above names but will be referred to as Mobic Tablets throughout the following patient information leaflet. Your medicine is available in two strengths. Your doctor will have decided which strength you need.

Please read this information leaflet about Mobic Tablets carefully before you start using your medicine. It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. Please keep this leaflet in a safe place, you may wish to refer to it again.

Each tablet contains 7.5mg of the active ingredient, meloxicam, in a round, pale yellow tablets marked 59D each side of a breakline on one side with a company logo on the other side.

Mobic Tablets also contain the following: sodium citrate dihydrate, lactose monohydrate, microcrystalline cellulose, povidone, anhydrous colloidal silica, crospovidone and magnesium stearate.

Mobic Tablets are available as blister packs of 20, 30 and 60 tablets.

Mobic is a non-steroidal anti-inflammatory drug (NSAID) which is used to reduce inflammation and pain in the joints and muscles.

These tablets are made by Boehringer Ingelheim Pharma KG, Binger Strasse 173, D-55216 Ingelheim AM Rhein, Germany. They are procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, AlpertonLane, Wembley, Middlesex, HA0 1DX, England.

Warnings and precautions:

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How does this medicine work?

Mobic Tablets are used in the short-term treatment of flare ups of osteoarthritis, and for the long-term treatment of rheumatoid arthritis and ankylosing spondylitis.

Before taking your medicine

Do not take this medicine if:

  • You are pregnant, planning to become pregnant or if you are breast feeding
  • You are allergic to Mobic or to any of the other ingredients listed
  • You are allergic to aspirin or other anti-inflammatory medicines
  • You have ever suffered from wheezing, nasal polyps (nasal obstruction due to swellings in the lining in your nose) along with a runny nose, swelling of the skin, urticaria (nettle rash) when taking aspirin or other anti-inflammatory medicines
  • You have or have ever had a gastrointestinal ulcer (ulcer of the stomach or intestines)
  • You have any kind of bleeding disorder or have ever suffered from gastrointestinal bleeding (bleeding in the stomach or intestines) or cerebrovascular bleeding (bleeding in the brain)
  • You have serious liver disease
  • You have serious kidney disease and are not undergoing dialysis
  • You have severe heart failure.

Take special care when taking this medicine 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
  • You have high blood pressure
  • You are elderly
  • You have heart, liver or kidney disease
  • You have diabetes
  • You have hypovolaemia (reduced blood volume) which may occur if you have serious blood loss or burns, surgery or low fluid intake
  • You have ever been diagnosed with high potassium levels in the blood.

Your doctor may monitor your progress whilst on treatment.

Warnings

Medicines such as MOBIC Tablets 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.

If you have heart problems, previous stroke or think that you might 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.

Pregnancy

This product should not be used during pregnancy. If you are planning to become pregnant, if you think or know you are pregnant you should talk to your doctor for advice.

Breast feeding

This product should not be given to breast feeding mothers.

Driving and using machinery

Visual disturbances, drowsiness, vertigo (dizziness) may occur with this product. If affected do not drive or operate machinery.

Information about lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Taking other medicines

As Mobic Tablets may affect or be affected by other medicines, please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, even those not prescribed. In particular please tell your doctor or pharmacist if you are taking/have taken any of the following:

  • Other anti-inflammatory drugs, including aspirin
  • Medicines which prevent blood clotting eg. Warfarin
  • Medicines which break down blood clots (thrombolytics)
  • Medicines to treat high blood pressure
  • Corticosteroids
  • Ciclosporin - a medicine often used after organ transplants, or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome
  • Any diuretic medicine ( water tablets ). Your doctor may monitor your kidney function if you are taking diuretics
  • Lithium - a medicine used to treat mood disorders
  • Selective Serotonin re-uptake inhibitors used in the treatment of depression
  • Methotrexate - a medicine mainly used to treat tumours or severe uncontrolled skin conditions and active rheumatoid arthritis
  • Cholestyramine - mainly used to lower cholesterol levels.

You are a woman who uses an intrauterine contraceptive device (IUD), usually known as a coil. If in doubt, ask your doctor or pharmacist

Taking your medicines

Follow your doctor s instructions about when and how to take your medicine and always read the label. The usual recommended doses are given below:

Flare-ups of osteoarthritis:
Mobic Tablet 7.5 mg strength once a day. This may be increased to 15 mg strength once a day.

Rheumatoid arthritis:
Mobic Tablet 15 mg strength once a day. This may be reduced to 7.5 mg strength once a day.

Ankylosing spondylitis:
Mobic Tablet 15 mg strength once a day. This may be reduced to 7.5 mg strength once a day.

The tablets should be swallowed with water, or another drink, during a meal.

Do not exceed the recommended maximum dose of 15 mg a day.

If any of the statements listed under the heading Take special care when taking this medicine if apply to you, your doctor may restrict your dose to 7.5 mg strength once a day.

Mobic Tablets should not be given to children under 15 years of age.

If you feel that the effect of Mobic Tablets is too strong or too weak, talk to your doctor or pharmacist.

If you take more Mobic Tablets than you should, talk to your doctor or pharmacist immediately.

If you forget to take Mobic Tablets do not take a double dose to make up for the missed dose.

If after several days you do not feel any improvement in your condition then you should talk to your doctor or pharmacist.

Side effects

All medicines can cause side effects. Medicines such as Mobic Tablets may be associated with a small increased risk of heart attack ( myocardial infarction ) or stroke.

The side effects described below have been experienced by people taking meloxicam and they are listed as either common, uncommon or rare. If a side effect is listed as

  • Common it has been experienced by between 1 in 10 and 1 in 100 people
  • Uncommon it has been experienced by between 1 in 100 and 1 in 1000 people
  • Rare it has been experienced by between 1 in 1000 and 1 in 10000 people.

Side effects associated with the digestive system (stomach and intestines)

Common: indigestion, feeling sick or being sick, abdominal pain, constipation, flatulence, diarrhoea

Uncommon: gastrointestinal bleeding (causing offensive, tarcoloured stools), ulcers of the stomach or intestines, inflammation or soreness of the mouth or the gullet

Rare: gastrointestinal perforation (a hole in the wall of the bowel), inflammation or soreness of the stomach or the colon

Ulcers of the stomach or intestines, gastrointestinal bleeding and gastrointestinal perforation can occur at any time and can sometimes be severe, especially in the elderly and very rarely have been fatal.

If you have a history of gastrointestinal symptoms whilst taking antiinflammatory drugs, your doctor may monitor your progress whilst on treatment.

Side effects associated with the skin

Common: itching, rash

Uncommon: urticaria (nettle rash)

Rare: severe blistering of the skin or peeling, swelling around the eyes, lips and face, rashes caused by exposure to sunlight

Side effects associated with the central nervous system

Common: lightheadedness, headache

Uncommon: vertigo (dizziness), tinnitus (noises in the ear), drowsiness

Rare: confusion, mood disorders, insomnia (inability to sleep), nightmares

If affected by any of these side effects do not drive or operate machinery.

Side effects associated with the eye

Rare: visual disturbances, for example blurred vision If affected by visual disturbances do not drive or operate machinery.

Side effects associated with the cardiovascular system

Common: swelling caused by fluid retention, including swollen ankles/legs

Uncommon: palpitations, increase in blood pressure, hot flushes

Side effects associated with the blood

Common: anaemia

Uncommon: abnormality of white blood cell or platelet numbers

Side effects associated with the immune system and with the respiratory system

Rare: severe allergic reactions which may include fainting, shortness of breath and skin reactions. Asthma attacks (seen in people who are allergic to aspirin or other non-steroidal antiinflammatory drugs)

If you suffer from an allergic reaction or asthma attack after taking Mobic Tablets, seek medical advice immediately.

Side effects associated with the liver

Uncommon: changes in tests of liver function

Rare: inflammation of the liver (hepatitis)

Side effects associated with the kidney

Uncommon: salt and water retention, increased potassium levels in the blood, changes in tests of kidney function

Rare: kidney failure

The following side effects have been seen with other medicines similar to Mobic Tablets but have not yet been reported by patients taking Mobic Tablets:

  • Changes to the kidney structure resulting in kidney failure: isolated cases kidney inflammation, death of some of the cells within the kidney, proteinuria (protein in the urine).

If you experience any of these side effects and they persist or become troublesome, consult your doctor.

If you experience any other side effects not mentioned above, consult your doctor or pharmacist.

Expiry Date:

Do not use after the expiry date printed on the carton or blister label.

Storage:

Do not store above 25 C. Store in original package.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

IMPORTANT:

This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist, who has access to additional information.

Leaflet prepared: 20 April 2012.

Mobic is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co KG, Germany.

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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