Mobic 15 mg
Suppositories
(Meloxicam)
What You Should Know About MOBIC 15 mg Suppositories
Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in the leaflet applies to MOBIC 15 mg Suppositories only. If after reading this you have any questions, ask your doctor or pharmacist.
The name of your medicine is MOBIC 15 mg Suppositories. Each suppository contains 15 mg meloxicam as the active ingredient.
The suppositories also contain the following inactive ingredients: hard fat and macrogolglycerolhydroxystearate.
MOBIC 15 mg Suppositories are available in cartons containing 12 suppositories.
MOBIC 15 mg Suppositories belong to a group of medicines called non-steroidal anti-inflammatory drugs which are used to reduce inflammation and pain in the joints and muscles.
The Marketing Authorisations for MOBIC 15 mg Suppositories in the U.K. and Republic of Ireland are held by:
and the suppositories are manufactured by:
In the U.K. and the Republic of Ireland the product is distributed by:
How MOBIC 15 mg Suppositories Help You
MOBIC 15 mg Suppositories are for the long-term treatment of rheumatoid arthritis and ankylosing spondylitis.
Before Using MOBIC 15 mg Suppositories
Do not take this medicine if:
- You are pregnant, planning to become pregnant or if you are breastfeeding
- You are allergic to meloxicam 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 gastrointestinal ulcer (ulcer of the stomach or intestines)
- You have ever suffered from rectal bleeding or inflammation of the rectum
- 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 15 mg Suppositories 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.
Taking Other Medicines
As MOBIC 15mg Suppositories 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 e.g. warfarin
- Medicines which break down blood clots (thrombolytics)
- Medicines to treat high blood pressure
- Corticosteroids
- Cyclosporin - 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.
How To Insert MOBIC 15 mg Suppositories
Follow your doctor’s instructions about when and how to use your medicine and always read the label. If you are unsure, ask your doctor or pharmacist.
The usual recommended doses are given below. As there are two strengths of suppositories (7.5 mg and 15 mg) your doctor will ensure that you are given the right strength.
Rheumatoid arthritis: 15 mg (one 15 mg suppository) once a day. This may be reduced to 7.5 mg (one 7.5 mg suppository) once a day.
Ankylosing spondylitis: 15 mg (one 15 mg suppository) once a day. This may be reduced to 7.5 mg (one 7.5 mg suppository) once a day.
The suppositories are for rectal use and should be used as follows. They should not be swallowed.
- 1. Remove foil wrapping.
- 2. Lie on your left side and draw your knees up towards your chest, with your right leg drawn up a little more than your left.
- 3. Using your forefinger (index finger) or middle finger, whichever you find easier, gently push the suppository into the rectum, pointed end first. The suppository should be inserted as far as possible.
- 4. Lower your legs to a comfortable position to help you to hold the suppository in place.
If you feel uncomfortable and feel that the suppository must come out immediately, it has probably not been inserted high enough.
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 (one suppository) once a day.
MOBIC 15 mg Suppositories should not be given to children under 15 years of age.
If you feel that the effect of MOBIC 15 mg Suppositories is too strong or too weak, talk to your doctor or pharmacist.
If you take more MOBIC 15 mg Suppositories than you should, talk to your doctor or pharmacist immediately.
If you forget to take MOBIC 15 mg Suppositories do not take a double dose (two suppositories) 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.
After Using MOBIC 15 mg Suppositories
All medicines can cause side effects. Medicines such as MOBIC 15 mg Suppositories 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 MOBIC 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, tar-coloured 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 anti-inflammatory 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
Rare: severe allergic reactions which may include fainting, shortness of breath and skin reactions
Side effects associated with the respiratory system
Rare: Asthma attacks (seen in people who are allergic to aspirin or other non-steroidal anti-inflammatory drugs)
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
Side effects associated with the route of administration
Irritation of the rectum - especially if suppositories are used for long periods, frequently or at high doses.
The following side effects have been seen with other medicines similar to MOBIC but have not yet been reported by patients taking MOBIC: 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.
How To Store MOBIC 15 mg Suppositories
The suppositories should not be used after the expiry date which is printed on the packaging.
Store below 30°C.
Keep this medicine out of the sight and reach of children.
This leaflet was revised in April 2007.
Remember this medicine is for you.
Only a doctor can prescribe it for you. Never give it to others as it may harm them even if their symptoms are the same as yours.
© Boehringer Ingelheim Limited 2007
437855/GB/10
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