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MOBIC 15MG TABLETS

Active substance: MELOXICAM

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PACKAGE LEAFLET: INFORMATION
FOR THE USER

MOBIC® 15mg TABLETS
(meloxicam)

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 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.
The name of your medicine is MOBIC 15mg
Tablets but will be referred to as MOBIC
throughout this leaflet.

In this leaflet:
1. What MOBIC is and what it is used for
2. Before you take MOBIC
3. How to take MOBIC
4. Possible side effects
5. How to store MOBIC
6. Further information

1. WHAT MOBIC IS AND WHAT IT IS
USED FOR
MOBIC contains the active substance
meloxicam. Meloxicam belongs to a group of
medicines called non-steroidal antiinflammatory drugs (NSAIDs) which are used
to reduce inflammation and pain in joints and
muscles.
MOBIC is used for the:
− short-term treatment of flare-ups of
osteoarthritis
− long-term treatment of
− rheumatoid arthritis
− ankylosing spondylitis (also known as
Bechterew’s Disease)

2. BEFORE YOU TAKE MOBIC
Do not take MOBIC if any of the following
apply:
− during the last three months of pregnancy
− children and adolescents under 16 years of
age
− allergy (hypersensitivity) to meloxicam
− allergy (hypersensitivity) to aspirin or other
anti-inflammatory medicines (NSAIDs)
− allergy (hypersensitivity) to any of the other
ingredients of MOBIC. (See section 6
“Further information” for a list of other
ingredients)
− any of the following signs after taking aspirin
or other NSAIDs:
− wheezing, chest tightness, breathlessness
(asthma)
− nasal blockage due to swellings in the
lining in your nose (nasal polyps)
− skin rashes/nettle rash (urticaria)
− sudden skin or mucosal swelling, such as
swelling around the eyes, face, lips, mouth
or throat, possibly making breathing
difficult (angioneurotic oedema)
− after previous therapy with NSAIDs and
history of
− bleeding in your stomach or intestines
− holes (perforations) in your stomach or
intestines
− ulcers or a bleeding in your stomach or
intestines
− recent or history of stomach or peptic ulcers
or bleeding (ulceration or bleeding occurring
at least twice)
− serious liver disease
− serious kidney disease and not undergoing
dialysis
− recent bleeding in the brain (cerebrovascular
bleeding)
− any kind of bleeding disorders
− severe heart failure
− intolerance to some sugars as this product
contains lactose (see also “Important
information about some of the ingredients of
MOBIC”)
If you are unsure whether any of the above
apply to you, please contact your doctor.

Take special care with MOBIC
Warnings
Medicines such as MOBIC may be associated
with a small increased risk of heart attack
(myocardial infarction) or stroke (apoplexy).
Any risk is more likely with high doses and
prolonged treatment. Do not take more than
the recommended dose. Do not take MOBIC
for longer than it is prescribed for you (see
section 3 “How to take MOBIC”).
If you have heart problems, previous stroke or
think that you might be at risk of these
conditions, you should discuss your treatment
with your doctor or pharmacist. For example if
you:
− have high blood pressure (hypertension)
− have high levels of sugar in the blood
(diabetes mellitus)
− have high levels of cholesterol in the blood
(hypercholesterolemia)
− are a smoker

If you develop severe allergic reactions, you
should discontinue MOBIC at first appearance
of skin rash, lesions of soft tissues (mucosal
lesions), or any other sign of allergy, and
contact your doctor.
Stop your treatment with MOBIC immediately
as soon as you notice bleeding (causing tarcoloured stools) or ulceration of your digestive
tract (causing abdominal pain).
MOBIC is not appropriate, if you require
immediate relief from acute pain.
MOBIC may hide the symptoms of infection
(e.g. fever). If you think you may have an
infection you should see your doctor.

Precautions for use
As it will be necessary to adjust the treatment,
it is important to ask your doctor’s advice
before you take MOBIC in case of:
− history of inflammation of the gullet
(oesophagitis), inflammation of the stomach
(gastritis) or a history of any other disease of
the digestive tract, e.g. Crohn’s Disease or
Ulcerative Colitis
− high blood pressure (hypertension)
− older age
− heart, liver or kidney disease
− high levels of sugar in the blood (diabetes
mellitus)
− reduced blood volume (hypovolaemia)
which may occur if you have a serious blood
loss or burn, surgery or low fluid intake
− intolerance to some sugars diagnosed by
your doctor as this product contains lactose
− high potassium levels in the blood previously
diagnosed by your doctor
Your doctor will need to monitor your progress
whilst on treatment.

Taking other medicines
As MOBIC 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, including
medicines obtained without a prescription.
In particular please tell your doctor or
pharmacist if you are taking/have taken, or are
using any of the following:
− other NSAIDs
− medicines which prevent blood clotting (e.g.
warfarin, heparin)
− medicines which break down blood clots
(thrombolytics)
− medicines to treat heart and kidney diseases
− corticosteroids (e.g. used against
inflammation or allergic reactions)
− cyclosporin – used after organ transplants,
or for severe skin conditions, rheumatoid
arthritis or nephrotic syndrome
− tacrolimus - used after organ transplants or
for severe skin conditions
− any diuretic medicine (“water tablets”)
Your doctor may monitor your kidney
function if you are taking diuretics.
− medicine to treat high blood pressure (e.g.
Beta-blockers)
− lithium – used to treat mood disorders
− selective Serotonin re-uptake inhibitors
(SSRIs) – used in the treatment of
depression
− methotrexate – used to treat tumours or
severe uncontrolled skin conditions and
active rheumatoid arthritis
− cholestyramine – used to lower cholesterol
levels
− if you are a woman who uses an intrauterine
contraceptive device (IUD), usually known
as a coil
If in doubt, ask your doctor or pharmacist.

Fertility
MOBIC 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 to become pregnant.

Pregnancy
If you become pregnant whilst using MOBIC,
you should tell your doctor. During the first 6
months of pregnancy only, your doctor may
prescribe you this medical product if
necessary.
During the last three months of pregnancy do
not use this product, because MOBIC can
have serious effects on your unborn child, in
particular heart, lung and kidney effects, even
with only one dose.

Breast-feeding
The active ingredient of this medicine is known
to pass into breast-milk. This product is not
recommended during breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Visual disturbances, including blurred vision,
dizziness, drowsiness, vertigo or other central
nervous system disturbances may occur with
this product. If affected do not drive or operate
machinery.

Important information about some of the
ingredients of MOBIC

Any side effects of the digestive tract,
especially:

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

− bleeding (causing tar-coloured stools)
− ulceration of your digestive tract (causing
abdominal pain)

3. HOW TO TAKE MOBIC
Always take MOBIC exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.

Bleeding of the digestive tract (gastrointestinal
bleeding), formation of ulcers or formation of
a hole in the digestive tract (perforation) may
sometimes be severe and potentially fatal,
especially in elderly.

Rheumatoid arthritis:

If you have previously suffered from any
symptoms of the digestive tract due to long
term use of NSAIDs, seek medical advice
immediately, especially if you are elderly. Your
doctor may monitor your progress whilst on
treatment.

15 mg (one tablet) once a day. This may be
reduced to 7.5 mg (half a tablet) once a day.

If affected by visual disturbances do not drive
or operate machinery.

Ankylosing spondylitis:

Side effects of meloxicam – the active
substance of MOBIC

The usual dose is:
Flare-ups of osteoarthritis:
7.5 mg (half a tablet) once a day. This may be
increased to 15 mg (one tablet) once a day.

15 mg (one tablet) once a day. This may be
reduced to 7.5 mg (half a tablet) once a day.
The tablets should be swallowed with water, or
another drink, during a meal.

Very common: affects more than 1 in 10
patients receiving the medicine

If any of the statements listed under the
heading “Take special care with MOBIC”
apply to you, your doctor may restrict your
dose to 7.5 mg (half a tablet) once a day.

− indigestion (dyspepsia)
− feeling sick (nausea) and being sick
(vomiting)
− abdominal pain
− constipation
− flatulence
− loose stools (diarrhoea)

MOBIC should not be given to children and
adolescents under 16 years of age.

Common: affects less than 1 in 10
patients receiving the medicine

If you feel that the effect of MOBIC is too
strong or too weak, or if after several days you
do not feel any improvement in your condition,
talk to your doctor or pharmacist.

− headache

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

If you take more MOBIC than you should
Whether you have taken too many tablets
or suspect an overdose, contact your
doctor or go to your nearest hospital
immediately

Symptoms following acute NSAID
overdose are usually limited to:
− lack of energy (lethargy)
− drowsiness
− feeling sick (nausea) and being sick
(vomiting)
− pain in the area of the stomach (epigastric
pain)
These symptoms generally get better when
you stop taking MOBIC. You may suffer from
bleeding of the stomach or intestines
(gastrointestinal bleeding).

Severe poisoning may result in serious
drug reaction (see section 4.):










high blood pressure (hypertension)
acute kidney (renal) failure
liver (hepatic) dysfunction
reduction/ flattening or stopping of breathing
(respiratory depression)
loss of consciousness (coma)
seizures (convulsions)
collapse of the blood circulation
(cardiovascular collapse)
stopping of the heart (cardiac arrest)
immediate allergic (hypersensitivity)
reactions, including:
− fainting
− shortness of breath
− skin reactions

If you forget to take MOBIC
Do not take a double dose to make up for a
forgotten dose. Just take the next dose at the
usual time.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, MOBIC can cause side
effects, although not everybody gets them.

Stop taking MOBIC and consult a doctor
or your nearest hospital immediately if
you notice:
Any allergic (hypersensitivity) reactions, which
may appear in the form of:
− skin reactions, such as itching (pruritus),
blistering or peeling of the skin, which can
be severe (Stevens-Johnson Syndrome and
toxic epidermal necrolysis), lesions of soft
tissues (mucosal lesions) or erythema
multiforme. Erythema multiforme is a serious
allergic skin reaction causing spots, red
welts or purple or blistered areas. It can also
affect the mouth, eyes and other moist body
surfaces.
− swelling of skin or mucosa, such as swelling
around the eyes, face and lips, mouth or
throat, possibly making breathing difficult,
swollen ankles or legs (oedema of the lower
limbs)
− shortness of breath or asthma attack
− inflammation of the liver (hepatitis). This can
cause symptoms such as:
− yellowing of the skin or the eyeballs
(jaundice)
− pain in the abdomen
− loss of appetite

Uncommon: affects less than 1 in 100
patients receiving the medicine


















dizziness (light-headedness)
a feeling of dizziness or spinning (vertigo)
somnolence (drowsiness)
anaemia (reduction of the concentration of
the red blood pigment haemoglobin)
increase in blood pressure (hypertension)
flushing (temporary redness of the face and
neck)
sodium and water retention
increased potassium levels (hyperkalaemia).
This can lead to symptoms such as:
− changes to your heartbeat (arrhythmias)
− palpitations (when you feel your heartbeat
more than usual)
− muscle weakness
belching
inflammation of the stomach (gastritis)
inflammation of the mouth (stomatitis)
skin rash
swelling caused by fluid retention (oedema)
momentary disturbance of liver function tests
(e.g. raised liver enzymes like
transaminases or an increase of the bile
pigment bilirubin). Your doctor can detect
these using a blood test.
disturbance of laboratory tests investigating
kidney (renal) function (e.g. raised creatinine
or urea)

Rare: affects less than 1 in 1,000 patients
receiving the medicine
− mood disorders
− nightmares
− abnormal blood count, including:
− abnormal differential blood count
− decreased number of white blood cells
(leucocytopenia) which may lead to
increased risk of infection
− decreased number of blood platelets
(thrombocytopenia) which may lead to
increased risk of bleeding or bruising
− ringing in the ear (tinnitus)
− feeling your heartbeat (palpitations)
− inflammation of the gullet (oesophagitis)
− nettle rash (urticaria)
− visual disturbances including:
− blurred vision
− conjunctivitis (inflammation of the eyeball
or eyelids)
− inflammation of the large bowel (colitis)

Very rare: affects less than 1 in 10,000
patients receiving the medicine
− acute failure of the kidneys (renal failure) in
particular in patients with risk factors such as
heart disease, diabetes or kidney disease.

Other side effects (frequency not
known)
− confusion
− disorientation
− shortness of breath and skin reactions
(anaphylactic/anaphylactoid reactions)
rashes caused by exposure to sunlight
(photosensitivity reactions)
− heart failure (cardiac failure) has been
reported in association with NSAID
treatment
− complete loss of specific types of white
blood cells (agranulocytosis), especially in
patients who take MOBIC together with
other drugs that are potentially inhibitory,
depressant or destructive to a component of
the bone marrow (myelotoxic drugs). This
can cause:
− sudden fever
− sore throat
− infections

General side effects of non-steroidal
anti-inflammatory medicines (NSAIDs)
The use of some non-steroidal antiinflammatory drugs (NSAIDs) may be
associated with a small increased risk of heart
attack (myocardial infarction) or stroke
(apoplexy), particularly at high doses and in
long term treatment.
The following side effects have been reported
after NSAID administration:
− vomiting of blood (haematemesis)
− worsening of inflammation of the digestive
tract (e.g. exacerbation of colitis or Crohn’s
disease)

Side effects caused by non-steroidal
anti-inflammatory medicines NSAIDs),
but not yet seen after taking MOBIC
Changes to the kidney structure resulting in
acute kidney failure:
− very rare cases of kidney inflammation
(interstitial nephritis)
− death of some of the cells within the kidney
(acute tubular or papillary necrosis)
− protein in the urine (nephrotic syndrome with
proteinuria)
If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE MOBIC
The tablets should not be used after the expiry
date, which is printed on the packaging.
Protect the tablets from moisture.
Keep this medicine out of the sight and reach
of children.
If the tablets become discoloured or show any
signs of deterioration, you should seek the
advice of your pharmacist.
If your doctor tells you to stop taking this
medicine, return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to.

6. FURTHER INFORMATION
What MOBIC contains
Each tablet contains 15mg meloxicam as the
active ingredient.
The tablets also contain the following inactive
ingredients: sodium citrate, lactose
monohydrate, microcrystalline cellulose,
povidone, anhydrous colloidal silica,
crospovidone and magnesium stearate.

What MOBIC looks like and contents of
the pack
The tablets are light yellow round tablets. One
side is engraved with the company logo. The
other side is engraved with ‘77C’ on each side
of a score line.
The tablets are available in cartons containing
30 tablets

Manufactured by: Boehringer Ingelheim
Pharma GmbH & Co.KG, D-55216 Ingelheim
am Rhein, Germany or
Boehringer Ingelheim Ellas A.E., Markopoulo,
Koropi, Greece.

Procured from within the EU and
repackaged by the Product licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip Middlesex HA4 0NU, UK

MOBIC 15mg Tablets
PL No. 18799/0502

POM

Leaflet date: 17.10.2012
MOBIC is a registered trademark of
Boehringer Ingelheim.

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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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