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MELOXICAM 7.5 MG TABLETS

Active substance(s): MELOXICAM

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Not known (frequency cannot be estimated
from the available data)
• 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 meloxicam 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 throats
• infections.

MELOXICAM 7.5 mg TABLETS
MELOXICAM 15 mg TABLETS

HOW TO STORE MELOXICAM

Do not use Meloxicam after the expiry date
which is stated on the carton. The expiry
date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
to protect the environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Meloxicam contains
The active substance is meloxicam. Each
tablet contains 7.5 mg or 15 mg meloxicam.
The other ingredients are sodium citrate,
lactose monohydrate, microcrystalline
cellulose, povidone K-30, colloidal
anhydrous silica, crospovidone and
magnesium stearate.
What Meloxicam looks like and contents of
the pack
Meloxicam 7.5 mg tablets are yellow
mottled, round, flat bevel-edged tablets
debossed with “MLX” over “7.5” on one
side and scored on the other side.
Meloxicam 15 mg tablets are yellow
mottled, oval, debossed with “MLX” over
“15” on one side and scored on the other
side.
The scoreline is only to help break the tablet
for ease of swallowing and not to divide it
into equal doses.
The product is available in pack sizes of 10,
14, 20, 28, 30, 50, 60, 100 or 500 (10 x 50)
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
TEVA UK Ltd,
Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG,
England.
This leaflet was last revised in May 2015
PL 00289/0870- 0871

Side effects caused by non-steroidal
anti-inflammatory medicines (NSAIDs), but
not yet seen after taking meloxicam
• 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)
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine

Meloxicam

85115-ZA
320 x 323

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• 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
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

• recent bleeding in the brain
(cerebrovascular bleeding)
• any kind of bleeding disorders
• severe heart failure
• during the last three months of pregnancy
• if you are breast-feeding
• children and adolescents under 16 years
of age.
Warnings and precautions
Medicines such as Meloxicam 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. Do not take Meloxicam
for longer than it is prescribed for you (see
section 3 “How to take Meloxicam”).

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.
WHAT IS IN THIS LEAFLET:
For example if you:
1. What Meloxicam is and what it is used for • have high blood pressure (hypertension)
2. What you need to know before you take
• have high levels of sugar in the blood
Meloxicam
(diabetes mellitus)
3. How to take Meloxicam
• have high levels of cholesterol in the blood
4. Possible side effects
(hypercholesterolemia)
5. How to store Meloxicam
• are a smoker.
6. Contents of the pack and other
Meloxicam is not appropriate if you require
information
immediate relief from acute pain.

1

WHAT MELOXICAM IS AND WHAT IT
NSAIDs including meloxicam may mask the
IS USED FOR

Meloxicam belongs to a group of drugs
called Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs), which are used to reduce
inflammation and pain in the joints and
muscles.
Meloxicam is used for:
• Short-term treatment of the symptoms of
osteoarthritis (excessive wear on joints)
when this condition flares up
• Long-term treatment of the symptoms of
rheumatoid arthritis
• Long-term treatment of the symptoms of
ankylosing spondylitis (inflammation of
the joints between the spine and pelvis).

symptoms (e.g. fever) of an underlying
infection. If you develop signs of infection,
or if the symptoms worsen, you should
contact your doctor.
If you are a woman, meloxicam may make it
more difficult to conceive. Tell your doctor if
you are planning to become pregnant or are
having problems conceiving. You should not
take meloxicam if you are undergoing
fertility treatment.

Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported
with the use of meloxicam, appearing
initially as reddish target-like spots or
WHAT YOU NEED TO KNOW BEFORE circular patches often with central blisters
2 YOU TAKE MELOXICAM
on the trunk. Additional signs to look for
include ulcers in the mouth, throat, nose,
Do not take Meloxicam
genitals and conjunctivitis (red and swollen
Do not take meloxicam in the following
eyes). These potentially life-threatening skin
circumstances:
• allergy (hypersensitivity) to meloxicam or rashes are often accompanied by flu-like
symptoms. The rash may progress to
to any of the other ingredients of this
widespread blistering or peeling of the skin.
medicine (listed in section 6)
The highest risk for occurrence of serious
• allergy (hypersensitivity) to aspirin or
skin reactions is within the first month of
other anti-inflammatory medicines
treatment. If you have developed
(NSAIDs)
Stevens-Johnson syndrome or toxic
• any of the following signs after taking
epidermal necrolysis with the use of
aspirin or other NSAIDs:
meloxicam, you must not be re-started on
• wheezing, chest tightness,
meloxicam at any time. If you develop a
breathlessness (asthma)
rash or these skin symptoms, stop taking
• nasal blockage due to swellings in the
meloxicam, seek urgent advice from a
lining in your nose (nasal polyps)
doctor and tell him that you are taking this
• skin rashes/nettle rash (urticaria)
• sudden skin or mucosal swelling, such medicine.
as swelling around the eyes, face, lips, Your doctor may want to monitor your liver
mouth or throat, possibly making
and kidneys during your treatment with
breathing difficult (angioneurotic
meloxicam, in order to make sure they are
oedema)
working properly.
• after previous therapy with NSAIDs and a
As it will be necessary to adjust the
history of:
• bleeding in your stomach or intestines treatment, it is important to ask for your
• holes (perforations) in your stomach or doctor's advice before you take meloxicam
in the following cases:
intestines
• history of inflammation of the gullet
• ulcers or bleeding in your stomach or
(oesophagitis), inflammation of the
intestines
stomach (gastritis) or any other disease of
• recent or history of stomach or intestinal
the digestive tract, e.g. ulcerative colitis,
ulcers or bleeding (ulceration or bleeding
Crohn’s disease
occurring at least twice)
• severely impaired liver function
Peel Here To Open
• non-dialysed severe kidney failure

Pharma code 558 (1000101111)
First bar is 105mm from top edge.

Very rare (may affect up to 1 in 10,000
people):
• blistering reactions of the skin (bullous
reactions) and 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
• 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
• acute failure of the kidneys (renal failure)
in particular in patients with risk factors
such as disease, diabetes or kidney
disease
• a hole in the wall of the bowels
(perforation).

5

Keep this medicine out of the sight and
reach of children.

Top of page cut-off to middle of registration mark = 44 mm

• feeling your heartbeat (palpitations)
• ulcers of the stomach or upper part of the
small bowels (peptic/gastroduodenal
ulcers)
• inflammation of the gullet (oesophagitis)
• onset of asthma attacks (seen in people
who are allergic to aspirin or other
NSAIDs)
• potentially life-threatening skin rashes
(Stevens-Johnson Syndrome and toxic
epidermal necrolysis) have been reported
(see section 2)
• nettle rash (urticaria)
• visual disturbances including:
• blurred vision
• conjunctivitis (inflammation of the
eyeball or eyelids)
• Inflammation of the large bowel (colitis).

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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
• high potassium levels in the blood
previously diagnosed by your doctor.
Your doctor may monitor your progress
whilst on treatment.
Higher doses than recommended can entail
serious risks. Therefore, do not exceed the
recommended daily dose, and do not use
other anti-inflammatory medicines (NSAIDs)
at the same time. This is especially
important if you are elderly, as the risk of
side effects is higher.
Other medicines and Meloxicam
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
In particular, please tell your doctor or
pharmacist if you are taking/have taken any
of the following:
• other NSAIDs
• medicines which prevent the blood clotting
• medicines which break down blood clots
(thrombolytics)
• medicines to treat heart and kidney disease
• corticosteroids
• ciclosporin - used after organ transplants,
or for severe skin conditions, rheumatoid
arthritis or nephrotic syndrome
• any diuretic medicine (“water tablets”).
Your doctor may want to monitor your
kidney function if you are taking diurectics
• lithium - used to treat mood disorders
• selective Serotonin re-uptake inhibitors –
used in the treatment of depression
• methotrexate - used to treat tumours or
severe uncontrolled skin conditions and
active rheumatoid arthritis
• cholestyramine - mainly used to lower
cholesterol levels
• if you are a woman who uses an
intrauterine contraceptive device (IUD),
usually known as a coil.

possibility of dizziness, drowsiness and
blurred vision as side effects of treatment. If
you experience such effects, do not drive or
use machines until the symptoms wear off.
Ask your doctor or pharmacist for advice.
Meloxicam contains lactose
Meloxicam tablets contain 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.

3

HOW TO TAKE MELOXICAM

Your doctor has decided the dose which is
suited to you. Always take this medicine
exactly as your doctor has told you. Check
with your doctor or pharmacist if you are
not sure. The recommended dose is
described below.
This medicinal product is for oral use only.
You must swallow your full daily dose as a
single dose with water or another liquid
during a meal.
The recommended dose is as follows:
Flare-ups of osteoarthritis:
One 7.5 mg tablet a day, which may be
increased after consultation with your
doctor to 15 mg a day (two 7.5 mg tablets or
one 15 mg tablet).
Rheumatoid arthritis:
One 15 mg tablet per day (or two 7.5 mg
tablets). This may be reduced to one 7.5 mg
tablet once a day.
Ankylosing spondylitis:
One 15 mg tablet per day (or two 7.5 mg
tablets). This may be reduced to one 7.5 mg
tablet once a day.
Do not exceed the dose of 15 mg a day.
Meloxicam must not be given to children
and adolescents under 16 years of age.
Please contact your doctor or pharmacist if
you are not sure how to take this medicine
or if you feel that the effect of meloxicam is
too strong or too weak.

Please note that this product is available in
other strengths and pharmaceutical forms
which may be more suitable for your
Taking other anti-inflammatory medicines or treatment.
medicines which prevent or break down
Information for elderly patients and for
blood clots at the same time as meloxicam
patients with impaired kidney or liver
may increase the risk of stomach or
function
intestinal ulcers, bleeding and damage to
For elderly patients, the recommended dose
the gut and stomach lining. The use of these for long-term treatment of rheumatoid
medicines at the same time as meloxicam is arthritis or ankylosing spondylitis is 7.5 mg
therefore not recommended.
per day. Also, patients at high risk of side
effects should start treatment with 7.5 mg a
Pregnancy and breast-feeding
day.
If pregnancy is established during use of
meloxicam, then the doctor is to be notified. If you have severe kidney dysfunction and
During the first 6 months of pregnancy your receive dialysis, the maximum dose of
meloxicam should be 7.5 mg per day.
doctor may punctually prescribe you this
medical product if necessary.
If you take more Meloxicam than you
During the last three months of pregnancy, should
do not use this product because meloxicam Symptoms of overdose are usually limited
to lethargy, drowsiness, nausea, vomiting
can have serious effects on your child, in
and pain in the stomach. These symptoms
particular cardiopulmonary and renal
are generally reversible. Severe overdose,
effects, even with only one administration.
however, may result in serious adverse drug
This product may not be used during
reactions (see section 4, below). Seek
breast-feeding.
medical advice immediately if the
prescribed dose has been exceeded.
If you are pregnant or breast-feeding, think
you may be pregnant or planning to have a If you forget to take Meloxicam
baby, ask your doctor or pharmacist for
Do not take a double dose to make up for a
advice before taking this medicine.
forgotten dose.
If you have any further questions on the use
Driving and using machines
of this medicine, ask your doctor or
Meloxicam may slightly affect your ability to
pharmacist.
drive and handle machines, due to the

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4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop taking Meloxicam 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 (Steven-Johnson Syndrome and
toxic epidermal necrolysis), lesions of soft
tissues (mucosal lesions) or erythema
multiforme.
Erythema multiforme is a serious allergic
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.
Any side effects of the digestive tract,
especially:
• bleeding (causing tar-coloured stools)
• ulceration of your digestive tract (causing
abdominal pain).











flatulence
constipation
indigestion (dyspepsia)
abdominal pain
tar-coloured stool due to bleeding in the
digestive tract (maleana)
vomiting of blood (haematemesis)
inflammation with building of ulcers in the
mouth (ulcerative stomatitis)
worsening of inflammation of the large
bowels (exacerbation of colitis)
worsening of inflammation of the
digestive tract (exacerbation of Crohn’s
disease).

Less frequently, inflammation of the
stomach (gastritis) has been observed.
Side effects of meloxicam
Very common (may affect more than 1 in 10
people):
• indigestion (dyspepsia)
• feeling sick (nausea) or being sick
(vomiting)
• abdominal pain
• constipation
• flatulence
• loose stools (diarrhoea).
Common (may affect 1 to 10 in 100 people):
• headache.

Uncommon (may affect up to 1 in 100
people):
• dizziness (light-headedness)
• a feeling of dizziness of 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
Bleeding of the digestive tract
and neck)
(gastrointestinal bleeding), formation of
ulcers or formation of a hole in the digestive • sodium and water retention

increased potassium levels (hyperkalaemia).
tract (perforation) may sometimes be severe
This can lead to symptoms such as:
and potentially fatal, especially in elderly.
• changes in your heartbeat (arrythmias)
• palpitations (when you feel your
If you have previously suffered from any
heartbeat more than usual)
symptoms of the digestive tract due to long
• muscle weakness
term use of NSAIDs, seek medical advice
• eructation
immediately, especially if you are elderly.
• inflammation of the stomach (gastritis)
Your doctor may monitor your progress
• bleeding of the digestive tract
whilst on treatment.
• inflammation of the mouth (stomatitis)
If affected by visual disturbances do not
• immediate allergic (hypersensitivity)
drive or operate machinery.
reactions
• itching (pruritus)
General side effects of non-steroidal
• skin rash
anti-inflammatory medicines (NSAIDs)
• swelling caused by fluid retention
The use of some non-steroidal
(oedema), including swollen ankles/legs
anti-inflammatory drugs (NSAIDs) may be
(oedema of the lower limbs)
associated with a small increased risk of
• sudden skin or mucosal swelling, such as
occlusion of arterial vessels (arterial
swelling around the eyes, face, lips, mouth
thrombotic events), e.g. heart attack
or throat, possibly making breathing
(myocardial infarction) or stroke (apoplexy),
difficult
(angioneurotic oedema)
particularly at high doses and in long term
• momentary disturbance of liver function
treatment.
tests (e.g. raised liver enzymes like
Fluid retention (oedema), high blood
transaminases or an increase of the bile
pressure (hypertension) and heart failure
pigment bilirubin). Your doctor can detect
(cardiac failure) have been reported in
these using a blood test
association with NSAID treatment.
• Disturbance of laboratory tests
investigating kidney (renal) function (e.g.
The most commonly-observed side effects
raised creatinine or urea).
affect the digestive tract (gastrointestinal
events):
Rare (may affect up to 1 in 1,000 people):
• ulcers of the stomach and upper part of
• mood disorders
the small bowels (peptic/gastroduodenal
• nightmares
ulcers)
• abnormal blood count, including:
• a hole in the wall of the bowels
• abnormal differential blood count
(perforation) or bleeding of the digestive
• decreased number of white blood cells
tract (sometimes fatal, particularly in the
(leucocytopenia)
elderly).
• decreased number of blood platelets
(thrombocytopenia)
The following side effects have been
These effects may lead to increased risk
reported after NSAID administration:
of
infection and symptoms such as
• feeling sick (nausea) and being sick
bruising or nosebleeds.
(vomiting)
• ringing in the ears (tinnitus)
• loose stools (diarrhoea)

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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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