MELOXICAM 15 MG TABLETS

Active substance: MELOXICAM

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user
Meloxicam 7.5 mg tablets
Meloxicam 15 mg tablets
{Meloxicam}
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.
What is in this leaflet
1 What Meloxicam is and what it is used for
2 What you need to know before you take Meloxicam
3 How to take Meloxicam
4 Possible side effects
5 How to store Meloxicam
6. Contents of the pack and other information

1.

What Meloxicam is and what it is used for
Meloxicam contains the active substance meloxicam. Meloxicam is one of a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam reduces inflammation and pain in joints
and muscles.
Meloxicam is used for
short-term treatment of the symptoms associated with osteoarthritis when this condition flares up.
long-term treatment of the symptoms associated with rheumatoid arthritis and ankylosing spondylitis
also known as Bechterew‟s Disease (a type of arthritis that causes pain and stiffness around the
spine).

2.

What you need to know before you take Meloxicam
Do not take Meloxicam:
if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
during the last three months of pregnancy
if you are allergic to aspirin or other anti-inflammatory medicines (NSAIDs)
if you have any of the following signs after taking aspirin or other NSAIDs:
- wheezing, chest tightness, breathlessness (asthma)
- nasal obstruction due to swellings in the lining in your nose (nasal polyps)
- skin rashes/nettle rash (urticaria)
- sudden skin or mucosal swelling, such as around the eyes, face, lips mouth or throat
possibly making breathing difficult (angioneurotic oedema)
if you have a history of gastro-intestinal bleeding or holes (perforation) in your stomach or intestines
related to previous NSAIDs therapy
if you have an active or history of recurrent peptic ulcer or bleeding (ulceration or bleeding occurring
at least twice)
if you have severe liver disease
if you have non dialysed severe kidney disease;

Page 1 of 9
gxML 016 UK

if you have recent bleeding in the brain (cerebrovascular bleeding)
if you have any kind of bleeding disorder
if you have severe heart disease.
If you are unsure whether any of the above apply to you please contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Meloxicam.


Potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use of Meloxicam, appearing initially as
reddish target-like spots or circular patches often with central blisters on the trunk.



Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes).



These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering or peeling of the skin.



The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.



If you have developed exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal
necrolysis with the use of Meloxicam, you must not be re-started on Meloxicam at any time.



If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him
that you are taking this medicine.

Medicines such as Meloxicam 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
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 you
should discuss your treatment with your doctor or pharmacist. For example if you:
have high blood pressure (hypertension)
high levels of sugar sugar in your blood (diabetes mellitus)
high levels of cholesterol in your blood ( hypercholesterolemia)
are a smoker.
Meloxicam is not appropriate if you require immediate relief from pain.
As it will be necessary to adjust the treatment, it is important to ask for your doctor‟s advice, before you
take Meloxicam 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)
old age
heart, liver or kidney disease
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

Page 2 of 9
gxML 016 UK

Meloxicam may hide the symptoms of infections (e.g. fever). If you think you may have an infection you
should see your doctor.
If you are a woman, Meloxicam may impair your fertility. Therefore you should not take if you are
planning to become pregnant or if you have fertility problems / dosing fertility tests.
In the elderly, the risk of side effects is higher, in particular bleeding in your stomach or intestines-and
peptic ulcers. Heart, liver and kidney functions should be closely monitored. The doses should be
reduced.
Consult your doctor if any of the above warnings is applicable to you or has been in the past.
Other medicines and Meloxicam
Tell your doctor or pharmacist if you are currently taking, have recently taken or might any other
medicines. There are some medicines that should not be taken together and others that may need their
doses to be altered when taken together.
Always inform your doctor or pharmacist if you are using or receiving any of the following medicines
before taking Meloxicam:
aspirin or other non-steroidal anti-inflammatory drugs
medicines which prevent blood clotting
medicines which break down blood clots (thrombolytics)
medicines to treat heart and kidney diseases
corticosteroids (used against inflammation or allergic reactions)
lithium (used to treat mood disorders)
methotrexate (used to treat tumours or severe uncontrolled skin conditions and active rheumatoid
arthritis)
medicines to treat high blood pressure (e.g. beta-blockers)
Selective Serotonin Reuptake Inhibitors (SSRIs) used in the treatment of depression
cyclosporin (used after organ transplant or for severe skin conditions, rheumatoid arthritis or nephritic
syndrome)
any diuretic medicine (“water tablets”) - your doctor may monitor your kidneys function if you are
taking diuretics
cholestyramine (used to reduce cholesterol levels)
if you are a woman using an intrauterine contraceptive device (IUD), usually known as a coil, .
If you have any doubt about taking other medicines with Meloxicam consult your doctor or pharmacist.
Meloxicam with food, drink and alcohol
Taking this medicine with alcohol may increase the risk of stomach ulcers and bleeding. Ask your doctor
or pharmacist for advice before taking alcohol with this medicine.
Pregnancy, breast-feeding and fertility
Pregnancy
If a pregnancy is established during use of Meloxicam, then the doctor is to be notified.
During the first 6 months of pregnancy your doctor may punctually prescribe you this medical product if
necessary.
During the last three months of pregnancy, do not use this product, because Meloxicam can have serious
effects on your child, in particular cardiopulmonary and renal effects, even with only one administration.
Breast-feeding
This product is not recommended during breast feeding.

Page 3 of 9
gxML 016 UK

Fertility
Meloxicam 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.

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 disturbance may occur with this medicine. If this happens you should not drive or use machines.
Meloxicam 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.
3.

How to take Meloxicam
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Meloxicam is for oral use only. The total daily amount (according to the dosage tablet, please see below)
should be swallowed as a single dose with water or another liquid during a meal.
The recommended dose for:
short-term treatment of osteoarthritis is: 7.5 mg (one tablet Meloxicam 7.5 mg / half tablet Meloxicam 15
mg) per day . The dose may be increased, after consultation with your doctor, to 15 mg per day (two
tablets Meloxicam 7.5 mg / one tablet Meloxicam 15 mg) per day. Depending on the therapeutic effect,
the dose may be reduced to 7.5 mg.
long term treatment of rheumatoid arthritis and ankylosing spondylitis is: 15 mg (two tablets Meloxicam
7.5 mg / one tablet Meloxicam 15 mg) per day. Depending on the therapeutic effect, the dose may be
reduced to 7.5 mg.
Do not exceed the dose of 15 mg a day.
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.
Information for elderly patients and for patients with restricted kidney and liver function
For elderly patients the recommended dose for long-term treatment of rheumatoid arthritis or ankylosing
spondylitis is 7.5 mg per day. Also, patients at high risk of side effects should start treatment with 7.5 mg
Meloxicam a day.
If you have a severe kidney dysfunction and receive dialysis the maximum dose of Meloxicam should be
7.5 mg per day.
Use in children and adolescents
Meloxicam is not recommended for children and adolescents under 16 years of age.
If you take more Meloxicam than you should
If you take too much Meloxicam or suspect and overdose, contact your doctor or go to the nearest
hospital immediately.
Symptoms following acute NSAID overdose are usually limited to:
lack of energy (lethargy)
drowsiness

Page 4 of 9
gxML 016 UK

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 Meloxicam. 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 standstill of breathing (respiratory depression)
loss of consciousness (coma)
seizures (convulsions)
collapse of the blood circulation (cardiovascular collapse)
cardiac arrest
immediate allergic (hypersensitivity) reactions, including fainting, shortness of breath and skin
reactions
If you forget to take Meloxicam
If you have missed a dose, continue in accordance with your doctor‟s prescription. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Meloxicam
This class of anti-inflamatory drugs is not known to have any negetive consequences (so called rebound
effects) if stopped suddenly, you should always check with your doctor or pharmacist if you are not sure.
If you have any further questions on the use this medicine, ask your doctor or pharmacist.
4.

Possible side effects
Like all medicines, Meloxicam 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:
potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported (see section 2).
skin reactions, such as itching (pruritus), blistering or peeling of the skin, which can be severe 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
Any side effects of the digestive tract, especially:
bleeding (causing tar-coloured stools)
ulceration of your digestive tract (causing abdominal pain
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.

Page 5 of 9
gxML 016 UK

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.
If affected by visual disturbances do not drive or operate machinery.
General side effects of non-steroidal anti-inflammatory medicines (NSAIDs)
The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small
increased risk of occlusion of arterial vessels (arterial thrombotic events), e.g. heart attack (myocardial
infarction) or stroke (apoplexy), particularly at high doses and in long term treatment.
Fluid retention (oedema), high blood pressure (hypertension) and heart failure (cardiac failure) have been
reported in association with NSAID treatment.
The most commonly-observed side effects affect the digestive tract (gastrointestinal events):
ulcers of the stomach and upper part of the small bowels (peptic /gastroduodenal ulcers)
a hole in the wall of the bowels (perforation) or bleeding of the digestive tract (sometimes fatal,
particularly in the elderly)
The following side effects have been reported after NSAID administration:
feeling sick (nausea) and being sick (vomiting)
loose stools (diarrhoea)
flatulence
constipation
indigestion (dyspepsia)
abdominal pain
tar-coloured stool due to bleeding in the digestive tract (melaena)
vomiting of blood (haematemesis)
inflammation with building of ulcers in the mouth (ulcerative stomatitis)
worsening of inflammation of the digestive tract (e.g. exacerbation of colitis or Crohn's disease)
Less frequently, inflammation of the stomach (gastritis) has been observed.

Side effects of meloxicam – the active substance of Meloxicam tablets
Very common: may affect more than 1 in 10 people
indigestion
feeling sick (nausea) and being sick (vomiting)
abdominal pain
constipation
flatulence
loose stools (diarrhoea)
Common: may affect up to 1 in 10 people
headache
Uncommon: may affect up to 1 in 100 people
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)

Page 6 of 9
gxML 016 UK

sodium and water retention
increased potassium levels (hyperkalaemia).This can lead to symptoms such as:
- changes in your heartbeat (arrhythmias)
- palpitations (when you feel your heartbeat more than usual)
- muscle weakness
Inflammation of the stomach (gastritis)
bleeding of the digestive tract
inflammation of the mouth (stomatitis)
eructation
immediate allergic (hypersensitivity) reactions
itching (pruritus)
skin rash
swelling caused by fluid retention (oedema) including swollen ankles/legs (odema of the lower limbs)
sudden skin or mucosal swelling, such as around the eyes, face, lips, mouth or throat, possibly
making breathing difficult (angioneurotic oedema)
momentary disturbance of liver function tests (e.g. raised liver enzyme 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: may affect up to 1 in 1,000 people
mood swings
nightmares
abnormal blood count, including:
- abnormal differential blood count
- decreased number of white blood cells (leucocytopenia)
- decreased number of blood platelets (thrombocytopenia)
These side effects may lead to increased risk of infections and symptoms such as bruising or
nosebleeds.
ringing in the ear (tinnitus)
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 to other NSAIDs)
severe blistering of the skin or peeling (Stevens-Johnson Syndrome and toxic epidermal necrolysis)
nettle rash (urticaria)
vision disturbances including:
- blurred vision
- conjunctivitis (inflammation of the eyeball or eyelids)
inflammation of the large bowel (colitis)
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)
- stomach pain
- loss of appetite
acute failure of the kidneys (renal failure) in particular in patients with risk factors such as heart
disease, diabetes or kidney disease.
a hole in the wall of the bowels (perforation)
Not known: frequency cannot be estimated from the available data
confusion

Page 7 of 9
gxML 016 UK

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 throat
- infections
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)
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
5.

How to store Meloxicam
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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 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 meloxicam.
- Each tablet contains 15 mg meloxicam.
- The other ingredients are sodium citrate, lactose monohydrate, microcrystalline cellulose, povidone K
25, anhydrous colloidal silica, crospovidone and magnesium stearate.
What Meloxicam looks like and contents of the pack
Tablet
Meloxicam 7.5 mg tablets are light yellow, round, uncoated tablet with score line between „F‟ and „1‟
debossed on one side and plain on the other side.
Meloxicam 15 mg tablets are light yellow, round, uncoated tablet with score line between „F‟ and „2‟
debossed on one side and plain on the other side. The tablet can be divided into two equal doses.
Meloxicam 7.5 mg tablets are available in packs of 6, 10, 12, 14, 20, 28, 30, 50, 60 and 100 tablets.
Meloxicam 15 mg tablets are available in packs of 6, 10, 12, 14, 20, 28, 30, 40, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.

Page 8 of 9
gxML 016 UK

Marketing Authorisation Holder

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer(s)
Pfizer Service Company BVBA
Hoge Wei 10
B-1930 Zaventem, Belgium
or
Pfizer PGM
Zone Industrielle
29, route des Industries
37530 Pocé -Sur-Cisse, France

This leaflet was last revised in 02/2013
Ref: gxML 2_1 UK

Page 9 of 9
gxML 016 UK

Expand view ⇕

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.

Hide
(web5)