MELOXICAM 7.5MG TABLETS

Active substance: MELOXICAM

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Meloxicam 7.5mg and 15mg Tablets

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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1.
What Meloxicam tablets are and what they are used for
2.
What you need to know before you take Meloxicam tablets
3.
How to take Meloxicam tablets
4.
Possible side effects
5.
How to store Meloxicam tablets
Contents of the pack and other information
6.
1.
What Meloxicam tablets are and what they are used for
Meloxicam tablets contain the active substance meloxicam. Meloxicam belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain
in joints and muscles.
Meloxicam tablets are used for the:
short-term treatment of flare-ups of osteoarthritis
long-term treatment of
o rheumatoid arthritis
o ankylosing spondylitis (also known as Bechterew’s Disease)
2.

What you need to know before you take Meloxicam tablets

Do not take Meloxicam tablets:
during the last three months of pregnancy
if you are under 16 years of age
if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs)
if you have had 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)
if after previous therapy with NSAIDs you have a history of
bleeding in your stomach or intestines
holes (perforations) in your stomach or intestines
if you have ulcers or a bleeding in your stomach or intestines
if you have recent or history of stomach or intestinal ulcers or bleeding (ulceration or bleeding
occurring at least twice)
if you have severely impaired liver function

if you have non-dialysed severe kidney failure
if you have had recent bleeding in the brain (cerebrovascular bleeding)
if you have any kind of bleeding disorders
if you have severe heart failure.
If you are unsure whether any of the above apply to you, please contact your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Meloxicam tablets
Medicines such as Meloxicam tablets 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 Meloxicam tablets for longer than it is prescribed for you (see section 3 “How to take
Meloxicam tablets”).
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 Meloxicam tablets 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 Meloxicam tablets immediately as soon as you notice bleeding (causing tarcoloured stools) or ulceration of your digestive tract (causing abdominal pain).
Meloxicam tablets are not appropriate if you require immediate relief from acute pain.
Meloxicam tablets may hide the symptoms of infection (e.g. fever). If you think you may have an
infection you should see your doctor.
As it will be necessary to adjust the treatment, it is important to ask your doctor’s advice before you
take Meloxicam tablets in case of:
- history of inflammation of the gullet (oesophagitis), inflammation of the stomach (gastritis) or any other
disease of the digestive tract, e.g. ulcerative colitis, Crohn’s disease
- 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
- bronchial asthma or a previous history of it
Your doctor will need to monitor your progress whilst on 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 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 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, stop taking meloxicam, seek urgent advice
from a doctor and tell him that you are taking this medicine.
Children and adolescents
Meloxicam tablets should not be given to children and adolescents under 16 years of age.
Other medicines and Meloxicam tablets
Meloxicam tablets may affect or be affected by other medicines.
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, or are using any of the
following:
- other NSAIDs
- medicines which prevent blood clotting
- medicines which break down blood clots (thrombolytics)
- medicines to treat heart disease
- medicine to treat kidney disease
- corticosteroids (e.g. used against inflammation or allergic reactions)
- ciclosporin or tacrolimus – 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.
- 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
- colestyramine – 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.
Meloxicam tablets with food and drink
The tablets should be swallowed whole with water, or another drink, during a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
If a pregnancy is established during use of Meloxicam tablets, 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 tablets 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.

Fertility
Meloxicam tablets 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 becoming pregnant.
Driving and using machines
Visual disturbances, drowsiness, vertigo (dizziness) or other central nervous system disturbances may
occur with this product. If affected do not drive or operate machinery.
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 medicine.
3.

How to take Meloxicam tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed whole with water, or another drink, during a meal.
If you need to take two tablets they must be taken together as a single dose.
Dose
Your doctor should prescribe as low a dose as possible. This will reduce any side effects you may
experience.
Flare-ups of osteoarthritis:
The recommended dose is 7.5mg a day. Your doctor may increase your dose to 15mg a day if needed.
Rheumatoid arthritis:
The recommended dose is 15mg a day. This may be reduced to 7.5mg a day if needed.
Ankylosing spondylitis:
The recommended dose is 15mg a day. This may be reduced to 7.5mg a day if needed.
Do not exceed the recommended maximum dose of 15mg a day.
If any of the statements listed under the heading "Warnings and precautions" apply to you, your doctor
may restrict your dose to 7.5 mg (one tablet) once a day.
Use in children and adolescents
Meloxicam tablets should not be given to children and adolescents under 16 years of age.
If you feel that the effect of Meloxicam tablets 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.
If you take more Meloxicam tablets 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 Meloxicam tablets. 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)
- standstill of the heart (cardiac arrest)
- immediate allergic (hypersensitivity) reactions, including:
- fainting
- shortness of breath
- skin reactions
If you forget to take Meloxicam tablets
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 medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Meloxicam tablets 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 (StevenJohnson 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
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.
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 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: affects more than 1 user in 10
- indigestion (dyspepsia)
- feeling sick (nausea) and being sick (vomiting)
- abdominal pain
- constipation
- flatulence
- loose stools (diarrhoea)
Common: affects 1 to 10 users in 100
- headache
Uncommon: affects 1 to 10 users in 1,000
- 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 (arrythmias)
- palpitations (when you feel your heartbeat more than usual
- muscle weakness

- eructation
- inflammation of the stomach (gastritis)
- bleeding of the digestive tract
- inflammation of the mouth (stomatitis)
- immediate allergic (hypersensitivity) reactions
- itching (pruritus)
- skin rash
- swelling caused by fluid retention (oedema), including swollen ankles/legs (oedema of the lower limbs)
- sudden skin or mucosal swelling, such as swelling around the eyes, face, lips, mouth or throat, possibly
making breathing difficult (angioneurotic 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 1 to 10 users in 10,000
- mood disorders
- 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 infection 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)
- inflammation of the large bowel (colitis)
- onset of asthma attacks (seen in people who are allergic to aspirin or other NSAIDs)
- nettle rash (urticaria)
- visual disturbances including:
- blurred vision
- conjunctivitis (inflammation of the eyeball or eyelids)
- potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported (see section 2).
Very rare: affects less than 1 user in 10,000
- 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 of the abdomen
- 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
- 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 tablets 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 tablets
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, pharmacist or nurse. This includes any side effects not
listed in this leaflet.
5.
How to store Meloxicam tablets
Keep this medicine out of the sight and reach of children.
This product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton.
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 tablets contain
The active substance (the ingredient that makes the medicine work) is meloxicam. Each tablet
contains either 7.5mg or 15mg meloxicam.
The other ingredients are maize starch, pregelatinised maize starch, colloidal anhydrous silica, sodium
citrate, lactose monohydrate, microcrystalline cellulose and magnesium stearate
What Meloxicam tablets look like and contents of the pack
The tablets are pale, yellow coloured and round with a central breakline on one side and plain on the other
side.
Pack sizes: 30 tablets.
Marketing Authorisation Holder
Actavis
Barnstaple
EX32 8NS
UK
Manufacturers
Actavis
Barnstaple
EX32 8NS
UK
PharmaPack International B.V.

Bleiswijkseweg 51, 2712 PB Zoetermeer,
The Netherlands
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,Dupnitsa, 2600,
Bulgaria
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark:
Malcox
The Netherlands: Meloxicam Actavis 7.5 mg
Meloxicam Actavis 15 mg
United Kingdom: Meloxicam
This leaflet was last revised in
December 2013

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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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