MELOXICAM 15MG TABLETS

Active substance: MELOXICAM

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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. • 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.
In this leaflet:
1. What Meloxicam Tablets are and what they are used for.
2. Before you take Meloxicam Tablets.
3. How to take Meloxicam Tablets.
4. Possible side effects.
5. How to store Meloxicam Tablets.
6. Further information.
1. WHAT MELOXICAM TABLETS ARE AND WHAT
THEY ARE USED FOR
Meloxicam belongs to the group of non-steroidal
anti-inflammatory drugs (NSAIDs) used for the treatment of
pain and to reduce inflammatory conditions in muscles and
joints.
Meloxicam Tablets have been approved for:
• the short-term symptomatic treatment of osteoarthrosis
(joint disease where the cartilage is lost)
• the long-term symptomatic treatment of pain in
connection with rheumatoid arthritis
• the long-term symptomatic treatment of a similar condition
called ankylosing spondylitis (inflammation of the spine).
2. BEFORE YOU TAKE MELOXICAM TABLETS
Do not take Meloxicam Tablets:
• if you are pregnant or breast-feeding
• if you are allergic (hypersensitive) to meloxicam or
any of the other ingredients of Meloxicam Tablets
• if you are allergic to acetylsalicylic acid (e.g. aspirin)
or other non-steroidal anti-inflammatory drugs
(NSAID). You must not use Meloxicam Tablets if you
have previously had symptoms of asthma, nasal
polyps, swelling in the skin or mucous membranes
(oedema) or hives (urticaria) following treatment with
acetylsalicyclic acid or other anti-inflammatory medicines
• if you have, or have had recurrent stomach or gut
ulcers or oesphagitis (inflammation of the gullet),
gastritis (inflammation of the stomach)
• if you have bleeding disorder or have ever suffered
from bleeding in the stomach or bowel
(gastrointestinal bleeding), or bleeding in the brain
(cerebrovascular bleeding)
• if you have severe liver problems
• if you have severe kidney failure and are not receiving
dialysis
• if you suffer from severe heart failure.
Take special care with Meloxicam Tablets:
• if you have previously had inflammation of the oesophagus
(oesophagitis); inflammation of the stomach lining (gastritis)
and/or stomach ulcers
• if you have a history of problems with your stomach
or gut (such as Crohn’s disease or ulcerative colitis)
• if you are elderly (because of increased side effects)
• if you have recently undergone major surgery
• if you have liver, kidney or heart problems
• if you are suffering from or have a history of asthma
• if you have an IUD (intra-uterine device e.g. coil)
fitted for contraception; the coil may not be as effective
• if you notice blood in your faeces (stools)
• if you notice any skin reaction
• if you have to take a blood or urine test, always

mention that you are taking Meloxicam Tablets
• if you are trying to become pregnant or undergoing
investigations of fertility
• if you suffer from an infectious disease, this medicinal
product may mask symptoms.
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 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 a high blood pressure, diabetes or high cholesterol or
are a smoker) you should discuss your treatment with your
doctor or pharmacist.
Taking other medicines - The following medicines
can affect or be affected by Meloxicam Tablets:
• anticoagulants, to stop your blood clotting, such as
warfarin, heparin and ticlopidine
• other non-steroidal anti-inflammatory drugs (NSAIDs)
such as aspirin
• Lithium (for mental illness)
• Methotrexate (for psoriasis and some cancers)
• thrombolytics (for heart conditions to dissolve blood clots)
• Cholestyramine (for reducing cholesterol)
• Ciclosporin (an immunosuppressant)
• diuretics (water tablets)
• medicines to treat high blood pressure such as atenolol
and enalapril
• corticosteroids (for asthma, inflammation and after
organ transplant surgery)
• selective serotonin-reuptake inhibitors (for depression)
• intrauterine contraceptive devices (contraceptive coils).
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Meloxicam Tablets with food and drink Meloxicam Tablets should be swallowed with water during
a meal.
Pregnancy and breast-feeding - You should not
take Meloxicam Tablets if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines - Meloxicam tablets
may cause side effects that may affect a person's ability to
drive and use machinery. Examples of side effects include
visual disturbances, drowsiness or dizziness. If you suffer
from any of these side effects it is advisable to refrain from
driving or using machinery.
Important information about some of the
ingredients of Meloxicam Tablets - 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 TABLETS
Always take Meloxicam Tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure.
Your doctor will give you the lowest possible dose, for the
shortest length of time, to treat your symptoms. If your
condition does not get better or you suffer from any side
effects, tell your doctor. Your doctor should monitor your
condition and treatment.
Dosage
Treatment of osteoarthrosis - The recommended
dose is 7.5 mg once daily. This may be increased by your
doctor to 15 mg once daily if the effect is too weak.

Treatment of pain from rheumatoid arthritis
and ankylosing spondylitis - The recommended
dose is 15 mg once daily.
Your doctor may reduce your dose to 7.5 mg a day if your
symptoms improve.
Never exceed a dose of 15 mg a day.
Kidney & liver impairment - In dialysis patients with
severe kidney failure, dosage should not exceed one tablet
of 7.5 mg a day. Patients with kidney or liver problems that
are not severe can be given the doses as stated above.
Meloxicam Tablets are not recommended for use for patients
with severe kidney failure who are not receiving dialysis.
Elderly - If you are elderly your doctor may recommend a
lower dose. The recommended dose for treatment of
rheumatoid arthritis and ankylosing spondylitis is 7.5 mg
once daily.
Children - Children under the age of 15 years should
not take Meloxicam Tablets.
Method of administration - Take Meloxicam Tablets
orally as a single dose with water and together with a meal.
If you take more Meloxicam Tablets than you
should - Contact your doctor or local emergency
ward. Take this leaflet and any tablets you still have with
you. Symptoms of overdose include lethargy, drowsiness,
feeling and being sick and stomach pains.
If you forget to take Meloxicam Tablets - If you
forget to take a dose, take it as soon as you remember it
unless it is nearly time for your next dose. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Meloxicam Tablets - Stopping
your medicine before finishing the course of treatment may
cause your pain or inflammation to get worse. It is important
not to stop taking your medicine without discussion with
your doctor.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Meloxicam Tablets can cause side
effects, although not everybody gets them. The following
side effects have been reported:
Common side effects (affecting fewer than 1 in 10
people): • anaemia (looking pale and feeling abnormally
tired) • dizziness (light-headedness) • headache
• indigestion • nausea (feeling sick) • vomiting • stomach
pain • constipation • wind • diarrhoea • intense itching
• rash • swelling especially of the lower limbs.
Uncommon side effects (affecting fewer than 1 in 100
people): • blood changes • vertigo • ringing in the ears
• drowsiness • palpitations • increased blood pressure
• feeling flushed • blood in your faeces (stools)
• stomach ulcers • inflammation of the oesophagus (food
pipe) symptoms include heartburn and a difficulty swallowing
• sore mouth or mouth ulcers • changes to kidney or liver
function tests • itchy swollen skin.
Rare side effects (affecting fewer than 1 in 1,000
people): • severe allergic reaction • mood disorders
• difficulty sleeping (insomnia) • nightmares • feeling
confused • eyesight problems such as blurred vision
• asthma attacks • pain due to tearing of the stomach or
gut wall • inflamed stomach or colon • hepatitis (liver
problems) • severe skin reactions (such as rash, fever and
blistering) • skin sensitivity to light • kidney failure.

Stomach ulcers may occur. These may bleed into the gut
(causing offensive, tar-coloured stools), rarely these ulcers
may perforate causing a hole in the wall of the bowel.
These can occur at any time and are especially important
in the elderly and very rarely have been fatal. If any of
these symptoms occur you should contact your doctor
immediately.
Rarely, serious allergic reactions such as anaphylactic
shock can occur. Symptoms include swelling of the face,
lips, tongue and throat which can result in breathing
difficulties. If you think you are having an allergic reaction
or you feel unwell stop the treatment and seek medical
advice immediately.
In rare cases, Meloxicam Tablets can affect the white blood
cells which can weaken your defence against infection. If
you contract an infection with symptoms such as fever, with
rapid deterioration in general condition, or fever with local
infection symptoms such as pain in the neck, throat, mouth
or difficulty passing urine, you must contact your doctor
immediately for a blood test to rule out a shortage of white
blood cells (agranulocytosis).
Medicines such as Meloxicam may be associated with a
small increased risk of heart attack ('myocardial infarction')
or stroke.
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.
5. HOW TO STORE MELOXICAM TABLETS
Keep out of the reach and sight of children.
Do not use Meloxicam Tablets after the expiry date which is
stated on the blister and carton. The expiry date refers to
the last day of that month. This medicinal product does not
require any special storage conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Meloxicam Tablets contain:
• The active substance is meloxicam. Each tablet contains
7.5 mg or 15 mg.
• The other ingredients are microcrystalline cellulose,
pregelatinised maize starch, lactose monohydrate, maize
starch, sodium citrate, colloidal anhydrous silica and
magnesium stearate.
What Meloxicam Tablets look like and contents
of the pack - Meloxicam 7.5 mg Tablets: Pale yellow,
round tablets with a score on one side.
Meloxicam 15 mg Tablets: Pale yellow, round tablets with a
score on one side.
PVC/PVdC/Al blister packs of 7, 10, 14, 15, 20, 28, 30,
50, 60, 100, 140, 280, 300, 500 or 1000 tablets (not all
pack sizes may be marketed).
Marketing authorisation holder: Generics [UK]
Limited, Potters Bar, Hertfordshire, EN6 1TL, England.

This leaflet was last approved
in: August 2009

LC2724 ITEM CODE

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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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