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MELOXICAM 7.5MG ORODISPERSIBLE TABLETS

Active substance(s): MELOXICAM / MELOXICAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Meloxicam 7.5 mg Orodispersible Tablets
Meloxicam 7.5 mg

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, please 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 become 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 orodispersible 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 ORODISPERSIBLE TABLETS
ARE AND WHAT THEY ARE USED FOR
Meloxicam tablets belong to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) which can be used to
reduce inflammation and pain in joints and muscles.
(Orodispersible tablets are tablets which dissolve easily in the
mouth).
Meloxicam tablets are used for:
 the short-term treatment of the symptoms of acute attacks of
osteoarthritis;
 the long-term treatment of the symptoms of:
- rheumatoid arthritis,
- ankylosing spondylitis (a disease of the backbone).
2. BEFORE YOU TAKE MELOXICAM TABLETS
Do not take Meloxicam tablets and tell your doctor if you:
 are allergic to Meloxicam or to any of the other ingredients
 (See section 6 for a list of these);
 are pregnant, planning to become pregnant or if you are breastfeeding;
 are allergic to aspirin or to other non-steroidal anti-inflammatory
medicines (NSAIDs);
 have ever developed signs of asthma (wheezing), nasal polyps
along with a runny nose, swelling of the skin or nettle-rash, when
taking aspirin or other anti-inflammatory medicines;
 have or have ever had an ulcer of the stomach or intestines;
 have any kind of bleeding disorder or have ever suffered from
bleeding in the stomach or intestines or bleeding in the brain;
 have severe liver disease;
 have severe kidney failure and are not receiving dialysis;
 suffer from severe heart failure
 have Crohn´s disease
 have ulcerative colitis
 suffer from pain after coronary artery bypass
If you think any of these apply to you, do not start taking these
Meloxicam tablets. Talk to your doctor first and follow the advice
given to you.
Take special care with Meloxicam tablets
Tell your doctor or pharmacist before taking this medicine:
 if you have high blood pressure;
 if you have heart, liver or kidney disease;
 if you have diabetes;
 if you are elderly (65 years old or more);
 if you have an inherited illness called phenylketonuria, because
this medicine contains aspartame (E951);
 if you have been told that you have intolerance to some sugars,
because this medicine contains sorbitol (E420), a kind of sugar,
 if you have a reduced volume of blood in your body, which
may occur if you have serious blood loss or burns, surgery or

low fluid intake;
 if you have ever been diagnosed with high potassium levels
in the blood;
Tell your doctor if you think any of these apply to you.
Warning
Medicines such as these Meloxicam tablets may be
associated with a small increased risk of heart attack or
stroke. Any risk is more likely with high doses and prolonged
treatment. Do not exceed the recommended dose or duration of
treatment.
Discuss your treatment with your doctor or pharmacist if you have
heart problems, have previously had a stroke or you think you
might be at risk of conditions such as high blood pressure,
diabetes or high cholesterol, or if you are a smoker.
Taking other medicines
When you are taking Meloxicam tablets, do not take any other
medicines – including medicines obtained without a prescription –
without first talking to your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking any of the
following medicines:
 any other non-steroidal anti-inflammatory drugs (NSAIDs),
including aspirin;
 medicines to prevent blood clotting, such as warfarin;
 medicines to break down blood clots;
 medicines to treat high blood pressure;
 oral corticosteroids;
 cyclosporin;
 any diuretic medicine (your doctor may monitor your kidney
function if you are taking diuretics);
 lithium, used to treat mood disorders;
 selective serotonin re-uptake inhibitors, used in the treatment
of depression;
 methotrexate;
 colestyramine;
 you use an intrauterine contraceptive device (IUD), usually
known as a coil.
Pregnancy and breast-feeding
Meloxicam tablets are not recommended for use by women who
are pregnant or breast-feeding.
Tell your doctor immediately if you are pregnant, think you may
be pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before using any
medicine.
Children (under 16 years old)
This medicine must not be given to children under 16years old.
Driving and using machinery
Do not drive or operate machinery until you know how Meloxicam
tablets affect you. If the tablets make you feel light-headed, dizzy
or drowsy, or cause blurred vision, do not drive or operate
machinery.
Important information about some of the ingredients of
Meloxicam tablets
 These tablets contain the sweetener aspartame (E951), a
source of phenylalanine. Contact your doctor before taking them
if you have an inherited illness called phenylketonuria.
 These tablets contain sorbitol (E420), a kind of sugar. If you
have ever been told you have intolerance to some sugars, contact
your doctor before taking these tablets.
3. HOW TO TAKE MELOXICAM TABLETS
Always take Meloxicam tablets exactly as your doctor has told you
to. Check with your doctor or pharmacist if you are not sure. Read
the label carefully.
Taking this medicine
 Place the tablet in your mouth on your tongue.
 allow it to dissolve, slowly for five minutes (It must never be
chewed or swallowed undissolved)
 swallow with a drink of 240 ml of water.
 If you have a dry mouth, use water to moisten it first.
 Never take more than the recommended maximum dose of

15 mg (two tablets) a day.
Dosage
The dose depends on the medical condition which is being
treated. Your doctor will let you know how much you should take.
For the treatment of acute attacks of osteoarthritis:
The usual dose is 7.5 mg (one tablet) a day. Your doctor may increase
your dose to 15 mg (two tablets) a day, if necessary.
For the treatment of rheumatoid arthritis and ankylosing
spondylitis:
The usual dose is 15 mg (two tablets) a day. Your doctor may
reduce your dose to 7.5 mg (one tablet) a day if necessary.
If you are aged 65 years and over, the recommended dose for
the long term treatment of rheumatoid arthritis and ankylosing
spondylitis is 7.5 mg (one tablet) a day.
If you have any of the conditions listed in Section 2 under the
heading “Take special care with Meloxicam tablets”, your doctor
may restrict your dose to 7.5 mg (one tablet) a day.
If you feel that the effect of these Meloxicam tablets is too strong or
too weak, or after several days you do not feel any
improvement in your condition, consult your doctor or
pharmacist.
If you take more of this medicine than you should
Contact your doctor or pharmacist immediately or go
immediately to the accident and emergency department of
your nearest hospital, taking this leaflet or the tablets with you.
If you forget to take your tablet
Never take two doses on the same day to make up for one you
have missed.
Take your usual dose the next day.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Meloxicam tablets can cause side effects,
although not everybody gets them.
 If you have a history of gastrointestinal symptoms while
taking anti inflammatory drugs, your doctor may monitor your
progress while
you are having this treatment.
Clinical trials and scientific data suggest that use of some
NSAIDs (particularly at high doses and in long term treatment)
may be
associated with a small increased risk of blood clots in the
arteries (which could, for
example, lead to heart attack
or stroke).
Contact your doctor immediately, or go immediately to the
accident and emergency department of your nearest hospital,
(taking this leaflet or the tablets with you), if you get the following
serious side effects:
 severe allergic reactions which may include fainting, shortness
of breath, skin reactions and asthma attacks (common side effect:
affects 1 to 10 users in 100);
 bleeding in the stomach or intestines, peptic ulcers, soreness or
inflammation of the mouth, or inflammation of the gullet
(uncommon side effect: affects 1 to 10 users in 1,000);
 severe blistering or peeling of the skin, swelling around the
eyes, lips and face, rashes caused by exposure to sunlight (rare
side effect: affects 1 to 10 users in 10,000).

 a hole in the bowel wall, inflammation or soreness of the
stomach or intestines (ulcers of the stomach or intestines,
bleeding and perforations in the stomach or intestines can
occur at any time, can some times, especially in the elderly,
be severe and could, very rarely, in fewer than 1 in every
10,000 patients treated, be fatal);
 confusion, mood swings, insomnia, nightmares;
 visual disturbances such as blurred vision;
 inflammation of the liver (hepatitis);
 kidney failure.
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.
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 Yellow
Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE MELOXICAM TABLETS
 Keep out of the reach and sight of children.
 Do not transfer the tablets to another container.
 This product does not require any other special storage
requirements in EU countries.
 Do not use Meloxicam 7.5 mg orodispersible tablets after the
expiry date, which is stated on the pack. The expiry date refers
to the last day of that month.
 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 7.5 mg orodispersible tablets contain
The active ingredient is Meloxicam.
Each tablet contains 7.5 mg.
The other ingredients are mannitol (E421), aspartame
(E951), sorbitol (E420), citric acid anhydrous (E330), yoghurt
flavour, forest fruit flavour, povidone (E1201), talc (E553b),
sodium lauryl sulfate and magnesium stearate (E572).
What Meloxicam tablets look like and contents of the pack
Meloxicam 7.5 mg tablets are round light yellow, flat tablet
embossed with AX6 on one side. The tablets are supplied in:
 Boxes containing 2 blister packs of 10 tablets each,
 Boxes containing 3 blister packs of 10 tablets each,
 Boxes with one polyethylene bottle with polypropylene childresistant tamper-evident screw cap with desiccant containing
30 tablets each.
 Boxes with one polyethylene bottle with polypropylene childresistant tamper-evident screw cap with desiccant containing
200 tablets each.

Contact your doctor if you get the following side effects:
Pancreatitis (inflammation of the pancreas)

Marketing Authorisation Holder
Alpex Pharma (UK) Limited,
Warren Plantation - Church End
Haynes, Bedford
MK45 3RJ – UK
Contact address:
PO BOX 849,
Bedford, MK45 9EG

Common side effects (affects 1 to 10 users in 100):
 indigestion, feeling or being sick, abdominal pain,
constipation, flatulence, diarrhoea; skin rashes or itching;
 light-headedness, headaches;
 swelling of ankles and legs;
 anaemia.

Manufacturer
Kymos Pharma Services, S.L.
Ronda de Can Fatjó, 7B
(Parque Tecnológico del Vallès),
Cerdanyola del Vallès, 08290 Barcellona
Spain

Uncommon side effects (affects 1 to 10 users in 1,000):
 hypersensitivity;
 nettle rash or hives;
 dizziness, tinnitus, drowsiness;
 irregular heart beat, increased blood pressure, hot flushes;
 abnormal white blood cell or platelet numbers;
 changes to liver function;
 salt and water retention, excessive potassium, changes to
kidney function.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Bulgaria & Poland: Trosicam
Czech Republic: Oramellox 7.5 mg
Greece & Republic of Cyprus: Meloxicam /Medical
Hungaria: Trosicam 7.5 mg szájban diszpergálódó tabletta
Romania: Trosicam 7.5 mg comprimate orodispersible
Slovakia: Oramellox 7.5 mg
UK: Meloxicam 7.5 mg Orodispersible Tablets

Rare side effects (affects 1 to 10 users in 10,000):

This leaflet was last approved in 29.06.2017.

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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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