Meloxicam 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Meloxicam

Available from:

Sandoz Ltd

ATC code:

M01AC06

INN (International Name):

Meloxicam

Dosage:

15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
M
ELOXICAM
7.5
MG AND
15
MG
T
ABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
!
_Keep this leaflet. You may need to read it again._
!
_Ask your pharmacist or doctor if you need more information or
advice._
!
_You must see a doctor if your symptoms worsen or do not improve._
!
_This medicine is prescribed for you personally and you should not
pass it on to others. It may harm_
_them, even if their symptoms are the same as yours._
IN THIS LEAFLET:
1.WHAT MELOXICAM IS AND WHAT IT IS USED FOR
2.BEFORE YOU TAKE MELOXICAM
3.HOW TO TAKE MELOXICAM
4.POSSIBLE SIDE EFFECTS
5.STORING MELOXICAM
6. FURTHER INFORMATION
The name of your medicine is Meloxicam 7.5mg or 15mg Tablets (referred
to as Meloxicam in this leaflet).
1. WHAT MELOXICAM IS AND WHAT IT IS USED FOR.
Meloxicam belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs are used to reduce
inflammation and pain in joints and muscles.
Meloxicam is used to treat short term bouts of osteoarthritis, and
long term for rheumatoid arthritis and ankylosing spondylitis.
2.
BEFORE YOU TAKE MELOXICAM
!
IF YOU ARE ALLERGIC TO MELOXICAM, TO ASPIRIN OR TO OTHER NSAID'S, or
to any of its ingredients
!
IF YOU HAVE DEVELOPED SIGNS OF ASTHMA (WHEEZING), nasal polyps (nasal
obstruction) along with runny nose, swelling of the
skin or rash when taking aspirin or other NSAIDs
!
IF YOU HAVE AN ACTIVE OR A HISTORY OF RECURRENT PEPTIC ULCERS (MORE
THAN TWO).
!
IF YOU HAVE A HISTORY OF GASTROINTESTINAL BLEEDING OR PERFORATION
RELATED TO THE USE OF NSAIDSS.
!
IF YOU HAVE SEVERE LIVER DISEASE
!
IF YOU HAVE SEVERE RENAL FAILURE and are not undergoing dialysis
!
IF YOU HAVE BLEEDING DISORDERS e.g. gastrointestinal or of the brain
!
IF YOU HAVE SEVERE UNCONTROLLED HEART FAILURE
!
DURING THE LAST TRIMESTER OF PREGNANCY OR IF YOU ARE PLANNING TO
BECOME PREGNANT OR BREAST FEEDING.
!
If you have high blood pressure or any liver, kidney or heart
problems.
!
If you have a history of gastrointestinal diseas

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Meloxicam 15mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15.0 mg of meloxicam.
Excipient: Each tablet contains 81.7 mg lactose (as lactose
monohydrate).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Pale yellow, round tablet with a score line on one side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of exacerbations of osteoarthrosis.
Long-term symptomatic treatment of rheumatoid arthritis or ankylosing
spondylitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
The total daily amount should be taken as a single dose, with water or
another liquid,
during a meal.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4). The
patient's need
for symptomatic relief and response to therapy should be re-evaluated
periodically,
especially in patients with osteoarthritis.
_Exacerbations of osteoarthrosis_: 7.5 mg/day (one tablet of 7.5 mg or
half a 15 mg
tablet).
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day
(two tablets of 7.5 mg or 1 tablet of 15 mg).
_Rheumatoid arthritis, ankylosing spondylitis_: 15 mg/day (two tablets
of 7.5 mg or 1
tablet of 15 mg) (see also “special populations”).
According to the therapeutic response, the dose may be reduced to 7.5
mg/day (one
tablet of 7.5 mg or half a 15 mg tablet).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
Special populations
_Elderly patients and patients with increased risks for adverse
reaction (see section _
_5.2): _
The recommended dose for long-term treatment of rheumatoid arthritis
and
ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients
with increased
risks for adverse reactions should start treatment with 7.5 mg per day
(see section
4.4).
_Renal impairment (see section 5.2): _
In dialysis patients with severe r