Meloxicam 7.5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Meloxicam

Disponibil de la:

Genus Pharmaceuticals Ltd

Codul ATC:

M01AC06

INN (nume internaţional):

Meloxicam

Dozare:

7.5mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 10010100

Prospect

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
6. Contents of the pack and other information
1.WHAT MELOXICAM TABLETS ARE AND
WHAT THEY ARE USED FOR
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
q
rheumatoid arthritis
q
ankylosing spondylitis (also known as Bechterew’s
Disease)
2.WHAT YOU NEED TO KNOW BEFORE
YOU TAKE MELOXICAM TABLETS
DO NOT TAKE MELOXICAM TABLETS IN THE FOLLOWING
CIRCUMSTANCES:
■
during the last three months of pregnancy
■
children and adolescents under 16 years of age
■
allergy to meloxicam
■
allergy (hypersensitivity) to aspirin or other anti-
inflammatory medicines (NSAIDs)
■
allergy (hypesensitivity) to any of the other
ingredients of this medicine (listed in section 6)
■
any of the following signs after taking aspirin or
other NSAIDs:
q
wheezing, chest tightness, breathlessness
(asthma)
q
nasal blockage due to swellings in the lining in
your nose (nasal polyps)
q
skin rashes/nettle rash (urticaria)
q
sudden skin or mucosal swelling, such as swelling
around the eyes, face, lips, mouth or throat,
possibly making breathing difficult (angioneurotic
oedema)
■
after previous therapy with NSAIDs and history of
q
bleeding in your stomach or intestines
q
holes (perforations) in your stomach or intestines
■
ulcers or a bleeding in your stomach or intestines
■
recent or history of stomach or peptic ulcers or
bleeding (ulceration or bleeding occurring at least
twice)
■
severely impaired liver function
■
non-dialysed kidney failure
■
recent bleeding in the brain (cerebrovascular
bleeding)
■
any kind of bleeding disorders
■
severe heart failure
■
intoleran

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Meloxicam 7.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg meloxicam.
Excipient: Each tablet contains 40.8 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 score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
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 impairme