APO-MELOXICAM meloxicam 15mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

meloxicam

Διαθέσιμο από:

Apotex Pty Ltd

INN (Διεθνής Όνομα):

Meloxicam

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

APO-MELOXICAM
TABLETS
_Contains the active ingredient, meloxicam_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE
This leaflet answers some common
questions about meloxicam. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Meloxicam. It contains the active
ingredient meloxicam.
It is used to treat the symptoms of:
•
osteoarthritis
•
rheumatoid arthritis.
Both diseases mainly affect the
joints, causing pain and swelling.
Although meloxicam can relieve
symptoms such as pain and
inflammation, it will not cure your
condition.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Meloxicam belongs to a family of
medicines called Non-Steroidal Anti-
inflammatory Drugs (NSAIDs).
These medicines work by relieving
pain and inflammation.
This medicine is available only with
a doctor's prescription

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PI – APO-MELOXICAM TABLETS
(MELOXICAM)
1
NAME OF THE MEDICINE
Meloxicam
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains meloxicam as the active ingredient. In addition,
each tablet contains the
following inactive ingredients: microcrystalline cellulose, lactose
monohydrate, magnesium stearate,
colloidal anhydrous silica, sodium citrate dihydrate, maize starch,
pregelatinised maize starch.
Excipients with known effect: Lactose
7.5 MG TABLETS:
Pale yellow, circular 7 mm, flat bevelled uncoated tablet, with
central break-line on one side and
plain on other side.
15 MG TABLETS:
Pale yellow, circular 10mm, flat bevelled uncoated tablet, with
central break-line on one side and
plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Meloxicam should be used at the lowest dose and for the shortest
duration consistent with effective
treatment.
The maximum recommended daily dose of meloxicam is 15 mg. A dose of 15
mg/day should not be
exceeded. As a dose for children has not been established, use should
be restricted to adults (SEE
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, PAEDIATRIC USE).
The dose of meloxicam in patients with end stage renal failure on
haemodialysis should not exceed
7.5
mg/day
(SEE
SECTION
5.2
PHARMACOKINETIC
PROPERTIES
–
RENAL
IMPAIRMENT
AND
HAEMODIALYSIS). No dose reduction is required in patients with mild or
moderate renal impairment
(i.e. in patients with a creatinine clearance of greater than 25
mL/min) nor in patients with mild to
moderate hepatic impairment. In non-dialysed patients with severe
renal impairment meloxicam is
contraindicated (SEE SECTION 4.3 CONTRAINDICATIONS).
In patients with increased risks of adverse reactions, e.g. a history
of gastrointestinal disease or risk
factors for cardiovascular disease, the treatment should be started at
7.5 mg/day and increased to
15 mg/day only if clinicall