APO-MELOXICAM

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meloxicam, Quantity: 15 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Meloxicam

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: titanium dioxide; sunset yellow FCF; magnesium stearate; maize starch; sodium citrate dihydrate; Gelatin; lactose monohydrate; brilliant blue FCF; quinoline yellow

Administration route:

Oral

Units in package:

20, 30, 100, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Product summary:

Visual Identification: Light green/light yellow, size '2' hard gelatin capsules filled with light yellow coloured granules.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-10-18

Patient Information leaflet

APO-MELOXICAM
1
APO-MELOXICAM
_CAPSULES _
_Meloxicam _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
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.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking meloxicam
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT THIS MEDICINE IS
USED FOR
Meloxicam is used to treat the
symptoms of osteoarthritis and
rheumatoid arthritis. These
conditions mainly affect the joints,
causing pain and swelling.
_HOW IT WORKS _
Meloxicam belongs to a group of
medicines called non- steroidal anti-
inflammatory drugs (NSAIDs).
These medicines work by relieving
pain and inflammation.
Although meloxicam can relieve
symptoms of 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 it
for another reason.
This medicine is not addictive.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
THERE IS NOT ENOUGH INFORMATION TO
RECOMMEND THE USE OF THIS
MEDICINE FOR CHILDREN UNDER THE
AGE OF 18 YEARS.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
meloxicam
•
aspirin or any other NSAIDs
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
rash, itching or hives on the skin
•
swelling of the face, lips, tongue,
or other parts of the body
•
shortness of breath
•
wheezing or difficulty breathing
DO NOT TAKE THIS MEDICINE IF YOU
HAVE ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
coronary artery bypass graft
surgery
•
heart disease with sh

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-MELOXICAM (MELOXICAM) CAPSULES
1
NAME OF THE MEDICINE
Meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains either 7.5 mg or 15 mg meloxicam as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate, gelatin.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
7.5 MG CAPSULES
Light green/light green, size ‘2’ hard gelatin capsules filled
with light yellow coloured granules.
15 MG CAPSULES
Light green/light yellow, size ‘2’ hard gelatin capsules filled
with light yellow coloured granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meloxicam is indicated for the symptomatic treatment of osteoarthritis
and rheumatoid arthritis.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Meloxicam capsules are intended for oral administration.
DOSAGE
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, treatment should be
started at dose of 7.5 mg/day
and increased to 15 mg/day only if clinically justified.
Patients on long term treatment