MELOBIC 15 meloxicam 15 mg capsule blister pack

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, hard

Composition:

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

Administration route:

Oral

Units in package:

30

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:

Licence status A

Authorization date:

2015-09-23

Patient Information leaflet

MELOBIC CMI
1
MELOBIC
_CAPSULES _
_Meloxicam _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Melobic.
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 Melobic
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Although Melobic can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Melobic belongs to a family of
medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs).
These medicines work by relieving
pain and inflammation.
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 available only with
a doctor's prescription.
•
have a disease of the heart with
shortness of breath, and swelling
of the feet or lips due to fluid
build-up
•
experience bleeding from the
stomach, gut or any other
bleeding
•
had a stroke resulting from a
bleed in the brain or have a
bleeding disorder
•
have a galactose intolerance
•
have a peptic (stomach) ulcer
•
have or have had inflammation of
the lining of the stomach or
bowel (e.g. Crohn's Disease or
Ulcerative Colitis)
This leaflet was last updated on the
•
have severe liver or kidney
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MELOBIC IS
USED FOR
Melobic is used to treat the
symptoms of:
•
osteoarthritis
•
rheumatoid arthritis.
Both diseases mainly affect the joints
causing pain and swelling.
BEFORE YOU TAKE
MELOB

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – MELOBIC 7.5 & 15
(MELOXICAM) CAPSULES
1
NAME OF THE MEDICINE
Meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MELOBIC capsules are intended for oral administration. Each capsule
contains either 7.5 mg or 15 mg
meloxicam as the active ingredient.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
MELOBIC 7.5 mg capsules: Light green/Light green, size ‘2’ hard
gelatin capsules filled with light yellow
coloured granules.
MELOBIC 15 mg capsules: Light green/Light yellow, size ‘2’ hard
gelatin capsules filled with light yellow
coloured granules.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Meloxicam is indicated for the symptomatic treatment of osteoarthritis
and rheumatoid arthritis.
4.2
D
OSE 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). 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
2
non-dialysed patients with severe renal impairment meloxicam is
contraindicated (see section 4.3
CONTRAINDICATIONS).
In patients with an increased risk of adverse reactions, e.g. a
history of gastrointestinal disease or risk
factors for cardiovascular disease, the treatment should be started at
a dose of 7.5 mg/day and
increased to 15 mg/day only if clinically justified.
OSTEOARTHRITIS
The recommended dos