MELOXICAM VIATRIS meloxicam 15 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meloxicam, Quantity: 15 mg

Available from:

Helix Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium citrate dihydrate; povidone; crospovidone

Administration route:

Oral

Units in package:

60, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Light yellow, round, uncoated tablet with score line between 'F' and '2' debossed on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-10-07

Patient Information leaflet

MELOXICAM VIATRIS
1
MELOXICAM VIATRIS
_TABLETS _
_Meloxicam _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MELOXICAM
VIATRIS.
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 VIATRIS against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
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 MELOXICAM
VIATRIS IS USED FOR
MELOXICAM VIATRIS is used to
treat the symptoms of:
•
osteoarthritis
•
rheumatoid arthritis.
Both diseases mainly affect the joints
causing pain and swelling.
Although MELOXICAM VIATRIS
can relieve the symptoms of pain and
inflammation, it will not cure your
condition. MELOXICAM VIATRIS
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.
BEFORE YOU TAKE
MELOXICAM VIATRIS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MELOXICAM
VIATRIS IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
meloxicam
•
any of the ingredients listed at the
end of this leaflet
•
aspirin or any other NSAIDs.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – MELOXICAM VIATRIS
(MELOXICAM) TABLETS
1
NAME OF THE MEDICINE
Meloxicam.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MELOXICAM VIATRIS is available as tablets containing 7.5 mg and 15 mg
of meloxicam.
Excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
7.5 mg: Light yellow, round, uncoated tablet with score line between
‘F’ and ‘1’ debossed on one side
and plain on the other side.
15 mg: Light yellow, round, uncoated tablet with score line between
‘F’ and ‘2’ debossed on one side
and plain on the other side.
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 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 be higher
than 7.5 mg/day (see 5.2 PHARMACOKINETIC PROPERTIES – Renal
Impairment; 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
4.3 CONTRAINDICATIONS).
2
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
a dose of 7.5 mg/day and
increased to 15 mg/day only if clinically justified.
OSTEOARTHRITIS
The recommended dose of meloxicam is 7.5 mg once daily, to be
s