MELOXICAM SANDOZ meloxicam 7.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meloxicam, Quantity: 7.5 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Meloxicam

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; sodium citrate dihydrate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Product summary:

Visual Identification: Pale-yellow, circular 7 mm, flat bevelled uncoated tablet, with break-line on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-07-12

Patient Information leaflet

MELOXICAM SANDOZ
1
MELOXICAM SANDOZ
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MELOXICAM SANDOZ?
MELOXICAM SANDOZ contains the active ingredient meloxicam. MELOXICAM
SANDOZ is used to treat the symptoms of
osteoarthritis and rheumatoid arthritis.
For more information, see Section 1. Why am I using MELOXICAM SANDOZ?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MELOXICAM SANDOZ?
Do not use if you have ever had an allergic reaction to meloxicam or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
Do not use at all during the last three months of pregnancy.
For more information, see Section 2. What should I know before I use
MELOXICAM SANDOZ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MELOXICAM SANDOZ and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MELOXICAM SANDOZ?
•
For the treatment of osteoarthritis: The usual dose of MELOXICAM
SANDOZ is 7.5 mg, taken as a single dose each day.
•
For the treatment of rheumatoid arthritis: The usual dose of MELOXICAM
SANDOZ is 15 mg taken as a single dose each
day.
Swallow the tablets whole with a full glass of water.
More instructions can be found in Section 4. How do I use MELOXICAM
SANDOZ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MELOXICAM SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using MELOXICAM SANDOZ.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking MELOXICAM
SANDOZ. MELOXICAM SANDOZ can slow down blood clotting.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - MELOXICAM SANDOZ (MELOXICAM)
1
NAME OF THE MEDICINE
Meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MELOXICAM SANDOZ 7.5 MG
Each tablet of MELOXICAM SANDOZ contains 7.5 mg of meloxicam
MELOXICAM SANDOZ 15 MG
Each tablet of MELOXICAM SANDOZ contains 15 mg of meloxicam
Excipients with known effect:
Contains lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablets
MELOXICAM SANDOZ tablets 7.5mg (pale yellow, circular, flat bevelled
uncoated tablet with a
central break-line on one side and plain on the other).
MELOXICAM SANDOZ tablets 15 mg (pale yellow, circular, flat bevelled
uncoated tablet with a
central break-line on one side and plain on the other).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.
4.2
DOSE AND METHOD OF ADMINISTRATION
MELOXICAM SANDOZ should be used at the lowest dose and for the
shortest duration consistent with
effective treatment.
The maximum recommended daily dose of MELOXICAM SANDOZ 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 SANDOZ 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 SANDOZ 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
a dose of 7.5 mg/day and increased
to 1