CIPLA MELOXICAM 7.5 meloxicam 7.5 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

meloxicam, Quantity: 7.5 mg

可用日期:

Cipla Australia Pty Ltd

药物剂型:

Tablet, uncoated

组成:

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

给药途径:

Oral

每包单位数:

30 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

產品總結:

Visual Identification: Pale-yellow, circular 7 mm, flat bevelled uncoated tablet, with a central 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

授权状态:

Registered

授权日期:

2018-04-03

资料单张

CIPLA MELOXICAM
1
CIPLA MELOXICAM
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 CIPLA MELOXICAM?
CIPLA MELOXICAM contains the active ingredient meloxicam. CIPLA
MELOXICAM is used to treat the symptoms of
osteoarthritis and rheumatoid arthritis.
For more information, see Section 1. Why am I using CIPLA MELOXICAM?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA MELOXICAM?
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
CIPLA MELOXICAM? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CIPLA MELOXICAM 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 CIPLA MELOXICAM?
•
For the treatment of osteoarthritis: The usual dose of CIPLA MELOXICAM
is 7.5 mg, taken as a single dose each day.
•
For the treatment of rheumatoid arthritis: The usual dose of CIPLA
MELOXICAM 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 CIPLA
MELOXICAM? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA MELOXICAM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using CIPLA MELOXICAM.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking CIPLA
MELOXICAM. CIPLA MELOXICAM can slow down blood clotting.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING

产品特点

AUSTRALIAN PRODUCT INFORMATION - CIPLA MELOXICAM (MELOXICAM)
1
NAME OF THE MEDICINE
Meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIPLA MELOXICAM 7.5 MG
Each tablet of CIPLA MELOXICAM contains 7.5 mg of meloxicam
CIPLA MELOXICAM 15 MG
Each tablet of CIPLA MELOXICAM 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
CIPLA MELOXICAM tablets 7.5mg (pale yellow, circular, flat bevelled
uncoated tablet with a central
break-line on one side and plain on the other).
CIPLA MELOXICAM 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
CIPLA MELOXICAM should be used at the lowest dose and for the shortest
duration consistent with
effective treatment.
The maximum recommended daily dose of CIPLA 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 CIPLA 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 CIPLA 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
a dose of 7.5 mg/day and increased
to 15 mg/day on