MELOXICAM SANDOZ 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:

Sandoz 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; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-04-11

Patient Information leaflet

MELOXICAM SANDOZ CMI V2
1
MELOXICAM SANDOZ
®
_MELOXICAM CAPSULES _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Meloxicam Sandoz.
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
Sandoz 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
The name of your medicine is
Meloxicam Sandoz. It contains the
active ingredient meloxicam.
It is used to treat the symptoms of
•
osteoarthritis
•
rheumatoid arthritis.
Both diseases mainly affect the joints
causing pain and swelling.
Although meloxicam can relieve
symptoms such as pain and
inflammation, it will not cure your
condition.
Meloxicam Sandoz 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 this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MELOXICAM SANDOZ IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
meloxicam
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines (such
as 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 of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU:
•
are about to undergo a coronary
artery bypass graft surgery
•

Summary of Product characteristics

210823-meloxicam-sandoz-pi
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
MELOXICAM SANDOZ
® (MELOXICAM) CAPSULES
1
NAME OF THE MEDICINE
Meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Meloxicam Sandoz
®
7.5 mg capsule contains 7.5 mg meloxicam.
Each Meloxicam Sandoz
®
15 mg capsule contains 15 mg meloxicam.
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Meloxicam Sandoz 7.5 mg capsules are light green/light green, size
‘2’ hard gelatin capsules
filled with light yellow coloured granules.
Meloxicam Sandoz 15 mg capsules are light green/light yellow, size
‘2’ hard gelatin capsules
filled with light yellow coloured granules.
_Not all strengths may be marketed in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Meloxicam Sandoz is indicated for the symptomatic treatment of
osteoarthritis and rheumatoid
arthritis.
4.2
D
OSE AND METHOD OF 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).
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 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
swallowed with fluid, in
conjunction with food. Depending on the adequacy of response, the
severity of the arthritic
condition and the patient’s concomitant diseases, the dose may be
increased to 15 mg/day.
Patients should generally be maintained on the lowest dose consistent
with achieving a
satisfactory therapeutic response.
210823-meloxicam-san