APO-MELOXICAM meloxicam 15 mg tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

meloxicam, Quantity: 15 mg

Dostępny od:

Apotex Pty Ltd

Forma farmaceutyczna:

Tablet, uncoated

Skład:

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

Droga podania:

Oral

Sztuk w opakowaniu:

30 tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Podsumowanie produktu:

Visual Identification: Pale-yellow, circular 10 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

Status autoryzacji:

Registered

Data autoryzacji:

2018-11-16

Ulotka dla pacjenta

APO-MELOXICAM
_Meloxicam_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about meloxicam. 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
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
Meloxicam is used to treat the
symptoms of osteoarthritis and
rheumatoid arthritis. These
conditions mainly affect the joints,
causing pain and swelling.
_HOW IT WORKS_
Meloxicam belongs to a group of
medicines called non- steroidal anti-
inflammatory drugs (NSAIDs).
These medicines work by relieving
pain and inflammation.
Although meloxicam can relieve
symptoms of pain and inflammation,
it will not cure your condition.
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 not addictive.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
THERE IS NOT ENOUGH INFORMATION TO
RECOMMEND THE USE OF THIS
MEDICINE FOR CHILDREN UNDER THE
AGE OF 18 YEARS.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
meloxicam
•
aspirin or any other NSAIDs
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
rash, itching or hives on the skin
•
swelling of the face, lips, tongue
or other parts of the body
•
shortness of breath
•
wheezing or difficulty breathing
DO NOT TAKE THIS MEDICINE IF YOU
HAVE ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
coronary artery bypass graft
surgery
•
heart disease with shortness of
breath, and swelling o

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION – APO-MELOXICAM
TABLETS(MELOXICAM)
1
NAME OF THE MEDICINE
Meloxicam
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains meloxicam as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT: Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
7.5 MG TABLETS:
Pale yellow, circular 7 mm, flat bevelled uncoated tablet, with
central break-line on one side and
plain on other side.
15 MG TABLETS:
Pale yellow, circular 10mm, flat bevelled uncoated tablet, with
central break-line on one side and
plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meloxicam is indicated for the Symptomatic treatment of osteoarthritis
and rheumatoid arthritis.
4.2
DOSE 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
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 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
7.5 mg/day and increased to
15 mg/day only if clinically justified.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk fact