MELOXIBELL meloxicam 15mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

meloxicam, Quantity: 15 mg

Disponível em:

Generic Health Pty Ltd

DCI (Denominação Comum Internacional):

Meloxicam

Forma farmacêutica:

Tablet, uncoated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Resumo do produto:

Visual Identification: Pale-yellow, circular 10 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

Status de autorização:

Registered

Data de autorização:

2007-07-31

Folheto informativo - Bula

CONSUMER MEDICINE INFORMATION
MELOXIBELL
(MELOXICAM) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Meloxibell.
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
Meloxibell 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 MELOXIBELL IS USED
FOR
Meloxibell is used to treat the
symptoms of:
•
osteoarthritis;
•
rheumatoid arthritis.
Both diseases mainly affect the
joints causing pain and swelling.
Although Meloxibell can relieve
the symptoms of pain and
inflammation, it will not cure your
condition.
Meloxibell 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
MELOXIBELL
_WHEN YOU MUST NOT TAKE IT _
Do not take Meloxibell 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 of the
body;
•
rash, itching or hives on the
skin.
Do not take Meloxibell if you:
•
are about to undergo a
coronary artery bypass graft
surgery;
•
have a disease of the heart
with shortness of breath, and
swelling of the feet or lips
due to fluid build-up;
•
experience bleeding from the
stomach, gut or any other
bleeding;
•
had a stroke resulting from a
bleed in the brain or have a
bl

Características técnicas

AUSTRALIAN PRODUCT INFORMATION – MELOXIBELL
(MELOXICAM) UNCOATED TABLET
1
NAME OF THE MEDICINE
Meloxicam.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Meloxibell tablet contains 7.5 mg or 15 mg of Meloxicam.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Meloxibell 7.5 mg tablets are pale-yellow, circular, flat-bevelled
uncoated tablet with a break-line on
one side and plain on the other.
Meloxibell 15 mg tablets are pale-yellow, circular, flat-bevelled
uncoated tablet with a 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
DOSAGE
Meloxibell should be used at the lowest dose and for the shortest
duration consistent with effective
treatment.
The maximum recommended daily dose of Meloxibell 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 Meloxibell 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 (ie. 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
Meloxibell is contraindicated (see
SECTION 4.3 CONTRAINDICATIONS).
Meloxibell v6
Page 2 of 20
(meloxicam) uncoated tablet
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.
Patients on long term treatment shou