MOXICAM meloxicam 15 mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

meloxicam, Quantity: 15 mg

Saatavilla:

Alphapharm Pty Ltd

INN (Kansainvälinen yleisnimi):

Meloxicam

Lääkemuoto:

Tablet, uncoated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

30 Tablets, 10 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Tuoteyhteenveto:

Visual Identification: Pale yellow coloured, circular 10mm, flat bevelled uncoated tablet, with central breakline on one side, plain on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2007-05-15

Pakkausseloste

MOXICAM TABLETS
_meloxicam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOXICAM. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking MOXICAM
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MOXICAM IS
USED FOR
MOXICAM is used to treat the
symptoms of osteoarthritis and
rheumatoid arthritis. Both diseases
mainly affect the joints causing pain
and swelling.
Although MOXICAM can relieve
symptoms such as pain and
inflammation, it will not cure your
condition.
MOXICAM 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.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
MOXICAM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MOXICAM IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
meloxicam
•
any of the other ingredients listed
at the end of this leaflet
•
aspirin or any other NSAID
medicine
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 MOXICAM IF:
•
you are about to undergo
coronary artery bypass graft
surgery
•
you have a disease of the heart
with shortness of breath and
swelling of the feet or lips due to
fluid build-up
•
you experience bleeding from the
stomach, gut or any other
bleeding
•
you have had a stroke resulting
from a bleed in the brain or have
a bleeding disorder
•
have a galact

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
MOXICAM
_meloxicam tablets _
1
NAME OF THE MEDICINE
Meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MOXICAM tablet consists of 7.5 mg or 15 mg of the active
ingredient meloxicam.
Excipient with known effect: lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MOXICAM meloxicam 7.5 mg tablets: Each tablet contains 7.5 mg of
meloxicam as the active ingredient,
presented as a yellow coloured, circular 7 mm, flat bevelled uncoated
tablet, with central break line on one
side, plain on the other.
MOXICAM meloxicam 15 mg tablets: Each tablet contains 15 mg of
meloxicam as the active ingredient,
presented as a pale yellow coloured, circular 10 mm, flat bevelled
uncoated tablet, with central break line on
one side, plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOXICAM tablets are indicated for the symptomatic treatment of
osteoarthritis and rheumatoid arthritis.
4.2
DOSE AND METHOD OF ADMINISTRATION
MOXICAM should be used at the lowest dose and for the shortest
duration consistent with effective treatment.
The maximum recommended daily dose of MOXICAM 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 MOXICAM 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 Section 5.2
PHARMACOKINETIC PROPERTIES – 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
MOXICAM is contraindicated (see Section 4.3 CONTRAINDICATIONS).
In patients with increased risks of adverse reactions, e.g. a history
of gastrointestinal dis