PHARMACOR MELOXICAM 15 meloxicam 15mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

meloxicam, Quantity: 15 mg

Tilgjengelig fra:

Pharmacor Pty Ltd

INN (International Name):

Meloxicam

Legemiddelform:

Tablet, uncoated

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

30 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Produkt oppsummering:

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

Autorisasjon status:

Registered

Autorisasjon dato:

2007-07-31

Informasjon til brukeren

Pharmacor Meloxicam (V 03)
1
Pharmacor Meloxicam
meloxicam
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common
questions about PHARMACOR
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 PHARMACOR
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.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
Pharmacist or doctor and may
contain important information about
the medicine and its use of which
you should be aware.
Keep this leaflet with the medicine.
You may need to read it again.
What PHARMACOR
MELOXICAM is used for
PHARMACOR MELOXICAM is used to
treat the symptoms
of:
• osteoarthritis
• rheumatoid arthritis.
Both diseases mainly affect the
joints causing pain and swelling.
Although PHARMACOR MELOXICAM
can relieve the symptoms of pain
and inflammation, it will not cure
your condition. PHARMACOR
MELOXICAM 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 it
When you must not take it
Do not take PHARMACOR
MELOXICAM 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, itchin

Preparatomtale

Pharmacor Meloxicam (V 03)
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR MELOXICAM (MELOXICAM) TABLETS
1
NAME OF THE MEDICINE
meloxicam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains meloxicam 15 mg or meloxicam 7.5 mg as the active
ingredient.
Excipient with known effect: Lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pharmacor Meloxicam tablets 7.5 mg are pale yellow, circular, flat
bevelled uncoated tablet with a
central breakline on one side and plain on the other.
Pharmacor Meloxicam tablets 15 mg are pale yellow, circular, flat
bevelled uncoated tablet with a
central breakline on one side and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Pharmacor Meloxicam should be used at the lowest dose and for the
shortest duration consistent
with effective treatment.
The maximum recommended daily dose of Pharmacor 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 Pharmacor 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.
Pharmacor Meloxicam (V