MOXICAM meloxicam 15 mg capsule blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

meloxicam, Quantity: 15 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Meloxicam

약제 형태:

Capsule, hard

구성:

Excipient Ingredients: lactose monohydrate; maize starch; sodium citrate dihydrate; magnesium stearate; Gelatin; titanium dioxide; sunset yellow FCF; brilliant blue FCF; quinoline yellow

관리 경로:

Oral

패키지 단위:

30

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2015-09-23

환자 정보 전단

MOXICAM
1
MOXICAM
_CAPSULES _
_contains the active ingredient 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 expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
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 of these
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 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 (the active ingredient)
•
any of the other ingredients listed
at the end of this leaflet. This
includes rare inherited conditions
of galactose intolerance.
•
aspirin or any other NSAID
medicine.
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
troubled breathing.
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 an

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
MOXICAM
Meloxicam
1.
NAME OF THE MEDICINE
Meloxicam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MOXICAM capsules are intended for oral administration. Each capsule
contains either 7.5 mg or 15
mg meloxicam as the active ingredient.
Excipients of known effect: sugars as lactose.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
MOXICAM 7.5 mg capsules: Light green/Light green, size ‘2’ hard
gelatin capsules filled with light
yellow coloured granules.
MOXICAM 15 mg capsules: Light green/Light yellow, size ‘2’ hard
gelatin capsules filled with light
yellow coloured granules.
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). 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 an increased risk 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.
OSTEOARTHRITIS
The recommended dose of meloxicam is 7.5 mg once