Mobic

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Meloxicam 7.5mg

Dostupné z:

Boehringer Ingelheim (NZ) Limited

INN (Medzinárodný Name):

Meloxicam 7.5 mg

Dávkovanie:

7.5 mg

Forma lieku:

Tablet

Zloženie:

Active: Meloxicam 7.5mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Sodium citrate dihydrate

Počet v balení:

Blister pack, PVC/PVDC or Al foil, 10 tablets

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Boehringer Ingelheim Bidachem SpA

Terapeutické indikácie:

· Symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease). · Symptomatic treatment of rheumatoid arthritis. In patients for whom longer-term use may be required, treatment efficacy should be reviewed within the first month of treatment and MOBIC withdrawn if there is a lack of therapeutic benefit. Patients on long-term treatment should be reviewed regularly, such as every three months with regards to efficacy, risk factors and the ongoing need for treatment. The decision to prescribe a selective COX-2 inhibitor should only be made after assessment of the individual patient's overall risk for developing severe adverse events e.g. history of cardiovascular, renal, or gastrointestinal disease, and after use of alternative therapies such as non-pharmacological interventions and simple analgesic therapy where these have been found to lack analgesic efficacy or to have unacceptable adverse effects.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Tube, glass - 10 tablets - 60 months from date of manufacture stored at or below 30°C - Tube, plastic, polypropylene - 60 tablets - 60 months from date of manufacture stored at or below 30°C

Dátum Autorizácia:

1994-07-11

Príbalový leták

MOBIC NZ CMI v01
1
MOBIC

_TABLETS _
_meloxicam _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mobic.
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 Mobic 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, doctor, or from
http://www.medsafe.govt.nz/
consumers/cmi/cmiform.asp 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 MOBIC IS USED
FOR
Mobic is used to treat the symptoms
of osteoarthritis and rheumatoid
arthritis.
Both diseases mainly affect the joints
causing pain and swelling.
Although Mobic can relieve the
symptoms of pain and inflammation,
it will not cure your condition. Mobic
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 MOBIC
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MOBIC IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
meloxicam (the active ingredient)
•
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.

Súhrn charakteristických

MOBIC NZ DS v06
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
MOBIC
®
7.5 mg tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MOBIC 7.5 mg tablet
Each MOBIC tablet contains meloxicam 7.5 mg.
Excipient(s) with known effect:
Each MOBIC tablet contains lactose monohydrate 23.5 mg.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
MOBIC 7.5 mg tablet
Pale yellow, round, uncoated tablet, marked 59D on one side, with a
break bar^ and the Boehringer
Ingelheim company logo on the other side.
^The score line is to facilitate breaking the tablet for ease of
swallowing only. It is not intended to
divide the tablet into fractions or equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of painful osteoarthritis (arthrosis,
degenerative joint disease).
Symptomatic treatment of rheumatoid arthritis.
In patients for whom longer-term use may be required, treatment
efficacy should be reviewed
within the first month of treatment and MOBIC withdrawn if there is a
lack of therapeutic benefit.
Patients on long-term treatment should be reviewed regularly, such as
every three months with
regards to efficacy, risk factors and the ongoing need for treatment.
The decision to prescribe a selective COX-2 inhibitor should only be
made after assessment of the
individual patient's overall risk for developing severe adverse events
e.g. history of cardiovascular,
renal,
or
gastrointestinal
disease,
and
after
use
of
alternative
therapies
such
as
non-
pharmacological interventions and simple analgesic therapy where these
have been found to lack
analgesic efficacy or to have unacceptable adverse effects.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
As the potential for adverse reactions increases with dose and
duration of exposure, the shortest
duration possible and the lowest effective daily dose should be used
in all patients.
The
total
daily
dose
of
MOBIC
should
be
administered
as
a
single
dose.
The
maximum
recommended daily dose is 15 mg.
_Painful Osteoarthritis_:
7.5 mg/day. If necessary, the do