Melorex

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

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Descarcare Prospect (PIL)
17-05-2011

Ingredient activ:

Meloxicam 15mg

Disponibil de la:

REX Medical Ltd

INN (nume internaţional):

Meloxicam 15 mg

Dozare:

15 mg

Forma farmaceutică:

Tablet

Compoziție:

Active: Meloxicam 15mg Excipient: Colloidal anhydrous silica Pregelatinised starch 1500 Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Sodium citrate dihydrate

Unități în pachet:

Blister pack, Amber Al/PVC/PVDC, 10 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Cipla Ltd

Rezumat produs:

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

Data de autorizare:

2004-12-22

Prospect

                                MELOREX 
 
MELOXICAM 7.5MG AND 15 MG TABLETS  
 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about MELOREX. 
 
It does not contain all of 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 
MELOREX 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 your medicine. You may need to read it again.
 
 
WHAT MELOREX IS USED FOR 
MELOREX is used to treat the symptoms of: 
• osteoarthritis 
• rheumatoid 
arthritis 
Both diseases mainly affect the joints causing pain and swelling.
MELOREX can relieve 
symptoms such as pain and inflammation (swelling, redness and
soreness), however, it 
will not cure your condition. 
 
MELOREX belongs to a family of medicines called Non-Steroidal
Antiinflammatory 
Drugs (NSAIDs). These medicines work by relieving pain and
inflammation. Ask your 
doctor if you have any questions about why MELOREX has been
prescribed for you. 
Your doctor may have prescribed MELOREX for another reason.
 
 
BEFORE YOU TAKE MELOREX 
_WHEN YOU MUST NOT TAKE MELOREX _
Do not take MELOREX if you have an allergy to: 
•  the active ingredient, meloxicam, or any of the other
ingredients in MELOREX 
listed at the end of this leaflet (see ingredients). 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. 
 
Ask your doctor if you are unsure if you are allergic to
these ingredients. 
 
Do not take MELOREX if: 
•  you are about to undergo coronary arte
                                
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Caracteristicilor produsului

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NEW ZEALAND DATASHEET
1 PRODUCT NAME
Melorex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Meloxicam tablets 7.5 mg, 15 mg.
Excipient(s) with known effect:
Each 7.5 mg tablet contains 43 mg of lactose monohydrate.
Each 15 mg tablet contains 86 mg of lactose monohydrate.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
MELOREX 7.5 mg tablets are pale yellow coloured, circular flat beveled
uncoated tablets.
MELOREX 15 mg tablets are pale yellow coloured, circular flat beveled
uncoated tablets with
central breakline on one side and plain on the other.
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 Melorex tablets 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
Melorex tablets may be administered in a dose of 7.5mg daily. As the
potential for adverse
reactions increases with dose and duration of exposure, all patients
taking Melorex tablets
should commence therapy at the lowest recommended dose, and be
titrated to the lowest dose
compatible with effective control of symptoms for the shortest
possible period.
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OSTEOARTHRITIS:
7.5 mg per day. If necessary, the dose may be in
                                
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