MOBIGLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MELOXICAM

Available from:

Niche Generics Limited

ATC code:

M01AC06

INN (International Name):

MELOXICAM

Dosage:

7.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

meloxicam

Authorization status:

Marketed

Authorization date:

2005-12-16

Patient Information leaflet

PA 1063/020/01-02
1
June 2017
PACKAGE LEAFLET
PA 1063/020/01-02
2
June 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mobiglan 7.5 mg Tablets
Mobiglan 15 mg Tablets
Meloxicam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Mobiglan Tablets are and what they are used for
2.
What you need to know before you take Mobiglan Tablets
3.
How to take Mobiglan Tablets
4.
Possible side effects
5.
How to store Mobiglan Tablets
6.
Contents of the pack and other information
1.
WHAT MOBIGLAN TABLETS ARE AND WHAT THEY ARE USED FOR
Mobiglan Tablets contain the active substance meloxicam. Meloxicam
belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which
are used to reduce
inflammation and pain in the joints and muscles.
Mobiglan Tablets are used for the:
-
short-term (acute) treatment of flare ups of osteoarthritis.
-
long-term treatment of
-
rheumatoid arthritis
-
ankylosing spondylitis (also known as Bechterew’s disease).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOBIGLAN TABLETS
DO NOT TAKE MOBIGLAN TABLETS IF:
-
you are in the last three months of your pregnancy
-
you are a child or adolescent under 16 years of age
-
you are allergic to meloxicam or to any of the other ingredients of
this medicine (listed in
section 6).
-
you are allergic to aspirin or other NSAIDs
-
you develop any of the following signs after taking aspirin or other
NSAIDs
-
wheezing, chest tightness, breathlessness (asthma)
-
nasal blockage due to swellings in the lining of your nose (nasal
polyps

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mobiglan 7.5 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 7.5 mg of Meloxicam
Exipient with known effect: 63.00 mg of Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
The 7.5 mg tablets are light yellow, round, biconvex bevelledged
tablets with B and 18 debossed on one side and plain
on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-Short-term symptomatic treatment of exacerbation of osteoarthrosis.
-Long-term symptomatic treatment of rheumatoid arthritis or of
ankylosing spondylitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
The patient’s need for symptomatic relief and response to therapy
should be re-evaluated
periodically, especially in patients with osteoarthritis.
_-_
_Exacerbations of osteoarthrosis:_ 7.5 mg/day (one 7.5 mg tablet or
half a 15 mg tablet).
If necessary, in the
absence of improvement, the dose may be increased to 15mg/day (two 7.5
mg tablets or one 15mg tablet).
_-_
_Rheumatoid arthritis, ankylosing spondylitis:_ 15mg/day (two 7.5 mg
tablets or one 15 mg tablet). (See also
section ‘Special populations’ below).
According to the therapeutic response, the dose may be reduced to 7.5
mg/day (one 7.5 mg tablet or half a 15 mg
tablet).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
Special populations
_Elderly patients and patients with an increased risk of undesirable
effects (see section 5.2):_
The recommended dose for long-term treatment of rheumatoid arthritis
and ankylosing spondylitis in elderlypatients is
7.5 mg per day. Patients with increased risk for adverse reactions
should start treatment with 7.5 mg per day (see
section 4.4).
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