Mobic 7.5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MELOXICAM

Available from:

Boehringer Ingelheim International GmbH Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

ATC code:

M01AC06

INN (International Name):

MELOXICAM 7.5 mg

Pharmaceutical form:

TABLET

Composition:

MELOXICAM 7.5 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2007-04-19

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
MOBIC
® 7.5 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 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. This
includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What MOBIC is and what it is used for
2. What you need to know before you take MOBIC
3. How to take MOBIC
4.
Possible side effects
5.
How to store MOBIC
6.
Contents of the pack and other information
1. WHAT MOBIC IS AND WHAT IT IS USED FOR
MOBIC contains 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
joints and muscles.
MOBIC is used for the:
- short-term 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 MOBIC
DO NOT TAKE MOBIC:
- allergy to meloxicam or any of the other
ingredients of this medicine (listed in section 6)
- during the last three months of pregnancy
- children and adolescents under 16 years of age
- allergy (hypersensitivity) to aspirin or other
anti-inflammatory medicines (NSAIDs)
- any of the following signs after taking aspirin or
other NSAIDs:
- wheezing, chest tightness, breathlessness
(asthma)
- nasal blockage due to swellings in the lining in
your nose (nasal polyps)
- skin rashes/nettle rash (urticaria)
- sudden skin or mucosal swelling, such as
swelling around the eyes, face, lips, mouth or
throat, possibly making breathing difficult
(angioneurotic oedema)
- after previous therapy with NSAIDs and his

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mobic 7.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg of Meloxicam.
Excipient(s) with known effect
Each tablet contains 22.3 mg lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Light yellow round tablet with the logotype of the company on one side
and a score with 59D/59D on the
other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Short-term symptomatic treatment of exacerbations of osteoarthrosis.
-
Long-term symptomatic treatment of rheumatoid arthritis or ankylosing
spondylitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The total daily amount should be taken as a single dose.
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).
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day (two 7.5 mg
tablets).
-
Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg
tablets).
(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).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
Special populations
_Elderly patients and patients with increased risks for adverse
reaction (see section 5.2): _
The recommended dose for long term treatment of rheumatoid arthritis
and ankylosing spondylitis in elderly
patients is 7.5 mg per day. Patients with increased risks for adverse
reactions should start treatment with 7.5
mg per day (see section 4.4).
_Renal impairment (see section 5.2): _
In dialysis patients with severe renal failure, the dos