Mobic 15 mg tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Meloxicam

Dostępny od:

Boehringer Ingelheim International GmbH

Kod ATC:

M01AC; M01AC06

INN (International Nazwa):

Meloxicam

Dawkowanie:

15 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Oxicams; meloxicam

Status autoryzacji:

Not marketed

Data autoryzacji:

1996-05-07

Ulotka dla pacjenta

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 history of
- bleeding in your stomach or intestines
- holes (perforations) in y

Charakterystyka produktu

Health Products Regulatory Authority
15 April 2019
CRN008JMN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mobic 15 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of Meloxicam.
Excipient(s) with known effect
Each tablet contains 19.0 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light yellow round scored tablet with the logotype of the company on
one side and a score with 77C/77C on the other side.
The tablet can be divided 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
● Mobic tablets are indicated in adults and children aged 16 years
and older
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 (half a 15 mg tablet).
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day (one 15 mg tablet).
● Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (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 (half a 15 mg tablet).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
Special populations
_Elderly patients (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 (see also sections 4.2 'Patients with increased risks for
adverse reaction' and 4.4).
_Patients with increased risks for adverse reaction (see section 4.4)_
In patients