Areloger 15 mg tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Meloxicam

Tillgänglig från:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kod:

M01AC; M01AC06

INN (International namn):

Meloxicam

Dos:

15 milligram(s)

Läkemedelsform:

Tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Oxicams; meloxicam

Bemyndigande status:

Not marketed

Tillstånd datum:

2004-09-17

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARELOGER 7.5 MG TABLETS
ARELOGER
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 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 Areloger is and what it is used for
2.
What you need to know before you take Areloger
3.
How to take Areloger
4.
Possible side effects
5.
How to store Areloger
6.
Contents of the pack and other information
1. WHAT ARELOGER IS AND WHAT IT IS USED FOR
Areloger contains the active ingredient meloxicam. Meloxicam belongs
to the group of non-
steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of
pain and inflammation in
muscles and joints.
Areloger can be used by adults and adolescents over 16 years of age
for:
•
the short-term treatment of flare-ups of osteoarthrosis (a disease of
the joints)
•
the long-term treatment of pain in connection with rheumatoid
arthritis (inflammation of the
joints)
•
the long-term treatment of a similar condition called ankylosing
spondylitis (inflammation of
the spine).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARELOGER
DO NOT TAKE ARELOGER
•
during the last three months of pregnancy
•
if you are a child or adolescent under 16 years of age
•
if you are allergic to meloxicam or any of the
_ _
other ingredients of this medicine (listed in
section 6)
•
if you are allergic to acetylsalicylic acid (e.g. aspirin) or other
non-steroidal anti-inflammatory
drugs (NSAIDs)
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•
if you have previously had symptoms of wheezing, chest tightness,
breathlessness (asthma),
swelling

Produktens egenskaper

Health Products Regulatory Authority
13 November 2023
CRN00DV84
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Areloger 15 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15.0 mg of meloxicam.
Excipient with known effect
Each tablet contains 81.7 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pale yellow, round, flat bevelled tablet with a break line on one
side. Approximately 10 mm in diameter.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Areloger is indicated in adults and adolescents over 16 years of age
for:
- 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
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 tablet of 7.5 mg or
half a 15 mg tablet).
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day (two tablets of 7.5 mg or 1 tablet of 15
mg).
_Rheumatoid arthritis, ankylosing spondylitis_: 15 mg/day (two tablets
of 7.5 mg or 1 tablet of 15 mg) (see also “Special
populations”).
According to the therapeutic response, the dose may be reduced to 7.5
mg/day (one tablet of 7.5 mg or half a 15 mg tablet).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
SPECIAL POPULATIONS
_Elderly patients and patients with increased risks for adverse
reactions (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