Meloxicam Chanelle Medical 15 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meloxicam

Available from:

Chanelle Medical Unlimited Company

ATC code:

M01AC; M01AC06

INN (International Name):

Meloxicam

Dosage:

15 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Oxicams; meloxicam

Authorization status:

Not marketed

Authorization date:

2005-12-02

Patient Information leaflet

ID: PL 55/56 M
VERSION: 16
REVIEW DATE: 17/05/2023
PAGE 8 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
MELOXICAM CHANELLE MEDICAL 7.5 MG TABLETS
MELOXICAM CHANELLE MEDICAL 15 MG TABLETS
Meloxicam
IN THIS LEAFLET:
1.
What Meloxicam Chanelle Medical tablets are and what they are used
for.
2.
What you need to know before you take Meloxicam Chanelle Medical
3.
How to take Meloxicam Chanelle Medical tablets.
4.
Possible side effects.
5.
How to store Meloxicam Chanelle Medical tablets.
6.
Contents of the pack and other information
Meloxicam 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.
Meloxicam Chanelle Medical tablets is used for:
• short-term treatment of flare-ups of osteoarthrosis
• long-term treatment of
- rheumatoid arthritis
- ankylosing spondylitis
DO NOT TAKE MELOXICAM CHANELLE MEDICAL TABLETS:
•
during the last three months of pregnancy.
•
children and adolescents under 16 years of age.
•
if you are allergic to meloxicam, aspirin or other anti-inflammatory
medicines (NSAIDs)
•
if you are allergic to any of the other ingredients of this medicine
(listed in section 6)
•
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 your stomach or intestines
•
ulcers or bleeding in your stomach or intestines
•
recent or history of stomach or peptic ulcers or bleeding (ulceration
or bleeding occurring at least twice)
•
severely impaired liver function
•
non dialysed severe kidney failure
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Summary of Product characteristics

Health Products Regulatory Authority
12 January 2024
CRN00DM09
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meloxicam Chanelle Medical 15 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 15 mg meloxicam.
Excipient: Each tablet contains 81.70 mg lactose (as lactose
monohydrate).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pale yellow coloured round tablet with a score line on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meloxicam Chanelle Medical is indicated in adults and children above
16 years.
- 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 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 (see section 5.2): _
_The recommended dose for long term treatment of rheumatoid arthritis
and ankylosing spondylitis in elderly patients is 7.5 mg _
_daily (see also sections 4.2 "Patients at increased risk of adverse
reactions" and 4.4)_
Health Products Regulatory Authority
12 January 2024
CRN00DM09
Page 2 of 13
_ _
_Patients at increased risk of adverse reactions (see section 4.4)_
_ _
_ _
_In patients who are