Meloxicam 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Meloxicam

Available from:

Waymade Healthcare Plc

ATC code:

M01AC06

INN (International Name):

Meloxicam

Dosage:

15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

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PAGE 1 OF 2
Received Date:
10/08/2016
CDL JOB No. :
62321
Required By :
10/08/2016
PRODUCT NAME:
Meloxicam Tabs
7.5 mg & 15 mg
PIP CODE:
GB 724-8255-APIL
COMPONENT:
Leaflet
SIZE:
210x543 mm
MARKET:
Great Britain
PRODUCT SITE:
TBC
SCALE:
100%
COLOURS:
Black
DATE:
10/08/2016
FONT SIZE:
10 pt
VERSION NO:
6
AMENDED BY:
CH
PROJECT:
Sovereign Medical
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Please 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 Meloxicam Tablets are and what they are used for
2. What you need to know before you take Meloxicam
Tablets
3. How to take Meloxicam Tablets
4. Possible side effects
5. How to store Meloxicam Tablets
6. Contents of the pack and other information
1. WHAT MELOXICAM TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Meloxicam 7.5 mg and 15
mg Tablets (referred to as Meloxicam Tablets in this
leaflet).
M

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Meloxicam 15 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg meloxicam
_ _
Excipients of known effect:
Each tablet contains 86 mg of lactose monohydrate.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Yellow, round, flat, uncoated tablet with bevelled edge. Scored from
one side, flat from the
other side.
The score line is not intended for breaking the tablet.
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
_Exacerbations of osteoarthrosis:_ 7.5 mg/day. If necessary, in the
absence of improvement,
the dose may be increased to 15 mg/day.
_Rheumatoid arthritis, ankylosing spondylitis: _15 mg/day. According
to the therapeutic
response, the dose may be reduced to 7.5 mg/day (see also section
‘Special populations’
below).
DO NOT EXCEED THE DOSE OF 15MG/DAY.
Special populations
_Elderly: _
The elderly are at an increased risk of the consequences of adverse
reactions. If an NSAID is
considered necessary, the lowest effective dose should be used and for
the shortest possible
duration. The patient should be monitored regularly for GI bleeding
during NSAID therapy.
_ _
_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 dose
should not exceed 7.5 mg per day. No dose reduction is required in
patients with mild to
moderate renal impairment (i.e. patients with a creatinine clearance
of greater than 25
ml/min). (For pati