Melocid 7.5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MELOXICAM

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

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Withdrawn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:

2007-03-27

Patient Information leaflet

Meloxicam 7,5mg, 15mg, PIL, Malta
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Item No: AAAH3259
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 Melocid is and what it is used for
2. What you need to know before you take Melocid
3. How to take Melocid
4. Possible side effects
5. How to store Melocid
6. Contents of the pack and other information
1. WHAT MELOCID IS AND WHAT IT IS USED FOR
Melocid Tablets are for the short-term treatment of the symptoms
associated with osteoarthritis when this condition flares up.
They are also used for the long-term treatment of the symptoms
associated with rheumatoid arthritis and ankylosing spondylitis (a
type of arthritis that causes pain and stiffness around the spine).
Meloxicam is one of a group of medicines called non-steroidal anti-
inflammatory drugs and it works by reducing inflammation and
pain in the joints and muscles.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELOCID
DO NOT TAKE MELOCID:
•  if you are

Summary of Product characteristics

 
Page 1 of 15 

SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 

Melocid 7.5 mg Tablets 
Melocid 15 mg Tablets 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Meloxicam 7.5 mg and 15 mg 
Excipients with known effect: 
Each 7.5mg tablet contains 23.5mg Lactose monohydrate. 
Each 15mg tablet contains 20.0mg Lactose monohydrate. 
For the full list of excipients, see section 6.1. 
3. 
PHARMACEUTICAL FORM  
Tablet 
7.5 mg: Pale yellow round tablets with “>” on one side and “ML
7.5” on the other. 
15 mg: Pale yellow round tablets with “>” on one side and “ML
breakline 15” on the 
other.  
The tablet can be divided into equal doses. 
4. 
CLINICAL PARTICULARS  
4.1 
THERAPEUTIC INDICATIONS  
- 
Short-term symptomatic treatment of exacerbation of
osteoarthrosis. 
- 
Long-term symptomatic treatment of rheumatoid arthritis or of
ankylosing spondylitis. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Oral use 
Exacerbation of osteoarthrosis: 7.5 mg once daily (one 7.5 mg tablet
or half a 15 mg 
tablet). In the absence of an effect, the dose may be increased to 15
mg once daily (two 
7.5 mg tablets or one 15 mg tablet). 
Rheumatoid arthritis, ankylosing spondylitis: 15 mg once daily
(two 7.5 mg tablets or one 
15 mg tablet). (See also "Special populations").Page 1 of 15 

Page 2 of 15 

Depending on the therapeutic effect, the dose may be reduced to 7.5
mg once daily (one 
7.5 mg tablet or half a 15 mg tablet). 
DO NOT EXCEED A DAILY DOSE OF 15 MG. 
Undesirable effects may be minimised by using the lowest effective
dose for the shortest 
duration necessary to control symptoms (see section 4.4). 

The dose should be taken as a single dose with water or other liquid
in conjunction with a 
meal. 
SPECIAL POPULATIONS 
_Elderly patients and patients with an increased risk of undesirable
effects (see section _
_5.2): _
For elderly patients the recommended dose for long-term treatment of
rheumatoid arthrit