Melorem Tablets 15

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Meloxicam

Available from:

Remedica LTD, CYPRUS

INN (International Name):

Meloxicam

Dosage:

15

Pharmaceutical form:

Tablets

Manufactured by:

Remedica Limited, CYPRUS

Product summary:

Physical description: Light yellow, round, flat tablets, score on one side; Local technical representative: Stanley Tanzania Limited (4885)

Authorization status:

Registered/Compliant

Authorization date:

2019-01-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MELOREM 7.5 MG TABLETS
MELOREM 15 MG TABLETS
Meloxicam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE
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 your 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 Melorem is and what it is used for
2.
What you need to know before you take Melorem
3.
How to take Melorem
4.
Possible side effects
5.
How to store Melorem
6.
Contents of the pack and other information
1.
WHAT MELOREM IS AND WHAT IT IS USED FOR
Melorem 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.
Melorem 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 MELOREM
DO NOT TAKE MELOREM

if you are allergic to meloxicam or any of the other ingredients of
this medicine (listed in
section 6).
cy-pl-melorem-tabs-a0 page 1 of 11

if you are allergic (hypersensitivity) to aspirin or other
anti-inflammatory medicines
(NSAIDs).

during the last three months of pregnancy.

children and adolescents under 16 years of age.

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 swe

Summary of Product characteristics

cy-spc-melorem-tabs-v02-r00-a0 page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Melorem 7.5 mg tablets
Melorem 15 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Melorem 7.5 mg tablets: Each tablet contains 7.5 mg meloxicam.
Melorem 15 mg tablets: Each tablet contains 15 mg meloxicam.
Excipient(s) with known effect
Melorem 7.5 mg tablets: This product contains 43 mg lactose.
Melorem 15 mg tablets: This product contains 86 mg lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Melorem 7.5 mg tablets
Light yellow, round, flat tablets, scored on one side.
The score line is only to facilitate breaking for ease of swallowing.
Melorem 15 mg tablets
Light yellow, round, flat tablets, scored on one 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.
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.
cy-spc-melorem-tabs-v02-r00-a0 page 2 of 15
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day.
-
rheumatoid arthritis, ankylosing spondylitis: 15 mg/day.
(see also section ‘Special populations’ below).
According to the therapeutic response, the dose may be reduced to 7.5
mg/day.
DO NOT EXCEED THE DOSE OF 15 mg/day.
Method of administration
Oral administration.
The total daily amount should be taken as a single dose, with water or
another liquid, during a
meal.
Special populations
_Elderly patients and patients with increased risks of adverse
reaction (see section 5.2): _
The