MOBICAM 7.5 Milligram Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

MELOXICAM

Tilgængelig fra:

Ranbaxy Ireland Limited

INN (International Name):

MELOXICAM

Dosering:

7.5 Milligram

Lægemiddelform:

Tablets

Recept type:

Product subject to prescription which may be renewed (B)

Autorisation status:

Authorised

Autorisation dato:

0000-00-00

Indlægsseddel

550mm
200mm
Meloxicam 7.5 mg PIL
Size: 200 x 550mm
550mm
200mm
Meloxicam 7.5mg  PIL
Size: 200 x 550mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOBICAM 7.5 MG TABLETS
Meloxicam
24LF
24LF
IF YOU FORGET TO TAKE MOBICAM TABLETS
If you forget to take a dose, do so as soon as you remember. However,
if it is almost time for your next dose, skip the missed dose 
and go back to your regular dosing schedule. Do not take a double dose
to make up for forgotten dose.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.  
4.  POSSIBLE SIDE EFFECTS 
Like all medicines, this medicine can cause side effects, although not
everybody gets them. 
SERIOUS SIDE EFFECTS 
If any of the following happen, stop taking Mobicam Tablets and tell
your doctor immediately or go to the casualty department at 
your nearest hospital immediately: 
- 
skin reactions, such as itching (pruritus), blistering or peeling of
the skin, which can be severe (Steven-Johnson 

Syndrome and toxic epidermal necrolysis), lesions of soft tissues
(mucosal lesions) or erythema multiforme. Erythema 

multiforme is a serious allergic skin reaction causing spots, red
welts or purple or blistered areas. It can also affect the 

mouth, eyes and other moist body surfaces.
- 
swelling of skin or mucosa, such as swelling around the eyes, face and
lips, mouth or throat, possibly making breathing 

difficult, swollen ankles or legs (oedema of the lower limbs)
- 
shortness of breath or asthma attack
- 
inflammation of the liver (hepatitis). This can cause symptoms such
as:

o 
yellowing of the skin or the eyeballs (jaundice)

o 
pain in the abdomen

o 
loss of appetite
Any side effects of the digestive tract, especially:
- 
bleeding (causing tar-coloured stools)
- 
ulceration of your digestive tract (causing abdominal pain)
Bleeding of the digestive tract (gastrointestinal bleeding), formation
of ulcers or formation of a hole in the digestive tract 
(perforation) may sometimes be severe and potentia

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mobicam 7.5 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Meloxicam 7.5 mg
Excipient: Each tablet also includes 40.9 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 score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of exacerbations of osteoarthrosis.
Mobicam is indicated in adults and adolescents above 16 years.
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 7.5mg)
If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two tablets of 7.5mg)
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
_SPECIAL POPULATIONS_
_Elderly patients and patients with increased risks for adverse reaction (see section 5.2):_
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 patients with non-dialysed severe renal failure, see�