Regulatory Information
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**Dosage and administration** As the potential for adverse reactions increases with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The total daily dose of MOBIC® should be administered as a single dose. For adults the maximum recommended daily dose regardless of formulation is 15 mg. Painful osteoarthritis : 7.5 mg/day. If necessary, the dose may be increased to 15 mg/day. Rheumatoid arthritis : 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day. Ankylosing spondylitis :15 mg/day. **Special populations** In patients with increased risks of adverse reactions, e.g. a history of gastro-intestinal disease or risk factors for cardiovascular disease, the treatment should be started at a dose of 7.5 mg/day (see Special warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 ml/min). In non-dialysed patients with severe renal impairment MOBIC® is contraindicated (see Contraindications). In patients with end-stage renal failure on haemodialysis the maximum daily dose should not exceed 7.5 mg/day. As a dosage for use in adolescents has not yet been established, usage should be restricted to adults. **Method of administration** _Tablets_ MOBIC® tablets are swallowed with water or other fluid in conjunction with food. There is insufficient information on the effect of mixing crushed tablets or contents of a capsule with food or fluids. Tablet break mark does not allow subdividing the 7.5 mg tablet into fractions of a full dose. Tablets 7.5 mg can only be subdivided for ease of swallowing.
ORAL
Medical Information
**Indication** **MOBIC®** is a non-steroidal anti-inflammatory drug indicated for - symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease). - symptomatic treatment of rheumatoid arthritis. - symptomatic treatment of ankylosing spondylitis.
**Contraindications** - Known hypersensitivity to meloxicam or any excipient of the product. - Use in patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), because of a potential for cross sensitivity. - Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery - Active or recent gastro-intestinal ulceration / perforation - Active Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis) - Severe hepatic insufficiency - Non-dialysed severe renal insufficiency - Overt gastro-intestinal bleeding, recent cerebrovascular bleeding or established systemic bleeding disorders - Severe uncontrolled heart failure - Pregnancy or breastfeeding. In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special precautions” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) the use of the product is contraindicated.
M01AC06
meloxicam
Manufacturer Information
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
BOEHRINGER INGELHEIM PHARMA GMBH & CO KG
Boehringer Ingelheim Hellas Single Member S.A.
Rottendorf Pharma GmbH (Ostenfelder)
Active Ingredients
Documents
Package Inserts
Mobic Tablet_PI.pdf
Approved: June 23, 2023