MOBIC TABLET 7.5 MG [SIN09554P]

Product Info

MOBIC TABLET 7.5 MG

[SIN09554P]

4.1 Therapeutic indications

MOBIC® is a non-steroidal anti-inflammatory drug indicated for symptomatic treatment of

• painful osteoarthritis (arthrosis, degenerative joint disease).

• rheumatoid arthritis.

• ankylosing spondylitis.

4.2 Posology and method of administration

Posology

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.

Painful osteoarthritis, rheumatoid arthritis and ankylosing spondylitis

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. According to the therapeutic response, the dose may be reduced to 7.5 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 for use – 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
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.

4.3 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.

• rare hereditary conditions that may be incompatible with an excipient of the product (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)