Each  Tablet  of  Mobixin®15 Contains:

• Meloxicam       15 mg.

Each  Tablet  of  Mobixin®7.5 Contains:

• Meloxicam      7. 5 mg.

Each  suppository of  Mobixin®15 Contains:

• Meloxicam       15 mg.

Mobixin® is a non-steroidal anti-inflammatory drug indicated for: 

• Short-term symptomatic treatment of exacerbations or osteoarthritis .
• Long term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis 

• Hypersensitivity to Mobixin®,or hypersensitivity to substances with a similar action  e.g. : NSAIDs as Aspirin . Mobixin®, should not be given to patients who have developed signs of asthma , nasal polyps ,angionurtic edema or urticaria following the administration of Aspirinor other NSAIDs.
• History of gastrointestinal bleeding or perforation ,related to previous NSAIDs therapy.
• Active ,or history of recurrent peptic ulcer , hemorrhage (two or more distinct episodes of proven  ulceration  or bleeding ) .
• Severely impaired  liver function  and non – dialyzed sever renal failure Gastrointestinal bleeding , cerebrovascular  bleeding  or other bleeding disorders ,sever heart failure ,Children under 15 years .

• Administration of several NSAIDs together may increase the risk of gastrointestinal ulceration and  bleeding via synergistic action.
• Corticosteroids: increase risk of  gastrointestinal ulceration or bleeding .
• Anticoagulants ,antiplatlet drugs, systemically administrated heparin ,thrombolytic increased risk of bleeding in the gastrointestinal tract by inhibiting platelet function and damaging the lining of the stomach and duodenum..
• Selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding . 
• NSAIDs increase lithium plasma levels, which may reach toxic values.
• NSAIDs can reduce tubular secretion of methotrexate therapy increasing plasma concentrations of methotrexate. 
• NSAIDs decrease the efficacy intrauterine devices .
• Diuretics: patient treated with NSAIDs and diuretics should be adequately hydrated and be monitored for renal function prior initiating treatment  .
• Antihypertensive effect reduced by NSAID.
• In patients with pre-existing renal impairment this may lead to acute renal failure,when  NSAID and angiotensin II are administered.
• Cholystyramine accelerated the elimination of  Meloxicam ,so that clearance for  Meloxicam  increase by  50% and half life of decrease to 13± 3hrs.

• is contraindicated during pregnancy ,especially during the third trimester .
• NSAIDs are known to pass into mother’s milk .administration should therefore be avoided in  women who are breast feeding .

• Common : light –headedness , headache ,dyspepsia, nausea ,vomiting, abdominal pain, constipation flatulence, diarrhea , Edema including edema of lower limbs.
• Uncommon : Anemia ,vertigo, tinnitus, drowsiness ,Palpitations (In this case, symptomatic and supportive therapy should be given as appropriate.(ECG and blood ) potassium levels should be monitored, increase in blood pressure , flushes, gastrointestinal bleeding, gastrointestinal ulcers, esophagitis,  stomatisis , Angioedema, pruritus , rash ,sodium and water retention, hyperkalaemia .
• Rare : disturbances of blood count :leucocytopenia , thrombocytopenia, agranulocytosis , anaphylactic / anaphylactoid reaction , Mood disorders, insomnia and nightmares,Confusion, Conjunctivitis , Visual disturbances including blurred  vision ,  onset of asthma attacks in certain individuals allergic to aspirin or other NSAIDs,  gastrointestinal perforation, gastritis, colitis ,peptic ulcers, perforation or gastrointestinal   bleeding that may occur  can be sometimes  sever , especially in elderly patients , Hepatitis, Urticaria ,Steven –Johnson  syndrome and toxic epidermal necrolysis , angioderma, bullous reactions , such as erythema  multiform , photosensitivity reactions, Acute functional renal failure  in patient with risk factors .
• Others : isolated cases of agranulocytosis have been reported in patients treated with Mobixin® and other potentially myelotoxic drugs.

Over dosage:

• In case of overdose the standard measures of gastric evacuation and general supportive  measures should be used as there is no known antidote .It has been shown in a clinical trial that cholystyramin accelerated the elimination of Mobixin®.

¤ Oral dosage: The total daily amount should be taken as single dose ,with water or another liquid during meal.

¤ Undesirable effects may be minimized by using the lowest  dose for the shortest duration necessary to control symptoms.

¤ The patient’s need for symptomatic relief , any  response to therapy should be re-evaluated periodically ,especially in patient with osteoarthritis. 

• Osteoarthritis: 7.5 mg/day .If necessary ,the dose may be increase to  15 mg/day.
• Rheumatoid arthritis: 15 mg/day According to the therapeutic response , the dose may decrease to 7.5 mg/day.
• Ankylosing spondylitis: 15 mg/day According to the therapeutic response the dose may decrease to 7.5 mg/day. 
• In dialysis patients with severe renal failure: the dose should exceed 7.5 mg/day no dose reduction is required in patients with mild to rnoderate renal impairment (i.e. patients with a creatinine clearance of greater than 25ml/min) .
• Hepatic impairment: no dose reduction  is required  in patients with mild to rnoderate hepatic impairment.
• Elderly patients and patients with increased risks for adverse reactions:

- the recommended  dose for long term treatment of rheumatic arthritis  and ankylosing  spondylitis in elderly patients is 7.5  mg/day .

• In patients with increased risks for adverse reactions:

- short  treatment at dose  of 7.5 mg/day.

• Adolescent: the maximum  recommended  dose 0.25 mg /kg

¤ as dose  for use  in children  has not yet been established ,usage should be restricted to adolescent  and adults.

¤ The maximum recommended daily dose of Mobixin® is 15 mg .

• Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
• The recommended maximum daily dose should not be exceeded in case of  insufficient therapeutic effect , nor  an additional should  be added to the therapy because this may increase the toxicity  with therapeutic advantage has been proven before starting treatment with Mobixin®.
• Any history of esophagitis ,gastritis and peptic ulcer must be sought in order to ensure their total cure , Attention should be paid to the possible onset of a recurrence in patient treated with Mobixin® and with a past history of this type.
• The use of  Mobixin® with Concomitant NSAIDS inclnding cyclo-oxygenase II selective  inhibitor should be avoided.

• Mobixin®  15   tablets  (blister  of 10 tablets ,pack of one  blister).
• Mobixin®  7.5  tablets  (blister  of 10 tablets ,pack of two  blister) .
• Mobixin®  15  suppositories (blister  of 6 suppositories , pack of one blister) .

• Tablets: Store at a temperature  below 30ºC in a dry place .
• suppositories: Store below 25°C ,and Protect from heat .