Flamexin table. 20 mg. 20 tablets
Flamexin table. 20 mg. 20 tablets
Each tablet contains:
Active substance: piroxicam beta-cyclodextrin 191.2 mg (equivalent to piroxicam 20 mg).
Excipients: lactose, crospovidone, sodium starch glycolate, colloidal anhydrous silica, pregelatinised starch, magnesium stearate.
Tablets - 20 per package.
Nonsteroidal anti-inflammatory and antirheumatic.
FLAMEXIN is used to treat pain and inflammatory conditions in rheumatic diseases (rheumatoid arthritis, osteoarthritis) and musculoskeletal disorders (tendinitis, bursitis, post - traumatic pain) - post-operative pain, primary dysmenorrhea (painful menstruation).
FLAMEXIN should not be used in case of hypersensitivity to any component or chemically similar substances.
This medicinal product must not be used in patients with gastrointestinal ulcers, gastritis, dyspepsia (stomach function disorder), severe liver or kidney disease, severe heart failure, severe hypertension, severe haematological diseases or patients with bleeding disorders.
There is potential for cross-sensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). This medicinal product must not be used in patients acetylsalicylic acid or other NSAIDs induce asthma, rhinitis, nasal polyps, angioedema (swelling of vascular) or urticaria (hives).
The use of the drug is contraindicated in suspected or proven pregnancy, during lactation, and in children
SPECIAL PRECAUTIONS BEFORE USE
FLAMEXIN can only be used under strict medical supervision in patients with a history of disorders of the upper gastro - intestinal tract. Particular care is required when treating patients with cardio - vascular disease, hypertension, liver or renal failure, decreased renal perfusion, past or present hematological disorders and in patients treated with diuretics and the elderly. In these cases it is recommended to periodically monitor the clinical and laboratory parameters, especially with prolonged use.
In patients with asthma or prone to it, the drug can cause bronchospasm, shock and other allergic reactions due to its effect on the metabolism of arachidonic acid.
With prolonged treatment, like other drugs of similar action, FLAMEXIN can cause moderate increases in blood urea nitrogen in some patients. After discontinuation of the values are normalized.
Frequent monitoring of blood sugar levels in diabetic patients, and prothrombin time in patients taking coumarin anticoagulants concomitantly.
Medicinal product, like other NSAIDs inhibit platelet aggregation and prolong bleeding time. This should be considered when conducting blood tests and requires attention when patients received both inhibitors of platelet aggregation. Since during treatment with NSAIDs have been reported some visual disturbances, prolonged use is recommended periodic eye examinations.
DRUG INTERACTIONS AND OTHER
Medicinal product interacts with aspirin, other NSAIDs and inhibitors of platelet aggregation.
Concurrent use of lithium and NSAIDs increases plasma lithium concentrations.
Due to the high degree of binding of the drug to plasma proteins can be expected shift related protein-bound drugs. Patients taking other drugs highly bound to plasma proteins, should be closely monitored by the doctor to adjust the dosage regimen if necessary.
The absorption of piroxicam increased slightly after administration of cimetidine, but this increase is not clinically relevant.
Can be obtained and other interactions piroxicam may decrease the efficacy of diuretics and most likely of antihypertensive drugs
In case of concomitant use of potassium - containing drugs or potassium - sparing diuretics, there is an additional risk of increased serum potassium levels (hyperkalemia).
Concomitant administration of glucocorticoids may increase the risk of bleeding from the gastrointestinal tract.
The concomitant use of piroxicam with aspirin or other NSAIDs. You should avoid alcohol.
Piroxicam may reduce the effectiveness of intrauterine spirals.
Concomitant administration of NSAIDs with drugs - quinolone antibacterials.
Piroxicam inhibits the synthesis and release of prostaglandins. This effect, as with other NSAIDs, is associated with increased incidence of dystocia (difficult birth) and prolonged parturition in pregnant animals in which the drug was administered in late pregnancy. Application of FLAMEXIN ®, as well as any other inhibitor of prostaglandin synthesis, cyclooxygenase, is not recommended for women planning pregnancy.
Using FLAMEXIN should be discontinued in women with fertility problems or undergoing fertility testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The medicine may affect alertness to such an extent that driving and using machines that require quick reactions may worsen.
DOSAGE AND ADMINISTRATION
Tablets: 1 tablet (20 mg) daily.
In elderly patients the dose should be determined carefully by the doctor, it may be necessary to reduce the dose of half a tablet) and limit the duration of treatment.
Prolonged administration of doses higher than 30 mg / day increases the risk of developing gastro - intestinal side effects.
Route of administration
Tablets - to split the tablet, you can put it on a flat surface with the score up. With gentle pressure with your thumb divide it into two equal halves.
In cases of overdose FLAMEXIN is indicated supportive and symptomatic treatmen
FLAMEXIN was better tolerated than conventional unrelated in complex with beta-cyclodextrin piroxicam because - short of the active substance present in the gastro - intestinal tract reduces the risk of irritation caused by direct contact.
Most - common side effects of piroxicam gastrointestinal disorders. These include nausea, stomach disorders, constipation, diarrhea, flatulence (gas in the stomach and small intestine), epigastric pain, and anorexia (decreased appetite). Rare cases of gastric ulcer with or without bleeding.
Other adverse reactions reported are hypersensitivity reactions such as rashes, allergic swelling of face and hands, increased skin sensitivity. Less can be vomiting, headache, dizziness, drowsiness, discomfort, tinnitus, hearing loss, asthenia (weakness), lab abnormalities, increases in blood urea nitrogen. Rarely found changes in liver function tests, jaundice. If signs or symptoms of liver injury, piroxicam should be discontinued.
Rare cases of pancreatitis.
One may observe cases of hematuria (blood in urine), dysuria (urinary disorder), acute renal failure, fluid retention, in the form of edema of the lower extremities, cardiovascular disorders (hypertension, decompensation). These side effects are usually transient and disappear quickly after you stop taking the product. In extremely rare, reported dry mouth, erythema (redness), scaling (exfoliation) of the skin, sweating, changes in blood sugar levels, weight changes, insomnia, depression, disorders of the bladder stomatitis (sores in the mouth), hair loss, irregular nail growth.
For all adverse events, including those that are not listed in this leaflet, the patient should immediately tell their doctor or pharmacist.
SPECIAL STORAGE CONDITIONS
No special storage conditions of the product.
Store at room temperature up to 25 ° C.
Keep out of reach of children.
3 years from date of manufacture.
This period is valid for properly stored in an unopened container product.