Flamexin 20 mg. 10 powders

COMPOSITION
Each sachet (scored) contains:
Active substance: piroxicam beta - cyclodextrin 191.2 mg (equivalent to piroxicam 20 mg).
Excipients: sorbitol, citrus flavor, aspartame, colloidal anhydrous silica

PACKAGE
20 pieces sachets (scored) in packaging.


WHAT Flamexin AND WHAT IT IS USED?
Flamexin 20 mgprah for oral solution contains aktivon substance called piroxicam. Piroxicam belongs to the group of nonsteroidal anti-inflammatory and antirheumatic agents.
Flamexin used to relieve some symptoms such as swelling, stiffness and joint pain in osteoarthritis / arthrosis, degenerative joint disease / rheumatoid arthritis and ankylosing spondylitis / rheumatism spine /. It does not cure arthritis and affects symptoms and will only help you as you continue taking it.
Before prescribing piroxicam, your doctor will assess the benefits of administering this drug against the risk of possible development of adverse reactions.

CONTRAINDICATIONS
FLAMEXIN should not be administered in case of hypersensitivity to any component or chemically similar substances.
The medicinal product should not be used in patients with gastrointestinal ulcer, gastritis, dyspepsia (stomach disorder in function), severe liver or kidney disease, severe heart failure, severe hypertension, severe haematological diseases or patients with hemorrhagic diathesis.
There is a potential for cross sensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). The medicinal product must not be used in patients in whom aspirin or other NSAIDs induce asthma, rhinitis, nasal polyposis, angioedema (angioedema) or urticaria (hives). FLAMEXIN powder for oral administration contains a sweetener such as aspartame and is therefore contraindicated in patients with phenylketonuria (a disease due to congenital deficiency of certain enzymes, wherein accumulate phenylalanine and its metabolites). The drug is contraindicated in suspected or proven in pregnancy, during lactation and in children.


SPECIAL PRECAUTIONS BEFORE USE
FLAMEXIN can be used only under strict medical supervision by patients with a history of violations in the upper gastrointestinal tract. Particular care is required when treating patients with cardio - vascular insufficiency, arterial hypertension, liver function or kidney failure, reduced renal perfusion, current or previous hematologic diseases and in patients treated with diuretics or elderly. In these cases it is recommended to periodically monitor clinical and laboratory parameters, especially after prolonged use.
In patients with asthma or predisposed thereto, the drug can cause bronchospasm, shock and other allergic reactions due to its effect on arachidonic acid metabolism.
With prolonged treatment, like other drug with a similar action, FLAMEXIN ® can cause moderate increases in blood urea nitrogen in some patients. After discontinuation values normalize.
Frequent monitoring of blood glucose 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 the patient concurrently platelet aggregation inhibitors. As during treatment with NSAIDs have been reported some visual disturbances, prolonged use recommended periodic eye examinations.


DRUG AND OTHER INTERACTIONS
Medicinal product is reacted with acetylsalicylic acid, other NSAIDs, and platelet aggregation inhibitors.
The concomitant use of lithium and NSAIDs increases lithium plasma concentrations.
Due to the high binding of drug with plasma proteins, can be expected to shift to other plasma proteins associated with the drugs. Patients receiving other drugs with a high plasma protein binding, should be closely monitored by the doctor to adjust the dosage regimen if necessary.
The absorption of piroxicam increases slightly after administration of cimetidine, but this increase has no clinical relevance.

May be prepared Interactions: Piroxicam may reduce the efficacy of diuretics and most likely of antihypertensive drugs.
If concomitant use of potassium - containing medications or potassium - sparing diuretics, there is an additional risk of elevated 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.
It should avoid alcohol.
Piroxicam may reduce the effectiveness of intrauterine spirals.
No concomitant use of NSAID medicines - quinolone antibacterial agents.


SPECIAL WARNINGS FOR USE
Piroxicam inhibits 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 when drug was administered in late pregnancy. Applying FLAMEXIN , as well as any other inhibitor of prostaglandin synthesis and cyclooxygenase, is not recommended for women planning pregnancy.
The use of FLAMEXIN should be discontinued in women with problems of fertility or undergoing fertility testing.


EFFECTS ON THE 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 METHOD OF ADMINISTRATION
Your doctor will order regular observations to provide an intake optimal dose. Your doctor will adapt the treatment to the lowest dose at which a best control the symptoms of your illness. Under no circumstances change the dose without first coordinate it with your doctor.
Adults and elderly patients
The maximum daily dose is 20 mg Flamexin / a powder for oral solution /, as a single daily dose. Take the drug with water, possibly at the same time during the day.
If you are aged over 70, your doctor may prescribe a lower dose or decrease the duration of treatment. When using the powder for oral solution, by opening the sachet along the line "half-dose" was prepared a dose of 10 mg. By opening a line "full dose" was prepared a dose of 20 mg. Your doctor may prescribe piroxicam simultaneously with another drug that prevents the stomach and intestines of possible side effects.

OVERDOSE
In cases of overdose FLAMEXIN shown Supportive and symptomatic treatment.

If you forget to take Flamexin:
Accept Flamexin soon as you remember. If it is almost time for your next dose, skip the missed dose and just take the next dose at the set time. Do not take a double dose to make up for a missed dose.
If you have any other questions about using this medicine, ask your doctor.


SIDE EFFECTS
FLAMEXIN is better tolerated than regular unbound in a complex with beta-cyclodextrin piroxicam, because - the brief presence of the active substance in the gastro - intestinal tract lowers the risk of irritation caused by direct contact.
The most - common side effects of piroxicam are 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 ulcers with or without bleeding.
Other adverse reactions reported were hypersensitivity reactions such as rashes, allergic swelling of the hands and face, increased skin sensitivity. Rarely can be observed vomiting, headache, dizziness, drowsiness, discomfort, tinnitus, hearing loss, asthenia (weakness), changes in blood counts, increases in blood urea nitrogen. Rarely found changes in liver function tests, jaundice. When signs or symptoms of liver damage, the intake of piroxicam should be discontinued. Rare cases of pancreatitis.
Can be seen cases of hematuria (blood in urine), dysuria (violation urination), acute renal failure, fluid retention in the form of swelling of the lower limbs, cardiovascular disorders (hypertension, decompensation). These side effects are usually transient and quickly resolve after discontinuation of the product. In extremely rare, isolated reports of dry mouth, erythema (redness), desquamation (exfoliation) of the skin, sweating, changes in blood glucose levels, body weight changes, insomnia, depression, disorders of the bladder, stomatitis (inflammation in the oral cavity), hair loss, growth disturbances of the nail.
For all adverse reactions, including those not listed in this leaflet, the patient must immediately reported to your doctor or pharmacist *

SPECIAL STORAGE CONDITIONS
No special storage conditions of the medicinal product.
Store at room temperature to 25 ° C.

KEEP OUT OF REACH OF CHILDREN PLACE.

EXPIRY DATE
3 years from date of manufacture.