PATIENT INFORMATION LEAFLET
INTERNATIONAL NONPROPRIETARY NAME
Description: round, biconvex, yellow film-coated tablets.
Film-coated tablet contains
Active substance: tenoxicam 20 mg.
Excipients: lactose monohydrate, magnesium stearate, maize starch pregelatinised, talc.
Coating composition: opadry II 85F220095 yellow (polyvinyl alcohol, titanium dioxide, polyethyle- ne glycol, talc, iron oxide yellow, Sunset Yellow FCF aluminium lake, tartrazine aluminium lake).
Nonsteroidal anti-inflammatory drugs. Oxicams.
PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS
Tenoxan – an effective nonsteroidal anti-inflammatorydrug (NSAID) with a high anti-inflammatory, analgesic and moderate antipyretic effect. The properties of the medicinal product are conditioned by inhibition of both isoforms of the cyclooxygenase enzyme, resulting in arachidonic acid metabo- lism disordersand prostaglandinsynthesisblockade.
An anti-inflammatory effect is associated with reduced capillary permeability (limits exudation), lysosomal membrane stabilization (prevents release of lysosomal enzymes, resulting in tissue damage), suppression of synthesis or inactivation of inflammatory mediators (prostaglandins, hista- mine, bradykinin, lymphokines, complement factors). It reduces the number of free radicals in the area of inflammation, suppresses chemotaxis and phagocytosis. It suppresses the inflammation proliferative stage, reduces post-inflammatory sclerosis of tissues; has a chondroprotective effect. The medicinal product reverses or reduces the intensity of pain syndrome of any etiology, reduces morning stiffness, increases impaired joint mobility. In long-term administration, it has a desensi- tizing effect.
Along-term effect is a peculiar feature of tenoxicam.
Tenoxicam is rapidly and completely absorbed from the gastrointestinal tract (GIT) while intake of food and antacids inhibits the absorption rate, with no effect on the total absorption rate. Peak blood plasma concentrations are reached after 2 hours. Bioavailability is 100%. It's 99% bound to plasma proteins. A long-term action and a prolonged half-life period of 72 hours is a peculiar feature of tenoxicam. Tenoxicam penetrates well into synovial fluid and easily through blood-tissue interfaces. It is transformed in liver into inactive metabolites. An average half-life period is 60-75 hours. It is excreted mainly in urine and partially in bile.
Inflammatory and degenerative disorders of the musculoskeletal system, accompanied by pain syndrome:
DOSAGE AND ADMINISTRATION
Tenoxan is taken orally.
The medicinal product should be prescribed at a dose of 20 mg once a day to be taken at the same time.
In acute gouty arthritis, the medicinal product should be taken at a dose of 40 mg once a day for 2 days, then – at a dose of 20 mg once a day for 5 days.
Gastrointestinal tract: dyspepsia (nausea, vomiting, heartburn, diarrhoea, flatulence), pain and ab- dominal discomfort, stomatitis, anorexia; after a long-term administration of high doses - erosive- ulcerative lesions of the GIT.
Nervous system and senses organs: headache, dizziness, mental depression, hyperexcitability.
Allergic reactions: urticaria, pruritus, erythema, Stevens-Johnson and Lyell syndromes.
Others: renal function disorder, increased levels of plasma creatinine, urea nitrogen, bilirubin and elevated hepatic transaminase activity, prolonged bleeding time.
Tenoxan should be prescribed with care to patients over the age of 65 as well as to patients with mild and moderate renal and hepatic function disorders.
Tenoxan should not be prescribed to patients with pending elective surgeries (in case of non- elective surgeries, a physician should be informed about Tenoxan taken by the patient).
Tenoxan should be prescribed with care to patients with gastrointestinal diseases (the patient's health condition should be controlled and Tenoxan should be discontinued in case of an ulceroge- nic action).
Possible sodium and water retention in the body should be taken into account when prescribing with diuretics to patients with arterial hypertension and cardiac insufficiency.
INFLUENCE ON ABILITY TO DRIVE AND OPERATE MECHANISMS
It's recommended to abstain from potentially dangerous activities requiring increased concentration of attention and fast psychomotor actions during the treatment period.
Medicinal product is contraindicated during pregnancy.
Tenoxicam and its metabolites are excreted in breast milk; therefore, the medicinal product should not be used during lactation.
Medicinal product should not be used in children under 12 years old.
Tenoxan should not be taken concomitantly both with salicylates and nonsteroidal anti-inflam- matory drugs and corticosteroids.
In concomitant use, Tenoxan potentiates the action of indirect anticoagulants and sulphonylurea derivatives.
Probenecid may potentiate elimination of tenoxicam.
When administered concurrently, tenoxicam slightly reduces the level of blood plasma cardiac gly- cosides.
Tenoxan should not be taken concurrently both with diuretics and potentially nephrotoxic agents. Tenoxan should not be prescribed to patients taking serotonin receptor antagonists and antipla- telet agents.
Tenoxicam increases methotrexate and lithium plasma concentrations. Antacids reduce absorption of tenoxicam.
An increased risk of convulsions is observed when tenoxicam is taken concomitantly with quino- lone antibiotics.
Symptoms: an increase in side effects is observed.
Treatment: there is no specific antidote. If an overdose of tenoxicam is suspected, the patient sho- uld be treated symptomatically.
Film-coated tablets. 10 tablets in a blister.
1 blister together with a leaflet in a carton box.
Store in a protected from moisture place at temperature not exceeding 25°C. Keep out of reach of children!
3 years from the manufacturing date. Do not use after expiration.
Sold under prescription.
TENOXAN is a product and a trade mark of "Sanolife", Great Britain.
"WORLD MEDICINE İLAÇ SAN. VE TİC. А.Ş.", TURKEY