Bula do remedy Reumotec

the package insert of the medicine Reumotec. Active principles Tenoxicam. Sale under medical prescription.

what For?

TENOXICAM is indicated for the initial treatment of the following inflammatory diseases and degenerative, painful, musculoskeletal system:
rheumatoid arthritis;
osteoarthritis;
osteoarthritis;
ankylosing spondylitis;
affections extra-articular, as, for example, tendinitis, bursitis, periarthritis of shoulder syndrome (shoulder-hand) or hips, strains ligament sprains and;
acute gout;
post-operative pain.

Dosage

How to use?

For all indications, except in acute gout, the recommended 20 mg (1 coated tablet) every day, always at the same time. The coated tablets should be taken with a little water. Although the therapeutic effect TENOXICAM soon becomes evident, there is a progressive increase of the response in the first two weeks, until the plasma concentration reaches the “state of dynamic equilibrium”. Doses higher than 20mg should be avoided, as this would increase the incidence and intensity of adverse reactions without a significant increase in effectiveness. For patients who require prolonged treatment can try to reduce the daily dose to 10 mg ( ½ film-coated tablet).

In acute gout attacks, the recommended dose is 40mg (2 coated tablets), once daily for two days followed by 20 mg (1 coated tablet), daily for five more days.

Instructions dosing special:
In principle, the dosage previously recommended applies also to the elderly and patients with kidney or liver disease (see contraindications). Due to the lack of clinical trial, still has not been established the safety and dosing for patients less than 18 years.

Side Effects

What are the evils that can cause me?

During clinical trials with a duration of two weeks to one year, RELMOTEC was generally well tolerated at the recommended dose of 20mg a day. The proportion of patients with adverse reactions clinical or laboratory was approximately 12.5%.

In general, were reactions mild and transient, disappearing even with continued treatment. Only in about 1% of all patients treated with the dose of 20mg a day was necessary to stop I dare the RELMOTEC. Based on these clinical trials can be envisaged in the following incidences of Adverse Reactions:
In treatments a few weeks to three months:
11% – the gastrointestinal Tract (gastralgia, heartburn, nausea, etc.);
3% – Central Nervous System (dizziness, headache);
1 2% – Skin (pruritus, rash, erythema, urticaria).

As with other nsaids, in rare cases may occur skin reactions serious, such as a Syndrome of Stevens-Johnson Syndrome or Lyell;
12% – the urinary Tract (increased nitrogen uréico blood or plasma creatinine) and to the kidneys;
12% – Pathways in liver and bile (increased SGOT, SGPT, GAMMA-GT AND BILIRUBIN).

adverse Reactions rare: reduction of hemoglobin, granulocytopenia, thrombocytopenia, edema slight and fotodermatose.

long term Studies (12 to 48 months): have not revealed any increase in the frequency of adverse reactions.

Warnings and Precautions

what should I know before using?

The nsaids inhibit the synthesis of prostaglandins and may, therefore, determine undesirable reactions on the hemodynamic and renal on the balance hydro-sodium. For this reason, it is important to properly control the functions of the heart and kidney (BUN, creatinine, onset of swelling, increase of weight, etc.) when the administration of TENOXICAM to patients with potential risk to develop renal failure, such as: kidney disease, preexisting, kidney failure in diabetics, hepatic cirrhosis, congestive heart failure. Hypovolemia, concomitant use of drugs with known nephrotoxic potential, diuretics and corticosteroids. This group of patients is considered high risk in the pre-and post-operative period of major surgeries due to the possibility of increased risk of bleeding. For this reason, these patients require a special monitoring during the post-operative period and convalescence. The TENOXICAM inhibits platelet aggregation and can cause disturbance in hemostasis. The TENOXICAM does not present significant influence on the clotting factors, blood clotting time, prothrombin time, or time of thromboplastin activated. Therefore, patients with coagulation disorders or who are receiving drugs that may interfere with hemostasis should be carefully observed when the use of TENOXICAM.

Patients in treatment with TENOXICAM showing symptoms of gastrointestinal illnesses should be carefully monitored. Treatment with TENOXICAM should be immediately suspended if ulceration peptic and gastrointestinal bleeding. In case of skin reactions serious (p.ex. Syndrome, Lyell’s or Stevens-Johnson Syndrome), treatment should be immediately suspended.

it is Recommended eye examination in patients who develop disorders of vision, once they have been reported adverse effects the eye with the use of TENOXICAM.

Because of the sharp connection of TENOXICAM bound to plasma proteins, caution is advised when the levels of albumin in plasma were far below normal.

As with other nsaids, TENOXICAM may mask the usual symptoms of infection. TENOXICAM granulated soluble should not be administered to patients who do not like or cannot tolerate dairy.

Pregnancy and lactation: Although there have been observed in teratogenic effects in animal studies, there are no data on the safety of TENOXICAM during pregnancy. The nsaids have an inhibitory effect on the synthesis of prostaglandin and, when administered during the last months of pregnancy, may cause obliteration of the ductus arteriosus in the fetus. When administered at term, prolong labour of parturition. The chronic treatment during the last trimester of pregnancy should be avoided. Data obtained after administration of a single dose show that a very small amount (about 0.2%) of TENOXICAM passes into breast milk. Until the moment, there are no data regarding adverse reactions in nursing mothers or in women who breastfeed in the use of TENOXICAM, but can not exclude this possibility. For this reason, you should suspend breast-feeding or treatment with TENOXICAM.

Interference on the ability to operate machinery or drive vehicles.

Patients who have adverse reactions such as vertigo, dizziness or visual disturbances should avoid driving vehicles or handling machinery that require attention.

Overdose

what to do if someone use a larger amount than is recommended?

Although there is no experience of overdosage acute REUMOTEC, one can expect that the signs and symptoms mentioned in “backlash” occurring more pronounced. In case of an overdose or if you suspect such, you should discontinue the treatment. No specific antidote is known up to the present. The overdose should be controlled through measures to reduce absorption and accelerate the elimination of the substance.

gastrointestinal Disorders can be treated with antacids and drugs H2-receptor antagonists. If necessary, the elimination of TENOXICAM can be significantly accelerated through the administration of three doses of 4g of cholestyramine.