Eksib of the tab. of p/o of 120 mg No. 10

Eksib – nonsteroid anti-inflammatory and antirheumatic drug, for symptomatic therapy in an osteoarthritis, a pseudorheumatism, an ankylosing spondylitis and also in the pains and signs of inflammation connected with acute gouty arthritis.

Short treatment of the moderate postoperative pain connected with dental operations.

Structure

• active ingredient: etoricoxib;
• 1 tablet, film coated, contains etorikoksib 120 mg;
• other components: calcium hydrophosphate, cellulose microcrystalline, croscarmellose sodium, krospovidon, the stearylfumarating sodium, talc, Opadray II 85F green - for tablets on 60 mg and 120 mg, Opadray of II 85F white - for tablets on 90.

Eksib® Medicine is contraindicated to

Contraindication

• at hypersensitivity to the operating or any excipient of drug;
• in an active round ulcer or active gastrointestinal bleeding;
• to patients who had a bronchospasm, acute rhinitis, nasal polyps, a Quincke's disease, a small tortoiseshell or other allergic reactions after use of acetylsalicylic acid or NPVS, including TsOG-2 inhibitors;
• during pregnancy and feeding by a breast;
• in heavy abnormal liver functions (blood serum albumine <25 g/l or ≥ 10 points on a scale of Chaylda-Pyyu);
by
• if calculated renal clearance of creatinine <30 ml/min.;
• to children up to 16 years;
• in inflammatory bowel diseases;
• in stagnant heart failure (NYHA II‒IV);
• to patients with arterial hypertension at which indicators of arterial blood pressure higher than 140/90 mm Hg are constant. also are insufficiently controlled;
• at the diagnosed coronary heart disease, diseases of peripheral arteries and cerebrovascular diseases.

Medicine Eksib to apply

orally. Medicine can be accepted irrespective of food. The beginning of effect of medicament comes rather at reception before food. It should be considered in need of fast weakening of symptoms.

As the risk of disturbance of a cardiovascular system at use of an etorikoksib increases at increase in a dose and duration of exposure, it is necessary to conduct the shortest courses of treatment at use of the smallest effective daily doses. It is necessary to overestimate periodically the need for relief of symptoms and the response to treatment, especially at patients with an osteoarthritis.

Osteoarthritis

Recommended dosage makes 30 mg of 1 times a day. At some patients at insufficient weakening of symptoms of increase in a dose up to 60 mg of 1 times a day can increase efficiency. In the absence of effect it is necessary to consider a question of other possible methods of treatment.

Pseudorheumatism

Recommended dose makes 60 mg once a day. At some patients at insufficient weakening of symptoms of a dose up to 90 mg of 1 times a day can improve therapeutic effect. At achievement of clinical stabilization of the patient it is reasonable to lower a dose to 60 mg once a day. In the absence of improvement of effect it is necessary to consider a question of other possible methods of treatment.

Ankylosing spondylitis

Recommended dose makes 60 mg once a day. At some patients at insufficient weakening of symptoms of a dose up to 90 mg of 1 times a day can improve therapeutic effect. At achievement of clinical stabilization of the patient it is reasonable to lower a dose to 60 mg once a day. In the absence of improvement of effect it is necessary to consider a question of other possible methods of treatment.

Acute pain

At appearance of an acute pain etorikoksib is applied only during the acute symptomatic period.

Acute gouty arthritis

Recommended dosage makes 120 mg of 1 times a day. During clinical trials of acute gouty arthritis etorikoksib applied within 8 days.

Postoperative pain connected with dental surgery the Recommended dose – 90 mg of 1 times a day within at most 3 days. For some patients the additional postoperative anesthesia can be required.

Dose, exceeding recommended for each indication, have no additional efficiency or were not studied therefore:

• dose in an osteoarthritis should not exceed 60 mg/days;
• dose in a pseudorheumatism and an ankylosing spondylitis should not exceed 90 mg/days;
• dose in acute gout should not exceed 120 mg/days during the maximum period of treatment of 8 days;
• dose in an acute pain after dental surgery should not exceed 90 mg/days during the maximum 3-day period.

Feature of use

Use during pregnancy or feeding by a breast

Is not present clinical data on use of an etorikoksib during pregnancy. Researches on animals showed reproductive toxicity. The potential risk for pregnant women is unknown. Use of an etorikoksib during the last trimester of pregnancy, as well as other medicaments inhibiting synthesis of prostaglandins can result in lack of reductions of a uterus and premature closing of a botalovy channel. Use of an etorikoksib is contraindicated during pregnancy. If the woman became pregnant during treatment, etorikoksib it is necessary to cancel.

whether gets etorikoksib into breast milk. At rats etorikoksib it is removed in milk. The women applying etorikoksib should not nurse.

Children

Medicine the Eksib is contraindicated to children up to 16 years.

Ability to influence speed of response at control of motor transport or other mechanisms

Patients who at use of an etorikoksib have a dizziness vertigo or drowsiness, should not run motor transport and work with other mechanisms.

Overdose

in the course of clinical trials after use of a single dose of an etorikoksib up to 500 mg or multiple dose up to 150 mg/days within 21 days did not observe considerable toxic effects. It was reported about acute overdose etorikoksiby though in most cases about side reactions it was not reported. The most often observed side reactions corresponded to a profile of safety of an etorikoksib (to reaction from a GIT, from heart and kidneys).

in case of overdose it is reasonable to p to take the usual supporting measures, for example removal of not absorbed medicament from a GIT, conducting clinical observation, in case of need – performing the supporting treatment.

at a hemodialysis; it is unknown whether medicine when carrying out peritoneal dialysis is removed.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.