tablets Arkoksiya are applied at the following indications:

• symptomatic therapy in an osteoarthritis, a pseudorheumatism, an ankylosing spondylitis and also in the pain and signs of inflammation connected with acute gouty arthritis;
• short treatment of the moderate postoperative pain connected with dental operations.

Decision on prescribing of selection TsOG-2 inhibitor has to be based on assessment of all individual risks at the patient.

Structure

Active ingredient: etoricoxib;

1 tablet contains 30 mg, 60 mg, 90 mg or 120 mg of an etorikoksib;

Excipients: calcium hydrophosphate anhydrous, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate;

a tablet Cover Opadray® II dye blue-green 39K11526 (for a dosage of 30 mg), Opadray® II green 39K11520 (for a dosage of 60 mg), Opadray® II white 39K18305 (for a dosage of 90 mg), Opadray® II green 39K11529 (for a dosage of 120 mg), wax of karnaubskiya;

Composition of Opadray® II dye blue-green 39K11526, Opadray® II green 39K11520, Opadray® II green 39K11529: lactose monohydrate, gipromelloza; titan dioxide (E 171) triacetin; indigotin (E 132) ferrous oxide yellow (E172);

Composition of Opadray® II dye white 39K18305: lactose monohydrate, gipromelloza; titan dioxide (E 171) triacetin.

Arkoksiya 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 NPVP, including TsOG-2 inhibitors (tsiklooksihexanaza-2);
• 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 Chayld-Pyyu);
• if the calculated renal clearance of creatinine <30 ml/minute;
• 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 of a mercury column are constant and are insufficiently controlled by
• ;
• at the diagnosed coronary heart disease, diseases of peripheral arteries and/or cerebrovascular diseases.

Route of administration

Medicine is applied orally. The medicament can be taken irrespective of meal. The beginning of effect of medicament comes quicker at reception before food. It needs to be considered in need of fast weakening of symptoms.

As the risk of emergence of disturbances from a cardiovascular system at use of an etorikoksib increases at increase in a dose and duration of exposure, it is necessary to conduct short courses of treatment at use of the most 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.

Pregnant

Use of an etorikoksib is contraindicated to

Feature of use

Children

Etorikoksib is contraindicated to children up to 16 years.

Drivers

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

Overdose

during clinical trials of use of a single dose of an etorikoksib up to 500 mg or multiple dose to 150 mg a day within 21 day did not make essential toxic effects. It was reported about acute overdose etorikoksiby though in most cases about side reactions it was not reported. Side reactions which were observed more often corresponded to a profile of safety of an etorikoksib (for example, reactions from digestive tract, from heart and kidneys).

in case of overdose it is reasonable to p to host the ordinary supporting actions, for example removal of not absorbed medicament from digestive tract, conducting clinical observation, in case of need - performing the supporting treatment.

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

Side effects

• Disorder of metabolism and food: often (≥ 1/100, <1/10) - liquid hypostases/delay.
• from nervous system: often (≥ 1/100, <1/10) - dizziness, a headache.
• from heart: often (≥ 1/100, <1/10) - heartbeat, arrhythmia.
• from the vascular system: often (≥ 1/100, <1/10) - hypertensia.
• from bodies of a respiratory system, a thorax and mediastinum: often (≥ 1/100, <1/10) - a bronchospasm.
• from digestive tract: very often (≥ 1/10) - an abdominal pain; often (≥ 1/100, <1/10) - a constipation, a meteorism, gastritis, heartburn / an acid reflux, diarrhea, dyspepsia/discomfort in the field of epigastrium, nausea, vomiting, an esophagitis, ulcers in an oral cavity.
• from digestive system: often (≥ 1/100, <1/10) - increase in ALT, increase in nuclear heating plant.
• from skin and hypodermic cellulose: often (≥ 1/100, <1/10) - ecchymomas.
• Disturbance of the general state and disturbance, connected with a route of administration: often (≥ 1/100, <1/10) - asthenia/fatigue, grippopodobny symptoms.

Interaction

Vorikonazol and Miconazolum. Simultaneous use of an oral vorikonazol or Miconazolum in the form of oral gel for topical administration (powerful CYP3A4 inhibitors) about Etorikoksib caused small increase in exposure of an etorikoksib that, however, was not considered clinically significant according to the published data.

Rifampitsin. Co-administration of an etorikoksib and rifampicin (powerful inductor of CYP enzymes) led to decrease in concentration of an etorikoksib in blood plasma for 65%. It can be followed by repeated manifestation of symptoms at simultaneous use about Etorikoksib. Whereas such data can indicate the need of increase in a dose, it is not recommended to apply etorikoksib in the doses exceeding specified for each indication as the combined use of rifampicin and an etorikoksib in such doses was not studied.

to Store

in original packing at a temperature not above 30 °C, out of children's reach.

Expiration date - 3 years.