Movalis of the tab. of 15 mg No. 20

Pharmacological properties

Pharmacodynamics. movalis — npvp a class of enoliyevy acid, has anti-inflammatory, analgeziruyushchy and antipyretic effect. to meloksika shows high anti-inflammatory activity on all standard models of inflammation. as well as for other npvp, its exact mechanism of action remains to unknown. however there is the general mechanism of development for all npvp (including meloksika): oppression of biosynthesis of prostaglandins which are inflammation mediators.

Pharmacokinetics

Absorption. Meloksikam is well absorbed in a GIT at oral administration, the absolute bioavailability is 90% (capsule). Tablets, suspension for oral administration and the capsule of a bioekvivalentna. After single use of a meloksikam With _max in blood plasma it is reached during 5–6 h for solid oral forms (the capsule and a tablet). At multiple dose the stable concentration are reached for 3-i-5-e days. The mode of dosing of 1 times a day results in average concentration in blood plasma with rather small fluctuations of peaks within 0.4-1.0 mkg/ml for 7.5 mg and 0.8-2.0 mkg/ml for 15 mg according to (the C _min and the C _max in a stable state respectively). Average concentration of a meloksikam in blood plasma in a stable state is reached during 5–6 h for tablets, capsules and suspension for oral administration respectively.

Concomitant use of food or use of inorganic antacids does not influence medicament absorption.

after an injection in oil. Relative bioavailability in comparison with oral administration — 100%. Therefore there is no need to korrigirovat a dose upon transition from in oil to an oral way to use. After an injection in oil 15 mg of the C _max in blood plasma are in limits of 1.6-1.8 mkg/ml and Distribution is reached during 1–6 h

. Meloksikam very well contacts proteins of blood plasma, mainly albumine (99%). Meloksikam gets into synovial fluid in which concentration is twice less, than in blood plasma. Distribution volume low, on average 11 l after in oil or in/in uses, are noted individual deviations within 7–20%. Distribution volume after repeated use of oral doses of a meloksikam (7.5-15 mg) is 16 l with deviation coefficient within 11–32%.

Biotransformation. Meloksikam is exposed to extensive biotransformation in a liver. In urine four various metabolites of a meloksikam which pharmakodinamichesk are inactive are identified. The main metabolite 5 '-karboksimeloksikam (60% of a dose) is formed by oxidation of an intermediate metabolite 5 '-hydroksimetilmeloksikama which is also allocated to a lesser extent (9% of a dose). The researches in vitro assume that CYP 2C9 plays an important role in the course of metabolism whereas isoenzymes promote CYP ZA4 to a lesser extent. The activity of peroxidase at patients, perhaps, is responsible for two other metabolites which make 16 and 4% of the accepted dose respectively.

Elimination. Removal of a meloksikam happens generally in the form of metabolites in equal parts to urine and a stake. Less than 5% of a daily dose are allocated in not changed view with a stake, the insignificant quantity is distinguished with urine. The t _½ changes from 13 to 25 h after oral administration, in oil and in/in uses. The plasma clearance is about 7-12 ml/min. after a single oral dose in/in or rectal use.

Linearity of a dose. Meloksikam shows linear pharmacokinetics within a therapeutic dose from 7.5 to 15 mg after oral and administration in oil.

Special groups of patients

Patients with a liver/renal failure. A liver and renal failure of easy and average degree significantly do not influence pharmacokinetics of a meloksikam. At patients with moderate degree of a renal failure noted higher general clearance. Decrease in linking with proteins of blood plasma was revealed at patients with a terminal renal failure. In a terminal renal failure the increase in volume of distribution can lead to increase in concentration of a free meloksikam. It is not necessary to exceed a dose of 7.5 mg (see USE).

Patients of advanced age. At patients of male advanced age the average pharmacokinetic parameters are similar at male young volunteers. At patients of female advanced age the AUC value is higher and the T _½ is longer in comparison with those at young volunteers of both sexes. The average clearance from blood plasma in an equilibrium state at patients of advanced age is slightly lower, than at young volunteers.

Indication

Tablet: short-term symptomatic treatment of exacerbation of an osteoarthrosis. long symptomatic treatment of a pseudorheumatism and ankylosing spondylitis.

Solution for injections: short-term symptomatic treatment of a bad attack of a pseudorheumatism and ankylosing spondylitis when oral and rectal ways of a primeniye cannot be applied.

Use

Tablet is applied inside.

General daily amount of medicine should be applied once, washing down with water or other liquid, during meal.

Side reactions can be minimized by use of a minimal effective dose during the minimum period of the treatment necessary for control of symptoms (see. Special INSTRUCTIONS). It is necessary to estimate periodically need of the patient for symptomatic improvement and the response to treatment.

Exacerbation of an osteoarthrosis: 7.5 mg/days (1 tablet of 7.5 mg or half of a tablet of 15 mg). If it is necessary, the dose can be raised to 15 mg/days (1 tablet 15 mg or 2 tablets of 7.5 mg).

Pseudorheumatism ankylosing a spondylitis: 15 mg/days (1 tablet 15 mg or 2 tablets of 7.5 mg).

See. Special categories of patients are lower.

According to therapeutic effect a dose can be lowered to 7.5 mg/days (1 tablet of 7.5 mg or a half of a tablet of 15 mg).

not to exceed a dose of 15 mg/days

Special categories of patients

Patients of advanced age and patients with the increased risk of development of side reactions. The recommended dose for long-term treatment of a pseudorheumatism and an ankylosing spondylitis at patients of advanced age makes 7.5 mg/days. Patients with the increased risk of development of side reactions should begin with 7.5 mg (see. Special INSTRUCTIONS).

Renal failure. At the patsint with a heavy renal failure which are on dialysis, the dose should not exceed 7.5 mg. The dose decline is not required to patients with a slight and moderate renal failure (namely patients with clearance of creatinine is higher than 25 have some) (concerning patients with a heavy renal failure without use of dialysis see CONTRAINDICATIONS).

Liver failure. With a slight and moderate liver failure of a dose decline it is not required to patients (concerning patients with a heavy liver failure see CONTRAINDICATIONS).

Solution for injections:

In oil use.

One injection of 15 mg of 1 times a day.

not to exceed a dose of 15 mg/days .

Treatment has to be limited to one injection at the beginning of therapy with the maximum duration up to 2-3 days in reasonable exceptional cases (for example when oral and rectal ways of use are impossible). Side reactions can be minimized by use of the smallest effective dose during the shortest time of the treatment necessary for control of symptoms (see. Special INSTRUCTIONS).

Should estimate periodically need of the patient for symptomatic simplification and its response to treatment.

Special categories of patients.

Patients of advanced age and patients with the increased risk of development of side reactions. The recommended dose for patients of advanced age makes 7.5 mg a day. Patients with the increased risk of development of side reactions should begin with 7.5 mg (half of an ampoule of 1.5 ml) (see. Special INSTRUCTIONS).

Renal failure. For the patients with a heavy renal failure who are on dialysis, the dose should not exceed 7.5 mg a day (half of an ampoule of 1.5 ml).

. Concerning patients with a heavy renal failure without use of dialysis see CONTRAINDICATIONS.

Liver failure. With a slight and average liver failure of a dose decline it is not required to patients. Concerning patients with a heavy liver failure see CONTRAINDICATIONS.

Route of administration. The medicament should be administered slowly, by a deep injection in oil in an upper external quadrant of a buttock, adhering to the strict aseptic equipment. In case of repeated introduction it is recommended to alternate the left and right buttocks. Before an injection it is important to check that the edge of a needle was not in a vessel.

Injection should be stopped immediately in case of severe pain during an injection.

in case of a prosthesis of a hip joint in other buttock.

Contraindication

Hypersensitivity to a meloksikam or other components of medicine or active agents with similar action, as npvp, acetylsalicylic acid. meloksika should not appoint to patients who had asthma symptoms, nasal polyps, a Quincke's disease or a small tortoiseshell after intake of acetylsalicylic acid or others npvp;

• III a pregnancy trimester (see Use during pregnancy and feeding by a breast);
• children and teenagers aged up to 16 years;
• gastrointestinal bleeding or the perforation connected with the previous therapy of NPVP in the anamnesis;
• an active or recurrent ulcer / bleeding in the anamnesis (2 or more separate confirmed cases of an ulcer or bleeding);
• heavy liver failure;
• a heavy renal failure without dialysis use;
• gastrointestinal bleeding, cerebrovascular bleeding in the anamnesis or other disturbances of blood clotting;
• heavy heart failure;
• is not applied to treatment of perioperatsionny pain at aortocoronary shunting;
• for solution for injections also — children aged up to 18 years;  disturbances of a hemostasis or simultaneous use of anticoagulants (contraindications are connected with way of use).

Given researches and epidemiological data allow to assume

that use of some npvp (especially in high doses and at long-term treatment) can be connected with the small increased risk of cases of the vascular trombotichesky phenomena (for example a myocardial infarction or a stroke) (see special instructions).

Hypostasis, AG and heart failure was revealed at treatment of NPVP.

Majority of noted side effects of gastrointestinal origin. The ulcer, perforation or gastrointestinal bleeding, sometimes lethal, especially at patients of advanced age are possible (see. Special INSTRUCTIONS). After use noted nausea, vomiting, diarrhea, a meteorism, a constipation, dyspepsia, an abdominal pain, a melena, vomiting blood, a stomacace, exacerbation of colitis and Crohn's disease (see. Special INSTRUCTIONS). With a smaller frequency revealed gastritis.

Criteria for evaluation of frequency of development of side reactions of medicine: very often (≥1/10), it is frequent (≥1/100, 1/10); infrequently (≥1/1000, 1/100), it is rare (≥1/10,000, 1/1000), is very rare (1/10,000), it is unknown (it is impossible to determine by the available data).

from the system of blood and lymphatic system: infrequently — anemia; seldom — deviations of indicators of blood test from norm (including change of quantity of leukocytes), a leukopenia, thrombocytopenia.

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It was reported about very exceptional cases of an agranulocytosis (see. Separate serious and/or frequent side reactions).

from the immune system: infrequently — allergic reactions, except anaphylactic or anaphylactoid; it is unknown — anaphylactic reactions, anaphylactoid reactions, including shock.

Mental disorders: seldom — change of mood, dreadful dreams; it is unknown — confusion of consciousness, a disorientation, insomnia.

from nervous system: often — a headache; seldom — dizziness, drowsiness.

from an organ of sight: seldom — the disorders of vision including illegibility of sight; conjunctivitis.

from an organ of hearing and a vestibular mechanism: infrequently — dizziness; seldom — a ring in ears.

Cardial disturbances: seldom — heartbeat.

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It was reported about the heart failure connected with treatment of NPVP.

Vascular disorders: infrequently — increase in the ABP (see. Special INSTRUCTIONS), inflows.

from the respiratory system, bodies of a thorax and mediastinum: seldom — asthma at patients with an allergy to acetylsalicylic acid and other NPVP; it is unknown — upper respiratory tract infections, cough.

from a digestive tract: very often — dyspepsia, nausea, vomiting, an abdominal pain, a constipation, a meteorism, diarrhea; infrequently — the concealed or macroscopic gastrointestinal hemorrhage, stomatitis, gastritis, an eructation; seldom — colitis, a gastroduodenal ulcer, an esophagitis; very seldom — gastrointestinal perforation.

Gastrointestinal bleeding, an ulcer or perforation can be heavy and potentially lethal, especially at patients of advanced age (see. Special INSTRUCTIONS).

from digestive system: infrequently — disturbance of indicators of function of a liver (for example increase in transaminases or bilirubin); very seldom — hepatitis; it is unknown — jaundice, a liver failure.

from skin and hypodermic cellulose: infrequently — a Quincke's disease, an itching, rash; seldom — Stephens's syndrome — Johnson, a toxic epidermal necrolysis, a small tortoiseshell; very seldom — bullous dermatitis, a multiformny erythema; it is unknown — a photosensitization, exfoliative dermatitis.

from an urinary system: infrequently — a delay of sodium and water, a hyperpotassemia (see. Special INSTRUCTIONS, VZIMODEYSTVIYa), changes of indicators of function of kidneys (increase in creatinine and/or urea in blood plasma); very seldom — OPN, in particular at patients with risk factors (see. Special INSTRUCTIONS); it is unknown — infections of urinary tract, disturbance of frequency of urination.

General disturbances and disturbances in the injection site: often — hardening in the place of an injection, pain in the place of an injection; infrequently — hypostasis, including hypostasis of the lower extremities; it is unknown — grippopodobny symptoms.

from the musculoskeletal system: it is unknown — the arthralgia, a dorsodynia, signs and symptoms connected with joints.

Separate serious and/or frequent side reactions. It was reported about very exceptional cases of an agranulocytosis at the patients accepting to meloksika and other potentially myelotoxic medicines (see INTERACTIONS).

Side reactions which did not note at medicament use, but which it is standard are characteristic

other connections of a class. Organic lesion of kidneys which probably leads to OPN: it was reported about very exceptional cases of interstitial nephrite, acute tubular necrosis, a nephrotic syndrome and papillary necrosis (see. Special INSTRUCTIONS).

Special instructions

Side reactions can be minimized by use of a minimal effective dose during the short duration of the treatment necessary for control of symptoms (see use and information on gastrointestinal and cardiovascular risks below).

Recommended maximum daily dose cannot be exceeded in case of insufficient therapeutic effect, it is also not necessary to apply in addition NPVP as it can increase toxicity whereas therapeutic advantages are not proved. It is necessary to avoid simultaneous use of a meloksikam with NPVP, including selection TsOG-2 inhibitors. Meloksikam is not suitable for treatment of patients who need reduction of severity of an acute pain.

in case of lack of improvement after several days should estimate clinical advantages of treatment repeatedly.

needs to pay attention to an esophagitis, gastritis and/or a round ulcer in the anamnesis for the purpose of ensuring their full treatment before therapy meloksikamy. It is regularly necessary to carry out monitoring of rather possible manifestation of a recurrence at the patients accepting to meloksika and patients with such cases in the anamnesis.

Disturbance from a GIT. As well as at use of other NPVP, potentially lethal gastrointestinal bleeding, an ulcer or perforation can arise in the course of treatment at existence or without the previous symptoms or serious gastrointestinal diseases in the anamnesis at any time.

at increase in a dose of NPVP at patients with the ulcer in the anamnesis which is especially complicated by bleeding or perforation (see CONTRAINDICATIONS), and at patients of advanced age. Such patients should begin treatment with a minimal effective dose. For such patients it is necessary to consider combination therapy with protective medicines (such as mizoprostol or inhibitors of a proton pomp) and also for the patients demanding use of a low dose of acetylsalicylic acid or other medicines increasing gastrointestinal risks (see information given below and the section INTERACTIONS).

to Patients with manifestations of gastrointestinal toxicity in the anamnesis, especially to patients of advanced age, it is necessary to report about all unusual abdominal symptoms (especially gastrointestinal bleedings), mainly at the initial stages of treatment.

Should show care concerning the patients who are at the same time accepting medicines which can increase risk of an ulcer or bleeding, in particular heparin as radical therapy or in geriatric practice, anticoagulants, such as warfarin or other NPVP, including acetylsalicylic acid in anti-inflammatory doses (≥1 g a single dose or ≥3 g the general daily dose) (see INTERACTIONS).

When developing gastrointestinal bleeding or ulcer at the patients applying to meloksika should cancel treatment.

NPVP should be applied with care at patients with gastrointestinal diseases in the anamnesis (ulcer colitis, Crohn's disease) as these states can become aggravated (see. Side EFFECTS).

Disturbance from a liver. At ≤15% of the patients accepting NPVP (including Movalis), can note increase in level of one or more hepatic tests. Such laboratory deviations can progress, remain invariable or to be temporary at treatment continuation. Significant increase in AlAT or AsAT (norms are about ≥3 times higher) was noted at 1% of patients during clinical trials with NPVP. It was in addition reported about exceptional cases of heavy hepatic reaction, including jaundice and lightning lethal hepatitis, necrosis of a liver and a liver failure, some of them with a lethal outcome.

Patients with symptoms or suspicion of hepatic dysfunction or at which revealed rejections of hepatic tests should be estimated on development of symptoms of heavier liver failure during medicament Movalis therapy. If clinical signs and symptoms are compared with development of diseases of a liver or if note system manifestations of a disease (for example an eosinophilia, rash, etc.), then Movalis's use should be stopped.

Cardiovascular disturbances. Behind a condition of patients with AG and/or stagnant heart failure of easy and average degree in the anamnesis recommend careful observation as at therapy of NPVP revealed a delay of liquid and hypostasis.

At patients with risk factors recommends clinical observation of the ABP at the beginning of therapy, especially at the beginning of a course of treatment meloksikamy. The given researches and epidemiological data allow to assume that use of some NPVP (especially in high doses and at long-term treatment) can be connected with small increase in risk of the vascular trombotichesky phenomena (for example a myocardial infarction or a stroke). There are not enough data for an exception of such risk for a meloksikam. Patients with uncontrollable AG, the stagnant heart failure established to an ischemic heart disease, a disease of peripheral arteries and/or cerebrovascular diseases should carry out therapy only the meloksikamy ambassador of the careful analysis. The similar analysis is necessary at the beginning of long-term treatment of patients with risk factors of cardiovascular diseases (such as AG, lipidemia, diabetes, smoking). NPVP can increase risk of serious cardiovascular trombotichesky complications, a myocardial infarction and stroke, sometimes with a lethal outcome. Increase in risk is connected with use duration. Patients with cardiovascular diseases or risk factors of developing such pathology can enter into group of the increased risk.

Disturbance from skin. It was reported about life-threatening severe damages of skin: Stephens's syndrome — Johnson and a toxic epidermal necrolysis at use of a meloksikam. Patients have to be informed on signs and symptoms of severe defeats and to watch closely reactions of skin. The greatest risk of emergence of a syndrome of Stephens — Johnson or a toxic epidermal necrolysis exists within the first weeks of treatment. If at the patient note symptoms or signs of a syndrome of Stephens — Johnson or a toxic epidermal necrolysis (for example the progressing skin rash, it is frequent with bubbles or damage of a mucous membrane), it is necessary to stop treatment meloksikamy. It is important to diagnose and stop as soon as possible use of any medicaments which can cause severe damages of skin: Stephens's syndrome — Johnson or a toxic epidermal necrolysis. The best forecast at severe damages of skin is connected with it. If at the patient are revealed Stephens's syndrome — Johnson or a toxic epidermal necrolysis at use of a meloksikam, medicament cannot be used at any time in the future.

Anaphylactic reactions. As well as at use of other NPVP, anaphylactic reactions can note at patients without the known reaction on Movalis. Movalis it is not necessary to apply at patients with an aspirinovy triad. This symptomatic complex is revealed at patients with OH at which it was reported about rhinitis with or without nasal polyps or with heavy, potentially lethal bronchospasm after use of acetylsalicylic acid or other NPVP. It is necessary to take measures of emergency aid at identification of anaphylactoid reaction.

Parameters of a liver and function of kidneys. As well as at treatment the majority of NPVP, described isolated cases of increase in level of transaminases, bilirubin in serum of blood or other indicators of function of a liver, as well as increase in creatinine in blood serum and urea nitrogen in blood, and other deviations of laboratory indicators. In most cases these deviations were insignificant and temporary. At considerable or steady confirmation of such deviations the use of a meloksikam should be stopped and carried out control tests.

Functional renal failure. NPVP by oppression of vasodilating influence of renal prostaglandins can induce a functional renal failure owing to decrease in glomerular filtration. This side effect is dose-dependent. In an initiation of treatment or after increase in a dose the careful control of a diuresis and function of kidneys at patients with such risk factors is recommended:

• advanced age;
• simultaneous use with APF inhibitors, antagonists of angiotensin II, a sartanama, diuretics (see INTERACTIONS);
• hypovolemia (any genesis);
• stagnant heart failure;
• renal failure;
• nephrotic syndrome;
• lyupus-nephropathy;
• heavy degree of hepatic dysfunction (plasma albumine of 25 g/l or ≥10 on classification of Chayld-Pyyu).

to interstitial nephrite, a glomerulonephritis, renal medullary necrosis or a nephrotic syndrome. The dose of a meloksikam for the patients with a terminal renal failure who are on dialysis should not exceed 7.5 mg. Patients with a renal failure of easy and average degree cannot reduce a dose (level of clearance of creatinine of 25 ml/min.).

Delay of sodium, potassium and water. NPVP can strengthen a delay of sodium, potassium and water and to affect natriuretic effect of diuretics. Besides, decrease in antihypertensive effect of hypotensive medicines is possible (see INTERACTIONS). Therefore as at sensitive patients the increase in expressiveness or exacerbation of hypostasis, heart failure or AG can note result. Therefore carrying out clinical monitoring is recommended to patients with such risks (see USE and CONTRAINDICATIONS).

Hyperpotassemia. The hyperpotassemia can be promoted by diabetes or simultaneous use of the medicines raising a kaliyemiya (see INTERACTIONS). In such cases it is necessary to carry out control of level of potassium regularly.

Combination with pemetreksedy. At the patients with a slight and moderate renal failure accepting pemetreksed the treatment meloksikamy should be suspended at least for 5 days before introduction of a pemetreksed, in day of introduction and a minimum for 2 days after introduction (see INTERACTIONS).

Other preventions and security measures. Side reactions are transferred often worse by patients of advanced age, the weak or weakened patients who need careful observation. As well as at treatment by other NPVP, it is necessary to be careful concerning elderly people at whom depression of function of kidneys, a liver and heart is more probable. At patients of advanced age note higher frequency of emergence of side reactions at use of NPVP, especially gastrointestinal bleedings and perforation which can be lethal (see USE).

Meloksikam, as well as any other NPVP, can mask symptoms of infectious diseases.

Use of a meloksikam can have negative effect on reproductive function and is not recommended to women who want to become pregnant. Therefore for the women who are planning pregnancy or undergoing inspection concerning infertility it is necessary to consider the possibility of the termination of reception of a meloksikam (see Use during pregnancy and feeding by a breast).

structure of the tablets Movalis of 7.5 mg and 15 mg includes lactose therefore the medicament is not recommended to be taken to patients with rare congenital intolerance of a galactose, deficiency of lactase or disturbance of absorption of glucose or a galactose.

Masking of inflammation and fever. Pharmacological action of Movalis for reduction of severity of fever and inflammation can complicate diagnostics at the suspected non-infectious pain syndrome.

Treatment by corticosteroids. Movalis cannot be the probable deputy of corticosteroids at treatment of corticosteroid insufficiency.

Hematologic effects. Anemia can be noted at the patients receiving NPVP, including Movalis. It can be connected with a liquid delay, gastrointestinal bleeding of unknown origin either the macroscopic or completely described influence on an erythrogenesis. To patients at long-term treatment of NPVP, including Movalis, it is necessary to control hemoglobin or gemokrit if symptoms and symptoms of anemia are revealed.

NPVP slow down aggregation of thrombocytes and can increase a bleeding time at some patients. Unlike acetylsalicylic acid, their influence on function of thrombocytes quantitatively is less, short-term and reversible. It is necessary to control carefully a condition of the patients accepting Movalis at whom side effects concerning changes of function of thrombocytes, in particular disturbance of blood clotting, or the patients receiving anticoagulants are possible.

Use for patients with asthma. At patients with asthma can note aspirinchuvstvitelny asthma. Use of acetylsalicylic acid for patients with aspirinchuvstvitelny asthma is associated with a heavy bronchospasm which can be deadly. Considering cross-reaction, including a bronchospasm, between acetylsalicylic acid and other NPVP it is not necessary to apply Movalis at the patients sensitive to acetylsalicylic acid, and it is necessary to appoint with care to patients with asthma.

Period of pregnancy and feeding by a breast.

Fertility. Meloksikam, as well as other medicines inhibiting COG/prostaglandin synthesis can have negative effect on reproductive function and is not recommended to the women planning pregnancy. Therefore for women who plan pregnancy or undergo inspection concerning infertility, it is necessary to consider the possibility of cancellation of a meloksikam.

Pregnancy. The inhibition of synthesis of prostaglandins can negatively influence pregnancy and/or development of an embryo and fruit. Data of epidemiological researches allow to assume increase in risk of an abortion and development of heart diseases and gastroshizis after use of inhibitors of synthesis of prostaglandins during the early period of pregnancy. Absolute risk of developing heart diseases increased from ≤1% to about 1.5%. It is supposed that this risk increases with increase in a dose and increase in duration of treatment.

B I and the II trimester of pregnancy to meloksika should not be applied, except for the urgent need. If the woman plans pregnancy or in I and II trimester of pregnancy applies to meloksika, the dose and duration of treatment have to be minimum.

In the III trimester of pregnancy all inhibitors of synthesis of prostaglandins can cause risk for a fruit:

• cardiopulmonary toxicity (with premature closing of an arterial channel and pulmonary hypertensia);
• a renal failure, can develop in a renal failure with oligogidramniony.

Possible risks in deadlines for pregnancy for mother and the newborn:

• probability of extension of a bleeding time, anti-aggregation effect even at reception of very low doses;
• oppression of reductions of a uterus that leads to a delay or delay in childbirth.

Therefore to meloksika it is contraindicated in the III trimester of pregnancy.

Feeding by a breast. Though there are no specific data on the medicament Movalis, but concerning NPVP it is known that they can get into breast milk. Therefore use is not recommended to the women nursing.

Children. Movalis, tablets of 7.5 mg and 15 mg, is contraindicated to children aged up to 16 years (see CONTRAINDICATIONS).

Solution for injections — is contraindicated to children aged up to 18 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. There are no special researches of influence of medicament on ability to drive the car or to work with mechanisms. However on the basis of a pharmakodinamichesky profile and the revealed side reactions it is possible to assume what to meloksika does not influence or has insignificant impact on the specified activity. However to patients at whom noted dysfunctions of sight including illegibility of sight, dizziness, drowsiness, vertigo or other disturbances from central nervous system, it is recommended to refrain from driving or work with mechanisms.

Interaction

Researches of interaction were conducted only with participation of adults.

Risks connected with a hyperpotassemia. Some medicines or therapeutic groups can promote a hyperpotassemia: potassium salts, kaliysberegayushchy diuretics, APF inhibitors, antagonists of receptors of angiotensin II, NPVP, low-molecular or unfractionated heparins, cyclosporine, takrolimus and Trimethoprimum.

Beginning of a hyperpotassemia can depend on whether there are related factors. Risk of development of a hyperpotassemia increases if above-mentioned medicines p