Movicsicam® odt

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOVIKSIKAM® ODT (MOVIXICAM® ODT)

Composition:

Active ingredient: meloxicam;

1 tablet contains 7.5 mg or 15 mg of meloxicam;

Excipients: mannite (E 421), crospovidone, talc, sorbitol (E 420), sodium lauryl sulfate, anhydrous citric acid, aspartame (E 951), magnesium stearate, yogurt flavor, forest berry flavor, povidone.

Pharmaceutical form.

Orally disintegrating tablets.

Main physicochemical properties:

7.5 mg dosage: flat, light-yellow tablets with "AX6" marked on one side, with a scent of forest berries and yogurt;

15 mg dosage: flat, light-yellow tablets with a break line and "AX" marked on one half and "5" on the other half on the side with the break line, with a scent of forest berries and yogurt.

Pharmacotherapeutic group.

Nonsteroidal anti-inflammatory and antirheumatic agents. Oxicams. ATC code M01AC06.

Pharmacological properties.

Pharmacodynamics.

MOVIKSIKAM® ODT is a non-steroidal anti-inflammatory drug of the enolic acid class, exhibiting anti-inflammatory, analgesic and antipyretic effects.

Meloxicam has demonstrated high anti-inflammatory activity in all standard models of inflammation. As with other NSAIDs, its exact mechanism of action remains unknown. However, there is a common mechanism of action for all NSAIDs (including meloxicam): inhibition of prostaglandin biosynthesis, which are mediators of inflammation.

Pharmacokinetics.

Absorption. Meloxicam is well absorbed from the gastrointestinal tract following oral administration. Absolute bioavailability of the drug is 89%. After single administration, maximum plasma concentration (Cmax) is reached within 5–6 hours.

Steady-state concentrations are achieved by day 3–5 with repeated dosing. Once-daily dosing results in average plasma concentrations with relatively small peak fluctuations: within 0.4–1.0 μg/mL for the 7.5 mg dose and 0.8–2.0 μg/mL for the 15 mg dose, respectively (Cmin and Cmax at steady state, respectively). Maximum plasma concentrations of meloxicam at steady state are reached within 5–6 hours.

Concomitant food intake or administration of inorganic antacids does not affect drug absorption.

Distribution. Meloxicam is highly bound to plasma proteins, primarily to albumin (99%). Meloxicam penetrates into synovial fluid, where its concentration is approximately half that in plasma. The volume of distribution is low, averaging 11 L, with individual variations within 7–20%. The volume of distribution after repeated oral doses of meloxicam (7.5–15 mg) is 16 L, with a coefficient of variation from 11 to 32%.

Biotransformation. Meloxicam undergoes extensive biotransformation in the liver.

Four different metabolites of meloxicam have been identified in urine, all of which are pharmacodynamically inactive. The main metabolite, 5’-carboxymeloxicam (60% of dose), is formed via oxidation of the intermediate metabolite 5’-hydroxymethylmeloxicam, which is also excreted to a lesser extent (9% of dose). In vitro studies suggest that CYP2C9 plays a major role in metabolism, while CYP3A4 isoenzymes contribute to a lesser extent. Peroxidase activity in patients may be responsible for two other metabolites, which account for 16% and 4% of the administered dose, respectively.

Elimination. Meloxicam is eliminated primarily as metabolites in equal proportions via urine and feces. Less than 5% of the daily dose is excreted unchanged in feces, and a negligible amount is excreted in urine. The mean elimination half-life is approximately 20 hours. The half-life ranges from 13 to 25 hours after oral administration. Plasma clearance averages 8 mL/min.

Dose linearity. Meloxicam exhibits linear pharmacokinetics within the therapeutic dose range of 7.5 to 15 mg.

Special patient groups.

Patients with hepatic/renal impairment. Mild to moderate hepatic or renal impairment does not significantly affect the pharmacokinetics of meloxicam. Patients with moderate renal impairment had significantly higher total clearance. Reduced plasma protein binding was observed in patients with end-stage renal disease. In end-stage renal disease, increased volume of distribution may lead to higher concentrations of free meloxicam. Daily dose should not exceed 7.5 mg (see section "Dosage and administration").

Elderly patients. In elderly male patients, mean pharmacokinetic parameters are similar to those in young male volunteers. In elderly female patients, AUC values are higher and elimination half-life is longer compared to young volunteers of both genders. Mean plasma clearance at steady state in elderly patients was slightly lower than in young volunteers.

Clinical characteristics.

Indications.

Short-term symptomatic treatment of osteoarthritis exacerbation.

Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.

Contraindications.

• Hypersensitivity to meloxicam or to any other component of the medicinal product, as well as to active substances with similar actions, such as NSAIDs, acetylsalicylic acid (meloxicam should not be administered to patients who have experienced asthma symptoms, nasal polyps, angioedema, or urticaria after taking acetylsalicylic acid or other NSAIDs);
• Third trimester of pregnancy (see section "Use during pregnancy or breastfeeding");
• Children under 16 years of age;
• Gastrointestinal bleeding or perforation related to previous NSAID therapy in medical history;
• Active or recurrent peptic ulcer/hemorrhage in medical history (two or more separate confirmed episodes of ulcer or bleeding);
• Severe hepatic insufficiency;
• Severe renal insufficiency without dialysis;
• Gastrointestinal bleeding, cerebrovascular bleeding in medical history, or other coagulation disorders;
• Severe heart failure;
• Treatment of perioperative pain in coronary artery bypass grafting.

Interaction with other medicinal products and other forms of interaction.

Meloxicam is metabolized in the liver, primarily by CYP2C9 and/or CYP3A4. There is a potential for pharmacokinetic interactions between meloxicam and medicinal products that are metabolized by CYP2C9 and/or CYP3A4.

Risks associated with hyperkalemia.

Some medicinal products or therapeutic groups may cause hyperkalemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists, NSAIDs, (low molecular weight or unfractionated) heparins, cyclosporine, tacrolimus, and trimethoprim.

The onset of hyperkalemia may depend on whether associated risk factors are present. The risk of hyperkalemia increases if the above-mentioned medicinal products are used concomitantly with meloxicam.

Pharmacodynamic interactions.

Other NSAIDs and acetylsalicylic acid. Combination with other NSAIDs, including acetylsalicylic acid at doses (≥ 500 mg – single dose or ≥ 3 g – total daily dose), is not recommended.

Corticosteroids. Concomitant use with corticosteroids requires caution due to an increased risk of gastrointestinal bleeding or ulceration.

Anticoagulants or heparin, antiplatelet agents, and thrombolytics. The risk of bleeding is significantly increased due to inhibition of platelet function and damage to the gastroduodenal mucosa. Concomitant use of NSAIDs and anticoagulants or heparin is not recommended in geriatric practice or at therapeutic doses (see section "Special precautions for use"). NSAIDs may enhance the effects of anticoagulants such as warfarin (see section "Special precautions for use").

When NSAIDs and heparin are used concomitantly at prophylactic doses, caution is required due to an increased risk of bleeding. Careful monitoring of the international normalized ratio (INR) is necessary if avoidance of this combination is not possible.

Selective serotonin reuptake inhibitors (SSRIs). Increased risk of gastrointestinal bleeding.

Diuretics, ACE inhibitors, and angiotensin II receptor antagonists. NSAIDs may reduce the efficacy of diuretics and other antihypertensive medicinal products. In some patients with impaired renal function (e.g., dehydrated patients or elderly patients with renal impairment), concomitant use of ACE inhibitors or angiotensin II antagonists and medicinal products that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, this combination should be used with caution, especially in elderly patients. Patients should receive adequate fluid intake. Renal function should be monitored after initiation of combined therapy and periodically thereafter.

Other antihypertensive agents (e.g., beta-blockers). NSAIDs may reduce the effect of antihypertensive medicinal products due to inhibition of vasodilatory prostaglandins.

Calcineurin inhibitors (e.g., cyclosporine, tacrolimus). NSAIDs may enhance the nephrotoxicity of calcineurin inhibitors through effects on renal prostaglandins, requiring careful monitoring of renal function when these agents are used concomitantly, especially in elderly patients.

Deferasirox. Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal adverse reactions. Caution should be exercised when combining these medicinal products.

NSAIDs reduce the effectiveness of intrauterine contraceptive devices.

Pharmacokinetic interaction: effect of meloxicam on the pharmacokinetics of other medicinal products.

Lithium. NSAIDs may increase plasma lithium concentrations (due to reduced renal excretion of lithium), which may reach toxic levels. Concomitant use of lithium and NSAIDs is not recommended. In cases of combined therapy, plasma lithium levels should be closely monitored at the beginning of treatment, during dose adjustment, and upon discontinuation of meloxicam.

MTX (methotrexate). NSAIDs may reduce tubular secretion of methotrexate, thereby increasing its plasma concentration. For this reason, concomitant use of NSAIDs is not recommended in patients receiving high-dose methotrexate (over 15 mg/week). The risk of interaction between NSAIDs and methotrexate should also be considered at low methotrexate doses, particularly in patients with impaired renal function. If combined treatment is necessary, blood parameters and renal function should be monitored. Caution is advised when NSAIDs and methotrexate are taken for three consecutive days, as plasma methotrexate levels may rise and increase toxicity. Although meloxicam does not affect the pharmacokinetics of methotrexate (15 mg/week), hematological toxicity of methotrexate may increase during treatment with NSAIDs.

Pemetrexed. When meloxicam is used concomitantly with pemetrexed in patients with creatinine clearance between 45 and 79 mL/min, meloxicam administration should be withheld for 5 days before, on the day of, and for 2 days after pemetrexed infusion. If combination of meloxicam with pemetrexed is necessary, patients should be closely monitored, particularly for signs of myelosuppression and gastrointestinal adverse reactions. Concomitant use of meloxicam with pemetrexed is not recommended in patients with severe renal impairment (creatinine clearance < 45 mL/min).

In patients with normal renal function (creatinine clearance ≥ 80 mL/min), 15 mg doses of meloxicam may reduce pemetrexed elimination and thus increase the frequency of adverse reactions associated with pemetrexed. Therefore, caution should be exercised when prescribing 15 mg meloxicam concurrently with pemetrexed in patients with normal renal function (creatinine clearance ≥ 80 mL/min).

Pharmacokinetic interaction: effect of other medicinal products on the pharmacokinetics of meloxicam.

Cholestyramine accelerates the elimination of meloxicam due to disruption of enterohepatic circulation, resulting in a 50% increase in meloxicam clearance and a reduction in half-life to 13±3 hours. This interaction is clinically significant.

No clinically significant pharmacokinetic interactions have been observed with concomitant administration of antacids, cimetidine, or digoxin.

Pharmacokinetic interaction: effect of combination of meloxicam and other medicinal products on pharmacokinetics.

Oral antidiabetic agents (sulfonylurea derivatives, nateglinide). Meloxicam is almost entirely eliminated via hepatic metabolism, approximately two-thirds mediated by cytochrome P450 enzymes (mainly CYP2C9, with a minor contribution from CYP3A4) and one-third via other pathways, such as peroxidase oxidation. Potential pharmacokinetic interactions should be considered when meloxicam is administered concomitantly with medicinal products that inhibit or are metabolized by CYP2C9 and/or CYP3A4. Interactions mediated by CYP2C9 may be expected in combination with oral antidiabetic agents (sulfonylureas, nateglinide), potentially leading to increased plasma concentrations of these agents and meloxicam. Patients receiving meloxicam and sulfonylurea or nateglinide should be closely monitored due to the risk of hypoglycemia.

No clinically significant pharmacokinetic interactions have been observed with concomitant administration of antacids, cimetidine, or digoxin.

Children. Interaction studies have been conducted only in adults.

Special precautions for use.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section "Dosage and administration" and information on gastrointestinal and cardiovascular risks below).

The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect, and additional NSAIDs should not be used concomitantly, as this may increase toxicity without proven therapeutic benefits. Concomitant use of meloxicam with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

Meloxicam is not suitable for the treatment of patients requiring relief from acute pain.

If there is no improvement after several days, the clinical benefits of treatment should be re-evaluated.

Particular attention should be paid to a history of esophagitis, gastritis, and/or peptic ulcer to ensure complete treatment before initiating meloxicam therapy. Such patients should be closely monitored during treatment due to the potential for recurrence.

Gastrointestinal disorders.

As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration, or perforation may occur during treatment, with or without prior symptoms or a history of serious gastrointestinal disease.

The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing NSAID doses, in patients with a history of peptic ulcer, especially if complicated by bleeding or perforation (see section "Contraindications"), and in elderly patients. Such patients should begin treatment with the lowest effective dose. Combination therapy with protective agents (such as misoprostol or proton pump inhibitors) may be appropriate for these patients, as well as for patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs increasing gastrointestinal risks (see information below and section "Interaction with other medicinal products and other forms of interaction"). Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment.

NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn’s disease), as these conditions may be exacerbated.

Concomitant use of meloxicam is not recommended in patients taking medications that increase the risk of ulceration or bleeding, such as heparin, anticoagulants (e.g., warfarin), or other NSAIDs, including acetylsalicylic acid at doses ≥ 500 mg single dose or ≥ 3 g total daily dose, particularly in radical therapy or geriatric practice (see section "Interaction with other medicinal products and other forms of interaction").

If gastrointestinal bleeding or ulceration occurs in patients receiving meloxicam, treatment should be discontinued.

Hepatic disorders.

Cases of elevated transaminase levels or other liver function test abnormalities have been reported in patients taking NSAIDs (including meloxicam). Most such laboratory abnormalities are transient and mild. If such abnormalities progress or persist, meloxicam should be discontinued and appropriate investigations performed. Rare cases of severe hepatic reactions, including jaundice, fulminant fatal hepatitis, hepatic necrosis, and hepatic failure, some with fatal outcomes, have been reported.

In patients with abnormal liver tests or symptoms indicating hepatic dysfunction during continued meloxicam therapy, more severe hepatic failure may develop. If clinical symptoms suggest hepatic dysfunction or systemic manifestations of disease (e.g., eosinophilia, rash) occur, meloxicam should be discontinued.

Cardiovascular disorders.

Close monitoring is recommended in patients with a history of arterial hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been observed during NSAID therapy.

Patients with cardiovascular risk factors should have their blood pressure monitored before and especially at the beginning of meloxicam treatment.

Clinical and epidemiological data indicate that the use of some NSAIDs (particularly at high doses and with long-term use) may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). There are insufficient data to exclude such a risk for meloxicam.

NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which may be fatal. The risk increases with duration of use. Patients with cardiovascular disease or cardiovascular risk factors may have an increased risk.

Meloxicam treatment should be initiated only after careful consideration in patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. Such consideration is also necessary before initiating long-term treatment in patients with cardiovascular risk factors (such as hypertension, hyperlipidemia, diabetes mellitus, smoking).

Skin reactions.

Serious skin reactions, some fatal, including exfoliative dermatitis, Stevens–Johnson syndrome, and toxic epidermal necrolysis, have been observed rarely with NSAIDs. Patients should be informed about signs and symptoms of severe skin reactions and closely monitored. The highest risk of such reactions occurs early in treatment, especially during the first month. If a patient develops symptoms or signs of Stevens–Johnson syndrome or toxic epidermal necrolysis (e.g., progressive skin rash often with blisters or mucosal involvement), meloxicam treatment must be discontinued. Prompt diagnosis and discontinuation of any agent that may cause severe skin reactions—Stevens–Johnson syndrome or toxic epidermal necrolysis—are crucial, as early intervention improves prognosis. Meloxicam must not be restarted at any time in the future in patients who have experienced Stevens–Johnson syndrome or toxic epidermal necrolysis during its use.

Cases of fixed drug eruption have been reported with meloxicam. Meloxicam should not be re-administered to patients with a history of fixed drug eruption associated with meloxicam. Potential cross-reactivity may occur with other oxicams.

Anaphylactic reactions.

As with other NSAIDs, anaphylactic reactions may occur in patients without known sensitivity to meloxicam. Meloxicam should not be used in patients with aspirin triad. This symptomatic complex occurs in patients with asthma who have experienced rhinitis (with or without nasal polyps) or severe, potentially fatal bronchospasm after taking acetylsalicylic acid or other NSAIDs. Immediate emergency measures should be taken if anaphylactic reaction occurs.

Liver parameters and renal function.

As with treatment with most NSAIDs, isolated cases of elevated serum transaminases, increased serum bilirubin or other liver function parameters, as well as increased serum creatinine and blood urea nitrogen, and other laboratory abnormalities have been reported. In most cases, these abnormalities were mild and transient. If significant or persistent abnormalities are confirmed, meloxicam should be discontinued and follow-up tests performed.

Functional renal impairment.

NSAIDs may induce functional renal impairment by inhibiting the vasodilatory effect of renal prostaglandins, leading to reduced glomerular filtration. This adverse effect is dose-dependent. Careful monitoring of diuresis and renal function is recommended at the beginning of treatment or after dose increase in patients with the following risk factors:

• advanced age;
• concomitant therapy with ACE inhibitors, angiotensin II receptor antagonists (sartans), diuretics;
• hypovolemia (of any origin);
• congestive heart failure;
• renal impairment;
• nephrotic syndrome;
• lupus nephropathy;
• severe hepatic dysfunction (serum albumin < 25 g/L or ≥ 10 according to Child–Pugh classification).

In rare cases, NSAIDs may cause interstitial nephritis, glomerulonephritis, renal medullary necrosis, or nephrotic syndrome.

The dose of meloxicam in patients with end-stage renal failure on dialysis should not exceed 7.5 mg. Dose adjustment is not required in patients with mild to moderate renal impairment (creatinine clearance > 25 mL/min).

Retention of sodium, potassium, and water.

NSAIDs may enhance retention of sodium, potassium, and water and may interfere with the natriuretic effects of diuretics. A reduced antihypertensive effect of antihypertensive drugs may occur (see section "Interaction with other medicinal products and other forms of interaction"). As a result, edema, heart failure, or arterial hypertension may worsen in susceptible patients. Therefore, clinical monitoring is recommended in such patients.

Hyperkalemia.

Hyperkalemia may be caused by diabetes mellitus or concomitant use of drugs that increase potassium levels. In such cases, regular monitoring of potassium levels is required.

Combination with pemetrexed.

In patients with mild to moderate renal impairment receiving pemetrexed, meloxicam treatment should be withheld at least 5 days before, on the day of, and for at least 2 days after pemetrexed administration (see section "Interaction with other medicinal products and other forms of interaction").

Elderly and debilitated patients require careful monitoring. As with other NSAIDs, caution is required in elderly patients, in whom renal, hepatic, and cardiac function are more likely to be impaired. Elderly patients have a higher frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal (see section "Dosage and administration").

Masking of inflammation and fever.

Meloxicam, like any other NSAID, may mask symptoms of infectious diseases. Due to its pharmacological action in reducing fever and inflammation, the use of the drug may complicate diagnosis in non-infectious pain syndromes.

Meloxicam may negatively affect fertility and is not recommended for women wishing to become pregnant. Therefore, for women planning pregnancy or undergoing infertility evaluation, discontinuation of meloxicam should be considered (see section "Use during pregnancy or breastfeeding").

Glucocorticoid therapy.

Meloxicam cannot be considered a substitute for corticosteroids in the treatment of corticosteroid deficiency.

Hematological effects.

Anemia associated with fluid retention, gastrointestinal bleeding, and effects on erythropoiesis may occur with NSAIDs, including meloxicam. Hematological parameters (including hemoglobin and hematocrit) should be monitored during long-term treatment if symptoms or signs of anemia are present.

NSAIDs may inhibit platelet aggregation and prolong bleeding time in some patients. Unlike acetylsalicylic acid, meloxicam's effect on platelet function is milder, reversible, and short-lived. Patients receiving meloxicam who are at risk of adverse effects on platelet function, coagulation disorders, or those taking anticoagulants should be carefully monitored.

Use in patients with asthma.

Administration of acetylsalicylic acid to patients with aspirin-sensitive asthma may lead to severe bronchospasm, which may be fatal. Due to cross-reactivity between acetylsalicylic acid and other NSAIDs, meloxicam should not be used in patients sensitive to acetylsalicylic acid and should be used cautiously in patients with asthma.

MOVICICAM® ODT tablets contain aspartame (E 951), and therefore should not be administered to patients with phenylketonuria.

The tablets also contain mannitol (E 421) and sorbitol (E 420), which may have a mild laxative effect.

Use during pregnancy or breastfeeding.

Fertility.

Meloxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may negatively affect reproductive function and is not recommended for women wishing to become pregnant. Therefore, for women planning pregnancy or undergoing infertility evaluation, discontinuation of meloxicam should be considered.

Pregnancy.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryofetal development. According to epidemiological studies, use of prostaglandin synthesis inhibitors in early pregnancy increases the risk of miscarriage and congenital heart defects and gastroschisis. The absolute risk of congenital heart defects increases from <1% to approximately 1.5%. This risk is considered to increase with higher doses and longer duration of treatment.

From week 20 of gestation, use of meloxicam may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible upon discontinuation. Additionally, there have been reports of ductus arteriosus constriction after treatment in the second trimester, most of which resolved after stopping treatment. Therefore, meloxicam should not be used during the first and second trimesters of pregnancy, except in cases of extreme necessity.

When meloxicam is prescribed to women planning pregnancy or during the first and second trimesters, the lowest effective dose for the shortest possible duration should be used.

Fetal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after drug exposure for several days starting from week 20 of gestation. The drug should be discontinued if oligohydramnios or ductus arteriosus constriction is detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:

Risks to the fetus:

• cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction (see above).

Risks to the mother at the end of pregnancy and to the newborn:

• possible prolongation of bleeding time, anti-aggregatory effect, which may occur even at very low doses;
• inhibition of uterine contractions, leading to delayed or prolonged labor.

Therefore, the drug is contraindicated during the third trimester of pregnancy (see section "Contraindications").

Lactation period.

Although specific data on meloxicam are lacking, NSAIDs are known to pass into breast milk. Therefore, use of the drug is not recommended in women who are breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No specific studies on the effect of the drug on the ability to drive or operate machinery have been conducted. Based on the pharmacodynamic profile and observed adverse reactions, meloxicam is unlikely to affect or has negligible effect on such activities. However, patients experiencing visual disturbances, including blurred vision, dizziness, somnolence, vertigo, or other central nervous system disorders, are advised to refrain from driving or operating machinery.

Method of Administration and Dosage.

For oral use.

The total daily dose should be taken once daily.

The tablet should be placed on the tongue and allowed to dissolve completely for approximately 5 minutes. The tablet must not be chewed or swallowed whole. After dissolution, drink 240 ml of water. Water may also be used to moisten the oral mucosa in patients experiencing dry mouth.

In acute exacerbation of osteoarthritis: 7.5 mg once daily (one 7.5 mg tablet or half of a 15 mg tablet); if necessary, the dose may be increased to 15 mg once daily (one 15 mg tablet or two 7.5 mg tablets).

In rheumatoid arthritis, ankylosing spondylitis: 15 mg once daily (one 15 mg tablet or two 7.5 mg tablets).

DO NOT EXCEED THE DOSE OF 15 mg ONCE DAILY.

Special Patient Categories.

Elderly patients at increased risk of adverse reactions.

The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg once daily.

Patients at increased risk of adverse reactions should initiate treatment with a dose of 7.5 mg once daily (see section "Special Warnings and Precautions for Use").

Renal impairment.

The dose for patients with severe renal impairment undergoing dialysis should not exceed 7.5 mg once daily.

Dose adjustment is not required in patients with mild to moderate renal impairment (creatinine clearance > 25 ml/min) (for patients with severe renal impairment not undergoing dialysis, see section "Contraindications").

Hepatic impairment.

Dose adjustment is not required in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment, see section "Contraindications").

Children.

MOVIKSIKAM® ODT 7.5 mg or 15 mg tablets are not indicated for children under 16 years of age.

Overdose.

Symptoms.

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding may occur. Severe poisoning may lead to arterial hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular failure, and cardiac arrest. Anaphylactoid reactions have been reported during therapeutic use of NSAIDs and may also occur in cases of overdose.

Treatment.

In case of NSAID overdose, symptomatic and supportive measures are recommended for patients. Studies have shown that meloxicam elimination is enhanced by administration of 4 oral doses of cholestyramine given 3 times daily.

Side effects.

The use of some NSAIDs, particularly at high doses and during prolonged treatment, may be associated with a small increased risk of vascular thrombotic events (e.g., myocardial infarction or stroke) (see section "Special precautions").

Edema, arterial hypertension, and heart failure have been observed during NSAID therapy.

Most of the adverse effects observed are gastrointestinal in origin. Peptic ulcer, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients, may occur (see section "Special precautions"). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, and exacerbation of colitis and Crohn’s disease (see section "Special precautions") are possible during administration of the medicinal product. Gastritis has been observed less frequently.

Serious skin reactions have been reported: Stevens–Johnson syndrome and toxic epidermal necrolysis (see section "Special precautions").

The following adverse reactions have been reported:

Blood and lymphatic system disorders: blood count abnormalities (including changes in leukocyte count), leukopenia, thrombocytopenia, anemia. Very rare cases of agranulocytosis have been reported (see "Specific serious and/or common adverse reactions").

Immune system disorders: allergic reactions, anaphylactic reaction, anaphylactoid reaction, including shock, and other immediate-type reactions.

Psychiatric disorders: confusion, disorientation, mood changes, night terrors, insomnia.

Nervous system disorders: dizziness, somnolence, headache.

Eye disorders: visual disturbances including blurred vision, conjunctivitis.

Ear and labyrinth disorders: dizziness, tinnitus.

Cardiac disorders: tachycardia, increased blood pressure, flushing.

Heart failure associated with NSAID treatment has been reported.

Respiratory system disorders: asthma in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs, upper respiratory tract infections, cough.

Gastrointestinal disorders: dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, occult or macroscopic gastrointestinal bleeding, stomatitis, gastritis, eructation, colitis, gastroduodenal ulcer, esophagitis, gastrointestinal perforation, pancreatitis.

Gastrointestinal bleeding, ulceration, or perforation may be severe and potentially fatal, especially in elderly patients (see section "Special precautions").

Hepatobiliary disorders: liver function test abnormalities (e.g., increased transaminases or bilirubin), hepatitis, jaundice, hepatic failure.

Skin and subcutaneous tissue disorders: toxic epidermal necrolysis, Stevens–Johnson syndrome, angioneurotic edema, pruritus, rash, urticaria, bullous dermatitis, erythema multiforme, photosensitivity reactions, exfoliative dermatitis, fixed drug eruption (see section "Special precautions").

Renal and urinary disorders: sodium and water retention, hyperkalemia, changes in renal function parameters (increased serum creatinine and/or urea), acute renal failure in patients with risk factors, urinary tract infections, micturition disorders.

Reproductive system and breast disorders: female infertility, ovulation delay.

Musculoskeletal and connective tissue disorders: arthralgia, back pain, joint-related symptoms.

General disorders: edema, including peripheral edema, influenza-like symptoms.

Specific serious and/or common adverse reactions.

Very rare cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially myelotoxic medicinal products (see section "Interaction with other medicinal products and other forms of interaction").

Adverse reactions not observed with this medicinal product but typical for other compounds of the class.

Organic renal damage, which may lead to acute renal failure: very rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, and papillary necrosis have been reported (see section "Special precautions").

Reporting suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows ongoing monitoring of the benefit-risk profile of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. No special storage conditions required.

Packaging.

For 7.5 mg dosage: 10 tablets per blister, 2 blisters per cardboard pack;

for 15 mg dosage: 10 tablets per blister, 1 or 2 blisters per cardboard pack.

Prescription status. Prescription only.

Manufacturer. Alpex Pharma SA.

Manufacturer's address and place of business.
Via Cantonale, 6805 Mezzovico-Vira, Switzerland.

Marketing Authorization Holder. MOVI Health LLC

Address of the Marketing Authorization Holder. 162A Shevchenka Street, Shevchenkove, Kyiv Oblast, 08140, Ukraine