Instructions Movalis tablets 7.5 mg blister No. 20
Composition
active ingredient: 1 tablet contains meloxicam 7.5 mg or 15 mg;
Excipients: sodium citrate, lactose monohydrate, microcrystalline cellulose, povidone, colloidal anhydrous silica, crospovidone, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round tablets from pastel yellow to lemon yellow. On one side convex, with beveled edges and marking of the company symbol. On the other side with a break line in half and a code. The surface of the tablet may be slightly rough.
MOVALIS 7.5 mg tablets: the score line is intended only to facilitate breaking for better swallowing and does not serve to divide into equal doses.
MOVALIS 15 mg tablets: the tablet can be divided into equal doses.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs and antirheumatic drugs. Oxycodone.
ATX code M01A C06.
Pharmacological properties
Pharmacodynamics.
Movalis is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class that has anti-inflammatory, analgesic, and antipyretic effects.
Meloxicam has shown high anti-inflammatory activity in standard models of inflammation. As with other NSAIDs, its exact mechanism of action remains unknown. However, there is a common mechanism of development for all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, which are mediators of inflammation.
Pharmacokinetics.
Absorption: Meloxicam is well absorbed from the gastrointestinal tract, with an absolute bioavailability of 90% after oral administration (capsules). Tablets, oral suspension and capsules have shown bioequivalence.
After a single dose of meloxicam, peak plasma concentrations are reached within 5-6 hours for solid oral forms (capsules and tablets).
With multiple dosing, steady-state concentrations are reached by days 3-5. Once-daily dosing results in mean plasma concentrations with relatively small peak fluctuations: within 0.4-1.0 μg/mL for 7.5 mg and 0.8-2.0 μg/mL for 15 mg, respectively (Cmin and Cmax at steady state, respectively).
The mean peak plasma concentrations of meloxicam at steady state are reached after 5–6 hours, respectively, when administered as tablets, capsules and oral suspension. During continuous treatment for periods of more than one year, plasma concentrations are comparable to those observed at steady state at the start of treatment. The absorption of oral meloxicam is not altered by food or concomitant administration of mineral antacids.
Distribution. Meloxicam is highly bound to plasma proteins, mainly albumin (99%). Meloxicam penetrates into the synovial fluid, where the concentration is half that in plasma. The volume of distribution is low, averaging 11 l after intramuscular or intravenous administration, and shows individual variations in the range of 7-20%. The volume of distribution after multiple oral doses of meloxicam (7.5 to 15 mg) is 16 l with a coefficient of variation in the range of 11% to 32%.
Biotransformation: Meloxicam undergoes extensive biotransformation in the liver.
Four different metabolites of meloxicam have been identified in urine, which are pharmacodynamically inactive. The main metabolite 5'-carboxymeloxicam (60% of the dose) is formed by oxidation of the intermediate metabolite 5'-hydroxymethylmeloxicam, which is also excreted to a lesser extent (9% of the dose). In vitro studies suggest that CYP 2C9 plays an important role in the metabolism process, while CYP 3A4 isoenzyme contributes to this to a lesser extent. Peroxidase activity in patients is probably responsible for the other two metabolites, which account for 16% and 4% of the administered dose, respectively.
Elimination. Meloxicam is excreted mainly as metabolites in equal parts with urine and feces. Less than 5% of the daily dose is excreted unchanged in the feces, a small amount is excreted in the urine. The half-life varies from 13 to 25 hours after oral, intramuscular and intravenous administration. Plasma clearance is about 7-12 ml/min after a single oral dose, intravenous or rectal administration.
Dose linearity: Meloxicam exhibits linear pharmacokinetics within the therapeutic dose range of 7.5 mg to 15 mg after oral and intramuscular administration.
Special groups of patients.
Elderly patients. In elderly male patients, mean pharmacokinetic parameters were similar to those in young male volunteers. In elderly female patients, AUC values were higher and the half-life was longer compared to those in young volunteers of both sexes. Mean steady-state plasma clearance in elderly patients was slightly lower than in young volunteers (see section 4.2).
Indication
Short-term symptomatic treatment of exacerbations of osteoarthritis.
Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.
MOVALIS tablets are indicated for the treatment of adults and children over 16 years of age.
Contraindication
Hypersensitivity to the active substance or to other components of the medicinal product;
Hypersensitivity to active substances with similar effects, such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin. Meloxicam should not be prescribed to patients who have experienced asthma symptoms, nasal polyps, angioedema or urticaria after taking aspirin or other NSAIDs;
III trimester of pregnancy (see section "Use during pregnancy or breastfeeding");
children under 16 years of age;
history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;
history of active or recurrent peptic ulcer/bleeding (two or more separate confirmed episodes of ulceration or bleeding);
severe liver failure;
severe renal failure without dialysis;
gastrointestinal bleeding, history of cerebrovascular bleeding, or other blood clotting disorders;
severe heart failure;
treatment of perioperative pain in coronary artery bypass grafting (CABG).
Interaction with other medicinal products and other types of interactions
Risks associated with hyperkalemia
Some medicinal products or therapeutic groups may contribute to hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs, (low molecular weight or unfractionated) heparins, ciclosporin, tacrolimus and trimethoprim.
The onset of hyperkalemia may depend on whether there are associated factors. The risk of hyperkalemia is increased if the above-mentioned drugs are used concomitantly with meloxicam.
Pharmacodynamic interactions.
Other non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid: Combination with other NSAIDs is not recommended (see section 4.4), including acetylsalicylic acid at doses ≥ 500 mg per dose or ≥ 3 g total daily dose.
Corticosteroids (e.g. glucocorticoids): Concomitant use with corticosteroids requires caution due to increased risk of gastrointestinal bleeding or ulceration.
Anticoagulants or heparin. The risk of bleeding is significantly increased due to inhibition of platelet function and damage to the gastroduodenal mucosa. NSAIDs may enhance the effects of anticoagulants such as warfarin (see section "Special precautions for use"). The concomitant use of NSAIDs and anticoagulants or heparin is not recommended in geriatric practice or at therapeutic doses (see section "Special precautions for use").
In other cases (e.g. at prophylactic doses) the use of heparin requires caution due to the increased risk of bleeding. Careful monitoring of the INR (international normalized ratio) is necessary if the combination cannot be avoided.
Thrombolytic and antiplatelet agents: Increased risk of bleeding due to inhibition of platelet function and damage to the gastroduodenal mucosa.
Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Diuretics, ACE inhibitors and angiotensin II antagonists. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant use of ACE inhibitors or angiotensin II antagonists and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter (see section 4.4).
Other antihypertensive drugs (e.g. beta-blockers). As with the following drugs, the antihypertensive effect of beta-blockers may be reduced (due to inhibition of vasodilating prostaglandins).
Calcineurin inhibitors (e.g. cyclosporine, tacrolimus). Nephrotoxicity of calcineurin inhibitors may be potentiated by NSAIDs due to mediation of renal prostaglandin effects. Renal function should be monitored during treatment. Close monitoring of renal function is recommended, especially in elderly patients.
Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal adverse reactions. Caution should be exercised when combining these drugs.
Pharmacokinetic interaction: the effect of meloxicam on the pharmacokinetics of other drugs.
Lithium. There is evidence that NSAIDs increase the plasma concentration of lithium (due to a decrease in renal excretion of lithium), which may reach toxic levels. The simultaneous use of lithium and NSAIDs is not recommended. If combination therapy is necessary, careful monitoring of plasma lithium levels is necessary at the beginning of treatment, during dose adjustment and when discontinuing treatment with meloxicam.
Methotrexate. NSAIDs may reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration. For this reason, concomitant use of NSAIDs is not recommended in patients receiving high doses of methotrexate (more than 15 mg/week) (see section "Special warnings and precautions for use"). The risk of interaction between NSAIDs and methotrexate should also be considered in patients receiving low doses of methotrexate, in particular in patients with impaired renal function. If combined treatment is necessary, blood count and renal function should be monitored. Caution should be exercised when NSAIDs and methotrexate are taken for 3 consecutive days, as plasma levels of methotrexate may increase and toxicity may increase. Although the pharmacokinetics of methotrexate (15 mg/week) were not affected by concomitant treatment with meloxicam, it should be considered that the haematological toxicity of methotrexate may be increased by treatment with NSAIDs (see information above) (see section "Adverse reactions").
Pemetrexed. When meloxicam is co-administered with pemetrexed in patients with creatinine clearance between 45 and 79 ml/min, meloxicam should be discontinued 5 days before, on the day of, and for 2 days after pemetrexed administration. If the combination of meloxicam and pemetrexed is necessary, patients should be closely monitored, especially for myelosuppression and gastrointestinal adverse reactions. In patients with severe renal impairment (creatinine clearance below 45 ml/min), the co-administration of meloxicam and pemetrexed is not recommended.
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), doses of 15 mg meloxicam may reduce the elimination of pemetrexed and, therefore, increase the incidence of adverse reactions associated with pemetrexed. Therefore, caution should be exercised when prescribing 15 mg meloxicam concomitantly with pemetrexed in patients with normal renal function (creatinine clearance ≥ 80 ml/min).
Pharmacokinetic interaction: the effect of other drugs on the pharmacokinetics of meloxicam.
Cholestyramine: Cholestyramine accelerates the elimination of meloxicam due to impaired intrahepatic circulation, so the clearance of meloxicam increases by 50% and the half-life decreases to 13±3 hours. This interaction is clinically significant.
Pharmacokinetic interaction: effect of the combination of meloxicam and other drugs on pharmacokinetics.
Oral antidiabetic agents (sulfonylureas, nateglinide)
Meloxicam is almost completely eliminated by hepatic metabolism, approximately two-thirds of which is mediated by cytochrome (CYP) P450 enzymes (primary CYP 2C9 and minor CYP 3A4) and one-third by other pathways, such as peroxidase oxidation. The possibility of pharmacokinetic interactions should be considered when meloxicam is co-administered with medicinal products that are known to inhibit or are metabolised by CYP 2C9 and/or CYP 3A4. Interactions mediated by CYP 2C9 may be expected in combination with medicinal products such as oral antidiabetic agents (sulfonylureas, nateglinide); this interaction may lead to increased plasma levels of these agents and meloxicam. Patients taking meloxicam and sulfonylureas or nateglinide should be closely monitored for hypoglycaemia.
No clinically significant pharmacokinetic interaction was found when co-administered with antacids, cimetidine, and digoxin.
Children
Interaction studies were conducted only in adults.
Application features
Adverse reactions can be minimised 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, nor should additional NSAIDs be used, as this may increase toxicity while the therapeutic benefit has not been proven. The concomitant use of meloxicam with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Meloxicam is not suitable for the treatment of patients requiring acute pain relief.
If there is no improvement after several days, the clinical benefit of treatment should be reassessed.
Attention should be paid to a history of esophagitis, gastritis and/or peptic ulcer in order to ensure that they are completely cured before starting therapy with meloxicam. Patients treated with meloxicam and patients with a history of such cases should be regularly monitored for possible recurrence.
As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration or perforation may occur at any time during treatment with or without previous 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 ulcer, particularly complicated by bleeding or perforation (see section 4.3), and in the elderly. In such patients, treatment should be initiated at the lowest effective dose. Combination therapy with protective agents (such as misoprostol or proton pump inhibitors) should be considered for such patients, as well as for patients who require concomitant use of low-dose aspirin or other agents that increase gastrointestinal risks (see information below and section 4.5).
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be informed of any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment.
The use of meloxicam is not recommended in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, including heparin as a radical therapy or in geriatric practice, anticoagulants such as warfarin, or other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid at doses ≥ 500 mg per dose or ≥ 3 g total daily dose (see section "Interaction with other medicinal products and other forms of interaction").
If gastrointestinal bleeding or ulceration occurs in patients taking meloxicam, treatment should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section "Adverse reactions").
Liver disorders.
Up to 15% of patients taking NSAIDs (including MOVALIS) may have elevations in one or more liver function tests. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued treatment. Marked elevations in ALT or AST (approximately three times or more above normal) have been observed in 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fulminant hepatitis, hepatic necrosis, and hepatic failure, some of which were fatal, have been reported.
Patients with symptoms or suspected liver dysfunction or who have had abnormal liver tests should be evaluated for the development of symptoms of more severe liver failure during therapy with MOVALIS. If clinical signs and symptoms are consistent with the development of liver disease or if systemic manifestations of the disease (e.g. eosinophilia, rash, etc.) are observed, MOVALIS should be discontinued.
Cardiovascular disorders.
Close monitoring is recommended in patients with hypertension and/or a history of mild to moderate congestive heart failure, as fluid retention and edema have been reported with NSAID therapy.
Clinical monitoring of blood pressure is recommended for patients with risk factors at the beginning of therapy, especially at the beginning of treatment with meloxicam.
Clinical and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a small increased risk of vascular thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude such a risk for meloxicam.
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with meloxicam only after careful consideration. Such consideration is necessary before initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, smoking).
NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which may be fatal. The increased risk is related to the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.
Life-threatening severe skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with meloxicam. Patients should be informed of the signs and symptoms of severe skin reactions and should be closely monitored for skin reactions. The greatest risk of developing Stevens-Johnson syndrome or toxic epidermal necrolysis is during the first weeks of treatment. If a patient develops symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (e.g. skin rash, often progressing with blisters or mucosal lesions), meloxicam treatment should be discontinued. It is important to promptly diagnose and discontinue any drugs that may cause severe skin reactions: Stevens-Johnson syndrome or toxic epidermal necrolysis. This is associated with a better prognosis in severe skin reactions. If a patient has developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using meloxicam, the drug should not be restarted at any time in the future.
Anaphylactoid reactions.
As with other NSAIDs, anaphylactoid reactions may occur in patients with no known reaction to MOVALIS. MOVALIS should not be used in patients with the aspirin triad. This symptom complex occurs in patients with asthma who have been reported to have rhinitis with or without nasal polyps or who have experienced severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency care should be sought if an anaphylactoid reaction occurs.
Liver parameters and kidney function.
As with most NSAIDs, isolated cases of increased 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 minor and transient. If significant or persistent abnormalities occur, meloxicam should be discontinued and follow-up tests performed.
Functional renal failure.
NSAIDs, by inhibiting the vasodilatory effects of renal prostaglandins, may induce functional renal failure due to a decrease in glomerular filtration. This side effect is dose-dependent. At the beginning of treatment or after increasing the dose, careful monitoring of renal function, including urine output, is recommended in patients with the following risk factors:
old age;
concomitant use with ACE inhibitors, angiotensin II antagonists, sartans, diuretics (see section "Interaction with other medicinal products and other types of interactions");
hypovolemia (of any origin);
congestive heart failure;
renal failure;
nephrotic syndrome;
lupus nephropathy;
severe hepatic dysfunction (serum albumin < 25 g/l or ≥ 10 according to the Child-Pugh classification).
In rare cases, NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis, or nephrotic syndrome.
The dose of meloxicam for patients with end-stage renal disease on dialysis should not exceed 7.5 mg. In patients with mild to moderate renal impairment, the dose may not be reduced (creatinine clearance greater than 25 ml/min).
Sodium, potassium and water retention.
NSAIDs may increase sodium, potassium and water retention and may interfere with the natriuretic effects of diuretics. In addition, the antihypertensive effect of antihypertensive drugs may be reduced (see section 4.5). As a result, edema, heart failure or hypertension may be precipitated or aggravated in susceptible patients. Clinical monitoring is therefore recommended in patients at risk (see sections 4.2 and 4.3).
Hyperkalemia.
Hyperkalemia may be caused by diabetes mellitus or concomitant use of medicinal products that increase potassium levels (see section 4.5). In such cases, potassium levels should be monitored regularly.
Combination with pemetrexed.
In patients with mild to moderate renal impairment receiving pemetrexed, meloxicam treatment should be suspended for at least 5 days prior to, on the day of, and for at least 2 days following pemetrexed administration (see section 4.5).
Other warnings and precautions.
Adverse reactions are often worse tolerated by elderly, frail or debilitated patients who require close monitoring. As with other NSAIDs, caution should be exercised in the elderly, who are more likely to have decreased renal, hepatic and cardiac function. Elderly patients have a higher incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
Meloxicam may impair reproductive function and is not recommended in women attempting to conceive. Therefore, in women attempting to conceive or undergoing investigation of infertility, discontinuation of meloxicam should be considered (see section 4.6).
MOVALIS 7.5 mg and 15 mg tablets contain lactose (1 MOVALIS 7.5 mg tablet contains lactose monohydrate equivalent to 22.3 mg of anhydrous lactose, 1 MOVALIS 15 mg tablet contains lactose monohydrate equivalent to 19.0 mg of anhydrous lactose), therefore this drug is not recommended for patients with rare congenital galactose intolerance, general lactase deficiency or glucose-galactose malabsorption.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially sodium-free.
Masking inflammation and fever.
The pharmacological action of MOVALIS, aimed at reducing fever and inflammation, may complicate the diagnosis of suspected non-infectious pain conditions.
Corticosteroid treatment.
MOVALIS cannot be a likely substitute for corticosteroids in the treatment of corticosteroid insufficiency.
Hematological effects.
Anemia may occur in patients receiving NSAIDs, including MOVALIS. This may be due to fluid retention, gastrointestinal bleeding of unknown origin, or macroscopic or incompletely described effects on erythropoiesis. Patients on long-term treatment with NSAIDs, including MOVALIS, should have their hemoglobin or hematocrit monitored if they develop symptoms and signs of anemia.
NSAIDs inhibit platelet aggregation and may prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively smaller, short-lived, and reversible. Patients taking MOVALIS who may have adverse effects related to changes in platelet function, including coagulation disorders, or patients receiving anticoagulants should be carefully monitored.
Use in patients with existing asthma.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which may be fatal. Because of cross-reactivity, including bronchospasm, between aspirin and other NSAIDs, MOVALIS should not be used in patients sensitive to aspirin and should be prescribed with caution in patients with pre-existing asthma.
Use during pregnancy or breastfeeding
Pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-foetal development. Epidemiological data suggest an increased risk of miscarriage and of cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiac malformations has increased from less than 1% to approximately 1.5%. This risk is thought to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo-foetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals treated with a prostaglandin synthesis inhibitor during organogenesis.
From the 20th week of pregnancy, the use of meloxicam may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus after treatment in the second trimester, most of which disappeared after discontinuation of treatment. Consequently, meloxicam should not be used during the first and second trimesters of pregnancy unless clearly necessary. If a woman is trying to conceive or is taking meloxicam during the first and second trimesters of pregnancy, the dosage and duration of treatment should be kept as low as possible. Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after exposure to meloxicam for several days, starting from the 20th week of pregnancy. If oligohydramnios or narrowing of the ductus arteriosus is detected, meloxicam should be discontinued.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose a risk to the fetus:
cardiopulmonary toxicity (with premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
kidney dysfunction (see above);
possible risks in the last stages of pregnancy for the mother and newborn:
possibility of prolongation of bleeding time, anti-aggregation effect even at very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, meloxicam is contraindicated during the third trimester of pregnancy.
Fertility: Meloxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may have an adverse effect on reproductive function and is not recommended in women attempting to conceive. Therefore, in women planning pregnancy or undergoing investigation of infertility, discontinuation of meloxicam should be considered.
The ability to influence the reaction speed when driving or working with other mechanisms
There are no specific studies on the effects of the drug on the ability to drive or use machines. However, based on the pharmacodynamic profile and the observed adverse reactions, it can be assumed that meloxicam is likely to have no or negligible influence on these activities. However, patients who have experienced visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other central nervous system disorders, are advised to refrain from driving or using machines.
Method of administration and doses
Dosage.
The total daily amount of the drug should be administered once.
Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient's need for symptomatic relief and response to treatment should be reassessed periodically, especially in patients with osteoarthritis.
Exacerbation of osteoarthritis:
7.5 mg/day (1 tablet of 7.5 mg or half a tablet of 15 mg). If necessary, the dose can be increased to 15 mg/day (1 tablet of 15 mg or 2 tablets of 7.5 mg).
Rheumatoid arthritis, ankylosing spondylitis:
15 mg/day (1 tablet of 15 mg or 2 tablets of 7.5 mg).
See also the section “Special patient categories” below.
According to the therapeutic effect, the dose can be reduced to 7.5 mg/day (1 tablet of 7.5 mg or half a tablet of 15 mg).
DO NOT EXCEED THE DOSE OF 15 mg/day.
Special categories of patients.
Elderly patients (see section "Pharmacokinetics").
The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day (see also section “Dosage and administration” – “Patients at increased risk of adverse reactions” and section “Special warnings and precautions for use”).
Patients with an increased risk of developing adverse reactions (see section "Special warnings and precautions for use").
Patients at increased risk of adverse reactions, such as a history of gastrointestinal disease or risk factors for cardiovascular disease, should start treatment with a dose of 7.5 mg per day.
Renal failure (see section "Pharmacokinetics").
This medicinal product is contraindicated in patients with severe renal impairment not undergoing haemodialysis (see section “Contraindications”).
For patients with end-stage renal disease undergoing hemodialysis, the dose should not exceed 7.5 mg per day. No dose reduction is required for patients with mild to moderate renal impairment (i.e., patients with creatinine clearance greater than 25 ml/min).
Hepatic failure (see section "Pharmacokinetics").
No dose reduction is required in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment, see section "Contraindications").
Method of application.
For oral use.
MOVALIS, 7.5 mg and 15 mg tablets, should be taken with water or other liquid, during meals.
Children
MOVALIS, 7.5 mg and 15 mg tablets, is contraindicated in children under 16 years of age (see section “Contraindications”)
Overdose
Symptoms.
Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive therapy. Gastrointestinal bleeding may occur. Severe poisoning may result in hypertension, acute renal failure, liver dysfunction, respiratory depression, coma, convulsions, cardiovascular failure, and cardiac arrest.
