Instructions for use Moviksikam ODT orodispersible tablets 15 mg blister No. 20
Composition
Orodispersible tablets.
Main physicochemical properties: flat light yellow tablets with a dividing line and marking "AX" on one half and "5" on the other half on the side of the tablet where the line is located, with the smell of wild berries and yogurt.
Dosage form
Orodispersible tablets.
Main physicochemical properties: flat light yellow tablets with a dividing line and marking "AX" on one half and "5" on the other half on the side of the tablet where the line is located, with the smell of wild berries and yogurt.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs (NSAIDs) and antirheumatic drugs.
ATX code M01A C06.
Pharmacological properties
Pharmacodynamics
MOVIXICAM® ODT is a nonsteroidal anti-inflammatory drug (NSAID) of the enoleic acid class that exhibits anti-inflammatory, analgesic and antipyretic effects.
Meloxicam has shown 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 principle of action 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 after oral administration. The absolute bioavailability of the drug is 89%. After a single dose of meloxicam, the maximum plasma concentration (Cmax) is reached within 5-6 hours.
With multiple dosing, steady-state concentrations are reached within 3-5 days. Once-daily dosing results in average 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). Peak plasma concentrations of meloxicam at steady state are reached within 5-6 hours.
Simultaneous food intake or the use of inorganic antacids does not affect the absorption of the drug.
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, 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 isoenzymes contribute 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 average half-life is about 20 hours. The half-life varies 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 insufficiency. Mild to moderate hepatic and renal insufficiency do not significantly affect the pharmacokinetics of meloxicam. Patients with moderate renal insufficiency had a significantly higher total clearance. Reduced binding to plasma proteins was observed in patients with end-stage renal failure. In end-stage renal failure, an increase in the volume of distribution may lead to an increase in the concentration of free meloxicam. The daily dose of 7.5 mg should not be exceeded (see section "Method of administration and dosage").
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 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.
Indication
Short-term symptomatic treatment of exacerbations of osteoarthritis. Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.
Contraindication
Hypersensitivity to meloxicam or to other components of the drug, as well as to active substances with a similar effect, such as NSAIDs, acetylsalicylic acid (meloxicam should not be prescribed to patients who have experienced symptoms of asthma, nasal polyps, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs); III trimester of pregnancy (see section "Use during pregnancy and lactation"); children under 16 years of age; gastrointestinal bleeding or perforation associated with previous NSAID therapy in history; active or recurrent peptic ulcer/bleeding in history (two or more separate confirmed cases of ulceration or bleeding); severe hepatic failure; severe renal failure without dialysis; gastrointestinal bleeding, cerebrovascular bleeding in history or other blood clotting disorders; severe heart failure; treatment of perioperative pain in coronary artery bypass grafting.
Interaction with other medicinal products and other types of interactions
Meloxicam is metabolized in the liver, mainly by CYP 2C9 and/or CYP 3A4. There is a possibility of pharmacokinetic interactions between meloxicam and drugs that are metabolized by CYP 2C9 and/or CYP 3A4.
Risks associated with hyperkalemia
Some medicinal products or therapeutic classes may cause hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, NSAIDs, (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 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 bleeding or ulceration in the gastrointestinal tract.
Anticoagulants, heparin (when used in the elderly or in therapeutic doses), antiplatelet and thrombolytic agents, selective serotonin reuptake inhibitors (SSRIs): concomitant use increases the risk of bleeding due to inhibition of platelet function and damage to the gastroduodenal mucosa.
Caution is advised when NSAIDs and heparin are used concomitantly at prophylactic doses due to the increased risk of bleeding. Close monitoring of the international normalized ratio (INR) is necessary if the combination cannot be avoided.
NSAIDs may enhance the effects of anticoagulants such as warfarin (see section "Special warnings and precautions for use").
Diuretics, ACE inhibitors and angiotensin II receptor 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. Renal function should be monitored in patients after initiation of concomitant therapy and periodically thereafter.
Other antihypertensive drugs (e.g. beta-blockers): NSAIDs may reduce the effect of antihypertensive drugs 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, necessitating careful monitoring of renal function during concomitant use of these drugs, 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 drugs.
NSAIDs reduce the effectiveness of intrauterine contraceptives.
Pharmacokinetic interaction: the effect of meloxicam on the pharmacokinetics of other drugs.
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). The risk of interaction between NSAIDs and methotrexate should also be considered with low doses of methotrexate, particularly in patients with impaired renal function. If combined treatment is necessary, blood counts and renal function should be monitored. Caution should be exercised when NSAIDs and methotrexate are administered for 3 consecutive days, as plasma levels of methotrexate may increase and toxicity may be increased. Although meloxicam does not affect the pharmacokinetics of methotrexate (15 mg/week), it is believed that the haematological toxicity of methotrexate may be increased by treatment with NSAIDs.
Pemetrexed. When meloxicam is co-administered with pemetrexed in patients with mild to moderate renal impairment (creatinine clearance 45 to 79 ml/min), meloxicam should be discontinued 5 days prior to, on the day of, and for 2 days following pemetrexed administration. If the combination of meloxicam and pemetrexed is necessary, patients should be closely monitored, particularly for myelosuppression and gastrointestinal adverse reactions. For 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.
No clinically significant pharmacokinetic interaction was found when co-administered with antacids, cimetidine, and digoxin.
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 relief of acute pain.
If there is no improvement after several days, the clinical benefit of treatment should be reassessed.
Attention should be paid to the patient's history of esophagitis, gastritis and/or peptic ulcer to ensure that they are completely cured before starting meloxicam therapy. Such patients should be closely monitored during treatment for possible recurrence.
Gastrointestinal disorders
As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration or perforation may occur 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, especially complicated by bleeding or perforation (see section 4.3), and in elderly patients. In such patients, treatment should be started at the lowest effective dose. For such patients, as well as for patients requiring concomitant low-dose acetylsalicylic acid or other medicinal products that increase gastrointestinal risks, combination therapy with protective medicinal products (such as misoprostol or proton pump inhibitors) may be appropriate (see information below and section 4.5). Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
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.
The use of meloxicam is not recommended in patients receiving concomitant medications that increase the risk of ulceration or bleeding, including heparin, as a radical therapy or in geriatric practice, anticoagulants such as warfarin, or other NSAIDs, including acetylsalicylic acid at doses ≥ 500 mg single dose or ≥ 3 g total daily dose (see section "Interaction with other medicinal products and other forms of interaction").
Isolated cases of elevations in transaminases or other liver function tests have been reported in patients taking NSAIDs (including meloxicam). Most of these laboratory abnormalities are transient and mild. If these abnormalities progress or persist, meloxicam should be discontinued and appropriate investigations should be performed.
In patients with abnormal liver function tests or symptoms suggestive of hepatic dysfunction, symptoms of more severe hepatic failure may develop during continued treatment with meloxicam. If clinical symptoms suggestive of hepatic dysfunction or systemic manifestations of the disease (e.g. eosinophilia, rash) occur, meloxicam should be discontinued.
Cardiovascular disorders
Close monitoring is recommended in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported with NSAID therapy.
In patients with risk factors, blood pressure monitoring is recommended before treatment and 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 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 increased risk is related to the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.
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 also necessary before initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, smoking).
Skin reactions
Serious skin reactions, some of which were fatal, have been reported with NSAIDs in isolated cases, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients should be informed of the signs and symptoms of serious skin reactions and should be closely monitored for skin reactions. The highest risk of such reactions was observed at the beginning of treatment, especially during the first month 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), treatment with meloxicam 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 lesions. If a patient has developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam, the drug should not be restarted at any time in the future.
Anaphylactic reactions
As with other NSAIDs, anaphylactic reactions may occur in patients with no known reaction to meloxicam. Meloxicam should not be used in patients with the aspirin triad. This symptom complex occurs in patients with asthma who have had rhinitis (with or without nasal polyps) or who have experienced severe, potentially fatal bronchospasm after taking acetylsalicylic acid or other NSAIDs.
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 decreased glomerular filtration. This adverse effect is dose-dependent. Close monitoring of urine output and renal function is recommended at the beginning of treatment or after dose increases in patients with the following risk factors:
In rare cases, NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis, or the development of 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 (creatinine clearance > 25 ml/min), the dose may not be reduced.
Sodium, potassium, and water retention
NSAIDs may increase sodium, potassium and water retention and may interfere with the natriuretic effects of diuretics. The antihypertensive effect of antihypertensive drugs may be reduced (see section 4.5). As a result, edema, heart failure or hypertension may worsen in susceptible patients. Therefore, clinical monitoring is recommended in patients at risk.
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 necessary.
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).
Elderly and debilitated patients require close supervision. 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).
Masking inflammation and fever
MOVIXICAM® ODT, like any other NSAID, may mask the symptoms of infectious diseases. Due to its pharmacological action to reduce fever and inflammation, the use of the drug may complicate the diagnosis of non-infectious pain syndrome.
Meloxicam may have an adverse effect on 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).
Corticosteroid treatment
Meloxicam cannot be a likely substitute for corticosteroids in the treatment of corticosteroid insufficiency.
Hematological effects
Anemia associated with fluid retention, gastrointestinal bleeding, and effects on erythropoiesis may occur with NSAIDs, including meloxicam. During long-term treatment, blood counts (including hemoglobin and hematocrit) should be monitored if symptoms and signs of anemia are present.
NSAIDs may inhibit platelet aggregation and prolong bleeding time in some patients. In contrast to acetylsalicylic acid, the effect of meloxicam on platelet function is milder, reversible and short-lived. Patients taking meloxicam who may have adverse effects on platelet function, coagulation disorders, and patients receiving anticoagulants should be carefully monitored.
Use in patients with asthma
The use of acetylsalicylic acid in patients with aspirin-sensitive asthma may result in 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 administered with caution to patients with asthma.
MOVIKSICAM® ODT tablets contain aspartame (E 951), therefore they should not be prescribed to patients suffering from phenylketonuria.
The tablets also contain mannitol (E 421) and sorbitol (E 420), which can have a mild laxative effect.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no specific studies on the effects of the drug on the ability to drive or use machines. Based on the pharmacodynamic profile and the observed adverse reactions, it can be assumed that meloxicam has 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.
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 after 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 believed to increase with increasing dose and duration of treatment. 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 dose and duration of treatment should be kept as short as possible.
Meloxicam is contraindicated during the third trimester of pregnancy, because all prostaglandin synthesis inhibitors carry risks to the fetus:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios.
There are 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.
Breastfeeding: Although there are no specific data for meloxicam, NSAIDs are known to pass into breast milk. Therefore, the use of the drug is not recommended in women who are breastfeeding.
Method of administration and doses
For oral use.
The total daily dose is administered once.
The tablet should be placed on the tongue and allowed to dissolve completely, approximately 5 minutes. The tablet should not be chewed or swallowed whole. After dissolving, drink 240 ml of water. Water can also be used to moisten the oral mucosa in patients with dry mouth.
In case of exacerbation of osteoarthritis: 7.5 mg per day (one 7.5 mg tablet or half a 15 mg tablet); if necessary, the dose can be increased to 15 mg per day (1 15 mg tablet or 2 7.5 mg tablets).
For rheumatoid arthritis, ankylosing spondylitis: 15 mg per day (1 tablet of 15 mg or 2 tablets of 7.5 mg).
DO NOT EXCEED THE DOSE OF 15 mg per day.
Special categories of patients
Elderly patients are 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 per day.
Patients at increased risk of adverse reactions should start treatment with a dose of 7.5 mg per day (see section "Special warnings and precautions for use").
Kidney failure
The dose for patients with severe renal insufficiency who are on dialysis should not exceed 7.5 mg per day.
No dose reduction is required in patients with mild to moderate renal impairment (creatinine clearance > 25 ml/min) (for patients with severe renal impairment not on dialysis, see section "Contraindications").
Liver failure
No dose reduction is required in patients with mild or moderate hepatic impairment (for patients with severe hepatic impairment, see section "Contraindications").
Children
MOVIXICAM® ODT, 7.5 mg or 15 mg tablets, are not prescribed to 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 therapy. Gastrointestinal bleeding may occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular failure, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic use of NSAIDs, which may also occur with overdose.
Therapy
In case of NSAID overdose, symptomatic and supportive measures are recommended. Studies have shown that meloxicam elimination is accelerated by administration of 4 oral doses of cholestyramine 3 times daily.
Adverse reactions
Edema, hypertension, and heart failure have been observed with NSAID treatment.
Most of the observed side effects are gastrointestinal in origin. Peptic ulceration, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients (see section "Special warnings and precautions for use").
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section "Special instructions") may occur with the use of the drug. Gastritis may occur infrequently.
The following adverse reactions have been reported:
From the blood and lymphatic system: deviation of blood test parameters from the norm (including changes in the number of leukocytes), leukopenia, thrombocytopenia, anemia.
Rare cases of agranulocytosis have been reported (see “Selected serious and/or common adverse reactions”).
Immune system disorders: allergic reactions, anaphylactic reaction, anaphylactoid reaction, including shock, and other immediate-type reactions.
From the nervous system: dizziness, drowsiness, headache.
On the part of the organs of vision: visual function disorders, including blurred vision, conjunctivitis.
From the side of the organs of hearing and vestibular apparatus: dizziness, tinnitus.
From the cardiovascular system: tachycardia, increased blood pressure, hot flashes.
Heart failure has been reported in association with NSAID treatment.
On the part of the respiratory system: asthma in patients allergic to acetylsalicylic acid and other NSAIDs, upper respiratory tract infections, cough.
On the part of the digestive tract: dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, occult or macroscopic gastrointestinal bleeding, stomatitis, gastritis, belching, colitis, gastroduodenal ulcer, esophagitis, gastrointestinal perforation, pancreatitis.
Gastrointestinal bleeding, ulceration or perforation may be fatal, especially in the elderly (see section "Special warnings and precautions for use").
Hepatobiliary system: abnormal liver function tests (e.g., increased transaminases or bilirubin), hepatitis, jaundice, liver failure.
Skin and subcutaneous tissue disorders: toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, pruritus, rash, urticaria, bullous dermatitis, erythema multiforme, photosensitivity reactions, exfoliative dermatitis.
From the urinary system: sodium and water retention, hyperkalemia, changes in renal function (increased serum creatinine and/or urea), acute renal failure in patients with risk factors, urinary tract infections, urination disorders.
General disorders: edema, including edema of the lower extremities, flu-like symptoms.
Musculoskeletal system: arthralgia, back pain, joint-related symptoms.
Certain serious and/or common adverse reactions
Very rare cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially myelotoxic drugs (see section "Interaction with other medicinal products and other forms of interaction").
Adverse reactions that have not been observed with this medicinal product but are typical of other compounds of the class.
Organic renal damage, possibly leading to acute renal failure: rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis have been reported (see section "Special warnings and precautions for use").
Expiration date
3 years.
Storage conditions
Does not require special storage conditions.
Packaging
For 15 mg dosage: 10 tablets in a blister, 1 blister in a cardboard pack.
Vacation category
According to the recipe.
Producer
Alpex Pharma SA.
Location of the manufacturer and its business address
Via Cantonale, 6805 Mezzovico-Vira, Switzerland.
