Meloxicam is a nonsteroidal anti-inflammatory drug of the enolic acid class, which has anti-inflammatory, analgesic and antipyretic effects. Meloxicam has high anti-inflammatory activity in all standard models of inflammation. The general mechanism of these effects may be the ability of meloxicam to inhibit the biosynthesis of prostaglandins - mediators of inflammation.
The safer mechanism of action of meloxicam is associated with selective inhibition of cyclooxygenase-2 (COX-2) compared to cyclooxygenase-1 (COX-1). The therapeutic effect of NSAIDs is associated with inhibition of COX-2 synthesis, while inhibition of COX-1 leads to side effects from the stomach and kidneys.
The selectivity of COX-2 inhibition by meloxicam has been demonstrated by many investigators both in vitro and ex vivo. Meloxicam (15 mg) preferentially inhibits COX-2 ex vivo, as evidenced by a greater inhibition of PGE2 production in response to lipopolysaccharide stimulation compared with thromboxane production in clotted blood (COX-1). These effects are dose-dependent. Meloxicam has no effect on platelet aggregation or bleeding time when used at recommended doses ex vivo, whereas indomethacin, diclofenac, ibuprofen, and naproxen significantly inhibit platelet aggregation and prolong bleeding.
Clinical studies have shown a low incidence of gastrointestinal adverse events (perforations, ulceration and bleeding) when using recommended doses of meloxicam compared to standard doses of other NSAIDs.
Pharmacokinetics
Meloxicam is well absorbed from the digestive tract, which is reflected in the high absolute bioavailability (89%).
When using a single dose of suppositories, the maximum concentration of meloxicam in the blood plasma is reached after 5-6 hours.
Stable concentrations are reached on the 3rd-5th day.
A single daily dose leads to the development of drug concentration in blood plasma with relatively small fluctuations between its maximum and lowest point in the range of 0.8-2 μg/ml for a dose of 15 mg (Сmin and Cmax at stable equilibrium concentration).
The maximum stable equilibrium concentration in blood plasma after the use of suppositories is reached after approximately 5 hours.
Continuous treatment for a long period (e.g. 6 months) did not result in changes in pharmacokinetic parameters compared to those after 2 weeks of meloxicam administration at a dose of 15 mg per day. Any changes are also unlikely with treatment durations longer than 6 months.
Distribution: In blood plasma, more than 99% of the drug is bound to plasma proteins (mainly albumin). Meloxicam penetrates into the synovial fluid at a concentration approximately half that in blood plasma.
The volume of distribution is low, averaging 11 L. Individual variations are 30-40%.
Biotransformation. Meloxicam undergoes extensive biotransformation in the liver. Meloxicam is almost completely metabolized to four pharmacologically inactive metabolites. The main metabolite, 5'-carboxymeloxicam (60% of the dose), is formed by oxidation of the intermediate metabolite 5'-hydroxymethylmeloxicam, and is also excreted to a lesser extent (9% of the dose). In vitro studies suggest that CYP2C9 plays an important role in the metabolism process, while CYP3A4 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.
Excretion. Meloxicam is excreted mainly in the form of metabolites, determined in equal amounts in urine and feces. Less than 5% of the daily dose is excreted unchanged in the feces, while only traces of unchanged components are excreted in the urine. The half-life is about 20 hours.
Plasma clearance is 8 ml/min.
Indication
Symptomatic treatment:
pain syndrome in osteoarthritis (arthrosis, degenerative joint diseases); rheumatoid arthritis; ankylosing spondylitis.
Contraindication
Hypersensitivity to meloxicam or to any of the excipients or to active substances with similar effects such as NSAIDs, aspirin; meloxicam should not be prescribed to patients who have experienced symptoms of asthma, nasal polyps, angioedema or urticaria after taking aspirin or other non-steroidal anti-inflammatory drugs; pregnancy and lactation (see section "Use during pregnancy or lactation"); children under 18 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); active inflammatory bowel disease (Crohn's disease or ulcerative colitis); severe hepatic insufficiency; severe renal insufficiency 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).
Composition
Active ingredient: meloxicam;
1 suppository contains meloxicam in terms of 100% dry matter 15 mg;
excipients: solid fat, polyethoxylated hydrogenated castor oil.
Interaction with other medicinal products and other types of interactions
Studies regarding interaction have only been conducted with adults.
Some drugs or therapeutic groups may contribute to hyperkalemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs, (low molecular weight or unfractionated) heparins, cyclosporine, tacrolimus and trimethoprim.
The onset of hyperkalemia may depend on whether there are associated factors. The risk of developing hyperkalemia increases 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 "Special warnings and precautions for use"), including acetylsalicylic acid at doses ≥ 500 mg per dose or ≥ 3 g daily dose. Corticosteroids (e.g. glucocorticoids). Concomitant use with corticosteroids requires caution due to an increased risk of bleeding or ulceration in the gastrointestinal tract.
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 (for example, at prophylactic doses), the use of heparin requires caution due to the increased risk of bleeding.
Thrombolytic and antiplatelet drugs: 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 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 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, a reduction in the antihypertensive effect of beta-blockers (due to inhibition of prostaglandins with vasodilatory effect) is possible.
Calcineurin inhibitors (e.g. cyclosporine, tacrolimus). The nephrotoxicity of calcineurin inhibitors may be potentiated by NSAIDs as a result of mediation of the effects of renal prostaglandins. Renal function should be monitored during treatment. Close monitoring of renal function is recommended, 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.
Pharmacokinetic interaction: the effect of meloxicam on the pharmacokinetics of other drugs. Lithium. There is evidence that NSAIDs increase the level of lithium concentration in the blood plasma (due to a decrease in the renal excretion of lithium), which can reach toxic values. The simultaneous use of lithium and NSAIDs is not recommended (see section "Special instructions"). If combination therapy is necessary, the content of lithium in the blood plasma should be carefully monitored at the beginning of treatment, when adjusting the dose and when discontinuing treatment with meloxicam.
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 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. For patients with severe renal impairment (creatinine clearance < 45 ml/min), co-administration of meloxicam and pemetrexed is NOT recommended. For 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 with pemetrexed to 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 with simultaneous administration with antacids, cimetidine and digoxin.
Application features
Adverse reactions can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see section "Method of administration" and information regarding gastrointestinal and cardiovascular risks below).
The recommended maximum daily dose may be exceeded in case of insufficient therapeutic effect, and additional NSAIDs should not 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 benefits of treatment should be reassessed.
Attention should be paid to a history of esophagitis, gastritis and/or ulcer in order to ensure that they have fully resolved before starting therapy with meloxicam. Regular attention should be paid to the possible manifestation of relapse in patients treated with meloxicam and patients with such cases in history.
Gastrointestinal disorders.
As with other nonsteroidal anti-inflammatory drugs, potentially fatal cases of 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, especially complicated by bleeding or perforation (see section "Contraindications"), and in elderly patients. In such patients, treatment should be started at the lowest effective dose. Combination therapy with protective drugs (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 drugs that increase gastrointestinal risks (see information below and section "Interaction with other drugs and other types of interactions").
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be advised to report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
The use of meloxicam is not recommended in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as 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 meloxicam) may have elevations in one or more liver function tests. These laboratory abnormalities may progress, may remain stable, 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.
Patients with symptoms or suspected liver dysfunction or who have abnormal liver function tests should be evaluated for the development of symptoms of more severe liver failure during treatment with meloxicam. If clinical signs and symptoms consistent with liver disease develop or if systemic manifestations of the disease occur (e.g. eosinophilia, rash, etc.), then meloxicam should be discontinued.
Cardiovascular disorders.
Close observation 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 treatment.
For patients with risk factors, clinical monitoring of blood pressure is recommended at the beginning of treatment, especially at the beginning of treatment with meloxicam.
Research 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 can be fatal. The increased risk is related to the duration of treatment. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.
Skin disorders.
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 blistering or mucosal lesions), meloxicam treatment should be discontinued. It is important to diagnose and discontinue any drugs that may cause severe skin reactions: Stevens-Johnson syndrome or toxic epidermal necrolysis as soon as possible. This is associated with a better prognosis for severe skin reactions. If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while using meloxicam, the drug should not be restarted at any other time in the future.
Anaphylactic reactions.
As with other NSAIDs, anaphylactic reactions may occur in patients with no apparent reaction to meloxicam. Meloxicam should not be used in patients with the aspirin triad. This symptom complex occurs in patients with asthma who have reported 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 tests, 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 control tests performed. Functional renal failure. NSAIDs, by inhibiting the vasodilator effect of renal prostaglandins, can 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 diuresis and renal function is recommended in patients with the following risk factors: - advanced age; - simultaneous 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 ≥ 10 according to the Child-Pugh classification).
The dose of meloxicam for patients with end-stage renal disease on dialysis should not exceed 7.5 mg (in tablet form). For patients with mild to moderate renal impairment (creatinine clearance greater than 25 ml/min), the dose may not be reduced.
Sodium, potassium and water retention. NSAIDs may increase sodium, potassium and water retention and influence the natriuretic effects of diuretics. In addition, a decrease in the antihypertensive effect of antihypertensive drugs may be observed (see section "Interaction with other medicinal products and other types of interactions"). As a result, edema, heart failure or arterial hypertension may accelerate or worsen in susceptible patients. Therefore, clinical monitoring is recommended in patients at such risk (see sections "Method of administration and dosage" and "Contraindications").
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 before, on the day of, and for at least 2 days after 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 elderly patients, 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, like any other NSAID, may mask the symptoms of infectious diseases.
Meloxicam may have a negative 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 (see section "Use during pregnancy and lactation").
Masking inflammation and fever.
The pharmacological action of meloxicam to reduce fever and inflammation may complicate the diagnosis of suspected non-infectious pain conditions.
Corticosteroid treatment.
REVMALGIN cannot be a likely substitute for corticosteroids in the treatment of corticosteroid insufficiency.
Hematological effects.
Anemia may occur in patients receiving NSAIDs, including meloxicam. This may be due to fluid retention, gastrointestinal bleeding of unknown or gross origin, or incompletely described effects on erythropoiesis. Patients receiving long-term treatment with NSAIDs, including meloxicam, 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 meloxicam who may have adverse effects on 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, meloxicam should not be used in aspirin-sensitive patients and should be prescribed with caution in patients with pre-existing asthma.
Use during pregnancy or breastfeeding
Fertility. Meloxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may have a negative 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.
Pregnancy: Meloxicam is contraindicated during pregnancy.
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-foetal development. Epidemiological data suggest an increased risk of miscarriage, heart defects, and gastroschisis following exposure to prostaglandin synthesis inhibitors in early pregnancy. This risk is thought to increase with increasing dose and duration of treatment.
Possible risks in late pregnancy for the mother and newborn:
possible prolongation of bleeding time, antiplatelet effect even at very low doses; suppression of uterine contractions, leading to delayed or prolonged labor.
Although there are no specific data on meloxicam, NSAIDs are known to pass into breast milk, so meloxicam is contraindicated in breastfeeding women.
Ability to influence reaction speed when driving vehicles or other mechanisms
No specific studies on the effects of the drug on the ability to drive or use machines have been conducted. However, based on the pharmacodynamic profile and the adverse reactions observed, it can be assumed that meloxicam is likely to have no or negligible influence on these activities. However, patients who experience visual impairment, including blurred vision, dizziness, drowsiness, vertigo or other central nervous system disorders, are advised to refrain from driving or operating machinery.
Method of administration and doses
Osteoarthritis: 15 mg/day (1 suppository).
Rheumatoid arthritis: 15 mg/day (1 suppository).
Ankylosing spondylitis: 15 mg/day (1 suppository).
The maximum recommended daily dose of meloxicam is 15 mg.
Since the risk of adverse reactions increases with increasing dose and duration of treatment, the lowest effective daily dose should be used for the shortest possible treatment period.
When using different forms of the drug (capsules, tablets, suppositories, suspension or solution for injection) in combination, the total daily dose of meloxicam should not exceed 15 mg.
Children
The drug should not be used to treat children under 18 years of age.
Overdose
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. Anaphylactoid reactions have been reported with therapeutic use of NSAIDs, which may also occur with overdose.
In case of NSAID overdose, symptomatic and supportive measures are recommended. Studies have shown that the elimination of meloxicam is accelerated by administration of 4 oral doses of cholestyramine 3 times daily.
Adverse reactions
Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and with long-term treatment) may be associated with a small increased risk of vascular thrombotic events (e.g. myocardial infarction or stroke) (see section "Special warnings and precautions for use").
Edema, hypertension, and heart failure have been observed with NSAID treatment.
Most of the observed side effects are of gastrointestinal origin. Ulceration, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients (see section "Special instructions"). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been observed after use. (See section "Special instructions"). Gastritis has been observed less frequently.
Severe skin reactions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis (see section "Special warnings and precautions for use").
Criteria for assessing the frequency of adverse drug reactions: very common (≥ 1/10); common (≥ 1/100,
From the blood and lymphatic system:
infrequently - anemia;
rarely - deviation of blood parameters from the norm (including changes in the number of leukocytes), leukopenia, thrombocytopenia.
Very rare cases of agranulocytosis have been reported (see Selected Serious and/or Common Adverse Reactions).
On the part of the immune system:
infrequently - allergic reactions, except anaphylactic or anaphylactoid;
unknown - anaphylactic reaction, anaphylactoid reaction, including shock.
Mental disorders:
rarely - mood swings, nightmares;
unknown - confusion, disorientation, insomnia.
From the nervous system:
often - headache;
infrequently - dizziness, drowsiness.
On the part of the organs of vision:
rarely - visual impairment, including blurred vision, conjunctivitis.
From the side of the organs of hearing and vestibular apparatus:
infrequently - dizziness;
rarely - ringing in the ears.
Cardiac disorders:
rarely - feeling of palpitations.
Heart failure has been reported in association with NSAID treatment.
Vascular disorders:
infrequently - increased blood pressure (see section "Special instructions for use"),
tides.
From the respiratory system, chest organs and mediastinum:
rarely - asthma in patients allergic to aspirin and other nonsteroidal anti-inflammatory drugs;
unknown - upper respiratory tract infections, cough.
Gastrointestinal tract:
infrequently - hidden or macroscopic gastrointestinal bleeding, stomatitis, gastritis, belching;
rarely - colitis, gastroduodenal ulcer, esophagitis;
very rarely - gastrointestinal perforation.
Gastrointestinal bleeding, ulceration or perforation may be severe and potentially fatal, especially in elderly patients (see section "Special warnings and precautions for use");
unknown - pancreatitis.
From the hepatobiliary system:
infrequently - disturbances in biochemical indicators of liver function (for example, increased levels of transaminases or bilirubin);
very rarely - hepatitis;
unknown - jaundice, liver failure.
Skin and subcutaneous tissue disorders:
infrequently - angioedema, itching, rash;
rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria;
very rarely - bullous dermatitis, polymorphic erythema;
unknown - photosensitivity reactions, exfoliative dermatitis.
From the urinary system:
infrequently - sodium and water retention, hyperkalemia (see sections "Features of use", "Interaction with other medicinal products and other types of interactions"), changes in kidney function indicators (increase in serum creatinine and/or urea);
very rarely - acute renal failure, particularly in patients with risk factors (see section "Special warnings and precautions for use");
unknown - urinary tract infections, urinary frequency disorders.
General disorders and administration site conditions:
infrequently - edema, including edema of the lower extremities;
unknown - flu-like symptoms.
On the part of the musculoskeletal system:
not known - arthralgia, back pain, joint-related signs and 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 types of interactions”).
Adverse reactions that were not observed during the use of the drug, but which are generally considered to be characteristic of other compounds of the class.
Organic renal damage, possibly leading to acute renal failure: very rarely 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
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 suppositories in a strip. 1 or 2 strips in a pack.
Vacation category
According to the recipe.
Producer
"Pharmex Group" LLC.
Location of production and its address of place of business
Ukraine, 08300, Kyiv region, Boryspil city, Shevchenko st., 100.
All cases of adverse reactions must be reported to the manufacturer:
LLC "PHARMEX GROUP", Ukraine, 08300, Kyiv region, Boryspil city, Shevchenko st., 100,
phone: +38 (044) 391-19-19, fax: +38 (044) 391-19-18
