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Instruction for use: Movalis

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Active substance Meloxicam

└ĎŇ M01AC06 Meloxicam

Pharmacological group

NSAIDs - Oxicams

Nosological classification (ICD-10)

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M25.9 Joint disease, unspecified

Arthropathy, Diseases of the joints, Swelling in the joints, Swelling of the joints, Articular Syndrome, Edema after interventions during sprains

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

Composition and form of release

Solution for intramuscular injection 1 amp.

active substance:

meloxicam 15 mg

auxiliary substances: meglumine; glycofurol; poloxamer 188 (Pluronic F68); sodium chloride; glycine; sodium hydroxide; water for injections

in ampoules of colorless glass type I 1.5 ml each, in contour cells 3 or 5 ampoules; in a pack of cardboard 1 package.

Tablets 1 table.

active substance:

meloxicam 7.5 mg/ 15 mg

auxiliary substances: sodium citrate; lactose; ICC; povidone (collidon 25), silicon dioxide colloid; crospovidone; magnesium stearate

in a blister of 10 pcs .; in a pack of cardboard 1 or 2 blisters.

Suppositories for rectal administration 1 supp.

active substance:

meloxicam 7.5 mg/15 mg

auxiliary substances: suppository mass (suppository BP), macrogol glyceryl hydroxy stearate (polyethylene glycol glyceryl hydroxy stearate-cremophor RH40)

in packages of contiguous cells for 6 pcs .; in a box of 1 or 2 packs.

Description of dosage form

Solution for the / m introduction: transparent, yellow with a green tint of color.

Tablets: round from pale yellow to yellow. One side is convex with a bevelled edge. On the convex side is the firm's logo; on the other side - concave risk, on both sides of which engraved "59D" - for tablets 7.5 mg or "77C" - for tablets 15 mg. The surface of the tablets may be rough.

Suppositories: smooth, yellowish-green in color, with a depression in the base.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

Movalis« is an NSAID, refers to the derivatives of enolic acid and has anti-inflammatory, analgesic and antipyretic effects. The pronounced anti-inflammatory effect of meloxicam is established on all standard models of inflammation. The mechanism of action of meloxicam is its ability to inhibit the synthesis of PG - known inflammatory mediators.

Meloxicam in vivo inhibits the synthesis of PG at the site of inflammation to a greater extent than in the mucous membrane of the stomach or kidneys.

These differences are associated with a more selective inhibition of COX-2 compared to COX-1. It is believed that inhibition of COX-2 provides therapeutic effects of NSAIDs, whereas inhibition of the constantly present COX-1 isoenzyme may be responsible for side effects from the stomach and kidneys. The selectivity of meloxicam for COX-2 has been confirmed in various test systems, both in vitro and in vivo. The selective ability of meloxicam to inhibit COX-2 is shown when using human whole blood in vitro as a test system. It was found that meloxicam (in doses of 7.5 and 15 mg) inhibited COX-2 more actively, exerting a greater inhibitory effect on the production of PGE2 stimulated by lipopolysaccharide (the reaction controlled by COX-2) than on the production of thromboxane participating in the blood coagulation process reaction controlled by COX-1). These effects depended on the size of the dose.

Ex vivo showed that meloxicam at recommended doses had no effect on platelet aggregation and bleeding time, in contrast to indomethacin, diclofenac, ibuprofen and naproxen, which significantly inhibited platelet aggregation and increased bleeding time. In clinical trials, side effects from the gastrointestinal tract as a whole occurred less frequently with 7.5 and 15 mg meloxicam than with other NSAIDs that were compared. This difference in the frequency of side effects from the gastrointestinal tract is mainly due to the fact that when taking meloxicam, there were less frequent phenomena such as dyspepsia, vomiting, nausea, abdominal pain. The frequency of perforations in the upper gastrointestinal tract, ulcers and bleeding that were associated with the use of meloxicam was low and depended on the magnitude of the dose of the drug.

Pharmacokinetics

Solution

Meloxicam completely absorbed after the / m introduction. The relative bioavailability compared with the bioavailability with oral administration is almost 100%. Therefore, when switching from an injection to an oral form, the dose is not required. After administration of 15 mg of the drug, the peak plasma concentration of about 1.62 μg / ml is achieved within about 60 minutes. Meloxicam very well binds to plasma proteins, mainly with albumin (99%). It penetrates into the synovial fluid, the concentration in the synovial fluid is approximately 50% of the concentration in the plasma. Vd is low, with an average of 11 liters. Interindividual differences account for 30-40%.

Pills

Meloxicam is well absorbed from the digestive tract, as evidenced by a high absolute bioavailability with oral administration of 89%. With a single administration of the drug in the form of tablets, the average Cmax in the plasma is reached within 5-6 hours. With repeated use, a stable state of pharmacokinetics is achieved in a period of 3 to 5 days. The range of differences between the maximum (Cmax) and basal concentrations (Cmin) of the drug during the steady state of pharmacokinetics after its administration once a day is relatively small and amounts to 0.4-1 μg / ml for a dose of 7.5 mg and 0.8 -2 μg / ml - for a dose of 15 mg. Cmax in plasma during the steady state of pharmacokinetics is achieved within 5-6 hours when taking tablets.

Concentrations of the drug after a constant intake for more than 6 months are similar to those observed after 2 weeks of oral intake of 15 mg per day. Simultaneous food intake does not affect the absorption of the drug.

Suppositories

It is shown that suppositories are bioequivalent to tablets. Cmax of the drug in the plasma during the steady state of pharmacokinetics is reached approximately 5 hours after the application of the drug.

The ranges of differences between the maximum (Cmax) and basal concentrations (Cmin) are similar for tablets and suppositories.

Distribution

Meloxicam binds well to plasma proteins (with albumin - 99%).

Meloxicam penetrates into the synovial fluid; local concentrations are approximately 50% of the plasma concentrations.

Vd is low, with an average of 11 liters. Individual fluctuations - 30-40%.

Metabolism

Meloxicam is almost completely metabolized in the liver with the formation of 4 pharmacologically inactive derivatives. The main metabolite - 5'-carboxymeloxicam (60% of the dose value) - is formed by oxidation of the intermediate metabolite - 5'-hydroxymethylmeloxicam, which is also excreted, but to a lesser extent (9% of the dose value). In vitro studies have shown that CYP2C9 plays an important role in this metabolic transformation, the CYP3A4 isoenzyme plays an additional role. In the formation of the other two metabolites (which make up 16 and 4% of the dose, respectively), peroxidase takes part, the activity of which, probably, varies individually.

Excretion

It is excreted equally with feces and urine, mainly in the form of metabolites. In unchanged form with feces less than 5% of the daily dose is excreted, in the urine in unchanged form the drug is found only in trace amounts. The average T1 / 2 meloxicam is 20 hours. Plasma clearance is an average of 8 ml / min.

Meloxicam demonstrates a linear pharmacokinetics in doses of 7.5-15 mg when ingested or in / m (intramuscular) administration.

Liver and / or kidney failure

Lack of liver function, as well as mild to moderate renal failure, does not significantly affect the pharmacokinetics of meloxicam. In terminal renal failure, an increase in Vd can lead to higher concentrations of free meloxicam, so in these patients the daily dose should not exceed 7.5 mg.

Elderly patients

In elderly patients, the average plasma clearance during the equilibrium state of pharmacokinetics is slightly lower than in young patients.

Children

During the study of meloxicam in children, the pharmacokinetics of the drug was studied in doses applied at the rate of 0.25 mg / kg. Comparing the indices for children of different ages (2-6 years, n = 7 and 7-14 years, n = 11), the trend is toward a lower Cmax (-34%) and AUC0-∞ (-28%) in young children , and the clearance of the drug (adjusted for body weight) in this group of children was higher. Concentrations of meloxicam in plasma in older children and adults are similar. In children of both age groups T1 / 2 meloxicam from plasma were similar (13 hours) and somewhat shorter than in adults (15-20 hours).

Indications

Solution for IM (intramuscular) administration

Initial period of treatment of pain syndrome and short-term symptomatic therapy of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

Tablets and Suppositories

Symptomatic treatment:

osteoarthritis (arthrosis, degenerative joint diseases);

rheumatoid arthritis;

ankylosing spondylitis.

Contraindications

Common for all dosage forms

increased sensitivity to the active ingredient or auxiliary components of the drug. There is a possibility of cross-hypersensitivity to acetylsalicylic acid and other NSAIDs;

symptoms of bronchial asthma, polyps of the nose, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs in the anamnesis;

peptic ulcer / perforation of the stomach and duodenum in the acute stage or recently transferred;

Crohn's disease or ulcerative colitis in the acute stage;

severe hepatic impairment;

severe renal failure (if hemodialysis is not performed, Cl creatinine is less than 30 ml / min, and with confirmed hyperkalemia), progressive kidney disease;

acute gastrointestinal bleeding, recent cerebrovascular bleeding or an established diagnosis of blood coagulation system diseases;

severe uncontrolled heart failure;

pregnancy;

breast-feeding;

therapy of perioperative pain during coronary artery bypass grafting.

For solution for intramuscular injection additionally:

children's age till 18 years.

For tablets and suppositories additionally:

Children under 12 years old, except for juvenile rheumatoid arthritis (if this indication is recorded).

Carefully

A solution - a history of gastrointestinal disease (presence of H. pylori infection); congestive heart failure; renal failure (Cl creatinine 30-60 ml / min); IHD; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; concomitant therapy with the following drugs: anticoagulants, oral GCS, antiaggregants, SSRIs; diseases of peripheral arteries; elderly age; long-term use of NSAIDs; smoking; frequent use of alcohol.

Tablets and suppositories - NSAIDs inhibit the synthesis of PG in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced BCC can lead to decompensation of latent renal failure. After the withdrawal of the NSAID, the kidney function is usually restored to its original level. The elderly are at greatest risk of developing this reaction; patients with dehydration, congestive heart failure, cirrhosis, nephritic syndrome or obvious kidney disease; patients receiving diuretics, ACE inhibitors, antagonists of AT-II receptors, and patients who underwent serious surgical interventions leading to hypovolemia. In such patients at the beginning of therapy, diuresis and renal function should be carefully monitored.

In rare cases, NSAIDs can cause interstitial nephritis, glomerulonephritis, medullary kidney necrosis or nephrotic syndrome.

In patients with terminal stage of renal failure who are on hemodialysis, the dose of Mawalis« should not exceed 7.5 mg. In patients with small or moderate impairment of kidney function ie, if Cl creatinine is greater than 25 ml / min, a dose reduction is not required.

pregnancy and lactation

Mawalis« is contraindicated during pregnancy. Suppression of GHG synthesis can have an undesirable effect on pregnancy and fetal development. Data from epidemiological studies indicate an increase in the risk of spontaneous abortions, heart defects and gastroschisis in the fetus after the use of PG synthesis inhibitors during pregnancy.

The absolute risk of heart disease increased from less than 1% to 1.5%. This risk increases with increasing dose and duration of therapy.

In the III trimester of pregnancy, the use of PG synthesis inhibitors can lead to the following disorders in the fetus:

- premature closure of the arterial duct and pulmonary hypertension due to toxic effects on the cardiopulmonary system;

- renal dysfunction with further development of renal failure with a decrease in the amount of amniotic fluid.

The mother during labor can increase the duration of bleeding and reduce the contractile capacity of the uterus, and as a result, the time of delivery increases. Antiaggregant effect can occur even when taking low doses.

It is known that NSAIDs penetrate into breast milk, so Mawalis« is not recommended for use during lactation.

Side effects

Common for all dosage forms

Side effects, the relationship of which with taking the drug was regarded as possible, and which were recorded with a wide application of the drug, are marked with *.

From the hematopoiesis: changes in the number of blood cells, including changes in the leukocyte formula, leukopenia, thrombocytopenia, anemia. The predisposing factor for the onset of cytopenia appears to be the simultaneous use of potentially myelotoxic drugs, in particular methotrexate.

On the part of the immune system: anaphylactic shock *, anaphylactoid / anaphylactic reactions *, other immediate-type hypersensitivity reactions *.

From the side of the central nervous system: headache, dizziness, tinnitus, drowsiness, confusion *, disorientation *, mood change *.

On the part of the gastrointestinal tract: perforation of the gastrointestinal tract, latent or obvious gastrointestinal bleeding, possibly fatal, gastroduodenal ulcers, colitis, gastritis *, esophagitis, stomatitis, abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, bloating, belching , transient changes in liver function indicators (eg, increased activity of transaminases or bilirubin), hepatitis *.

From the skin and skin appendages: toxic epidermal necrolysis *, Stevens-Johnson syndrome *, angiootec *, bullous dermatitis *, erythema multiforme *, itching, skin rash, urticaria, photosensitization.

On the part of the respiratory system: bronchial asthma in patients with an allergy to acetylsalicylic acid or other NSAIDs.

On the part of the CAS: increased blood pressure, palpitations, a rush of blood to the face, swelling.

On the part of the genitourinary system: acute renal failure *, changes in renal function (increased serum creatinine and / or urea levels), urination disorders, including acute urinary retention *.

From the side of the organ of vision: conjunctivitis *, visual impairment, including blurred vision *.

For the solution for the / m injection, in addition

On the part of the genitourinary system: as for other NSAIDs, the possibility of interstitial nephritis, glomerulonephritis, renal medullary necrosis, nephrotic syndrome is not ruled out.

Common phenomena: pain and swelling at the injection site.

Interaction

Common for all dosage forms

Other inhibitors of PG synthesis, including HA and salicylates, when taken concomitantly with meloxicam, increase the risk of ulceration in the gastrointestinal tract and gastrointestinal bleeding (due to synergism of action) and therefore their combination is not recommended. Simultaneous reception with other NSAIDs is not recommended.

SSRIs - increased risk of gastrointestinal bleeding.

Lithium preparations - NSAIDs increase the concentration of lithium in plasma, by reducing the excretion of it by the kidneys. It is recommended to monitor the concentration of lithium during the period of the appointment of Movalisa«, with a change in the dose of lithium preparations and their cancellation.

Methotrexate - NSAIDs reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration and hematological toxicity, the pharmacokinetics of methotrexate remain unchanged. In this regard, the simultaneous administration of Mawalisa« and methotrexate in a dose of more than 15 mg / week is not recommended. The risk of developing an interaction between NSAIDs and methotrexate may also occur in patients using methotrexate in low doses, especially in patients with impaired renal function. Therefore, constant monitoring of the number of blood cells and the function of the kidneys is necessary.

Simultaneous use of meloxicam did not affect the pharmacokinetics of methotrexate at a dose of 15 mg per week, but it should be taken into account that the hematological toxicity of methotrexate is enhanced with the simultaneous administration of NSAIDs.

With the combined use of meloxicam and methotrexate for 3 days, the risk increases the toxicity of the latter.

Contraception - NSAIDs decrease the effectiveness of intrauterine contraceptive devices.

Diuretics - the use of NSAIDs in case of dehydration of patients is accompanied by a risk of developing acute renal failure.

Patients receiving Movalis« and diuretics should be adequately hydrated. Before the beginning of treatment it is necessary to study the function of the kidneys.

Antihypertensives (beta-blockers, ACE inhibitors, vasodilators, diuretics) - NSAIDs reduce the effect of antihypertensive agents, due to the inhibition of PG with vasodilating properties.

Angiotensin II receptor antagonists when co-administered with NSAIDs increase the decrease in glomerular filtration, which can lead to the development of acute renal failure, especially in patients with impaired renal function. In the case of combined therapy, kidney function should be monitored.

NSAIDs, having an effect on renal PG, can enhance the nephrotoxicity of cyclosporine.

When used in conjunction with meloxicam drugs that have a known ability to inhibit CYP2C9 and / or CYP3A4 (or are metabolized with the participation of these enzymes), the possibility of pharmacokinetic interaction should be taken into account.

It is impossible to exclude the possibility of interaction with hypoglycemic drugs for oral administration.

With the simultaneous use of antacids, cimetidine, digoxin and furosemide, no significant pharmacokinetic interactions were identified.

For tablets and suppositories additionally

The combined use of aspirin (1000 mg 3 times daily) and meloxicam in healthy volunteers resulted in an increase in AUC (10%) and Cmax (24%) meloxicam. The clinical significance of this interaction is not known.

Cholestyramine, binding meloxicam in the digestive tract, leads to its faster excretion.

Dosing and Administration

In / m.

In / m introduction of the drug is shown only during the first 2-3 days of therapy. Further treatment is continued with the use of enteral forms. The recommended dose is 7.5 mg or 15 mg once a day, depending on the intensity of pain and the severity of the inflammatory process.

The maximum recommended daily dose is 15 mg.

The drug is injected through a deep intravenous injection.

Given the possible incompatibility, the contents of the Movalis« ampoules should not be mixed in one syringe with other medicines.

Impaired renal function. In patients with severe renal failure who are on hemodialysis, the dose should not exceed 7.5 mg / day.

The drug should not be administered IV.

Inside, with food, washing with water or other liquid; rectally.

Osteoarthritis, rheumatoid arthritis - 7.5 mg / day. If necessary, this dose can be increased to 15 mg / day. Depending on the therapeutic effect, this dose can be reduced to 7.5 mg / day.

Ankylosing spondylitis - 15 mg / day. Depending on the therapeutic effect, this dose can be reduced to 7.5 mg / day.

In patients with an increased risk of adverse reactions, it is recommended to start treatment with a dose of 7.5 mg / day. For patients with severe renal failure who are on hemodialysis, the dose should not exceed 7.5 mg / day.

Teens

The maximum dose for adolescents is 0.25 mg / kg.

As a rule, the drug should be used only in adolescents and adults (see section "Contraindications"). The maximum recommended daily dose is 15 mg.

Rectal suppositories are recommended to be applied at a dose of 7.5 mg 1 time per day. In more severe cases, candles can be used at a dose of 15 mg.

Due to the fact that the risk of adverse reactions depends on the size of the dose and duration of application, the drug should be used within the shortest possible time, possibly at the lowest effective dose.

Combined application. The total daily dose of the drug Movalis«, used in the form of tablets, suppositories, injections, should not exceed 15 mg.

Overdose

Symptoms: Data on cases associated with overdose of the drug accumulated insufficiently. Probably, there will be symptoms typical of overdose of NSAID drugs, in severe cases - drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole. When an overdose of tablets or suppositories - increased side effects.

Treatment: antidote is not known. In case of an overdose of the drug, symptomatic therapy should be used. When an overdose of tablets - gastric lavage.

special instructions

Common for all dosage forms

Patients suffering from gastrointestinal diseases should be observed regularly. If ulcerative gastrointestinal lesions or gastrointestinal bleeding occur, Mawalis« should be discontinued. Gastrointestinal ulcers, perforation or bleeding may occur during treatment at any time, as with the presence of alarming symptoms or information about serious gastrointestinal complications in the history, and in the absence of these symptoms. The consequences of these complications are generally more serious in the elderly.

When using Movalis « (as well as most other NSAIDs), an occasional increase in the activity of transaminases in the serum or other indicators of liver function is possible. In most cases, this increase was small and transient. If the changes identified are significant or do not decrease over time, Movalis« should be discontinued and observed for laboratory changes identified.

Weakened or emaciated patients can tolerate undesirable events worse, and therefore, such patients should be carefully observed.

Like other NSAIDs, Movalis« can mask the symptoms of a major infectious disease.

Solution for the / m introduction

Particular attention should be given to patients reporting the development of adverse skin and mucous membrane effects, as well as reactions of hypersensitivity to the drug, especially if similar reactions were observed during previous courses of treatment. The development of such reactions is observed, as a rule, during the first month of treatment. In such cases, the issue of discontinuing the use of Movalis« should be considered.

Like other NSAIDs, Movalis« can increase the risk of serious cardiovascular thrombosis, myocardial infarction, angina attack, possibly fatal. This risk increases with prolonged use of the drug, as well as in patients with the above mentioned diseases in the history and predisposed to such diseases.

NSAIDs inhibit the synthesis of PG in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or a reduced BCC can lead to decompensation of the secretive renal failure. After the withdrawal of the NSAID, the kidney function is usually restored to its original level. The elderly patients, patients with dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome or acute renal dysfunction, concomitantly receiving diuretics, as well as patients undergoing serious surgical interventions that lead to hypovolemia. In such patients at the beginning of therapy, diuresis and renal function should be carefully monitored. The use of NSAIDs together with diuretics can lead to a delay in sodium, potassium and water, as well as a decrease in natriuretic action of diuretics. As a result, predisposing patients may have signs of heart failure or hypertension. Therefore, careful monitoring of the condition of such patients is needed, and adequate hydration should be maintained. Before the beginning of treatment it is necessary to study the function of the kidneys.

In the case of combined therapy, kidney function should also be monitored.

As a preparation that inhibits COX and the synthesis of PG, Movalis« can have an effect on fertility, and therefore is not recommended for women who have difficulty with conception. In this regard, women who are undergoing examination in this regard, it is recommended to cancel taking Mawalisa«.

Influence on ability to drive vehicles and mechanisms. Special clinical studies of the effect of the drug on the ability to control the car and mechanisms were not carried out. However, when driving and working with machinery, the possibility of developing dizziness, drowsiness, or other abnormalities from the CNS should be taken into account.

For tablets, suppositories additionally

Care should be taken (as with other NSAIDs) in the treatment of patients with a history of gastrointestinal disease and patients receiving anticoagulants. During the use of NSAIDs very rarely reported on the development of serious allergic reactions (some of which resulted in the death of patients), incl. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk of these reactions in patients appears to be observed at the very beginning of the course of treatment, these reactions in most cases started within the first month of treatment. In the case of the appearance of the first signs of skin rash, changes in the mucous membranes or any other symptoms of hypersensitivity meloxicam should be discarded. NSAIDs may increase the risk of serious thrombotic cardiovascular disease, myocardial infarction and stroke, which can lead to death. This risk may increase as the duration of NSAID use increases. The greatest risk can be observed in patients with cardiovascular diseases or in the presence of risk factors for the development of cardiovascular diseases, renal failure, on hemodialysis (the dose of the drug Mawalis« should not exceed 7.5 mg). In patients with small or moderate renal impairment (ie, if Cl creatinine> 25 mL / min), a dose reduction is not required. In patients with clinically stable cirrhosis, a dose reduction is not required.

Caution (as with other NSAIDs) should be observed in the treatment of elderly patients who are more likely to have impaired renal, hepatic, and cardiac function. The use of NSAIDs in conjunction with diuretics can lead to a delay in sodium, potassium and water, and affect the natriuretic effect of diuretics. As a result, predisposing patients may have signs of heart failure or hypertension. Clinical observation of patients with a risk of developing these complications is recommended.

The drug is intended for symptomatic therapy, pain reduction and inflammation. As well as for other NSAIDs, combined treatment of the disease is necessary to influence progression.

Suppositories should not be used in patients with any inflammatory damage to the rectum or anus, or in patients with recent bleeding from the rectum or anus.

Influence on ability to drive vehicles and mechanisms. Special studies on the effect of the drug on the ability to drive vehicles and mechanisms were not carried out. This activity should be refrained to patients with visual impairment, patients who report drowsiness or other disorders from the central nervous system.

Tablets 7.5 and 15 mg contain 47 and 20 mg of lactose, respectively.

Patients with rare hereditary intolerance to galactose, with lapp-lactase deficiency or impaired glucose / galactose absorption, should not take this drug.

Conditions of leave from pharmacies

On prescription.

Storage conditions

At a temperature not exceeding 30 ░ C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.

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