Movasin, pills 15 mg, 20 pcs.

Composition

of 1 tab. :

– meloxicam (in terms of 100% substance) 7.5 mg or 15 mg

Auxiliary substances:

povidone-12.6 thousand(polyvinylpyrrolidone low molecular weight medical 12600± 2700),

lactose monohydrate (milk sugar),

crospovidone (collidone CL, collidone CL-M),

potato starch,

talc,

magnesium stearate,

microcrystalline cellulose.

Pharmacological action

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is associated with inhibition of prostaglandin synthesis as a result of selective suppression of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in prostaglandin biosynthesis in the inflammatory region.

When prescribed in high doses, long-term use and individual characteristics of the body, selectivity for COX-2 decreases. Inhibits prostaglandin synthesis in the area of inflammation to a greater extent than in the gastric mucosa or kidneys, which is associated with a relatively selective inhibition of COX-2.

Less often causes erosive and ulcerative diseases of the gastrointestinal tract (GIT). To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), which is involved in the synthesis of prostaglandins that protect the gastrointestinal mucosa and take part in the regulation of blood flow in the kidneys.

Indications

• Symptomatic treatment of osteoarthritis;
• symptomatic treatment of rheumatoid arthritis;
• symptomatic treatment of ankylosing spondylitis (ankylosing spondylitis).

Use during pregnancy and lactation

It is recommended to consult your doctor before use.

Contraindications

• hypersensitivity to meloxicam or auxiliary substances of the drug; the composition of the drug includes lactose, therefore patients with rare hereditary problems such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug;
• status after conducting coronary artery bypass grafting;
• uncompensated heart failure;
• complete or incomplete combination of bronchial asthma, polynosis nose and intolerance of acetylsalicylic acid and other NSAIDs;
• erosive and ulcerative changes in the mucous membrane of the stomach or 12 duodenal ulcer, active gastrointestinal bleeding;
• inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• cerebrovascular bleeding or other bleeding;
• severe hepatic impairment or active liver disease;
• chronic renal failure in patients not undergoing dialysis (creatinine clearance (CC) of less than 30 ml/min), progressive kidney disease, including confirmed hyperkalemia;
• pregnancy, lactation;
• children’s age up to 12 years.

With caution. Coronary heart disease( CHD), cerebrovascular diseases, compensated heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial diseases, smoking, creatinine clearance 30-60 ml / min. Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Heliacobacter pulori infection, elderly age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs:- anticoagulants (for example, warfarin);- antiplatelet agents (for example, acetylsalicylic acid, clopidogrel);- oral glucocorticosteroids (corticosteroids) (e. g. prednisone);- selective serotonin reuptake inhibitors (e. g. citalopram, fluoxetine, paroxetine, sertraline). To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

Side effects

From the digestive system: more than 1% – dyspepsia, including nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% – transient increase in the activity of “liver” transaminases, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including hidden), stomatitis; less than 0.1% – perforation of the gastrointestinal tract, colitis, hepatitis, gastritis. From the hematopoietic organs: more than 1% – anemia; 0.1-1% – changes in the blood formula, including leukopenia, thrombocytopenia. From the skin: more than 1% – pruritus, skin rash; 0.1-1% – urticaria; less than 0.1% – photosensitization, bullous rashes, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the respiratory system: less than 0.1% – bronchospasm.

Nervous system disorders: more than 1% – dizziness, headache; 0.1-1% – vertigo, tinnitus, drowsiness; less than 0.1% – confusion, disorientation, emotional lability.

From the cardiovascular system( CVS): more than 1% – peripheral edema; 0.1-1% – increased blood pressure (BP), palpitations, “hot flashes” of blood to the skin of the face.

From the urinary system: 0.1-1% – hypercreatininemia and / or increased urea in the blood serum; less than 0.1% – acute renal failure; association with meloxicam intake is not established – interstitial nephritis, albuminuria, hematuria.

From the sensory organs: less than 0.1% – conjunctivitis, visual impairment, including blurred vision.

Allergic reactions: less than 0.1% – angioedema, anaphylactoid / anaphylactic reactions.

Interaction

• with simultaneous use with other NSAIDs (or acetylsalicylic acid) increases the risk of erosive and ulcerative lesions and bleeding in the gastrointestinal tract;
• while the use of Novasina with antihypertensive drugs may reduce their effectiveness;
• with the simultaneous use with lithium preparations may develop accumulation of lithium and increase its toxic effect (it is recommended to monitor the concentration of lithium in the blood);
• while the use of Novasina with methotrexate increases adverse effect on the hematopoietic system (the risk of anemia and leukopenia shows periodic monitoring of complete blood count);
• with simultaneous use with diuretics and cyclosporine increases the risk of renal failure;
• while the use of Novasina with intrauterine contraceptives may reduce the effectiveness of the latter;
• with the simultaneous use of anticoagulants (heparin, tiklopidin, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin) increases the risk of bleeding (requires periodic monitoring of indicators of blood coagulation);
• while the use of Novasina with kolestiraminom accelerated excretion of the drug from the body;
• while the use of selective inhibitors of serotonin reuptake, increases the risk of bleeding from the gastrointestinal tract.

How to take, course of administration and dosage

The drug Movasin is taken orally with meals in a daily dose of 7.5-15 mg. Recommended dosage regimen:- rheumatoid arthritis: 15 mg of Movasin per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day. – osteoarthritis: 7.5 mg of Movasin per day. If ineffective, the dose can be increased to 15 mg per day. – ankylosing spondylitis: 15 mg of Movasin per day. The maximum daily dose is 15 mg.

In patients with an increased risk of side effects, as well as in patients with severe renal insufficiency who are on hemodialysis, the dose should not exceed 7.5 mg of Movasin per day.

Overdose

Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, liver failure, respiratory arrest, asystole.

Treatment: there is no specific antidote; in case of overdose of the drug, gastric lavage, taking activated charcoal (within the next hour), symptomatic therapy should be performed. Forced diuresis, urine alkalinization, and hemodialysis are ineffective due to the high binding of the drug to blood proteins.

Special instructions

• caution should be exercised when using Movasin in patients with a history of gastric and duodenal ulcers, as well as in patients undergoing anticoagulant therapy. These patients are at increased risk of erosive and ulcerative diseases of the gastrointestinal tract;
• use caution and monitor the indicators of renal function with use of the drug Mohsin from elderly patients, patients with chronic heart failure (CHF) with symptoms of circulatory failure in patients with cirrhosis, and in patients with hypovolemia as a result of surgical interventions;
• patients with slight or moderate decrease in renal function (QC more than 30 ml/min) does not require correction of dosing regimen;
• patients concurrently receiving diuretics and meloxicam, should take plenty of fluids;
• if in the course of treatment had an allergic reaction (itching, skin rash, urticaria, photosensitivity), you must consult a doctor to solve the issue of termination of drug Mohsin;
• meloxicam, like other NSAIDs, may mask the symptoms of infectious diseases;
• the use of meloxicam, like other drugs that block prostaglandin synthesis, may impair fertility and is not recommended for women who wish to conceive.

Driving vehicles, servicing machines and mechanismsapplication of the drug Movasin can cause undesirable effects in the form of headaches and dizziness, drowsiness, so during the period of taking the drug, you should stop driving vehicles and servicing machines and mechanisms that require concentration of attention.

Form of production

Pills.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Meloxicam

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 12 gr.