Sinmeton (naʙumetone) coated tablets 500 mg. №30

Description

Sinmeton (naʙumetone) coated tablets 500 mg. №30

Composition

active substance: nabumetone;

1 tablet contains: nabumetone 500 mg or 750 mg;

Excipients: microcrystalline cellulose, corn starch, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate (type A), colloidal anhydrous silica, talc, hypromellose, titanium dioxide (E 171), polyethylene glycol.

Dosage form

Coated tablets.

Basic physical and chemical properties:

• Sinmeton 500 mg: reddish-brown tablets, round, biconvex, coated;
• Sinmeton 750 mg: reddish-brown tablets, oval, biconvex, with a line, coated.

Pharmacotherapeutic group

Agents affecting the musculoskeletal system. Non-steroidal anti-inflammatory and anti-rheumatic drugs. Nabumetone.
ATX code M01A X01.

Pharmacological properties

The active substance of the drug Sinmeton – nabumetone – belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Has anti-inflammatory, antipyretic, analgesic effect. The mechanism of action is associated with blockade of cyclooxygenase, which leads to disruption of arachidonic acid metabolism and decreased concentrations of prostaglandins, thromboxanes. Inhibits exudative and proliferative processes in the inflammatory focus, reduces the concentration of bradykinin and histamine, as well as increases the threshold of susceptibility to pain receptors. Hypothermic action is due to a decrease in the concentration of pyrogens in the cerebrospinal fluid and hypothalamic area, increased heat transfer (no effect on heat production).
A characteristic feature of nabumetone is the lack of effect on the gastric mucosa. A lower incidence of peptic ulcer disease, bleeding and perforation was reported compared to other NSAIDs. Has little effect on platelet aggregation caused by collagen and does not affect the bleeding time.

Indication:

• Acute and chronic osteoarthritis.
• Rheumatoid arthritis.
• Soft tissue rheumatism.
• Ankylosing spondylitis.

Contraindication

Hypersensitivity to the active substance or to other components of the drug.
History of hypersensitivity (eg, bronchial asthma, angioneurotic edema, urticaria, rhinitis) associated with the use of acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Active peptic ulcer disease or a history of gastrointestinal bleeding, perforation or peptic ulcer disease (2 or more episodes).
History of gastrointestinal bleeding or perforation associated with nonsteroidal anti-inflammatory drugs.
Severe heart and / or hepatic and / or renal failure.
Cerebrovascular or other active form of bleeding, hemorrhagic diathesis.

Use during pregnancy or breastfeeding

Pregnancy
The safety and efficacy of nabumetone in pregnant women have not been established. Nabumetone, like other nonsteroidal anti-inflammatory drugs, can cause premature closure of the arterial duct in the fetus, the development of heart and lung defects.
The drug is contraindicated for use in the III trimester of pregnancy. The use of the drug in the I and II trimesters of pregnancy is possible when the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period
The excretion of nabumetone in breast milk has not been studied. If you use the drug should stop breastfeeding.

Method of application and dosage

The drug Sinmeton tablets should be used orally by adults during or after meals.

The recommended starting dose is 500 – 750 mg once a day. The recommended daily dose is 1 g – 1 time a day before bedtime. In cases of severe or persistent symptoms, the dose can be increased to 1.5 – 2 g per day by adding one or two tablets (500 mg – 1 g) in the morning dose. The maximum daily dose is 2 g

The drug should be used for the shortest time in the lowest effective dose required to control the symptoms of the underlying disease.

The duration of treatment is determined by the doctor individually depending on the effect achieved, the nature of therapy and tolerability of the drug.

Children

The drug is not recommended for use in pediatric practice, as the safety and effectiveness of nabumetone in children have not been established.

Overdose

Symptoms: headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, disorientation, agitation, coma, drowsiness, dizziness, tinnitus, fainting, convulsions; in case of severe poisoning, acute renal failure and liver damage are possible.
Treatment: during the first hour after an overdose should use activated charcoal, gastric lavage, forced diuresis, further therapy – symptomatic. Liver and kidney function should be closely monitored. The patient should be closely monitored for at least 4 hours after an overdose.

Side effects:

• From the blood and lymphatic system: thrombocytopenia, leukopenia, agranulocytosis, granulocytopenia, neutropenia, aplastic anemia, hemolytic anemia.
• From the immune system: hypersensitivity reactions, including anaphylactic shock, anaphylactoid reactions.
• From the psyche: confusion, nervousness, insomnia, depression, hallucinations.
• From the nervous system: drowsiness, dizziness, headache, paresthesia, agitation, aseptic meningitis.
• From the eyes: visual disturbances, optic neuritis.
• From the organs of hearing and vestibular apparatus: tinnitus, hearing impairment.
• From the cardiovascular system: heart failure, arrhythmias, hypertension, hypotension, edema, vasculitis.
• From the respiratory system, chest and mediastinum: shortness of breath, respiratory disorders, nosebleeds, interstitial pneumonitis, asthma, increased asthma, bronchospasm.
• From the digestive tract: diarrhea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence, ulcers of the mucous membrane of the digestive tract, gastrointestinal bleeding, exacerbation of ulcerative colitis and Crohn’s disease, gastrointestinal disorders, melena, vomiting, heartburn, stomatitis, dry mouth, pancreatitis.
• From the hepatobiliary system: liver failure, jaundice.
• From the urinary system: renal failure, nephrotic syndrome, interstitial nephritis, dysuria.
• From the musculoskeletal system and connective tissue: myopathy.
• Skin and subcutaneous tissue disorders: rash, pruritus, photosensitization, urticaria, increased sweating, bullous reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioneurotic edema, pseudoporrhoea.
• From the reproductive system and mammary glands: metrorrhagia.
• General disorders: edema, asthenia, fatigue, malaise.