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Instruction for use: Artrotec

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Active substance Diclofenac + Misoprostol

ATX Code M01AB55 Diclofenac in combination with other drugs

Pharmacological group

NSAIDs - Acetic acid derivatives and related compounds

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

M15-M19 Osteoarthritis

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

R52.2 Other constant pain

Pain syndrome, rheumatic origin, Pain at vertebral lesions, Pain in the chamber, Pain for burns, Pain syndrome weak or moderate, Perioperative pain,Moderate to severe pain, Moderately or weakly expressed pain syndrome, Moderate to severe pain, Ear pain of otitis, Neuropathic pain, neuropathic pain

Composition and form of release

1 coated tablet contains diclofenac sodium 50 mg or 75 mg and misoprostol 200 μg; in the blister 10 pcs., in the box 2 blisters.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Diclofenac inhibits cyclooxygenase and reduces the formation of PG (prostaglandins). Misoprostol (synthetic analogue PGE1) prevents the negative effect of diclofenac on the mucosa and the development of NSAIDs (nonsteroidal anti-inflammatory drugs) -gastropathy.

Pharmacokinetics

Misoprostol is rapidly absorbed and metabolized to the active metabolite - misoprostol acid, the latter has a decay period of about 30 min. 70% of the administered dose of misoprostol is excreted in the urine as inactive metabolites. Diclofenac sodium is also rapidly and almost completely absorbed, reversibly binds to plasma proteins; from 40 to 60% is excreted in the urine, the rest - with bile and feces.

Indications

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, pain syndrome of various etiologies, rheumatic diseases.

Contraindications

Hypersensitivity, bleeding (including gastrointestinal).

pregnancy and lactation

Contraindicated.

Side effects

Digestive disorders (gastrointestinal tract) (abdominal pain, nausea, dyspepsia, flatulence, diarrhea); decreased platelet aggregation, prolonged bleeding time, fluid retention and edema (especially in predisposed patients), menorrhagia and metrorrhagia in pre- and post-menopausal women, headache, dizziness, skin rash.

Dosing and Administration

Inside, not liquid, during meals, 1 table. 2-3 times a day.

Precautionary measures

Caution is prescribed for patients with congestive heart failure, impaired renal function, predisposition to fluid retention in the body.

storage conditions

In a dry place, at a temperature of no higher than 25 ° 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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