Indomethacin Sopharma suppositories 50 mg strip No. 6

Indomethacin suppositories (candles) are indicated for the effectiveness of short-term symptomatic treatment with indomethacin in the following conditions:

acute and chronic pain in inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis; acute and in the acute stage of chronic ankylosing spondylitis (Bechterew's disease); gout attack and gouty arthritis; osteoarthritis from moderate to severe form; diseases of the periarticular tissues: tendonitis, bursitis (acute painful shoulder), tendobursitis, tendovaginitis, pain syndrome and inflammation after injuries (including in athletes) and surgical interventions; discopathy, sprains, radiculoneuritis; dysmenorrhea.

Composition

Active ingredient: indomethacin;

1 Suppository contains indomethacin 50 mg;

Excipients: hard fat (type I), hard fat (type II).

Contraindication

Hypersensitivity to the active substance or to any of the excipients of the drug. Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs with clinical manifestations of asthmatic attacks, urticaria or rhinitis, angioedema. History of gastrointestinal bleeding or perforation caused by the use of drugs of the non-steroidal anti-inflammatory drug group in the past. Active or recurrent peptic ulcer or bleeding (two or more cases of proven ulcers or bleeding), ulcerative colitis and / or enterocolitis. Simultaneous use of other non-steroidal anti-inflammatory drugs, including specific cyclooxygenase-2 inhibitors, due to an increased risk of undesirable effects. Severe heart failure. Severe hepatic and renal failure. Hemorrhoids, anal fistulas and fissures, proctitis and other diseases of the rectum and anus. Bleeding from hemorrhoids. Pre- and postoperative pain during coronary artery bypass graft surgery.

Method of application

Indomethacin Sopharma, suppositories, are used rectally.

The incidence of side effects can be reduced by using the lowest effective dose for the shortest time to control symptoms.

Adults: The usual dose is 50 mg (1 suppository) twice daily or 100 mg (2 suppositories) once daily. The maximum daily dose is 200 mg.

When using a daily dose exceeding 150-200 mg, the risk of side effects increases.

Application features

Pregnant women

Contraindicated.

Children

Safety in children has not been established. The drug should not be used to treat children under 14 years of age.

Drivers

Indomethacin Sopharma may cause side effects (tinnitus, dizziness, drowsiness, hearing and visual disturbances) that may impair active attention and reflexes, affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms: nausea, vomiting, severe headache, dizziness, memory impairment and disorientation. In more severe cases, paresthesias and seizures are observed.

Treatment: symptomatic and supportive. It is impossible to remove indomethacin from the body by hemodialysis.

Side effects

The most common adverse reactions are gastrointestinal disorders. Ulceration, perforation or gastrointestinal bleeding (sometimes fatal) may occur, mainly in elderly patients.

Interaction

Zidovudine: Concomitant administration with zidovudine increases the myelotoxicity of indomethacin and the risk of hematological toxicity. The risk of indomethacin toxicity is increased when used with ritonavir. Caution should be exercised when used simultaneously with antiepileptic drugs due to increased action of phenytoin. Concomitant administration with haloperidol increases drowsiness. Concomitant administration with benzodiazepines increases the risk of dizziness. Concomitant administration with desmopressin increases the effect of the latter. Nonsteroidal anti-inflammatory drugs should be avoided for 8-12 days after mifepristone administration.

Storage conditions

Keep out of reach of children.

Store in the original packaging at a temperature not exceeding 25 °C.

Shelf life - 2 years.