Indometacin of the tab. of p/o of 25 mg No. 30

tablets Indometacin are shown for efficiency of short-term symptomatic treatment by indometacin is established concerning the following states:

• acute and chronic pain at inflammatory and degenerative diseases of the musculoskeletal system: pseudorheumatism; sharp and in an aggravation stage a chronic ankylosing spondylarthritis (Bekhterev's disease); attack of gout and gouty arthritis; an osteoarthritis from moderated to a severe form;
• a disease of circumarticular fabrics: tendinites, a bursitis (sharp painful shoulder), tendobursita, a tendovaginitis, a pain syndrome and inflammations after injuries (including at athletes) and surgeries;
• diskopathy, plexitis, radiculoneuritis;
• dysmenorrhea.

Structure

Active ingredient: indometacin;

1 tablet, coated, kishechnorastvorimy contains indometacin 25 mg;

Excipients: lactoses monohydrate, starch wheat, K 25 povidone, cellulose microcrystalline, magnesium stearate, talc, silicon dioxide colloidal waterless;

Cover kishechnorastvorimy: copolymer methacrylic acid: % ethyl acrylate (1:1) 30 dispersion (Eudragit of L 30 D-55), copolymer methyl acrylate: methylmethacrylate: methacrylic acid of 30% dispersion (Eudragit of FS 30 D), sodium hydroxide, triethyl citrate, polysorbate 80, suspension of pigments – brown W.A.S. FS (talc, triethyl citrate, titan dioxide (E 171), ferrous oxide yellow (E 172), ferrous oxide red (E 172), propane-1.2 diolalginat, potassium sorbate).

Contraindication

• hypersensitivity to medicine components;
• hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory medicaments with clinical manifestation of an asthmatic attack, a Quincke's disease, urticaria or rhinitis;
• an active round ulcer of a stomach and duodenum or a recurrence (two or more cases of the proved ulcers or bleedings), ulcer colitis and/or a coloenteritis;
• gastrointestinal bleedings or perforation in the anamnesis connected with application of NPVS in the anamnesis;
• simultaneous use of other non-steroidal anti-inflammatory drugs, including specific inhibitors of cyclooxygenase-2, in connection with the increased risk of emergence of undesirable effects;
• heavy heart failure;
• heavy liver and renal failure;
• before - and post-operational pain at operation of aortocoronary roundabout shunting.

Route of administration

to use Drug orally, after meal. It is necessary to swallow of a tablet entirely, washing down with enough liquid.

Adults and children are more senior than 14 years. An initial dose – 25-50 mg (1-2 tablets) 2-4 times a day.

At insufficient therapeutic effect to 150 mg (6 tablets) a day, dividing into 3 receptions. The maximum daily dose makes 200 mg (8 tablets). At long treatment the daily dose should not exceed 75 mg (3 tablets).

Feature of application

Pregnant

It is contraindicated.

Children

use of indometacin Is contraindicated to children aged up to 14 years.

Drivers

Indometatsin of Sofarm can cause side reactions (sonitus, dizziness, drowsiness, acoustical and visual violations) which can break active attention and reflexes and to affect ability to steer vehicles and to work with other mechanisms.

Overdose

Symptoms: nausea, vomiting, abdominal pain, severe headache, dizziness, memory violation, confusion of consciousness, disorientation or lethargy. There are messages about paresthesias, constraint and spasms.

Treatment: symptomatic and supporting.

Should wash out as soon as possible a stomach if the medicament was taken recently. If there is no spontaneous vomiting, it is necessary to cause vomiting, using the patient ipecacuanha drugs. After gastric emptying it is possible to apply 25 g or 50 g of activated carbon. Depending on a condition of the patient the continuous medical observation and nursing care can be necessary. The patient has to be several days under observation as it is reported about a gastrointestinal ulceration and bleeding as about side effects of indometacin. Use of antacids can be useful. It is impossible to bring indometacin out of an organism by means of a hemodialysis.

Side effects

Most frequent side reactions are gastrointestinal violations. Appearance of a round ulcer, perforation or bleeding from digestive tract (sometimes with a lethal outcome), mainly at patients of advanced age is possible.

Interaction

• Simultaneous application of a zaltsitabin and indometacin causes changes in their pharmacodynamics.
• Simultaneous application of a zidovudine and indometacin increases risk of hematologic toxicity.
• Risk of manifestation of toxicity of indometacin increases at application with ritonaviry.
• With care should be applied at the same time with antiepileptic medicines in connection with strengthening of effect of Phenytoinum.
• Simultaneous application with a haloperidol increases drowsiness.
• At a concomitant use with benzodiazepines the risk of developing of dizziness increases.
• Indometatsin increases bioavailability of diphosphonates at simultaneous application with tiludronovy acid.
• At a concomitant use with desmopressin the action of the last amplifies.
• Should avoid intake of non-steroidal anti-inflammatory medicaments within 8-12 days after use of mifepristone.
• Indometatsin is capable to reduce the clearance rate of Baclofenum and, thus, to increase the level of its toxic action.

to Store

out of children's reach.

to Store

in original packing at a temperature not above 25 °C.

Expiration date - 5 years.