Indomethacin Sopharma tablets enteric-soluble 25mg No. 30×1

Name:
Indomethacin Sopharma tab 25mg blister pack No. 30×1
Description:
Indomethacin belongs to the group of non-steroidal anti-inflammatory or antirheumatic drugs (NSAIDs). It has a pronounced anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action is the suppression of the synthesis of prostaglandins, which play an important role in the processes of inflammation, pain and fever. Indomethacin Sopharma tablets are used for short-term symptomatic treatment of: acute and chronic pain in inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis; inflammation of the periarticular tissues (bursitis and / or tendonitis); acute gouty arthritis. Do not take the drug if if you are hypersensitive (allergic) to the active substance or any of the excipients of the medicinal product; if you are hypersensitive (allergic) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and if they have caused an asthmatic attack (difficulty breathing), allergic rhinitis or urticaria if you have a peptic ulcer of the stomach and duodenum and / or evidence of an ulcer or bleeding from the gastrointestinal tract, previously identified; if you have had gastrointestinal bleeding caused by other drugs from the non-steroidal group anti-inflammatory drugs; if you have severe heart failure; if you have perioperative pain during coronary artery bypass surgery (CABG); if you have severe impairment of liver and kidney function; in the last three months of pregnancy or while breastfeeding; if you are younger than 14- Precautions Indomethacin should be taken with extreme caution in the following cases: Indomethacin may be irritating to the gastrointestinal tract at any time during treatment with or without symptoms. An increased risk of gastrointestinal complications exists in patients who have previously been ill peptic ulcer, who had bleeding from the gastrointestinal tract, in patients over 65 years of age, as well as in alcohol abuse and in smokers. An increased risk of such complications also exists in patients who take oral corticosteroids (hormones) simultaneously with indomethacin and anticoagulants Indomethacin should be used with extreme caution in patients with gastrointestinal diseases such as ulcerative colitis and Crohn’s disease. The use of drugs such as Indomethacin Sopharma is associated with a slightly increased risk of myocardial infarction or stroke to the brain). Any of these risk factors are more likely with high doses and long-term treatment. Do not exceed recommended doses and duration of treatment. If you have heart problems or have had a stroke, or think you may be at risk (for example, you have high blood pressure, diabetes, high cholesterol, or smoke), treatment should be discussed. with your doctor or pharmacist. It is necessary to prescribe the drug with caution in all manifestations of hypersensitivity to food and drugs, as well as in patients suffering from chronic allergic rhinitis, chronic sinusitis and / or nasal polyps, bronchial asthma. Indomethacin should be taken with caution in patients with kidney diseases due to possible additional kidney damage. The use of Indomethacin in patients with mental disorders, depression, epilepsy, parkinsonism can lead to a worsening of the underlying disease. treatment with a drug. Treatment with indomethacin, as with other drugs from the NSAID group, can cause changes in hepatic function, which requires periodic monitoring of liver enzymes. Rarely, indomethacin can cause serious skin reactions. At the first skin symptoms of hypersensitivity, treatment with Indomethacin should be discontinued. It should be taken with caution in elderly patients, as well as in patients taking drugs to lower blood pressure, drugs to treat heart rhythm disorders, diuretics (diuretics). Due to its anti-inflammatory effect, the drug may mask the symptoms of active inflammation, which requires excluding the presence of a bacterial infection when prescribing it. In women of reproductive age, there is a possibility of suppressing fertility (possibility of pregnancy) when using the drug. In patients with or without epilepsy or seizures in history, the simultaneous use of quinolones (ciprofloxacin) with indomethacin may increase the risk of seizures. The tablets contain lactose as an excipient. If you have been told by your doctor that you have an intolerance to some sugars, talk to him before taking this medicine. Indomethacin Sopharma tablets contain wheat starch and are suitable for people with celiac disease (celiac disease). Patients with wheat allergy (other than celiac disease) should not take this drug. Other medicinal products -intestinal tract, kidneys and liver. Due to the threat of fatal gastrointestinal hemorrhage, simultaneous use with diflunisal (non-steroidal anti-inflammatory drug) is not recommended. Indomethacin can increase the toxicity of digoxin (used for heart failure), lithium salts (for the treatment of mental illness), drugs that suppress the immune system (methotrexate, cyclosporine) with their simultaneous use. Indomethacin, like other non-steroidal anti-inflammatory drugs, reduces the therapeutic effect of diuretics (diuretics) and drugs to lower blood pressure. Probenecid (for the treatment of gout) may increase the toxicity of Indomethacin. When used simultaneously with anticoagulants and antiplatelet and selective serotonin reuptake inhibitors, the risk of ulcers and hemorrhages increases. Caution should be taken by patients who take drugs from the group of quinolone antibacterial drugs drugs (for example, ciprofloxacin). Indomethacin does not affect the action of antidiabetic drugs. Simultaneous administration with pentoxifylline (a drug that improves microcirculation) increases the risk of bleeding. Simultaneous use with bisphosphonates (a class of drugs that prevent bone loss used to treat osteoporosis and other similar diseases) increases the bioavailability of indomethacin. Simultaneous administration with zidovudine (an antiviral drug active against HIV – human immunodeficiency virus) increases reduces the myelotoxicity of indomethacin. Pregnancy and breast-feeding Talk to your doctor or pharmacist before using any medicine. The use of Indomethacin Sopharma tablets during pregnancy (especially in the last 3 months) and during breastfeeding is contraindicated. Driving and operating machines Due to the possible occurrence of tinnitus, dizziness, drowsiness, hearing and visual disturbances, drivers of vehicles and machine operators should take Indomethacin Sopharma tablets with caution. Directions for use Take Indomethacin Sopharma Tablets as directed by your healthcare professional. If you are in any doubt, ask your doctor or pharmacist for advice. The dose and duration of treatment are determined by your doctor. In order to reduce the frequency of side effects, it is recommended to use the minimum effective dose for the shortest period of treatment. The duration of taking indomethacin for the relief of an acute attack of gout is 3-5 days; in the treatment of diseases of the periarticular tissues is no more than 7-14 days. The duration of taking indomethacin for the treatment of pain in rheumatoid arthritis, ankylosing spondylitis and osteoarthritis is determined by the doctor. Adults and children over 14 years of age: the initial dose is 25-50 mg (1-2 tablets) 2-4 times a day. If necessary, the dose is increased to 150 mg per day, divided into 3 doses. The maximum daily dose is 200 mg. Gout For the relief of an acute gouty attack, an initial dose of 100 mg is prescribed, after which 50 mg are taken 3 times a day until the pain decreases. Elderly patients (over 65 years old) For elderly patients, there is an increased risk of side effects. The lowest effective dose is recommended for the shortest possible treatment period. Patients should be monitored for possible bleeding from the gastrointestinal tract. Children under 14 years of age Should not be taken by children under 14 years of age. When taking a higher dose than prescribed, the following symptoms may occur: abdominal pain, nausea, vomiting, severe headache, dizziness, memory impairment and disorientation. In more severe cases, paresthesias and convulsions are observed. Treatment: induce vomiting, gastric lavage, symptomatic. If you miss a dose of Indomethacin Sopharma If you miss one dose, take it as soon as possible. If it is already time for your next dose, take it as usual, skipping the forgotten dose. Do not take a double dose to make up for a missed one. Continue taking the medicine as directed by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects Like all medicines, Indomethacin Sopharma Tablets can cause side effects, although not everyone gets them. The most frequent side effects are manifested from the gastrointestinal tract. Ulcer, perforation, hemorrhage are observed mainly in elderly patients. The frequency of occurrence of side effects is defined as follows: very often (more than 1 in 10 patients), often (from 1 to 10 per 100 patients), infrequently (from 1 to 10 per 1,000 patients), rarely (from 1 to 10 per 10,000 patients). patients), very rare (less than 1 in 10,000 patients, including individual reports), the frequency is unknown (it is impossible to determine the frequency of occurrence based on the available data). Blood and lymphatic system disorders Uncommon: leukopenia (decreased number of white blood cells, which increases the chance of infection), thrombocytopenia (decreased number of platelets, which increases the risk of bleeding or bruising), agranulocytosis (decreased number of white blood cells, which increases the chance of infection). infections), hemolytic anemia, aplastic anemia (decrease in the number of red blood cells, weakness). Immune system disorders Very rare: bronchospasm (difficulty breathing), asthma attacks, allergic (anaphylactic or anaphylactoid) reactions in allergic patients. Metabolic and nutritional disorders Uncommon: fluid retention, hyperglycemia (increased blood sugar), glucosuria (sugar in the urine), hyperkalemia (increased blood potassium). Nervous system disorders Common: dizziness, headache, drowsiness, depression, fatigue. Uncommon: Anxiety, impaired concentration, sensory disturbances, including paresthesias (numbness, goosebumps), disorientation, insomnia, irritability, peripheral neuropathy (peripheral nerve dysfunction), memory disorders, psychotic reactions. On the part of the organ of vision Infrequently: double or blurred vision. Hearing and labyrinth disorders Very rare: hearing impairment, tinnitus. Cardiac disorders Uncommon: tachycardia (rapid heart rate), angina pectoris (chest pain), palpitations (palpitations), arrhythmias (abnormal heart rhythm), edema. Very rare: worsening of heart failure associated with the use of NSAIDs. Medicines such as Indomethacin Sopharma are associated with a slightly increased risk of heart attack or stroke (bleeding in the brain). Vascular disorders Uncommon: increase or decrease in blood pressure. Gastrointestinal disorders Common: Nausea, vomiting, diarrhea, dyspepsia, constipation, abdominal pain. Uncommon: flatulence (bloating), melena (blood in the stool), hematemesis (vomiting blood), ulcerative stomatitis, exacerbation of ulcerative colitis (colon disease), Crohn’s disease, exacerbation of an existing ulcer. Liver and biliary tract disorders Rare: toxic hepatitis with or without jaundice (inflammation of the liver with or without jaundice). Very rare: fulminant hepatitis (rapid inflammation of the liver). Skin and subcutaneous tissue disorders Uncommon: rash, itching, urticaria, petechiae (pinpoint hemorrhages), ecchymosis (larger bruising). Very rare: more severe skin reactions (exfoliative dermatitis, purpura, erythema nodosum, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). Renal and urinary disorders Uncommon: Protein or blood in the urine, nephrotic syndrome, interstitial nephritis (inflammation of the kidneys), acute renal failure, renal disorders (papillary necrosis). Influence on the results of laboratory and instrumental studies Increased levels of liver enzymes, turning into an increase in bilirubin. If any of the side effects gets serious or you notice other side effects not listed in this leaflet, tell your doctor or pharmacist. Reporting adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children! Medicines should not be disposed of in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you do not need. These measures will contribute to the protection of the environment. Shelf life 5 (five) years. Do not use Indomethacin Sopharma tablets after the expiry date which is stated on the package. The expiration date corresponds to the last day of the specified month. Composition 1 (one) tablet contains: Tablet core: Active substance: indomethacin – 25.0 mg. Excipients: lactose monohydrate, wheat starch, microcrystalline cellulose (type 101), povidone K25, anhydrous colloidal silicon dioxide, magnesium stearate, talc. Enteric coating: 30% methacrylic acid:ethyl acrylate copolymer dispersion (1:1); 30% dispersion of methyl acrylate: methyl methacrylate: methacrylic acid copolymer; sodium hydroxide; polysorbate 80; pigment suspension – brown (talc, triethyl citrate, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), propane-1,2 diol-alginate, potassium sorbate); triethyl citrate. What the medicine looks like and contents of the pack Round, biconvex, orange-brown, enteric-coated tablets. 30 enteric-coated tablets in a hard colorless, transparent PVC/aluminum foil blister pack. 1 blister in a carton box along with a leaflet for the consumer. Conditions for dispensing from the pharmacy network By prescription