Index of drugs

Symptomatic treatment of pain and inflammation in: acute arthritis (including gout); chronic arthritis, especially in rheumatoid arthritis (chronic polyarthritis); ankylosing spondylitis (Bechtereva disease) and other rheumatic inflammations of the spine; in degenerative disease of the spine and osteoarthritis of the joints; inflammatory rheumatic diseases of soft tissues; painful swelling and post-traumatic inflammation.

1 suppository contains 50 mg of Diclofenac sodium.

A non-steroidal anti-inflammatory drug that inhibits prostaglandin synthesis. Diclofenac reduces pain associated with inflammation, edema and fever, and inhibits platelet aggregation induced by ADP and collagen. The maximum concentration of the drug in plasma occurs after about 30 minutes after application. Diclofenac is 99% bound to plasma proteins. Metabolized in the liver.

Hypersensitivity to the active substance or to any of the excipients. In the history of bronchospasm, asthma, runny nose or urticaria after Acetylsalicylic acid or other NSAIDs. Disorders of blood formation of unknown origin. Active or recurrent peptic ulcer of the stomach and / or duodenum as well as bleeding (two or more separate episodes of confirmed ulceration or bleeding). Gastrointestinal bleeding or perforation associated with prior NSAID treatment. Bleeding from cerebral vessels or other active bleeding. Severe hepatic or renal failure. Severe heart failure. Third trimester of pregnancy. Congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral vascular disease and / or cerebrovascular disease.

The concomitant use of the preparation with other NSAIDs, including selective COX-2 inhibitors, should be avoided. Taking the medicine in the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. The incidence of adverse reactions during NSAID treatment, especially gastrointestinal bleeding and perforation, which may lead to death is higher in elderly patients. When using NSAIDs, there is a risk of gastrointestinal bleeding, gastric ulcer and / or duodenal ulceration and perforation, which increases with increasing NSAID dosages, is higher in patients with history of peptic ulcer and / or duodenal ulceration, in particular if it was complicated by bleeding or perforation and in the elderly. In such patients, treatment should be started with the lowest effective doses. In such patients and in patients requiring simultaneous administration of low-dose acetylsalicylic acid or other medications that may increase the risk of gastrointestinal events, co-administration with a gastric mucosal protective drug (eg, misoprostol or proton pump inhibitors) should be considered. Caution should be exercised in patients receiving concomitant medications that may increase the risk of stomach ulcers and / or duodenum or bleeding. In case of bleeding from the gastrointestinal tract or stomach ulcer and / or duodenal ulcer, the drug should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as they may have exacerbated disease. Patients with a history of hypertension or congestive heart failure (NYHA class I) should be appropriately monitored and given appropriate instructions, as fluid retention and edema have been reported in association with NSAID treatment. Clinical trials and epidemiological data suggest that taking Diclofenac, particularly at high doses (150 mg / day) over a long period of time, may be associated with a small increase in the risk of arterial blockages (eg myocardial infarction or stroke). Diclofenac should be used very carefully in patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes, smoking).In the event of the first signs of skin rash, changes in the mucosa or other symptoms of hypersensitivity, the drug should be discontinued. Before deciding to start using diclofenac in patients with impaired liver function, caution should be exercised as they may exacerbate the disease. If the preparation is to be used for a long time or repeatedly, regular monitoring of liver function parameters is recommended. The preparation should be discontinued immediately if signs of liver dysfunction occur. The drug can only be used after careful consideration of the benefit / risk ratio: in congenital disorders of porphyrin metabolism (eg acute intermittent porphyria); in systemic lupus erythematosus (SLE) and in mixed connective tissue disease. It can only be used under close medical supervision: in stomach and intestinal disorders or in case of inflammatory bowel disease (ulcerative colitis, Crohn's disease) in a history; in the case of increased blood pressure or mild to moderate heart failure; in kidney problems; in liver dysfunction; immediately after major surgery; in patients with hay fever, nasal polyps or chronic obstructive pulmonary diseases, because there is an increased risk of allergic reactions in such patients; in patients who have allergic reactions to other substances. Diclofenac may temporarily inhibit platelet aggregation - patients with coagulation disorders should be carefully monitored. Diclofenac may mask the signs and symptoms of infection. If the symptoms of infection occur or become worse during use, the patient should immediately contact a physician. Check if there is an indication for anti-infective therapy. During long-term administration of the drug, regular monitoring of liver function, renal function and blood counts is required. If analgesics are used at high doses for a long time, you may experience a headache that can not be treated by increasing the dose of these medicines. The habitual use of analgesics, especially combinations of several active substances with analgesic effect, may cause irreversible kidney damage associated with the risk of renal failure (nephropathy caused by analgesics). The product is not recommended for use in children and adolescents.

In the I and II trimester, administer only if there is a definite necessity. If diclofenac is used in women planning pregnancy or during the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. The inhibitory effect of prostaglandin synthesis may have a negative effect on pregnancy and / or the development of the embryo or fetus. Data from pharmacoepidemiological studies suggest an increased risk of abortion and heart failure after the use of a prostaglandin synthesis inhibitor in early pregnancy. It is considered that the risk increases with increasing the dose and duration of treatment. In the third trimester of pregnancy, the drug is contraindicated. During the third trimester of pregnancy, diclofenac may cause fetus: toxic effects on the cardiovascular system and lungs (with premature closure of the ductus arteriosus and pulmonary hypertension), renal dysfunction, which may lead to renal failure with oligohydramnios. In women and the fetus, at the end of pregnancy, the drug may prolong bleeding time (antiaggregation may occur after using small doses) and inhibit uterine contractions (delaying or prolonging delivery). The drug and metabolites are excreted in small amounts in breast milk, however, due to the absence of harmful effects for the child, it is not necessary to stop breastfeeding during short-term treatment with diclofenac. During long-term administration of high doses of diclofenac, consideration should be given to early termination of breastfeeding. The use of the preparation may adversely affect female fertility and is not recommended in women planning pregnancy. For women who have difficulty conceiving or are tested for infertility, the end of treatment should be considered.

Very common: gastrointestinal complaints (such as nausea, vomiting, diarrhea, low blood loss from the gastrointestinal tract, which in exceptional cases may cause anemia). Common: o.u.n.(such as: headache and headache, agitation, irritability, fatigue), indigestion, bloating, stomach cramps, abdominal pains as well as gastric or duodenal ulcers (with the risk of bleeding or perforation), local irritation, mucus and blood shedding or painful defecation after administration of suppositories, hypersensitivity reactions (eg rash and pruritus), increase in serum transaminases. Uncommon: bloody vomiting, tarry stools, bloody diarrhea, edema - especially in patients with hypertension or renal failure, alopecia, urticaria, liver damage - especially during long-term treatment, acute hepatitis with or without jaundice (very rarely showing a fulminant course, even without prodromal symptoms). Very rare: palpitations, edema, heart failure, myocardial infarction (anemia, leukopenia, thrombocytopenia, plastic anemia, agranulocytosis), haemolytic anemia - the first symptoms of these blood and lymphatic disorders may be fever, sore throat, erosions in the cavity oral flu, extreme fatigue, nosebleeds and bleeding from the skin; sensory disorders, dysgeusia, impaired memory, confusion, seizures (blurred and double vision), tinnitus, temporary hearing loss, stomatitis, tongue inflammation, esophageal injury, exacerbation of colitis or Crohn's disease, constipation, inflammation pancreas, kidney damage (interstitial nephritis, papillary necrosis), acute renal failure, proteinuria, hematuria, nephrotic syndrome, bullous rash, eczema, erythema hypersensitivity to light, purpura (including allergic purpura), severe forms of skin reactions including Stevens syndrome -Johnson and toxic necrotic decay of the epidermis, exacerbation of inflammation caused by infection (eg development of necrotizing fasciitis), signs of sterile inflammation of the tires (ie stiffness of the neck, headache, nausea, vomiting, fever, unconsciousness) - it seems that patients with autoimmune diseases (S. LE, mixed connective tissue diseases) are predisposed; hypertension, general hypersensitivity reactions (swelling of the face, swollen tongue and larynx, with narrowing of the airways, shortness of breath, fast heart beat, sudden reduction of blood pressure up to life-threatening shock), allergic vasculitis and pneumonia, psychotic reactions, depression, anxiety, nightmares.

Rectally. Adults: the recommended daily dose is 50-150 mg (1-3 suppositories) per day. The total daily dose should be divided into 1 to 3 doses. In rheumatic disorders, long-term use of the drug may be necessary. No dosage adjustment is required in the elderly or in patients with mild to moderate renal and hepatic impairment. Elderly patients should be carefully monitored. The drug should be used at the lowest effective dose and no longer than necessary to control the symptoms. Suppositories should be inserted deep into the anus; preferably after defecation.