Diclopol tablets retard p/o 100mg №10×2

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Diclopol tab retard p/o 100 mg in bl. in pack. №10×2
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Diclopol retard is an orange, round, biconvex tablet with a slightly rough surface. The main active ingredient Diclofenac Release form Tablets Dosage 100 mg Special instructions Diclopol retard tablets contain dye – orange yellow lacquer (E 110), which can cause allergic reactions. Indications for use The drug Diclopol retard contains diclofenac, a substance from the group of non-steroidal anti-inflammatory drugs that has anti-inflammatory, analgesic and antipyretic effects. It is used in the treatment of the following acute and chronic diseases: rheumatoid arthritis; ankylosing spondylitis; osteoarthritis; pain syndromes from the soft tissues (myositis, ligamentitis, fasciitis, bursitis, tendovaginitis). . In case of any doubt, the doctor should be contacted again. The drug should be taken orally, preferably during or immediately after a meal, with plenty of water. Tablets should not be chewed. The following dosing regimen is generally recommended: Adults 100 mg (1 tablet) per day. Taking the minimum effective dose for the shortest period of time reduces the risk of side effects. The drug is not recommended for use in children and young people under 18 years of age. Use during pregnancy and lactation Before using any drug, you should consult your doctor. During the first 6 months of pregnancy, the use of the drug is not recommended, it can be used only in cases where, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus. During the last three months of pregnancy, taking the drug is contraindicated, as this may increase the risk of complications in the mother and the child in the perinatal period. The drug can be excreted in small amounts in breast milk, so it is not recommended to use it during breastfeeding. The ability to influence the reaction rate when driving vehicles or working with other mechanisms Patients who develop dizziness, drowsiness, fatigue or visual disturbances should stop driving vehicles or operating machinery. Precautions When to take special care when taking the drug if the patient has or had in the past gastrointestinal disorders or diseases of the digestive system (for example, ulcerative colitis, Crohn’s disease), given the possibility of exacerbation of symptoms of the disease, including the development of bleeding; if the patient has or had a history of ulceration of the gastrointestinal tract, due to an increased risk of bleeding or perforation; if the patient has impaired function of the heart, kidneys or liver; in patients with excessive loss of extracellular fluid (for example, after prolonged surgical interventions); in patients with hepatic porphyria, as the drug can provoke an increase in the severity of the symptoms of the disease; if the patient has blood coagulation disorders or abnormal blood test results; if the patient has or had in the past bronchial asthma, given the possibility of developing bronchospasm; if the patient has systemic lupus erythematosus or connective tissue disease, given the possibility of an increased risk of aseptic meningitis. There is a risk of gastrointestinal bleeding (often manifested by hematemesis and tarry stools), ulcers and / or perforation, which can be fatal and which are not always accompanied precursor symptoms or may develop in patients who have experienced such symptoms. In the event of gastrointestinal bleeding or ulcers, the drug should be discontinued immediately. Patients with a history of gastrointestinal disease, especially the elderly, should report to the doctor all atypical symptoms related to the gastrointestinal tract (especially bleeding), especially at the initial stage of treatment. Patients with asthma, allergic rhinitis, swelling of the nasal mucosa (eg due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections are more likely to develop allergic reactions to diclofenac (exacerbation of asthma symptoms, angioedema or urticaria). The caution also applies to patients with hypersensitivity to other substances (eg who develop skin reactions, itching or urticaria). In these patients, the drug should be used with extreme caution (preferably under medical supervision). The use of medicines such as diclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the drug. Do not use large doses and for a longer period than recommended. Inform your doctor before taking diclofenac if: if you smoke; if you have diabetes; if you have angina pectoris, thrombosis, hypertension, high cholesterol or triglycerides in the blood. About the development of severe skin reactions (some of them fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis associated with the use of non-steroidal anti-inflammatory drugs have been reported rarely. The greatest risk of these severe reactions occurs at the beginning of treatment, in most cases in the first month of drug use. You should contact your doctor and stop using the drug after the first symptoms of skin rash, mucosal damage or other symptoms of hypersensitivity appear (see section “Possible adverse effects”). If the patient develops liver function changes or any symptoms suggestive of liver disease, the doctor may stop the drug. If long-term use of the drug is necessary (especially in patients over 65 years of age), the doctor recommends a functional study of the kidneys and liver, as well as a blood test. The drug may mask the symptoms of an existing infectious disease. The simultaneous use of the medicinal product and systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of evidence of benefit from their combined use and the potential increase in side effects. The drug may temporarily inhibit platelet aggregation. The drug may make it difficult to conceive. If the patient is planning a pregnancy or has difficulty conceiving, she should inform the doctor. Undesirable effects can be minimized by taking the lowest possible effective doses for the shortest period of time necessary. A doctor should be consulted even if the above warnings apply to situations that have occurred in the past. Use of the medicinal product in children The medicinal product is not recommended for use in children. Use in elderly patients Elderly people may be more sensitive to the action of the drug. It is necessary to follow the recommendations contained in the package leaflet, in accordance with the recommendations of the doctor, use the minimum effective dose and inform the doctor about all side effects that occur during therapy. The use of the drug in patients with impaired liver and (or) kidney function In patients with impaired liver and (or) kidney function, there is a risk of increasing the undesirable effects of the drug, therefore, dosage adjustment may be required, depending on the degree of liver and (or) kidney failure . The drug is contraindicated in case of severe liver and (or) kidney failure. Interactions with other drugs The information contained in this package leaflet may also refer to drugs that have been used in the past or will be used in the future. You should tell your doctor about all recent medications, including those available without a prescription, and especially the use of: lithium (an antidepressant) anticoagulants (for example, acenocoumarol) hypoglycemic drugs methotrexate (antineoplastic drug) antibacterial quinolones other non-steroidal anti-inflammatory drugs, including selective inhibitors of cyclooxygenase-2. Given the increased risk of adverse effects, the simultaneous use of these drugs should be avoided. Corticosteroids (eg, prednisolone or dexamethasone) eg digoxin (a drug used primarily for heart failure) mifepristone (a drug used primarily to treat uterine fibroids) antihypertensive drugs, eg beta-adrenolytics (eg propranolol, bisoprolol), angiotensin converting enzyme inhibitors (eg enalapril , captopril), angiotensin II antagonists (eg, irbesartan) cyclosporine, and tacrolimus (drugs used primarily in the treatment of transplant patients) CYP2C9 inhibitors such as voriconazolphenytoin colestipol and chole styramine. It is recommended to take diclofenac at least one hour before or 4-6 hours after the use of colestipol / cholestyramine. ) and, in particular, to acetylsalicylic acid; attacks of asthma, urticaria or acute rhinitis provoked by taking acetylsalicylic acid or other NSAIDs; previous liver disease; acute or recurrent ulcer / bleeding (two or more episodes of a verified ulcer or bleeding in history); – intestinal bleeding or perforation associated with previous use of NSAIDs; inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis); liver failure; renal failure; established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease or cerebrovascular disease; treatment of postoperative pain after coronary artery bypass surgery (or using a heart-lung machine); during intensive diuretic therapy; in case of impaired hematopoiesis; in the last trimester of pregnancy, during breastfeeding. is diclofenac sodium. 1 tablet contains 100 mg diclofenac sodium. Other components of the drug are: Evdragit RS 30D, Evdragit L 100-55, Evdragit RS RO, cellulose, powder, colloidal anhydrous silicon dioxide, talc, povidone K-25, magnesium stearate (constituting the tablet core) and hypromellose, macrogol 6000, talc , titanium dioxide, orange yellow varnish (E 110), propylene glycol (coated tablets). Overdose If you take a larger than recommended dose of the drug, you should immediately consult a doctor. Symptoms that appear after acute overdose are mainly limited to headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely – diarrhea, disorientation, agitation, coma, drowsiness, tinnitus, fatigue, sometimes convulsions. In rare cases of severe intoxication, acute renal failure and impaired liver function may develop. If you accidentally take more than the recommended number of tablets, you should immediately contact your doctor, pharmacist or go to the hospital. Missing a dose of the drug Diclopol retard If you miss a dose of the drug, you should take the next dose at a certain time. Do not take a double dose to make up for a missed dose. Side effects Like all medicines, Diclopol retard can cause side effects, although not everybody gets them. Undesirable effects are grouped by frequency of occurrence as follows: Very common: More than 1 in 10 treated patients Common: Less than 1 in 10, but more than 1 in 100 treated patients Not very common: Less than 1 in 100, but more than 1 in 1,000 treated patients Rare: less than 1 in 1,000 but more than 1 in 10,000 treated patients Very rare: less than 1 in 10,000 treated patients, unknown (cannot be determined from available data) of the gastrointestinal tract: Often: epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia Rare: gastritis, gastrointestinal bleeding (blood vomiting, tarry stools, bloody diarrhea), stomach ulcer or intestines accompanied or not accompanied by bleeding or perforation (sometimes with a severe course, especially in elderly patients). If such symptoms develop, the drug should be discontinued and a doctor should be contacted. Very rare: aphthous stomatitis, glossitis, changes in the mucosa of the esophagus, disorders of the distal colon (for example, non-specific hemorrhagic colitis and exacerbation of non-specific ulcerative colitis or Crohn’s disease, damage to the colon, intestinal stenosis) pancreatitis, constipation. Nervous system disorders Common: headaches and dizziness Rare: drowsiness, excessive fatigue Very rare: sensory disturbances, paresthesias (tingling, burning, crawling), memory disturbances, convulsions, phobias, hallucinations, anxiety, tremors, psychotic reactions, aseptic meningitis (especially in patients with autoimmune diseases, for example, with systemic lupus erythematosus and connective tissue diseases), with symptoms such as: fever, stiff neck, headache, nausea and vomiting. If such symptoms develop, the drug should be discontinued and a doctor should be contacted. Psychiatric disorders Very rare: confusion, depression, insomnia, nightmares, irritability, psychotic reactions. Eye disorders Very rare: visual disturbances (blurred vision, optic neuritis, diplopia). Hearing and balance disorders Common: dizziness Very rare: hearing impairment, tinnitus. Skin and subcutaneous tissue disorders Not very common: skin rash Rare: urticaria Very rare: bullous skin rash, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (acute toxic epidermal necrolysis), erythroderma (exfoliative dermatitis), prolapse hair, photosensitivity reactions, purpura, including Henoch-Schonlein disease, itching. Renal and urinary disorders Rare: Fluid retention, edema, and hypertension Very rare: Acute renal failure, urinary changes (eg, hematuria, proteinuria), tubulointerstitial nephritis, nephrotic syndrome; papillary necrosis. From the hepatobiliary system Often: elevated serum transaminases Rare: hepatitis, jaundice, liver dysfunction Very rarely: fulminant hepatitis, hepatonecrosis, liver failure. Blood and lymphatic system disorders Very rare: anemia (including hemolytic anemia and aplastic anemia), thrombocytopenia (decreased number of platelets), leukopenia (decreased number of white blood cells) and agranulocytosis (absence of granulocytes in the blood). The first symptoms of agranulocytosis are fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, bleeding (eg, hematomas, petechiae, purpura, epistaxis). If such symptoms develop, the drug should be discontinued and a doctor should be contacted. Since the cardiovascular system Infrequently: myocardial infarction, heart failure, palpitations, chest pain. Very rare: arterial hypertension, vasculitis. From clinical trials and epidemiological data, it appears that the use of certain non-steroidal anti-inflammatory drugs (especially long-term and in high doses) is associated with a slight increase in the risk of arterial embolism (eg, myocardial infarction or stroke). Edema has also been reported during treatment with non-steroidal anti-inflammatory drugs. Respiratory, thoracic and mediastinal disorders Rare: Asthma (including dyspnoea) Very rare: Pneumonia General disorders and injection site conditions Rare: Edema Very rare: Impotence, taste disturbances Immune system disorders: Rare: Hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including hypotension and shock) Very rare: vasomotor edema (including swelling of the face). From the results of clinical studies and epidemiological data, it follows that the use of some NSAIDs (especially long-term and in high doses) is associated with a slight increase in the risk of developing arterial embolism (for example: myocardial infarction or stroke). Edema, arterial hypertension and heart failure have also been reported during NSAID therapy. In case of aggravation of any undesirable effect or occurrence of adverse reactions not mentioned in the leaflet, the doctor or pharmacist must be informed. Storage conditionsKeep out of the reach of children. Store in a place protected from moisture and light, at a temperature not exceeding 25°C. Do not use the medicinal product after the expiration date indicated on the package. Buy Diclopol retard tablets p/o 100mg No. 10×2