Diclofenac Reneval, 50 mg 20 pcs

Special Instructions

Gastrointestinal damage

When using diclofenac, as well as other NSAIDs, events such as bleeding or ulceration/perforation of the GI tract have been reported, in some cases with fatal outcome. These events can occur at any time during the use of these drugs with or without previous symptoms or a history of serious gastrointestinal disease. In elderly patients, such complications may have serious consequences. If patients receiving diclofenac develop bleeding or gastrointestinal ulcers, the drug should be discontinued.

To reduce the risk of gastrointestinal toxicity in patients with gastrointestinal ulcers, especially those complicated by bleeding or a history of perforation, and in elderly patients, the drug should be used in the lowest effective dose.

In patients at increased risk of gastrointestinal complications, as well as in patients receiving therapy with low doses of acetylsalicylic acid, gastroprotective agents (proton pump inhibitors or misoprostol) or other drugs should be used during therapy with the drug to reduce the risk of adverse effects on the GIT.

Patients with a history of gastrointestinal damage, especially the elderly, should inform their physician of any abdominal symptoms.

Patients with bronchial asthma

. Bronchial asthma exacerbation (NSAID intolerance/bronchial asthma triggered by taking NSAIDs), Quincke’s edema, and urticaria are most commonly reported in patients with bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic infectious airway disease (especially those associated with allergic rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other drugs (skin rash and itching or urticaria) special caution should be exercised when using diclofenac (readiness for resuscitation measures).

Skin reactions

Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases with fatal outcome, during diclofenac use were very rarely observed. The greatest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If the patient receiving diclofenac develops the first signs of skin rash, lesions of mucous membranes or other symptoms of hypersensitivity the drug should be discontinued.

In rare cases when using diclofenac, as well as other NSAIDs, anaphylactic/anaphylactoid reactions may develop in patients who have not previously received diclofenac.

Impacts on the liver

As during the use of diclofenac increased activity of one or more “liver” enzymes may be noted, during long-term therapy with the drug as a precautionary measure, control of liver function is indicated. In case of preservation and progression of liver function disorders or signs of liver disease or other symptoms (such as eosinophilia, rash and the like), the drug should be stopped. It should be noted that hepatitis with diclofenac may develop without prodromal signs.

Impacts on the kidneys

. During the therapy with diclofenac it is recommended to monitor renal function in patients with hypertension, heart or renal function disorders, elderly patients, patients receiving diuretics or other drugs affecting renal function, as well as in patients with significant reduction of extracellular fluid volume of any etiology, for example, before and after massive surgical interventions. After discontinuation of therapy by the drug the normalization of renal function parameters to initial values is usually observed.

Influence on the cardiovascular system

. Therapy with NSAIDs, including diclofenac, especially long-term and high-dose therapy, may be associated with a small increase in the risk of serious cardiovascular thrombotic complications
(including myocardial infarction and stroke).

In patients with cardiovascular diseases and high risk of cardiovascular diseases (e.g., arterial hypertension, hyperlipidemia, diabetes, smoking) the drug should be used with extreme caution, in the lowest effective dose with the shortest possible duration of treatment because the risk of thrombotic complications increases with increasing dose and duration of treatment. At prolonged therapy (more than 4 weeks) daily dose of diclofenac in such patients should not exceed
100 mg. The effectiveness of treatment and the patient’s need for symptomatic therapy should be periodically evaluated, especially in cases when its duration is more than 4 weeks. If the first symptoms of thrombotic disorders (e.g., chest pain, shortness of breath, weakness, speech disorders) appear, the patient should seek medical attention immediately.

Influence on the hematopoietic system

Diclofenac may temporarily inhibit platelet aggregation; therefore, in patients with hemostasis disorders, careful monitoring of relevant laboratory parameters is necessary. During long-term use of diclofenac it is recommended to perform regular clinical peripheral blood tests.

Masking signs of an infectious process

The anti-inflammatory effects of diclofenac may complicate the diagnosis of infectious processes.

Combined use with other NSAIDs

Diclofenac should not be used with other NSAIDs, including selective cyclooxygenase-2 inhibitors (COX-2) because of the risk of NS.

Influence on driving, operating machinery

Patients who experience visual disturbances, dizziness, drowsiness, vertigo or other central nervous system disorders while using diclofenac should not drive vehicles or operate machinery.

Synopsis

Round biconvex film-coated tablets, light brown to brown in color. On cross section the nucleus is white or almost white.

Contraindications

• High sensitivity to diclofenac and any other drug components;
• acute gastric and duodenal ulcer disease, gastrointestinal (GI) bleeding, GI perforation;
• .As other NSAIDs, diclofenac is contraindicated in patients with a complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history);
• Severe liver function impairment, renal failure (glomerular filtration rate (GFR) less than 15 ml/min/1.73 m²), chronic heart failure (NYHA functional class II-IV);
• clinically confirmed coronary heart disease;
• cerebrovascular disease, peripheral artery disease;
• high risk of arterial thrombosis and thromboembolism, uncontrolled arterial hypertension;
• conditions with risk of bleeding;
• confirmed hyperkalemia;
• aortocoronary bypass surgery (perioperative period);
• inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase;
• active liver disease;
hereditary severe lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome (because the formulation contains lactose);
• III trimester of pregnancy;
Breast-feeding period;
• Diclofenac Reneval, film-coated, enteric-soluble tablets, 25 mg is not recommended for children under 6 years of age; 50 mg – for children under 14 years of age.

With caution

. When using diclofenac and other NSAIDs, caution should be exercised and patients with symptoms/signs suggestive of GI lesions/diseases or with history suggestive of gastric or intestinal ulceration, bleeding or perforation should be closely monitored; patients with a history of Helicobacter pylori infection, ulcerative colitis, Crohn’s disease, a history of impaired liver function, and in patients with complaints suggestive of GI disease. The risk of gastrointestinal bleeding increases with increasing dosage of NSAIDs or with a history of ulcerous lesions, especially bleeding and ulcer perforation, and in elderly patients.

The administration of NSAIDs, including diclofenac, may be associated with an increased risk of anastomosis leakage located in the gastrointestinal tract. Close medical supervision and caution are recommended when using diclofenac after gastrointestinal surgery.

Particular caution should be exercised when using diclofenac in patients receiving drugs that increase the risk of gastrointestinal bleeding: Systemic glucocorticosteroids (including prednisolone), anticoagulants
(including warfarin), antiaggregants (including clopidogrel, acetylsalicylic acid) or selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Caution is necessary when using diclofenac in patients with mild to moderate liver dysfunction, as well as in patients with hepatic porphyria, because diclofenac can provoke porphyria attacks.

The drug should be used with caution in patients with bronchial asthma, seasonal allergic rhinitis, nasal mucosal edema
(including nasal polyps), chronic obstructive pulmonary disease, chronic infectious respiratory diseases (especially associated with allergic rhinitis-like symptoms).

Particular caution is required when treating patients with cardiovascular disease, impaired renal function, including chronic renal failure (FFR 15-60 ml/min/1.73 m²), dyslipidemia/hyperlipidemia, diabetes mellitus, arterial hypertension, when treating patients who smoke or abuse alcohol, when treating elderly patients, patients receiving diuretics or other drugs that affect renal function, and patients with significant reduction in circulating blood volume (RBC) of any etiology, such as in the periods before and after massive surgical interventions.

Diclofenac should be used with caution in patients with defects of the hemostatic system.

Caution should be exercised when using diclofenac in elderly patients. This is especially true in frail or low body weight elderly people. In patients in this category it is recommended to use the drug in the lowest effective dose.

Side effects

The following are the adverse events (AEs) that have been identified in clinical trials as well as in the use of diclofenac in clinical practice. The following criteria were used to assess the frequency of NIs:
“frequent” (≥ 1/100, < 1/10); “infrequent” (≥ 1/1000, < 1/100); “rare” (≥ 1/10000, < 1/1000); “very rare” (< 1/10000). The NUIs are grouped according to the system-organ class of the MedDRA Medical Regulatory Dictionary; within each class, the NUIs are listed in decreasing order of frequency of occurrence; within each group, allocated by frequency of occurrence, the NUIs are categorized in decreasing order of importance.

Disorders of the blood and lymphatic system: very rarely, thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.

Disorders of the immune system: very rarely – hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased blood pressure (BP) and shock; very rarely – angioedema (including facial edema).

Mental disorders: very rarely – disorientation, depression, insomnia, nightmares, irritability, mental disorders.

Nervous system disorders: frequently – headache, dizziness;
rarely – drowsiness; very rarely – sensory disorders, including paresthesias, memory disorders, tremors, seizures, anxiety, acute cerebral circulation disorders, aseptic meningitis.

Visual disorders: very rare – visual disturbances (blurred vision), diplopia.

Hearing organ and labyrinth disorders:often – vertigo; very rarely – hearing disorders, tinnitus.

Cardiac disorders: infrequent – myocardial infarction, heart failure, palpitations, chest pain.

Vascular disorders:very rarely – increased BP, vasculitis.

Disorders of the respiratory system, thoracic and mediastinal organs: rarely – bronchial asthma (including dyspnea); very rarely – pneumonitis.

Disorders of the gastrointestinal tract: often – abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, decreased appetite; rarely – gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea with blood, stomach and intestinal ulcers (with or without bleeding, stenosis or perforation, with possible development of peritonitis); very rarely – stomatitis, glossitis, esophageal damage, occurrence of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, ischemic colitis, exacerbation of ulcerative colitis or Crohn’s disease), constipation, pancreatitis.

Hepatic and biliary tract disorders:often – increased plasma aminotransferase activity; rarely – hepatitis; jaundice, liver function disorders; very rarely – fulminant hepatitis, liver necrosis, liver failure.

Dermatological and subcutaneous tissue disorders: frequent – skin rash;
rare – urticaria; very rare – bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, alopecia, photosensitivity reactions, purpura, Schoenlein-Henoch purpura.

Renal and urinary tract disorders: very rarely – acute kidney injury (acute renal failure), hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.

General disorders and disorders at the site of administration: not infrequently, edema.

Disorders of the cardiovascular system: Data from clinical studies indicate a slight increase in the risk of cardiovascular thrombotic complications (e.g., myocardial infarction), especially with long-term use of diclofenac at high doses (daily dose over 150 mg).

Visual disturbances: Visual disturbances, such as visual disturbances, blurred vision, or diplopia, appear to be class effects of NSAIDs and are reversible after discontinuation. A possible mechanism for the development of such disorders is the inhibition of the synthesis of prostaglandins and other related substances, which alters the regulation of blood flow in the retina, which manifests as potential visual impairment. If these symptoms develop with diclofenac therapy, ophthalmologic evaluation should be considered to exclude any other cause.

It is important to report the development of adverse reactions to ensure continuous monitoring of the benefit-risk ratio of the drug. If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor. Healthcare professionals report any adverse reactions to the medicine through the national adverse reaction reporting systems.

Pregnancy use

Pregnancy

There is insufficient data on the safety of diclofenac use in pregnant women; therefore, diclofenac should be used in I and II trimesters of pregnancy only when the expected benefits to the mother exceed the potential risk to the fetus. Diclofenac, as well as other NSAIDs (inhibitors of prostaglandin synthesis) is contraindicated in the last 3 months of pregnancy (inhibition of uterine contractility, impaired renal function in the fetus with subsequent oligohydroamnios and/or premature closure of the fetal arterial duct is possible).

Breast-feeding period

While diclofenac, like other NSAIDs, penetrates into the breast milk in small amounts, the drug should not be used during breast-feeding to avoid adverse effects on the baby. If it is necessary to use the drug in a woman during this period, breastfeeding should be stopped.

Fertility

Because diclofenac, like other NSAIDs, can have adverse effects on fertility, women who are planning to become pregnant are not recommended to take the drug.

In patients who are being evaluated and treated for infertility, the drug should be stopped.

Similarities

Diclac, Diclofenac-Teva, Diclo-F, Orthofen, Diclovit, Voltaren, Voltaren Emulsgel, Diclofenac, Voltaren Patch, Dicloran Plus, Orthofen, Diclofenac-Altfarm, Diclofenac-SOLofarm, Dialrapid