Dialrapid, 50mg sachet 9 pcs

For short-term treatment of the following acute conditions:

• post-traumatic pain, inflammation and swelling, such as due to ligament injuries;
• postoperative pain, inflammation and swelling, such as after dental or orthopedic surgery;
• Migraine attacks;
• spinal pain syndromes;
• Rheumatic diseases of extra-articular soft tissue.

Isolated fever is not an indication for the use of the drug Dialrapid.

Active ingredient

How to take, the dosage

Interaction

Special Instructions

Gastrointestinal tract involvement

Bleeding or ulceration/perforation of the gastrointestinal tract, in some cases with fatal outcome, have been reported with all NSAIDs, including diclofenac. These events can occur at any time during treatment in patients with or without a history of prior symptoms or gastrointestinal disease. In elderly patients, such complications may have serious consequences. If patients develop bleeding or gastrointestinal ulceration during the use of Dialrapid, the drug should be discontinued.

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

Patients at increased risk of gastrointestinal complications, as well as patients receiving therapy with low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal damage should take gastroprotective agents (e.g., proton pump inhibitors or misoprostol).

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

Patients with bronchial asthma

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

Serious dermatologic reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases with a fatal outcome, against the use of NSAIDs, including diclofenac, have been very rare. The highest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If the first signs of skin rash, mucosal lesions or other symptoms of hypersensitivity develop in patients receiving Dialrapid, the drug should be withdrawn. In rare cases patients who are not allergic to diclofenac may develop anaphylactic/anaphylactoid reactions when using Dialrapid.

Hypatic and biliary tract effects

Since Dialrapid, as with other NSAIDs, may cause increased activity of one or more liver enzymes during long-term therapy with the drug, liver function monitoring is indicated as a precautionary measure. If liver function abnormalities persist or progress or if there are signs of liver disease or other symptoms (e.g., eosinophilia, rash, etc.), the drug DiAlrapid should be stopped. It should be noted that hepatitis with the drug Dialrapid may develop without prodromal signs.

Renal effects

With NSAID therapy, including diclofenac, fluid retention and edema have been noted, therefore special caution should be used and monitoring of renal function is recommended in patients with hypertension, impairedp> heart or renal function disorders, elderly patients, patients receiving diuretics or other drugs that affect renal function, as well as patients with significant reduction in circulating blood plasma volume of any etiology, e.g., before and after massive surgical interventions. After discontinuation of therapy by the drug normalization of renal function parameters to initial values is usually noted.

Cardiovascular effects

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 disease and high risk of cardiovascular disease (e.g., arterial hypertension, hyperlipidemia, diabetes, smokers) the drug should be used with extreme caution, at 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. In long-term therapy (more than 4 weeks) the daily dose of diclofenac in these patients should not exceed 100 mg. The effectiveness of treatment and the patient’s need for symptomatic therapy should be periodically evaluated, especially when its duration is more than 4 weeks. The patient should be instructed to seek immediate medical attention if the first symptoms of thrombotic disorders (e.g., chest pain, shortness of breath, weakness, speech disorders) occur.

Impacts on the hematopoietic system

Dialrapid, like other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, in patients with hemostasis disorders it is necessary to monitor closely the corresponding laboratory parameters. Dialrapid is recommended for short-term treatment only; however, during long-term use of Dialrapid, like other NSAIDs, systematic monitoring of peripheral blood counts is indicated.

Masking signs of infection

Dialrapid, like other NSAIDs, may mask signs of infection due to its pharmacodynamic properties.

Sharing with other NSAIDs

Dialrapid should not be used simultaneously with other NSAIDs, including selective COX-2 inhibitors due to the risk of increased frequency of adverse events.

Impact on driving and/or operating machinery

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

Contraindications

Hypersensitivity to the active substance and other components of the drug, as well as to other non-steroidal anti-inflammatory drugs (NSAIDs);

Exacerbation of gastric and duodenal ulcers, ulcerative bleeding, perforations;

Inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase;

Complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including a history);

Severe liver function impairment, renal failure (GFR less than 15 mL/min/1.73m2);

Chronic heart failure, NYHA functional class II-IV;

clinically confirmed coronary heart disease;

diseases of peripheral arteries and cerebral vessels;

uncontrolled arterial hypertension;

Partum III trimester of pregnancy;

Breastfeeding period.

The drug should not be used in patients with phenylketonuria because it contains a source of phenylalanine.

The drug is not recommended for children under 14 years of age (due to difficulty dosing the drug).

WARNING

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

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

Cautious use of the drug is necessary when using Dialrapid in patients with liver dysfunction of mild to moderate degree, as well as in patients with hepatic porphyria because the drug may provoke porphyria attacks. Special caution is required when treating patients with impaired renal function, including chronic renal failure (FFR 15-60 ml/min/1.73 m2), dyslipidemia/hyperlipidemia, diabetes mellitus, arterial hypertension, treatment of patients who smoke or abuse alcohol, treatment of 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.

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

Caution should be exercised when using Voltaren Rapid® in patients at risk of cardiovascular thrombosis (including myocardial infarctions and strokes).

Caution should be exercised when using Dialrapid in elderly patients. This is especially true in frail or underweight elderly people.

Side effects

The following are the adverse events (AEs) that have been identified in clinical trials as well as in the clinical use of diclofenac.

The following criteria were used to estimate the incidence of NIs: “frequently” – >1/100, <1/10, “infrequently” ->1/1000, <1/100, “rarely” – >1/10000, <1/1000, “very rarely” – <1/10000, including individual cases. 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: rarely – hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased arterial pressure (BP) and shock; very rarely – angioedema (including facial edema).

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

Nervous system disorders: frequently – headache, dizziness; rarely – somnolence; very rarely – sensory disorders, including paraesthesia, memory disorders, tremor, seizures, anxiety, acute cerebral circulation disorders, aseptic meningitis.

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

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

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

Vascular disorders: very rarely – increase in BP, vasculitis.

Respiratory system disorders, organs of the chest mediastinum: rarely – bronchial asthma (including dyspnea); very rare – pneumonitis.

Gastrointestinal disorders: frequent – abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, decreased appetite; rare – gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea with blood admixture, stomach and intestinal ulcers (with or without bleeding, stenosis or perforation, with possible development of peritonitis); Very rare

– 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, dysgeusia. Liver and biliary tract disorders: often – increased plasma aminotransferase activity; rarely

Hepatitis, jaundice, liver function abnormalities; very rarely – hepatitis fulminant, liver necrosis, liver failure. Skin and subcutaneous tissue disorders: common – 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 reaction, purpura, Schoenlein-Henoch purpura.

Renal and urinary tract disorders: very rarely – acute renal damage (acute renal failure), hematuria, proteinuria, tubulo-interstitial nephritis, nephrotic syndrome, papillary necrosis.

General disorders and disorders at the site of administration:Rarely, edema.

Cardiovascular disorders

The data of clinical studies indicate a slight increase in the risk of cardiovascular thrombotic complications (e.g., myocardial infarction), especially with long-term use of diclofenac in 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 disturbances. If these symptoms develop with diclofenac therapy, ophthalmologic evaluation should be considered to rule out any other cause.

Overdose

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