Instructions for use DICLOBERL RETARD

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Diclofenac is a non-steroidal substance with pronounced antipyretic, antirheumatic, analgesic and anti-inflammatory properties. The main mechanism of action is considered to be inhibition of the synthesis of prostaglandins , which play a major role in the development of inflammation.

At the concentrations used in the treatment of patients, the drug does not suppress the synthesis of proteoglycans in cartilage tissues.

For rheumatic disorders, the anti-inflammatory and analgesic effect of the drug Dikloberl Retard causes a decrease in the severity of pain, swelling of the joints, morning stiffness, and normalization of the patient's functional state.

For inflammation caused by surgery or injury, the described remedy quickly eliminates both pain during movement and spontaneous pain, and also removes tissue swelling. When used simultaneously with opioids to relieve severe pain, the drug can significantly reduce the dosage of opioids without loss of effectiveness.

Diclofenac also exhibits a pronounced analgesic effect in moderate non-rheumatic pain syndrome .

Pharmacokinetics

Due to the slow release of diclofenac from Diclofenac Retard capsules, the maximum concentrations of the active substance in the blood are lower than after taking tablets from other manufacturers. The highest concentration is recorded on average 5-6 hours after administration. Food does not affect absorption and bioavailability. After repeated administration, the pharmacokinetics of diclofenac does not change. Accumulation of the drug is not observed if the recommended dosages are observed.

Blood protein binding is approximately 99.8%. Easily penetrates into the joint fluid, where its maximum concentration is recorded 3 hours later than in the blood. The half-life of the joint fluid is approximately 4-5 hours. Approximately 2 hours after the onset of maximum concentration in the blood, the content of the active substance in the synovial fluid remains higher than in the blood. This phenomenon occurs around 12 o'clock.

Metabolized by glucuronidation, hydroxylation and methoxylation to form a number of phenolic derivatives, the vast majority of which form complexes with glucuronic acid . The half-life from the blood is approximately one and a half hours. About 60% of the dose taken is excreted in the urine, the remaining part is evacuated through the intestines, while no more than 1% of diclofenac .

Pharmacological properties of the drug Dicloberl retard

Diclofenac sodium (sodium salt of [2-(2,6-dichloroanilino)phenyl]acetic acid) belongs to the NSAID group of phenylacetic acid derivatives. Has a pronounced anti-inflammatory, analgesic and antipyretic effect, reduces tissue swelling during inflammation; the effects are associated with the ability to block prostaglandin synthesis. Inhibits platelet aggregation caused by ADP and collagen. After intramuscular administration, the maximum concentration in the blood plasma is reached after 10–20 minutes, after rectal administration - after 30 minutes. After oral administration, diclofenac is completely absorbed from the intestine. The maximum concentration in the blood plasma is achieved after 1–16 hours, on average within 2–3 hours. After absorption in the digestive tract, diclofenac undergoes first-pass metabolism as a result of the effect of primary passage through the liver, only 35–70% enters the posthepatic circulation. Approximately 30% of the active substance is metabolized and excreted in the feces. About 70% after hydroxylation and conjugation in the liver in the form of pharmacologically inactive metabolites is excreted in the urine. The half-life does not depend on liver and kidney function and is about 2 hours. Almost 99% is bound to plasma proteins.

Indications for use

Treatment of pain and inflammation of varying severity with:

• joint pathologies ( osteoarthritis , ankylosing spondylitis, rheumatoid arthritis , exacerbation of gout );
• acute disorders of the musculoskeletal system ( periarthritis , tendonitis , bursitis , tendovaginitis );
• other pathological conditions caused by injuries (lower back pain, fractures, dislocations, sprains, surgical interventions).

The underlying disease must be treated with basic therapy. An increase in temperature in itself is not diclofenac

Contraindications

• acute ulcer , bleeding or perforation of the intestine or stomach;
• allergy to the components of the drug;
• increased risk of postoperative bleeding, hemostasis disorders, cerebrovascular bleeding or hematopoietic disorders;
• bleeding or perforation of the digestive system in the past associated with taking anti- inflammatory non-steroidal drugs;
• inflammatory bowel diseases;
• exacerbation of peptic ulcer , peptic ulcer bleeding, including in the past;
• third trimester of pregnancy;
• congestive heart failure;
• cerebrovascular disorders in persons who have suffered a stroke or cases of ischemic attacks;
• liver or kidney failure ;
• peripheral arterial disease;
• coronary heart disease in persons who have had a heart attack or suffer from angina pectoris ;
• treatment of pain before and after coronary artery bypass surgery ;
• proctitis;
• allergic reactions to Ibuprofen , Aspirin or other non-steroidal anti-inflammatory drugs .

INDICATIONS:

Dicloberl tablets

Symptomatic therapy for pain and inflammation in the following conditions:

• acute arthritis, including attacks of gout;
• chronic inflammation of the joints (in particular rheumatoid arthritis);
• Ankylosing spondylitis (ankylosing spondylitis) and other inflammatory rheumatic diseases of the spine;
• inflammatory diseases of rheumatic origin with damage to soft tissues;
• swelling with pain or post-traumatic inflammation.

Dicloberl capsules

Symptomatic therapy for pain and inflammation with:

• acute arthritis, including attacks of gout;
• chronic inflammation of the joints (in particular rheumatoid arthritis);
• Ankylosing spondylitis (ankylosing spondylitis) and other inflammatory rheumatic diseases of the spine;
• inflammatory diseases of rheumatic origin with damage to soft tissues;
• swelling with pain or post-traumatic inflammation.

Dikloberl solution

When administered, the drug is intended for the treatment of patients with:

• inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, non-articular rheumatism;
• acute attacks of gout;
• renal and biliary colic;
• pain and swelling after injuries and operations;
• severe migraine attacks.

Side effects

• Hematopoietic reactions: pancytopenia, thrombocytopenia, leukopenia, agranulocytosis, anemia . The first symptoms of these disorders may be pharyngitis , fever, superficial ulcerations in the mouth, nosebleeds, apathy , and skin bleeding.
• Immune reactions: skin rash, urticaria , allergic vasculitis, angioedema , itching, pneumonia .
• Mental disorders: depression , disorientation, irritability, insomnia , psychotic disorders, nightmares, other mental disorders.
• Reactions from nervous activity: taste disorders, dizziness, hallucinations, headache, memory impairment, agitation, dizziness, drowsiness, paresthesia, sensory disturbance, fatigue, tremor , anxiety, aseptic meningitis , convulsions, confusion, stroke , general malaise.
• Reactions from sensory organs: diplopia , blurred vision, neuritis , tinnitus, vertigo , hearing disorders.
• Circulatory reactions: arterial hypotension , heart failure, chest pain, palpitations, vasculitis, arterial hypertension, myocardial infarction.
• Respiratory reactions: pneumonitis, asthma.
• Digestive reactions: abdominal pain, vomiting, flatulence , anorexia , gastritis , dyspepsia, diarrhea, bleeding from the digestive organs, gastric ulcer (with possible perforation or bleeding), constipation , disruption of the esophagus, colitis , glossitis, stomatitis, pancreatitis , intestinal stenosis, hepatitis , increased transaminases , liver disorders, jaundice, hepatonecrosis , fulminant hepatitis , liver failure.
• Skin reactions: manifestations of eczema and erythema , hair loss, Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, purpura , photosensitivity, itching.
• Reactions from the genitourinary tract: edema, acute renal failure , hematuria, proteinuria, nephrotic syndrome, impotence, interstitial nephritis, papillary necrosis of kidney tissue.

Instructions for Dikloberl Retard tablets (Method and dosage)

To reduce the risk of adverse reactions, the lowest possible effective dose should be used for the shortest possible period of time.

Capsules (tablets) Dicloberl Retard, instructions for use

The dose is selected individually. The recommended starting dose is 75-150 mg of the drug per day. For long-term treatment, taking 1 capsule of the drug per day is sufficient. If the signs of the disease are more pronounced at night, then Dicloberl Retard is recommended to be taken in the evening. The daily dosage should not be more than 150 mg. The capsules must not be chewed; they must be swallowed whole with water (preferably during or after meals).

Elderly patients

Anti-inflammatory nonsteroidal drugs should be used with caution in this group of people, since they are generally more prone to adverse reactions. Frail elderly patients or patients with low weight should be prescribed the smallest effective doses of Dicloberl.

Note!

Description of the drug Dicloberl retard caps. 100 mg No. 20 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Overdose

Signs of overdose: nausea, headache, epigastric pain, vomiting, bleeding from the digestive organs, drowsiness, convulsions, dizziness, diarrhea, disorientation , coma , agitation , tinnitus, liver damage, acute renal failure .

Treatment of overdose: symptomatic, gastric lavage (if no more than an hour has passed since the overdose). For frequent or prolonged convulsions, Diazepam .

Interaction

Cholestipol and Cholestyramine can cause a slowdown or decrease in the absorption of oral forms of diclofenac , so it is recommended to prescribe the latter at least an hour before or 5-6 hours after taking Cholestipol or Cholestyramine .

With simultaneous use, Dicloberl can increase the lithium in the blood. In such cases, monitoring of lithium in the blood is recommended.

When used together with Digoxin, an increase in the concentration of the latter in the blood is possible. In such cases, monitoring the concentration of Digoxin in the blood is recommended.

Concomitant use of diclofenac with antihypertensive drugs and diuretics may lead to a weakening of their antihypertensive effect due to suppression of the synthesis of angiodilating prostaglandins . Patients should receive adequate amounts of fluids, and regular monitoring of kidney function is also recommended after starting such treatment.

Concomitant use with Cyclosporine , potassium-sparing diuretics , Trimethoprim or Tacrolimus may increase potassium in the blood, so the condition of such patients should be monitored more often.

Concomitant use with anticoagulants may increase the risk of bleeding, since diclofenac in large doses can reversibly inhibit platelet adhesion. Therefore, such patients should be carefully examined regularly.

Concomitant use of diclofenac and other non-steroidal anti-inflammatory drugs or glucocorticosteroids may increase the likelihood of ulcers or gastrointestinal bleeding. Therefore, simultaneous use of two or more anti-inflammatory nonsteroidal drugs should be avoided.

Concomitant use of non-steroidal anti-inflammatory drugs and serotonin reuptake blockers increases the risk of bleeding from the digestive organs.

Diclofenac can be prescribed together with oral forms of hypoglycemic agents and this does not affect their therapeutic effect. But there are some reports of the occurrence of hyperglycemia and hypoglycemia , which necessitated adjustment of the dosage of antidiabetic agents while taking diclofenac . Therefore, it is recommended to monitor glucose during combination treatment.

Diclofenac can reduce the rate of elimination of Methotrexate , which leads to an increase in the level of the latter in the blood. Diclofenac should be used no earlier than 24 hours before taking Methotrexate to avoid cases of increased concentration of the latter and increased toxic effects.

Concomitant use with cyclosporines can increase their nephrotoxicity, which is why diclofenac should be prescribed in reduced doses.

When using anti-inflammatory non-steroidal drugs with Tacrolimus , the risk of nephrotoxicity may increase.

It is possible that seizures may develop in people who simultaneously use quinolone derivatives and Dicloberl. This phenomenon can be observed in patients with or without a history of seizures. Caution should be exercised when deciding whether to prescribe quinolones to patients already receiving anti -inflammatory non-steroidal drugs.

When taking Phenytoin together with diclofenac , it is necessary to monitor the content of the former in the blood due to a possible increase in its content.

Medicines containing probenecid slow down the elimination of diclofenac from the body.

The simultaneous administration of cardiac glycosides and anti-inflammatory non-steroidal drugs can aggravate heart failure, inhibit the glomerular filtration process and increase the content of glycosides in the blood.

Diclofenac should not be used within 9-12 days after the last dose of Mifepristone , since diclofenac can weaken the effect of the latter.

Caution is recommended when using diclofenac with strong CYP2C9 inhibitors , as this may lead to an increase in the concentration of diclofenac in the blood due to inhibition of its metabolism.

Dicloberl 100 mg No. 20 caps. retard

Instructions for medical use of the drug Diclofenac retard Trade name Diclofenac retard International nonproprietary name Diclofenac Dosage form Long-acting capsules, 100 mg Composition One capsule contains the active substance - diclofenac sodium 100 mg excipients: sucrose, corn starch, talc, shellac, Eudragit RL PO ( ammonium methacrylate copolymer, type A), gelatin, titanium dioxide (E 171) Description Hard gelatin capsules, size 2, white to cream color (color no more intense than RAL 9001). Capsule contents: spherical granules from white to ivory color (color no more intense than RAL 1014). Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Anti-inflammatory and antirheumatic drugs. Acetic acid derivatives. Diclofenac. ATC code M01AB05 Pharmacological properties Pharmacokinetics After oral administration of conventional dosage forms that are resistant to gastric juice, diclofenac is completely absorbed in the intestine. Depending on the duration of the gastric passage, maximum concentrations of the drug in plasma are achieved after 1-16 hours, on average - 2-3 hours after administration. After intramuscular administration, maximum plasma concentrations are reached within 10-20 minutes, and after rectal administration - after approximately 30 minutes. When administered orally, diclofenac undergoes noticeable changes as a result of the “first-pass-effect”, after which 35–70% of the absorbed active substance enters the blood unchanged. Approximately 30% of the active substance is excreted in the feces in the form of metabolites. Approximately 70% of the active substance after biotransformation in the liver (hydroxylation and conjugation) is excreted through the kidneys in the form of pharmacologically inactive metabolites. The half-life - almost independent of liver and kidney function - is approximately 2 hours. Plasma protein binding is about 99%. Pharmacodynamics Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac is based on the suppression of prostaglandin synthesis. When used, diclofenac reduces pain, swelling and fever caused by inflammatory processes. In addition, like other anti-inflammatory nonsteroidal drugs, diclofenac (at a dose of 1.1 mg/kg body weight) suppresses platelet aggregation induced by ADP and collagen. Indications for use Symptomatic treatment of pain and inflammation in: - acute arthritis (including attacks of gout) - chronic arthritis, in particular in rheumatoid arthritis (chronic polyarthritis) - ankylosing spondylitis (Bechterew's disease) and other inflammatory diseases of the spine of a rheumatic nature - painful tissue sensitivity for arthrosis and spondyloarthrosis - inflammatory diseases of a rheumatic nature with damage to soft tissues - edema with pain or post-traumatic inflammation Due to the slow release of the active substance from Dikloberl® retard capsules, this drug is not suitable for the initial treatment of diseases that require a rapid onset of action. Method of administration and dosage The dosage of diclofenac is determined depending on the severity of the disease. The recommended dose in adults is 1 capsule of Diclofenac retard extended release per day (equivalent to 100 mg of diclofenac sodium). Dicloberl® retard should be taken orally whole, without chewing, and washed down with plenty of liquid. Patients with chronic stomach diseases are recommended to take Dicloberl® retard with meals. Treatment of rheumatic diseases may require long-term use of the drug Dicloberl® retard. The question of the duration of use of the drug is decided by the attending physician. Side effects of Dicloberl® retard can be reduced by prescribing the minimum effective dose of the drug for the shortest possible period of time necessary to relieve the symptoms of the disease. Elderly patients: When prescribing the drug to elderly patients, no dose adjustment is required. Due to the profile of possible side effects in elderly patients, particularly careful monitoring of their health status should be carried out. Patients with renal impairment: When prescribing the drug to patients with mild to moderate renal impairment, no dose reduction is required. Patients with liver dysfunction When prescribing the drug to patients with mild to moderate liver dysfunction, no dose reduction is required. Children and adolescents The drug is contraindicated for use in children and adolescents. Side effects With regard to the following adverse reactions to taking Dicloberl® retard, it should be taken into account that the development and intensity of these reactions mainly depend on the dose and are individual in nature. Very common (³ 1/10) - nausea, vomiting and diarrhea, as well as minor gastrointestinal bleeding, which in some cases can lead to the development of anemia Common (³ 1/100 to < 1/10) - headache, dizziness , agitation, irritability or fatigue - dyspepsia, flatulence, stomach cramps, lack of appetite, as well as the formation of gastrointestinal ulcers (sometimes accompanied by bleeding and perforation) - hypersensitivity reactions such as skin rash and itching. Patients should be informed that if they experience hypersensitivity reactions, they should immediately inform the doctor and stop taking the drug - increased transaminase levels in the blood. Sometimes (from ³ 1/1000 to < 1/100) - bloody vomiting, tarry stools or bloody diarrhea, colitis, including hemorrhagic colitis, exacerbation of ulcerative colitis and Crohn's disease - the occurrence of edema, especially in patients suffering from arterial hypertension or renal failure - alopecia - urticaria - liver damage, especially with long-term therapy, acute hepatitis, with or without jaundice (very rarely turning into fulminant hepatitis, even in the absence of warning symptoms) In this regard, with long-term use of the drug, regular monitoring of liver functional parameters should be carried out. Very rare: < 1/10,000 - increased heart rate, edema, heart failure , myocardial infarction - hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis), hemolytic anemia. The first signs of these conditions may be fever, sore and sore throat, superficial ulcers in the mouth, flu-like conditions, severe fatigue, as well as nose and skin bleeding. When carrying out long-term therapy with the drug, regular monitoring of the blood picture should be carried out. - sensory disturbances, taste disturbances, memory disturbances, disorientation, convulsions, tremor - visual disturbances (blurred vision and double vision) - tinnitus, transient hearing impairment - stomatitis, glossitis (inflammation of the tongue), damage to the esophagus, exacerbation of ulcerative colitis or Crohn's disease, intestinal obstruction, pancreatitis, diaphragm-like intestinal strictures. Patients should be informed that if they experience severe pain in the upper abdomen, tarry stools, or bloody vomiting, they should immediately stop taking the drug and consult a doctor. - damage to the renal tissue (interstitial nephritis, papillary necrosis), which may be accompanied by the development of acute renal failure, proteinuria and/or hematuria, nephrotic syndrome. In this regard, patients should undergo regular monitoring of renal function. - exanthema, eczema, erythema, photosensitivity, purpura (including allergic purpura) and bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) - arterial hypertension - severe generalized hypersensitivity reactions. These reactions can be manifested by swelling of the face, tongue, internal swelling of the pharynx with narrowing of the airways, difficulty breathing, rapid heartbeat, as well as a drop in blood pressure up to life-threatening shock. If any of the above symptoms appear, which may occur even with the first use of Dicloberl® retard, drug therapy should be stopped immediately and immediate medical attention is required. - allergic vasculitis and pulmonitis (pneumonia) - psychotic reactions, depression, anxiety, nightmares - exacerbation of infectious inflammatory diseases (for example, the development of necrotizing fasciitis) associated with the systemic administration of non-steroidal anti-inflammatory drugs. In cases where symptoms of infectious diseases appear or worsen during the use of Dicloberl® retard, patients are advised to immediately consult a doctor. The need for antibacterial therapy should be resolved. - symptoms of aseptic meningitis, including stiff neck, headache, nausea, vomiting, fever and confusion. Patients suffering from autoimmune diseases (SLE, mixed connective tissue diseases) are predisposed to the development of aseptic meningitis. Contraindications - hypersensitivity to diclofenac or other components of the drug - with a history of allergic reactions (bronchospasm, asthma, rhinitis or urticaria) to taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs - with acute peptic ulcers, as well as relapses of peptic ulcers or gastrointestinal bleeding history (two or more documented episodes of gastrointestinal ulcers or bleeding) - with a history of gastrointestinal bleeding or perforation associated with therapy with drugs of the NSAID class (non-steroidal anti-inflammatory drugs) - with a gastric or intestinal ulcer in the acute phase with bleeding or perforation - with cerebrovascular or other fresh bleeding - with severe impairment of liver or kidney function - with diagnosed heart failure (NYHA II-IV), coronary heart disease, peripheral arterial disease and/or cerebrovascular accident - disease of the hematopoietic system - pregnancy and lactation - children and adolescents under 18 years of age - treatment of postoperative pain after coronary artery bypass surgery or use of a heart-lung machine Drug interactions Other NSAIDs, including salicylates: Concomitant use of several NSAIDs may lead to an increased risk of ulcers and bleeding in the gastrointestinal tract due to synergistic effects. For this reason, the simultaneous use of diclofenac and other NSAIDs is not recommended. Digoxin, phenytoin, lithium preparations: Simultaneous administration of Dicloberl® retard and digoxin, phenytoin or lithium preparations may lead to increased concentrations of these drugs in the blood. In this regard, where appropriate, it is necessary to monitor the concentration of lithium in the blood, and it is also recommended to monitor the concentrations of digoxin or phenytoin in the blood. Diuretics, ACE inhibitors and angiotensin II antagonists: Nonsteroidal anti-inflammatory drugs may reduce the effect of diuretics and antihypertensive drugs. In patients with impaired renal function (for example, dehydrated or elderly patients), concomitant use of ACE inhibitors or angiotensin II antagonists with drugs that inhibit cyclooxygenase type 2 may lead to worsening of impaired renal function, including the possible development of acute renal failure, often having an irreversible nature. In this regard, the above-mentioned drug combinations should be prescribed with caution, especially in elderly patients. Patients should be advised of the importance of taking sufficient fluids. After starting combination therapy, regular monitoring of renal function indicators is necessary. The simultaneous administration of Dicloberl® retard and potassium-sparing diuretics can lead to the development of hyperkalemia. In this regard, during concomitant therapy it is recommended to monitor potassium levels. Glucocorticoid drugs: Concomitant administration of glucocorticoid drugs increases the risk of developing ulcers and bleeding in the gastrointestinal tract. Antiplatelet agents and serotonin reuptake inhibitors (SSRIs): Concomitant use of antiplatelet agents or drugs of the SSRI class increases the risk of developing ulcers and bleeding in the gastrointestinal tract. Methotrexate: Taking Dicloberl® retard within 24 hours before or after taking methotrexate may lead to an increase in the concentration of methotrexate in the blood and to an increase in its toxic effect. Cyclosporine: Nonsteroidal anti-inflammatory drugs (which include diclofenac sodium) may increase the toxic effects of cyclosporine on the kidneys. Anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin. Probenecid and sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone may slow down the elimination of diclofenac. Special instructions Precautions regarding the gastrointestinal tract The simultaneous administration of Dicloberl® retard with other drugs of the NSAID class, including selective inhibitors of cyclooxygenase type 2, should be avoided. Side effects of Dicloberl® retard can be reduced by prescribing the minimum effective dose of the drug for the shortest possible period of time necessary to relieve the symptoms of the disease. Elderly patients: Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulcers and perforations: Cases of gastrointestinal bleeding, ulcers and perforations, which can be fatal, have been reported with the use of any NSAID class of drugs. These complications can occur at any stage of treatment with or without warning symptoms and do not depend on the presence of a history of serious gastrointestinal disorders. The risk of developing gastrointestinal bleeding, ulcers and perforations increases with increasing doses of NSAIDs. In addition, the risk of these conditions is increased in patients with a history of gastrointestinal ulcers, especially those complicated by bleeding or perforation, as well as in elderly patients. Such patients should begin therapy with the lowest dose. In relation to the above category of patients, as well as in patients requiring additional therapy with acetylsalicylic acid in low doses or therapy with other drugs that can increase the risk of developing gastrointestinal complications, combination therapy should be considered, including agents that protect the gastrointestinal mucosa tract (eg, misoprostol or proton pump inhibitors). Patients with a history of gastrointestinal toxicity from NSAIDs, especially the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), especially during the initial phase of therapy. . In patients receiving concomitant therapy with drugs that increase the risk of developing gastrointestinal ulcers or bleeding, such as oral corticosteroid drugs, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or drugs that reduce platelet aggregation (eg, aspirin), Dicloberl ® retard should be prescribed with caution. If gastrointestinal bleeding or gastrointestinal ulcers occur while taking Dicloberl® retard, therapy with this drug should be discontinued immediately. In patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), NSAID therapy should be prescribed with caution, as this may lead to an exacerbation of these conditions. Effects on the Cardiovascular and Cerebrovascular System: Patients with a history of hypertension and/or mild to moderate congestive heart failure require appropriate medical monitoring and consultation as there have been reports that in some cases, NSAID therapy may lead to fluid retention. body and swelling. The results of clinical studies and epidemiological data indicate that the use of diclofenac, especially in high doses (100 mg of “retard” form per day) and with a long duration of therapy is associated with increasing the risk of arterial thrombosis (for example, myocardial infarction or stroke). Patients with significant risk factors for the development of cardiovascular pathology (e.g., arterial hypertension, hyperlipidemia, diabetes mellitus, smoking) should be prescribed diclofenac only after a thorough assessment of their condition. Since the risk of developing cardiovascular pathology when taking a diclofenac can increase with an increase in the dose and duration of administration, it is necessary to use the drug in the smallest effective daily dose for the least possible time. Periodically, it is necessary to repeat the assessment of the patient's need for symptomatic treatment and his reaction to treatment. There are reports that in very rare cases, the use of NSAIDs was associated with the development of serious skin allergic reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyel syndrome). Apparently, the risk of developing toxic skin reactions is the highest in the initial period of therapy, since, in most cases, skin reactions develop during the first month of therapy. When the first signs of a skin rash, damage to the mucous membranes or other manifestations of hypersensitivity, therapy with Diclobertle® retard should be immediately stopped immediately stopped. Influence on the liver in the case of patients with impaired liver function should be careful for the prescription of the drug, since in the treatment of diclofenac their condition may worsen. With prolonged or repeated therapy with Diklobert® Retared, regular control of the liver function is necessary for precaution. If signs of violation of its function appear, immediately stop taking the drug. Other instructions of Diclobert® Retard should be prescribed only after a thorough analysis of the benefits/risk of therapy for the following conditions: - with congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria); - with systemic lupus erythematosus (SLE), as well as with mixed diseases of the connective tissue. Diklobberl® Retard should be used under a particularly thorough medical supervision: - in case of impaired renal function; - in case of impaired liver function; - immediately after significant surgical interventions; - in patients suffering from hay fever (pollinosis), nose polyps or chronic obstructive respiratory diseases, since such patients have increased risk of allergic reactions. Allergic reactions can be expressed in asthma attacks (the so -called “analgetic” asthma), quinca edema or urticaria; - In patients who are allergically responding to other substances, since when prescribing such patients the drug Diklobert® Retard, there is also an increased risk of hypermensitivity reactions. Very rarely, when using diclofenac, the development of acute hypersensitivity reactions (for example, anaphylactic shock) was observed. If the first signs of the development of hypersensitivity reactions occur during the use of Diclobert® retardia, the drug should be canceled immediately. An urgent symptomatic treatment is necessary. Diclofenac can reversibly suppress platelet aggregation. For this reason, you should carefully monitor patients suffering from blood coagulation disorders. Due to its pharmacodynamic properties, diclofenac, like other drugs of the NSAID class, can mask the symptoms of infection. If signs of infection appear or aggravated, it is recommended to urgently consult a doctor during taking the Diclobert® retard. The issue of the need for antibacterial therapy should be resolved. With prolonged use of Diclobert® Retard, regular control of the kidney function and blood paint is necessary. With prolonged use of painkillers, headaches can be observed that cannot be treated with increased doses of these drugs. In general, a frequent intake of painkillers, especially the combination of several painkillers, can lead to a persistent damage to the kidneys, accompanied by the risk of renal failure (the so -called “analgesic nephropathy”). The accompanying alcohol consumption can enhance side effects caused by the active substances of the NSAIDs of the NSAID, especially the side effects from the gastrointestinal tract and the central nervous system. The drug contains sucrose. Patients suffering from rare hereditary fructose intolerance, glucose and galactose malliabsorption syndrome, as well as sucrhasis or isomaltase deficiency, Diclobert® Retard should not be taken. Pregnancy and lactation Pregnancy The suppression of the synthesis of prostaglandins can adversely affect pregnancy and/or the development of the embryo/fetus. The results of epidemiological studies indicate an increased risk of spontaneous abortion (miscarriages), malformations of the heart and non -abbreviation of the anterior abdominal wall associated with the use of prostaglandin synthesis inhibitors in the early period of pregnancy. It is believed that the risk of developing side effects increases in parallel to an increase in the dose and duration of therapy. In animal experiments, it was shown that the purpose of inhibitors of the synthesis of prostaglandins led to an increase in the frequency of fruit loss at the stage before and after implantation, as well as an increase in the mortality of embryos/fruits. In addition, in animals that received prostaglandin synthesis inhibitors during organogenesis, an increased frequency of various malformations was noted, including malformations of the cardiovascular system. Diclofenac should not be prescribed during the first and second trimesters of pregnancy, with the exception of cases when the benefit exceeds the risk. In cases of prescribing diclofenac to women planning pregnancy, or when using the drug in the first and second trimesters of pregnancy, the dose and the duration of therapy should be, if possible, minimal. The appointment of prostaglandin synthesis inhibitors in the third trimester of pregnancy can have the following adverse effects on the fetus: · toxic effects on the heart and lungs (with premature closure of the duct’s bottle and the development of hypertension in the pulmonary artery system); · Violation of the renal function, which can progress and entail the development of renal failure and low water (oligohydramnia); - adverse effects in relation to the mother and the newborn when prescribing at the end of pregnancy: · possible lengthening of the time of bleeding, which is determined by the inhibitory effect of the drug to aggregate platelets, which can manifest itself even when prescribing very low doses; · The suppression of contractile activity of the uterus, which leads to late or protracted childbirth. Consequently, the purpose of Diclofenac in the third trimester of pregnancy is contraindicated. Lactation The active substance diclofenac and the products of its decay in small quantities go into breast milk. Since there are still no reports on the negative consequences for the infant, with the short -term use of the drug, there is usually no need to stop breastfeeding. In cases of prescribing high doses or prolonged therapy with a drug for the treatment of rheumatic diseases, it is necessary to temporarily stop taking the drug during breastfeeding. Diclobert® Retared Farm Fertilizer can lead to violations of the fertile function in women and, in this regard, the appointment of this drug to women trying to get pregnant is not recommended. In women experiencing difficulties in conception, as well as in women undergoing an examination of infertility, you should think about canceling therapy with Diklobertle® Retard. Features of the influence on the ability to drive a vehicle or potentially dangerous mechanisms when using the drug Diklobert® retard in high doses may take side effects of the central nervous system, for example, fatigue and dizziness, which can lead to a decrease in the reaction and impaired the ability to drive a vehicle. These violations are especially pronounced with the simultaneous use of Diklobert® Retard with alcohol. Overdose symptoms: headache, dizziness, darkening and loss of consciousness, abdominal pain, nausea and vomiting. In addition, gastrointestinal bleeding, as well as impaired liver and kidney function, the development of arterial hypotension, inhibition of respiration and cyanosis, are possible. Treatment: there is no specific antidote. Supporting and symptomatic therapy. The output and packaging form of 10 capsules are placed in a contour cell package from a white film polypropylene-cycloolefine copolymer-polypropylene, welded with soft aluminum foil. 2 contour cell packages along with instructions for medical use in the state and Russian languages ​​are invested in a pack of cardboard. Storage conditions are stored at a temperature of not higher than 25 ° C. Keep out of the reach of children! The shelf life of 3 years is not used after expiration of the shelf life! Conditions for the vacation from pharmacies according to the recipe manufacturer Berlin-Hemi AG (Menarini Group) Glinniker Veg 125 12489 Berlin, Germany, owner of the Berlin Hemi registration certificate of AG (Menarini Group) Gliniker Veg 125 12489 Berlin, Germany Organizer-Menerini-Fon Hayden, Germany Address organizations receiving in the territory of the Republic of Kazakhstan claims from consumers regarding the quality of products (goods): the representative office of Berlin-Hemi AG JSC in the Republic of Kazakhstan Tel.: +7 727 2446183, 2446184, 2446185 Fax: +7 727 2446180 Email address

special instructions

In order to reduce the risk of adverse reactions, treatment should begin with the minimum effective dose, which should be taken in the shortest course necessary to relieve symptoms.

Co-administration of Dicloberl Retard with systemic anti-inflammatory non-steroidal drugs due to a possible increase in side effects.

Due to its pharmacological properties, the drug Dikloberl Retard is able to mask the signs of infection.

With the use of all non-steroidal anti-inflammatory drugs, cases of bleeding from the digestive organs, perforation and ulceration, which can be fatal, have been identified. If such disorders are diagnosed in patients receiving diclofenac , its use should be discontinued immediately.

Elderly patients have an increased risk of adverse reactions to non-steroidal anti-inflammatory drugs , especially bleeding and perforation. For this group of patients, as well as those in need of simultaneous use of acetylsalicylic acid , the issue of prescribing combination therapy using gastroprotective agents ( proton pump inhibitors or Misoprostol ) should be decided.

Close medical supervision is necessary when prescribing Dikloberl Retard to patients with liver diseases, due to the possible deterioration of their condition.

During long-term treatment with the described drug, constant monitoring of liver function and liver enzyme levels is prescribed. If liver dysfunction persists or worsens, or clinical signs appear that are thought to be related to disease progression, use of Dicloberl Retard should be discontinued immediately.

Since an increase in the frequency and severity of edema has been reported during therapy with anti-inflammatory non-steroidal drugs , special attention should be paid to persons with arterial hypertension , cardiac or renal dysfunction, the elderly, those receiving diuretics or nephrotoxic agents , and before or after major surgery.

In patients with systemic lupus erythematosus or other connective tissue diseases, an increased risk of aseptic meningitis .

The use of diclofenac may be associated with an increased likelihood of thrombotic events ( heart attack or stroke ).

Patients with peripheral arterial disease, coronary heart disease , congestive heart failure, severe arterial hypertension, and cerebrovascular disease are not recommended to prescribe the drug; in extreme cases, it is possible to use a dosage of up to 100 mg per day.

When taking this drug for a long time, regular monitoring of blood tests is necessary.

bleeding diathesis, impaired hemostasis or hematological disorders taking Dicloberl Retard should be closely monitored

Patients with chronic obstructive pulmonary disease, asthma, allergic rhinitis, nasal polyps or chronic respiratory tract infections are more likely to experience side effects ( asthma , Quincke's edema , urticaria ) due to taking non-steroidal anti-inflammatory drugs . This also applies to persons with allergic reactions to other substances, such as itching, rash, hives .

With prolonged use of painkillers, a headache may occur, which should not be treated by increasing the dosage of the medication.

vertigo during treatment with the drug should not drive.

APPLICATION:

The dosage and interval between doses of diclofenac sodium depends on the severity of the disease and is 50–150 mg of diclofenac sodium per day, for which different dosage forms of Diclofenac with different contents of the active substance are used. It is recommended to use the minimum effective dose of the drug for the shortest period. When using different dosage forms of the drug in combination, the maximum daily dose should not exceed 150 mg of diclofenac sodium.

Dicloberl tablets. Adults and children over 16 years of age. Dicloberl 50 tablets are used 1 tablet 1-3 times a day, which corresponds to 50-150 mg of diclofenac sodium per day. The tablets are taken orally on an empty stomach 1–2 hours before meals, without chewing and with a glass of liquid. The duration of treatment is determined by the doctor and may be longer for diseases of rheumatic origin.

Elderly patients. No dose adjustment is required. Due to the increased possibility of developing adverse reactions, particularly careful monitoring of their health should be carried out.

Renal dysfunction. For mild to moderate disorders, there is no need for dose adjustment.

Liver dysfunction. For mild to moderate disorders, there is no need for dose adjustment.

Dicloberl capsules. Adults: take 1 capsule per day, which is equivalent to 100 mg of diclofenac sodium. The capsules are taken orally without chewing and with a glass of water. For patients with gastrointestinal disorders, the drug is recommended to be taken with meals. The duration of treatment is determined by the doctor and may be longer.

Elderly patients. No dose adjustment is required. Due to the increased risk of adverse reactions, it is necessary to carefully monitor the condition of these patients.

Renal dysfunction. For mild to moderate disorders, there is no need for dose adjustment.

Liver dysfunction

Dikloberl district Usually administered deep intramuscularly (into the gluteal muscle) in a single dose of 75 mg. If long-term therapy with Dicloberl N 75 is necessary, it is continued using forms for oral or rectal use. On the day of injection of Diclofenac N 75, the total daily dose of diclofenac should not exceed 150 mg. Due to the possible development of anaphylactic reactions, up to the development of shock, the patient should be monitored for at least 1 hour after the injection, and the medical kit necessary for emergency care should be ready.

Analogs

Level 4 ATC code matches:
Voltaren

Rapten

Zerodol

Dikloberl N 75

Dicloberl

Ketanov

Dolak

Panoxen

Ketorolac

Naklofen Duo

Naklofen

Olfen-100

Olfen-75

Neurodiclovit

Nizilat

Fanigan

Aertal

Methindol retard

Ortofen

The most common analogues of Dikloberl are listed below: Almiral, Arguette Rapid, Bioran, Voltaren, Diclofenac, Diclak, Diclobry, Ketarolak, Naklofen, Olfen, Ortofen, Ibuprofen, Rapten, Feloran.

During pregnancy and lactation

In the first two trimesters of pregnancy, Dikloberl Retard is allowed to be prescribed only under strict indications and under medical supervision, and the duration of therapy should be as short as possible. In the last trimester of pregnancy, the use of the drug is prohibited due to the risk of inhibition of uterine contractility and early closure of the ductus arteriosus.

Diclofenac can pass into milk during breastfeeding, so the drug should not be used during lactation to avoid negative effects on the baby.

Dicloberl can also negatively affect fertility in women, so it is not recommended for use by women planning pregnancy.

Use of the drug Dicloberl retard

Capsules are taken orally after meals as a whole, with plenty of liquid. For patients with gastrointestinal pathology, the drug is recommended to be taken with meals. The dose of the drug is determined depending on the severity of the disease. The recommended daily dose range for adults and adolescents over 15 years of age is 50–150 mg diclofenac sodium. The average single and daily dose of Dicloberl retard is 100 mg (1 capsule). If it is necessary to increase the daily dose of diclofenac sodium, use the drug Dicloberl 50 in the form of suppositories or enteric-coated tablets. The duration of use of the drug is determined individually depending on the course of the disease.