Composition and release forms
The active ingredient of the drug is diclofenac sodium. The compound has an anti-inflammatory effect by blocking the synthesis of prostaglandins.
Ukrainian pharmacies offer several dosage forms:
- pills;
- Dicloberl retard capsules;
- injection;
- rectal suppositories.
Injections and suppositories are used for quick pain relief, and tablets and Dicloberl capsules are used for long-term therapy.
Contraindications and side effects
The analgesic is not prescribed to patients with hypersensitivity to diclofenac or other drugs from the NSAID group.
Contraindications for use:
- stomach or duodenal ulcer;
- peptic ulcer;
- bronchial asthma;
- blood diseases;
- age under 15 years;
- pregnancy, breastfeeding.
Possible side effects while taking an anti-inflammatory drug:
- nausea, vomiting;
- dyspepsia;
- constipation;
- loss of appetite;
- exacerbation of peptic ulcer;
- gastrointestinal bleeding;
- headache;
- insomnia;
- convulsions;
- muscle rigidity;
- allergic rashes, itching;
- swelling of the nasopharyngeal mucosa;
- decreased blood pressure;
- anemia.
In isolated cases, bloody vomiting and bloody diarrhea are possible. If severe adverse reactions occur, treatment is suspended.
Instructions for use DICLOBERL N 75 (DICLOBERL N 75)
Gastrointestinal Precautions
Co-administration of Dicloberl® N 75 and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Undesirable effects can be reduced by using the minimum effective dose for the shortest period necessary to relieve symptoms.
Elderly patients
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, including deaths.
Gastrointestinal bleeding, ulcer and ulcer perforation
Gastrointestinal bleeding, ulceration or perforation, in some cases with fatal outcome, were observed with all NSAIDs at any stage of treatment, with or without warning symptoms and regardless of the presence or absence of a history of serious gastrointestinal pathology.
The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, and in elderly patients. In such cases, treatment should begin with the lowest possible dose. For these patients, as well as for patients receiving low-dose aspirin or other drugs that increase the risk of GI adverse events, combination therapy with drugs that have GI protective effects (eg, misoprostol or proton pump inhibitors) should be considered. pump).
Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding); this is most important for the initial stages of treatment. Caution should be exercised when prescribing diclofenac to patients concomitantly taking medications that may increase the risk of ulceration or bleeding; These drugs include oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or platelet aggregation inhibitors (antiplatelet agents) such as aspirin.
If gastrointestinal bleeding develops during treatment with diclofenac, the drug should be discontinued.
Nonsteroidal anti-inflammatory drugs should be prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) due to the risk of exacerbation.
Effects on the cardiovascular system and cerebrovascular circulation
Diclofenac should be prescribed with caution to patients with arterial hypertension and/or a history of decompensated heart failure of mild to moderate severity, since fluid retention and the development of edema are possible when treated with NSAIDs.
According to the results of clinical studies and epidemiological data, the use of diclofenac, especially in high doses (150 mg / day) and for a long time, may be accompanied by a slight increase in the risk of arterial thrombosis (for example, myocardial infarction or stroke).
In patients with uncontrolled arterial hypertension, heart failure, coronary heart disease, obliterating endarteritis and/or cerebrovascular pathology, diclofenac should be prescribed only after carefully weighing everything. The same issues must be addressed before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Skin reactions
Rare cases of serious skin reactions, sometimes fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), have been reported during treatment with NSAIDs. The risk of such reactions is greatest at the beginning of treatment; Most of the described phenomena were observed in the first months of therapy. Dicloberl® N 75 should be discontinued at the first appearance of a skin rash, damage to the mucous membranes or other signs of hypersensitivity.
Liver effects
Diclofenac should be prescribed with caution to patients with impaired liver function, as their condition may worsen during treatment. During long-term treatment or repeated administration of diclofenac, it is recommended - as a precaution - to regularly check liver function. If clinical signs of liver pathology appear, the drug must be discontinued.
Other information
In the following cases, Dicloberl® N 75 should be prescribed only after a thorough assessment of the benefit-risk ratio:
- with congenital disorders of porphyrin metabolism (for example, with acute intermittent porphyria);
- with systemic lupus erythematosus (SLE) and mixed collagenoses.
- with decreased kidney function;
- in case of liver dysfunction;
- immediately after major surgery;
- for pollen allergies, nasal polyps and chronic obstructive respiratory diseases, since such patients have an increased risk of allergic reactions. These reactions may manifest as asthma attacks (called analgesic asthma), angioedema or urticarial rash;
- if you are allergic to other substances, since such patients have an increased risk of hypersensitivity reactions, including during treatment with Dicloberl® N 75.
In the following cases, particularly careful monitoring by the attending physician is necessary:
Dicloberl® N 75 should not be injected into the site of inflammation or infection.
Severe acute hypersensitivity reactions (eg, anaphylactic shock) have been observed very rarely. When the first signs of a hypersensitivity reaction appear, Dicloberl® N 75 should be discontinued and professional treatment should be started in accordance with the developed symptoms.
Diclofenac may temporarily inhibit platelet aggregation. In this regard, it is necessary to monitor the condition of patients with bleeding disorders.
Like other NSAIDs, diclofenac can mask the manifestations of infection due to its pharmacodynamic properties. If, during treatment with Dicloberl® 75, symptoms of infection reappear or worsen, the patient is advised to immediately consult a doctor, who will determine whether there are indications for prescribing anti-infective therapy or antibiotic therapy.
During long-term treatment with diclofenac, kidney function and a complete blood count should be checked regularly.
With prolonged use of painkillers, headaches may occur. You should not try to eliminate headaches by increasing the dose of the drug.
With long-term use of painkillers, especially when combining several analgesic active ingredients, permanent kidney damage is possible with the risk of renal failure (analgesic nephropathy).
When NSAIDs and alcohol are combined, the undesirable effects of the active substance of the drug may be enhanced, especially on the gastrointestinal tract or central nervous system.
Impact on the ability to drive a car and maintain machinery.
When treated with Dicloberl® N 75 in high doses, side effects from the central nervous system such as increased fatigue and dizziness may occur; therefore, in some cases, patients may experience impaired reaction and deterioration in the ability to actively participate in street traffic and operate machinery. These phenomena intensify when the drug is combined with alcohol intake.
Popular questions about Dicloberl
What is Dicloberl from?
The medicine is used as an analgesic and anti-inflammatory agent. The drug is indicated for diseases of the musculoskeletal system, muscle pain, neuralgia, etc.
How to take Dicloberl?
Dikloberl injections are given intramuscularly. The tablets are taken with meals, without chewing and with a small amount of water. Suppositories are placed in the rectum after bowel movements. The dosage and course of treatment are determined by the attending physician.
How to inject Dicloberl ampoules?
Injections are placed in the upper outer region of the gluteal muscle. The daily dose of the drug is 1 ampoule.
How often can you inject Dikloberl?
The daily dose of analgesic (75 mg) is administered at one time. In case of emergency, the dose can be increased to 150 mg per day. The duration of the course is no more than 2 days. If the patient's condition does not improve, you need to switch to tablets, capsules or suppositories.
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
Note!
The description of the drug Dicloberl 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.