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ATC code:M MEDICINES AFFECTING THE MUSCULOSKOLE SYSTEM; M01 ANTI-INFLAMMATORY AND ANTIRHEUMATIC MEDICINES; M01A NON-STEROIDAL ANTI-INFLAMMATORY AND ANTIRHEUMATIC MEDICINES; M01A B Acetic acid derivatives and related compounds; M01A B05 Diclofenac
Main physicochemical properties: hard gelatin capsules from white to cream color (color not more intense than 9001 according to RAL) (capsule size 2). Contents: spherical granules from white to ivory color (color not more intense than 1014 according to RAL).
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A B05.
Pharmacological properties
Pharmacodynamics.
Diclofenac – the active ingredient of Dicloberl Retard, is a non-steroidal compound with pronounced antirheumatic, antipyretic, analgesic and anti-inflammatory properties. The main mechanism of action of diclofenac, established in experimental conditions, is considered to be inhibition of prostaglandin biosynthesis. Prostaglandins play an important role in the genesis of inflammation, pain and fever.
In vitro, diclofenac sodium at concentrations equivalent to those achieved in patients does not inhibit the biosynthesis of cartilage proteoglycans.
In rheumatic diseases, the anti-inflammatory and analgesic effect of Dicloberl Retard leads to a significant reduction in the severity of pain (both at rest and during movement), morning stiffness, swelling of the joints, and thereby to an improvement in the patient's functional state.
In the presence of inflammation caused by trauma or surgery, Dicloberl Retard quickly eliminates both spontaneous pain and pain during movement, and also reduces inflammatory tissue swelling and edema in the surgical wound area. When used simultaneously with opioids to eliminate postoperative pain, Dicloberl Retard significantly reduces the need for opioids.
In clinical studies, it was found that diclofenac also exhibits a strong analgesic effect in moderately to severely expressed pain of non-rheumatic origin.
Pharmacokinetics.
Analysis of unchanged diclofenac and its hydroxylated metabolites excreted in the urine showed that the amount of diclofenac released and absorbed was the same as when an equivalent dose of diclofenac sodium was administered as enteric-coated tablets. However, the systemic bioavailability of diclofenac (released from Dicloberl Retard) was on average 82% of that after the same dose of the enteric-coated Dicloberl Retard tablet. Due to the slow release of the active substance from Dicloberl Retard, the maximum plasma concentrations of the drug are lower than those achieved with enteric-coated tablets. The mean peak concentration of 0.4 μg/ml or 0.5 μg/ml (1.25 or 1.6 μmol/l) is achieved on average 5–6 hours after administration of a 75 mg or 100 mg tablet. Food intake does not clinically affect the absorption and systemic bioavailability of Dicloberl Retard. On the other hand, the average plasma concentration of 13 ng/ml (40 nmol/l) can be observed due to
24 hours (16 hours) after the use of diclofenac sodium in the prolonged form of 75 mg. The amount of absorbed active substance is linearly dependent on the dose of the drug. Since about half of diclofenac is metabolized during the first passage through the liver ("first-pass effect"), the area under the "concentration/time" curve (AUC) after the use of DicloberlÒ Retard capsules is almost half as small as in the case of parenteral administration of an equivalent dose of the drug. After repeated use of DicloberlÒ Retard, the pharmacokinetic parameters do not change. If the recommended intervals between taking individual doses of the drug are observed, cumulation is not observed. The corresponding concentrations are 22 ng/ml or 25 ng/ml (70 nmol/l or 80 nmol/l) when using diclofenac in the prolonged form of 75 mg 2 times a day.
Distribution.
99.7% of diclofenac is bound to serum proteins, mainly albumin (99.4%). The volume of distribution is 0.12–0.17 l/kg. Diclofenac penetrates into the synovial fluid, where its maximum concentration is noted 2–4 hours later than in blood plasma. The apparent half-life from the synovial fluid is 3–6 hours. 2 hours after reaching maximum concentrations in blood plasma, the concentration of the active substance in the synovial fluid is higher than in blood plasma and remains higher for 12 hours.
Biotransformation.
The biotransformation of diclofenac is carried out partly by glucuronidation of the unchanged molecule, but mainly by single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy-diclofenac), most of which are conjugated with glucuronic acid. Two of these phenolic metabolites are pharmacologically active, but to a much lesser extent than diclofenac.
The total systemic clearance of diclofenac from plasma is 263+56 ml/min. The terminal half-life in plasma is 1–2 hours. The half-life of 4 metabolites, including 2 pharmacologically active ones, is also short and is 1–3 hours. One of the metabolites, 3'-hydroxy-4'-methoxydiclofenac, has a longer half-life in plasma. However, this metabolite is completely pharmacologically inactive.
About 60% of the administered dose is excreted in the urine as glucuronide conjugates of the intact molecule of the active substance and as metabolites, most of which are also converted into glucuronide conjugates. Less than 1% of diclofenac is excreted unchanged. The remainder of the administered dose is excreted as metabolites through the bile and feces.
Pharmacokinetics in certain groups of patients.
The effect of patient age on the absorption, metabolism, and excretion of the drug has not been determined.
In patients with impaired renal function receiving therapeutic doses, no accumulation of unchanged active substance was observed. In patients with creatinine clearance less than
At 10 mL/min, the estimated steady-state plasma concentrations of hydroxylated metabolites were approximately 4-fold higher than in healthy subjects. However, all metabolites were ultimately excreted in the bile.
In patients with chronic hepatitis or compensated cirrhosis of the liver, the pharmacokinetics and metabolism of diclofenac are similar to those in patients without liver disease.
Indication
Pain relief and reduction of inflammation of varying degrees in various conditions, including:
· acute musculoskeletal diseases such as periarthritis (e.g., shoulder scapular periarthritis), tendonitis, tendovaginitis, bursitis;
· other pathological conditions caused by injuries, including fractures, back pain, sprains, dislocations, orthopedic, dental and other minor surgical interventions.
Contraindication
· Hypersensitivity to the active substance or to any other component of the drug.
· Acute gastric or intestinal ulcer; gastrointestinal bleeding or perforation, history of gastrointestinal bleeding or perforation after taking nonsteroidal anti-inflammatory drugs (NSAIDs), history of acute or recurrent gastric or intestinal ulcer.
· Dicloberl® Retard, like other NSAIDs, is contraindicated in patients who experience attacks of bronchial asthma, urticaria, or acute rhinitis in response to the use of acetylsalicylic acid or other NSAIDs.
Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Severe liver failure (Child-Pugh class C, cirrhosis or ascites).
Severe renal failure (creatinine clearance <30 ml/min).
Congestive heart failure (NYHA II–IV).
· Treatment of perioperative pain during coronary artery bypass grafting (or the use of a cardiopulmonary bypass machine).
· Ischemic heart disease in patients with angina pectoris who have had a myocardial infarction.
Cerebrovascular disease in patients who have had a stroke or have episodes of transient ischemic attacks.
· Peripheral artery disease.
· Third trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
The following interactions have been observed with diclofenac tablets coated with a gastro-resistant coating and/or other diclofenac dosage forms.
Lithium. When used simultaneously with Dicloberl Retard, lithium plasma concentrations may increase. It is recommended to monitor lithium plasma levels.
Digoxin. Dicloberl Retard may increase plasma digoxin concentrations when used concomitantly. Monitoring of plasma digoxin levels is recommended.
Diuretics and antihypertensive drugs. Like other NSAIDs, Dicloberl Retard may weaken the antihypertensive effect of concomitantly used diuretics or antihypertensive drugs (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors) by inhibiting the synthesis of vasodilator prostaglandins. Therefore, such a combination should be used with caution, and blood pressure should be regularly monitored in patients, especially the elderly. Patients should be adequately hydrated and renal function should be monitored at the beginning of combination therapy and regularly thereafter, in particular because of the increased risk of nephrotoxicity when diuretics and ACE inhibitors are used.
Anticoagulants and antithrombotic agents: Caution is recommended as concomitant use may increase the risk of bleeding.
Other NSAIDs, including selective cyclooxygenase-2 inhibitors and corticosteroids. Concomitant use of diclofenac and other systemic NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. The simultaneous use of two or more NSAIDs should be avoided. Concomitant use of diclofenac and corticosteroids may increase the frequency of adverse reactions.
Antidiabetic agents. Clinical studies have shown that Dicloberl Retard can be administered together with oral antidiabetic agents without affecting the clinical effect of the latter. However, isolated reports of both hypoglycemic and hyperglycemic reactions after the use of diclofenac have been received, requiring dose adjustment of the antidiabetic agent. For this reason, it is recommended to monitor blood glucose levels as a precautionary measure during combination therapy.
Methotrexate. Diclofenac may inhibit the renal tubular clearance of methotrexate, leading to increased methotrexate levels. NSAIDs, including diclofenac, should be used with caution when administered less than 24 hours before methotrexate treatment, as methotrexate blood levels may increase and methotrexate toxicity may be increased. Cases of serious toxicity have been observed when methotrexate and NSAIDs, including diclofenac, were administered less than 24 hours apart. This interaction is mediated by accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Cyclosporine: Diclofenac, like other NSAIDs, may potentiate the nephrotoxicity of cyclosporine through its effects on renal prostaglandins. Therefore, the drug should be used at lower doses than in patients not receiving cyclosporine.
Tacrolimus: There is a possible increased risk of nephrotoxicity when NSAIDs are administered concomitantly with tacrolimus. This may be mediated through the mechanism of inhibition of renal prostaglandins by both the NSAID and the calcineurin inhibitor.
Quinolone antibiotics. The interaction of quinolone antibiotics with NSAIDs may lead to the occurrence of seizures. This may occur in patients with or without a history of epilepsy or seizures. Therefore, quinolone antibiotics should be used with caution in patients already receiving NSAIDs.
Phenytoin: When phenytoin and diclofenac are used concomitantly, phenytoin plasma concentrations should be monitored, given the expected increase in phenytoin exposure.
Probenecid: Medicinal products containing probenecid may inhibit the excretion of diclofenac sodium.
Colestipol and cholestyramine: These drugs may delay or reduce the absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4-6 hours after administration of colestipol/cholestyramine.
Cardiac glycosides. Concomitant use of cardiac glycosides and NSAIDs in patients may exacerbate heart failure, decrease glomerular filtration rate (GFR), and increase plasma glycoside concentrations.
Mifepristone: NSAIDs should not be used for 8–12 days after taking mifepristone, as NSAIDs may reduce the effect of mifepristone.
Potent CYP2C9 inhibitors: It is recommended to use diclofenac with caution when co-administering potent CYP2C9 inhibitors (e.g. sulfinpyrazone and voriconazole) as this may lead to a significant increase in maximum plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.
Selective serotonin reuptake inhibitors (SSRIs).
Concomitant use of NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding.
Drugs that may cause hyperkalemia.
Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may cause an increase in serum potassium levels, which should be monitored.
Application features
- General
The concomitant use of Dicloberl Retard and systemic non-steroidal anti-inflammatory drugs, such as selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of any evidence of a synergistic effect and due to potential additive side effects.
Caution should be exercised in prescribing treatment to patients over 65 years of age in accordance with the recommendations for this patient group. In particular, it is recommended to use the minimum effective dose in frail elderly patients or patients with low body weight.
As with other NSAIDs, including diclofenac, allergic reactions, including anaphylactic/anaphylactoid reactions, may rarely occur, even when the drug is used for the first time.
Like other NSAIDs, diclofenac, due to its pharmacodynamic properties, may mask the symptoms of infection.
Dicloberl Retard contains sucrose, therefore it is not recommended for use in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.
Gastrointestinal bleeding (hematemesis, melena), ulceration or perforation, which can be fatal, have been reported with the use of non-steroidal anti-inflammatory drugs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events. In elderly patients, such complications are usually more serious. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be discontinued.
As with all NSAIDs, close medical supervision and special caution are required when prescribing diclofenac to patients with symptoms suggestive of gastrointestinal disorders or with a history of suspected gastric or intestinal ulcer, bleeding or perforation. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing doses of NSAIDs, including diclofenac, and in patients with a history of ulcer, particularly complicated by bleeding or perforation.
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
NSAIDs, including diclofenac, may be associated with an increased risk of gastrointestinal bleeding. Close supervision and caution are recommended when using diclofenac after gastrointestinal surgery.
To reduce the risk of gastrointestinal toxicity, patients with a history of ulcer, especially with bleeding or perforation, and elderly patients should be treated with the lowest effective dose.
Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for such patients, as well as for patients requiring concomitant use of low-dose acetylsalicylic acid (ASA)/aspirin-containing medicinal products or other medicinal products that may increase gastrointestinal risk.
Patients with a history of gastrointestinal toxicity, especially the elderly, should be monitored for unusual abdominal symptoms (especially gastrointestinal bleeding).
Caution should be exercised in patients receiving concomitant treatment with drugs that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid.
Close medical supervision and caution are required in patients with ulcerative colitis or Crohn's disease, as these conditions may be exacerbated.
- Hepatobiliary effects
Careful medical supervision is required if Dicloberl Retard is prescribed to patients with impaired liver function, as their condition may worsen.
As with other NSAIDs, one or more liver enzymes may increase. During long-term treatment with diclofenac, regular monitoring of liver function is indicated as a precautionary measure. If changes in liver function tests persist or worsen, clinical symptoms of liver disease appear or other manifestations are observed (eosinophilia, rash), the use of Dicloberl Retard should be discontinued. Hepatitis may develop during treatment with diclofenac without prodromal symptoms. Diclofenac should be used with caution in patients with hepatic porphyria, as it may cause exacerbation.
- Effect on kidneys
Since fluid retention and oedema have been reported with NSAIDs, including diclofenac, special caution should be exercised in patients with impaired cardiac or renal function, a history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that may significantly affect renal function, and patients with significant volume depletion from any cause, e.g. before or after major surgery. In such cases, monitoring of renal function is recommended as a precautionary measure when using diclofenac. After discontinuation of therapy, the patient's condition usually returns to pre-treatment levels.
- Effects on the skin
Serious skin reactions, some of which were fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely with NSAIDs, including Dicloberl Retard. The risk of these reactions is highest at the beginning of therapy, and the development of these reactions is noted in most cases in the first month of treatment. Dicloberl Retard should be discontinued at the first appearance of skin rash, mucosal ulceration or any other signs of hypersensitivity.
- SLE and mixed connective tissue diseases
Patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases may be at increased risk of aseptic meningitis.
Diclofenac should only be prescribed to patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes mellitus, smoking) after careful clinical evaluation. Since the cardiovascular risks of diclofenac may increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the lowest effective dose. The patient's need for diclofenac to relieve symptoms and the response to therapy should be periodically reviewed.
Appropriate medical supervision and advice is required in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and oedema have been reported with the use of NSAIDs, including diclofenac.
Clinical trial results and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg per day) and in long-term treatment, may be associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke).
Treatment with Dicloberl® Retard is contraindicated in patients with existing cardiovascular disease (congestive heart failure (NYHA II-IV), diagnosed ischemic heart disease, peripheral artery disease) or uncontrolled hypertension. If necessary, patients with existing cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) may use Dicloberl® Retard only after careful consideration and only in daily doses ≤ 100 mg if treatment is continued for more than 4 weeks.
Patients requiring symptomatic treatment should be periodically examined, especially when treated for longer than 4 weeks.
Patients should be informed about the symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurred speech), which may occur suddenly.
- Hematological manifestations
During long-term treatment with diclofenac, as with other NSAIDs, blood tests to determine the number of formed elements are recommended.
Dicloberl Retard may reversibly inhibit platelet aggregation. Patients with hemostatic disorders, hemorrhagic diathesis or hematological abnormalities require careful monitoring.
- Respiratory effects (if asthma is present)
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if associated with symptoms similar to allergic rhinitis), reactions to NSAIDs similar to asthma exacerbations (so-called aspirin-induced asthma with intolerance to analgesics), angioedema and urticaria are observed more frequently than in other patients. In this regard, special precautions (emergency medical assistance readiness) are recommended for such patients. This also applies to patients who have allergic reactions to other substances, such as rash, itching or urticaria.
General.
Acute hypersensitivity reactions (e.g. anaphylactic shock) are rare. At the first signs of a hypersensitivity reaction after using Dicloberl® Retard, therapy should be discontinued.
Hypersensitivity reactions may also progress to Kounis syndrome, a serious allergic reaction that can cause myocardial infarction. Symptoms of such reactions may include chest pain that occurs in conjunction with an allergic reaction to diclofenac.
With prolonged use of painkillers, a headache may occur, which should not be treated by increasing the dose of the drug.
With concomitant use of alcohol, adverse reactions associated with the action of the active substance, especially those affecting the gastrointestinal tract or the central nervous system (CNS), may be exacerbated by the use of NSAIDs.
Use during pregnancy or breastfeeding
Pregnancy
Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryonal/foetal development. Epidemiological data suggest an increased risk of miscarriage and/or cardiac malformations and gastroschisis following exposure to prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%.
The risk is believed to increase with increasing dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has resulted in increased pre- and post-implantation fetal death and embryo-fetal lethality.
In addition, in animals treated with prostaglandin synthesis inhibitors during the period of organogenesis, the incidence of various malformations, including cardiovascular, was increased. If Dicloberl Retard is administered to women planning pregnancy, or during the first trimester of pregnancy, the dose should be as low and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may affect the fetus in the following ways:
– cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
– impaired renal function, which may progress to renal failure with oligohydramnios (see above);
effects on the mother at the end of pregnancy and the newborn:
– possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses;
– inhibition of uterine contractions, which leads to delayed or prolonged labor.
Therefore, Dicloberl Retard is contraindicated in the third trimester of pregnancy (see the section "Contraindications").
Breast-feeding
Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, in order to prevent the development of adverse reactions in infants, this drug is contraindicated during breastfeeding.
Female fertility
As with other NSAIDs, diclofenac may impair female fertility and is therefore not recommended in women attempting to conceive. Discontinuation of diclofenac should be considered in women who are unable to conceive or in women undergoing investigation of infertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients who experience dizziness or other adverse effects from the CNS, including visual disturbances, while taking Dicloberl Retard are not recommended to drive or operate machinery.
Method of administration and doses
The dose should be selected individually, starting with the minimum effective dose, and should be used for the shortest possible period.
The recommended initial dose of diclofenac for adults is 75–150 mg per day (1 capsule of Dicloberl Retard 100 mg) depending on the severity of the symptoms of the disease. For long-term therapy, 1 capsule of Dicloberl Retard 100 mg per day is usually sufficient. If the symptoms of the disease are most pronounced at night or in the morning, Dicloberl Retard should be used in the evening. The daily dose of the drug should not exceed 150 mg. The capsules should be swallowed whole, without chewing, with liquid, preferably during meals.
Elderly patients: No clinically significant changes in pharmacokinetics have been observed when Dicloberl Retard is administered to elderly patients. However, NSAIDs should be used with caution in elderly patients, as they are more susceptible to adverse reactions. It is recommended to use the minimum effective dose in elderly patients or patients with low body weight, as well as in patients who require constant monitoring for possible gastrointestinal bleeding during the use of NSAIDs.
Existing cardiovascular disease or significant risk factors.
Treatment with Dicloberl Retard is generally contraindicated in patients with pre-existing cardiovascular disease or uncontrolled hypertension. If necessary, Dicloberl Retard should be used in patients with pre-existing cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease only after careful consideration and only at daily doses ≤100 mg if treatment is continued for more than 4 weeks.
Patients with renal impairment.
No specific studies have been conducted in patients with renal impairment and no dose adjustment recommendations are available. Dicloberl Retard should be used with caution in patients with moderate or severe renal impairment.
Patients with impaired liver function.
Specific studies in patients with hepatic impairment have not been conducted and no dose adjustment recommendations are available. Dicloberl Retard should be administered with caution to patients with moderate or severe hepatic impairment.
Children
Dicloberl Retard is contraindicated for the treatment of children due to the high content of the active substance.
Overdose
There is no typical clinical picture of diclofenac overdose. Overdose may cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, tinnitus, or convulsions. Acute renal failure and liver damage are possible in severe intoxication.
Treatment.
Treatment of acute poisoning with NSAIDs, including diclofenac, consists of supportive and symptomatic therapy. This applies to the treatment of manifestations such as arterial hypotension, renal failure, convulsions, gastrointestinal disorders, respiratory depression. It is unlikely that such specific therapeutic measures as forced diuresis, dialysis or hemoperfusion will be effective in removing NSAIDs, including diclofenac, since the active substances of these drugs are largely bound to blood proteins and undergo intensive metabolism. Activated charcoal may be used after the use of potentially toxic doses, and gastric decontamination (e.g., induction of vomiting, gastric lavage) after the use of potentially life-threatening doses.
Adverse reactions
The frequency category of adverse reactions is defined as follows: very common (> 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), unknown, including isolated reports.
The following undesirable effects include those associated with administration under conditions of short-term and long-term use.
Blood and lymphatic system disorders
Very rare
Thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis
On the part of the immune system
Rarely
Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock)
Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, loss of appetite
Rarely
Gastritis, gastrointestinal bleeding, hematemesis, hemorrhagic diarrhea, melena, gastric and intestinal ulcers with or without bleeding or perforation (sometimes fatal, especially in elderly patients)
Very rare
Colitis (including hemorrhagic colitis, and exacerbation of ulcerative colitis or Crohn's disease), including
Specifications
Characteristics
Active ingredient
Diclofenac sodium
Adults
Can
ATC code
M MEDICINES AFFECTING THE MUSCULOSKOLE SYSTEM; M01 ANTI-INFLAMMATORY AND ANTIRHEUMATIC MEDICINES; M01A NON-STEROIDAL ANTI-INFLAMMATORY AND ANTIRHEUMATIC MEDICINES; M01A B Acetic acid derivatives and related compounds; M01A B05 Diclofenac
Country of manufacture
Germany
Diabetics
With caution
Dosage
100 мг
Drivers
With caution
For allergies
With caution
For children
It is impossible.
Form
Capsules
Method of application
Inside, hard, prolonged
Nursing
It is impossible.
Pregnant
It is impossible.
Primary packaging
blister
Producer
Berlin-Chemie AG
Quantity per package
20 pcs
Trade name
Dicloberl
Vacation conditions
By prescription
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