Ukraine Product

Diclotol Tablet

Diclotol Tablet

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Symptomatic treatment of pain syndrome and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, as well as other diseases of the musculoskeletal system, accompanied by pain (eg, shoulder-palpation periarthritis or extra-articular rheumatism).As an analgesic with conditions accompanied by pain (including pain in the lumbar, dental pain and primary (functional) dysmenorrhea).

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

    • Gastrointestinal tract: dyspepsia, abdominal pain, nausea, vomiting, blood vomiting, gastritis, gastrointestinal ulcer, flatulence, diarrhea, constipation, melena, hemorrhagic diarrhea, gastrointestinal hemorrhage, gastrointestinal bleeding, perforation of the gastrointestinal tract , exacerbation of Crohn's disease and ulcerative colitis, stomatitis, pancreatitis.
    • Blood system and lymphatic system: anemia, hemolytic anemia, bone marrow suppression, aplastic anemia, granulocytopenia, agranulocytosis, thrombocytopenia, neutropenia, increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
    • Immune system: hypersensitivity reactions; anaphylactic reactions (including shock); pseudoallergic reactions manifested as anaphylactic reactions, reactivity of the airways including asthma, worsening of asthma, bronchospasm or dyspnoea, various skin reactions including rashes of various types, pruritus, urticaria, purpura, anhioedemy, at least - and exfoliative bullous dermatitis (including epidermal necrolysis and erythema multiforme).
    • Metabolism and nutrition: hyperkalaemia.
    • Psychic disorders: depression, unusual dreams, insomnia.
    • Nervous system disorders: dizziness, paresthesia, tremor, drowsiness, headache, dysgeusia (taste disorder), cases of aseptic meningitis (especially in patients with autoimmune disorders such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as numbness ( Rigidity) neck muscles, fever, disorientation, confusion, hallucinations, malaise.
    • Vision disorders: visual impairment, optic neuritis.
    • Acoustic organs and vestibular apparatus: vertigo, ringing in the ears.
    • Cardiovascular system disorders: heart palpitations, heart failure, arterial hypertension, deterioration of arterial hypertension, hyperemia, tides, vasculitis.
    • Respiratory system, the chest and mediastinum: shortness of breath, bronchospasm, stridor.
    • Liver and the biliary system disorders: liver damage (including hepatitis), jaundice.
    • Skin and subcutaneous tissue: itching, rash, dermatitis, urticaria, angioedema, purpura, eczema, severe skin and mucous membrane reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), photosensitization, skin infections, and m 'Which tissues (when using NSAIDs during the sickle of the chickenpox).
    • Kidneys and the urinary system disorders: nephrotic syndrome, renal failure, interstitial nephritis.
    • General disorders and local reactions: edema, increased fatigue, muscle cramps (at the legs).
    • Results of the laboratory tests: increased activity of liver enzymes, increased activity of alkaline phosphatase in the blood, increased urea concentration in the blood, increased creatinine in the blood, increased body mass.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

The undesirable effects can be minimized by the short-term use of a lower effective dose for symptom control (see below the risks associated with the gastrointestinal tract and the cardiovascular system). Concomitant use of Diclotol and NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Effect on the gastrointestinal tract
Bleeding, ulceration or perforation of the gastrointestinal tract with a lethal effect were observed in the administration of all NSAIDs in any treatment period, both in the presence of and without dangerous symptoms, regardless of the presence of a history of severe acute-intestinal disease.
The risk of bleeding, ulceration and perforation of the gastrointestinal tract increases with an increase in the dose of NSAIDs in patients with a history of ulcer, especially if accompanied by hemorrhage or perforation (see section "Contraindications") and in elderly patients. These patients should receive the minimum effective dose of the drug. They need combined therapy with the use of protective agents (e.g. misoprostol or proton pump inhibitors), and similar therapy is required for patients who use small doses of acetylsalicylic acid (aspirin) or other drugs that have a negative effect on the state of the gastrointestinal tract (see section "Interaction with other medicines and other types of interactions ").
Patients with diseases of the digestive tract, including the elderly, should be informed of any unusual symptoms associated with the gastrointestinal tract (including gastrointestinal bleeding), including the initial stage of treatment. Particular care should be taken in patients taking concomitant medications that increase the risk of bleeding or ulcers, such as systemic corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiagregants (such as acetylsalicylic acid) (see section "Interaction with other medicines and other types of interactions ").
In case of bleeding or ulcers of the gastrointestinal tract in patients taking Diclotol®, treatment should be discontinued.
Cardiovascular and cerebrovascular effects
Appropriate monitoring and special instructions are required for patients with arterial hypertension and / or congestive heart failure of mild to moderate hepatic status, as fluid fluid retention and edema associated with NSAIDs have been reported. Clinical studies and epidemiological data showing that some NSAIDs (particularly at high doses and prolonged use) slightly increased risk of arterial thrombotic events (e.g.  myocardial infarction or stroke).
Patients with heart failure (functional class I for NYHA), with risk factors for cardiovascular (e.g. hypertension, hyperlipidemia, diabetes and smoking) should observe extreme caution when taking aceclofenac. Since the adverse effect on the cardiovascular system increases with increasing dosage and duration of treatment, the minimum effective daily dose should be used as soon as possible. The need for further symptomatic treatment of the patient and the effectiveness of therapy should be periodically reviewed.
Aceclofenac should be used with caution and under close medical supervision for patients under the following conditions (since there is a risk of exacerbation of the disease) (see section "Adverse reactions"):
- symptoms that indicate the presence of a gastrointestinal tract infection, including its upper and lower divisions;
- history of ulceration, bleeding or perforation of the gastrointestinal tract;
- ulcerative colitis;
- Crohn's disease;
- Proliferation to bleeding, SLE (systemic lupus erythematosus), porphyria and haemopoiesis and hemostasis.
Effect on the liver and kidneys
Receiving NSAIDs may cause dose-dependent reduction of prostaglandin formation and sudden renal insufficiency. The importance of prostaglandins for renal blood flow should be taken into account when administering the drug to patients with impaired function of the heart, kidneys or liver, diuretics, patients after surgery, and elderly patients.
Caution should be exercised when using the drug for patients with mild or moderate liver and kidney function, as well as for patients with other conditions that are accompanied by fluid retention in the body. In these patients, the use of NSAIDs may cause renal dysfunction and fluid retention. Caution should also be exercised when Diclotol® is used in patients taking diuretics or those with a high risk of hypovolemia. Requires a minimum effective dose and regular medical monitoring of kidney function. Renal effects usually end after the withdrawal of aceclofenac.
The use of aceclofenac should be discontinued if the liver function deviation is maintained or increased, clinical symptoms of liver disease develop or other manifestations develop (eosinophilia, rash). Hepatitis can develop without prodrome symptoms. The use of NSAIDs in patients with hepatic porphyria may provoke an attack.
Systemic lupus erythematosus and mixed connective tissue disease
Patients with systemic lupus erythematosus and mixed connective tissue diseases increase the risk of aseptic meningitis (see section "Adverse reactions").
Hypersensitivity and skin reactions
Like other NSAIDs, Diclotol® can cause allergic reactions, including anaphylactic/anaphylactoid reactions, even if the drug is taken for the first time. Severe skin reactions (some of which may lead to death), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, were observed very rarely after NSAID administration (see section "Adverse reactions"). The highest risk of these reactions in patients is observed at the beginning of the drug, and the development of these undesirable reactions is observed during the first month of drug administration. In case of skin rash, damage to the mucous membrane of the mouth or other signs of hypersensitivity, you should stop taking aceclofenac.
In special cases, wind wicks may have complications: severe skin and soft tissue infections. At this time, the role of NSAIDs can not be ruled out for the deterioration of the course of these infections. Therefore, the use of Diklotol® with wind wool should be avoided.
Hematologic disorders
Aceclofenac may cause reversible inhibition of platelet aggregation (see section "Adverse reactions").
Respiratory system adverse reactions
Caution should be exercised when taking the drug in patients with bronchial asthma, including in the history, as taking NSAIDs can provoke the development of sudden bronchoconstriction in such patients.
Elderly patients
Caution should be exercised when using the product for the elderly (aged 65 years), since they often have side effects (especially bleeding, perforation of the gastrointestinal tract) when receiving NSAIDs. Complications can be lethal. In addition, older patients are more likely to suffer from diseases of the kidneys, liver or cardiovascular system.
Long-term application
All patients who receive long-term treatment of NSAIDs should be under close medical supervision (general blood tests, functional liver and kidney tests).

What to do if you accidentally take too much (overdose) of the medicine?

There is no data on overdose with aceclofenac in humans.
Possible symptoms
Headache, nausea, vomiting, stomach ache, dizziness, drowsiness, irritation of the gastrointestinal tract, gastrointestinal bleeding, diarrhea, disorientation, excitement, coma, ringing in the ears, arterial hypotension, respiratory depression, loss of consciousness, convulsions. In cases of severe poisoning, acute renal failure and damage to the liver function may occur.
Treatment
Treatment of acute poisoning of NSAIDs involves the use of antacids (if necessary) and other maintenance and symptomatic treatment of complications such as arterial hypotension, renal failure, seizures, irritation of the gastrointestinal mucosa and respiratory depression.
Treatment of acute poisoning when taking aceclofenac inside is to prevent absorption of the drug through gastric lavage and the use of activated charcoal (repeated doses) in the shortest possible time after an overdose. Forced diuresis, dialysis, or hemoperfusion may not be sufficiently effective in eliminating NSAIDs due to the high degree of binding of NSAIDs to blood proteins and extensive metabolisms.

Is it safe in pregnancy and breast-feeding?

Pregnancy
There is no data on the use of aceclofenac in pregnancy.The inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or the development of the embryo/fetus.Data from epidemiological studies indicate increased risk of miscarriage, heart disease and gastroschisis after the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The absolute risk of developing heart disease increases from less than 1% to about 1.5%. The risk increases with increasing dose and duration of treatment.
In animals, the intake of prostaglandin synthesis inhibitors leads to pre- and post-implantation fetal death and fetal mortality. In addition, animals that receive prostaglandin synthesis inhibitors increase the incidence of various congenital malformations, including heart disease, during organogenesis.
During the 1st and 2nd trimesters of pregnancy, preparations containing aceclofenac should not be prescribed without urgent need. If aceclofenac is taken by a woman who is planning a pregnancy or is in the 1st or 2nd trimester of pregnancy, the dose should be as low as possible and the duration of treatment should be as short as possible.
During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus, causing:
-  Cardio-pulmonary toxicity (premature closure of arterial duct and pulmonary hypertension);
- Renal dysfunction, which may progress to renal insufficiency in the background of malnutrition.
The use of aceclofenac at the end of pregnancy can lead to:
- increasing the duration of bleeding, decrease in the ability to platelet aggregation, even with the application of very low doses of the drug;
- Inhibition of contractile function of the uterus, which can lead to an increase in the duration of labor.
Thus, the use of aceclofenac is contraindicated in the third trimester of pregnancy.

Breast feeding period
The limited amount of available data suggests that NSAIDs are found in breast milk at very low concentrations. There is no conclusive clinical data on the penetration of aceclofenac in breast milk. Therefore, the drug is contraindicated in women during breastfeeding, in order to avoid undesirable effects on the child.

Storage Conditions:

Store at a temperature below 25 °C in original package.
Keep it out of reach of children.

Drug Description

Composition:
Active substance: aceclofenac;
1 tablet contains 100 mg of aceclofenac;
excipients: microcrystalline cellulose, сroscarmellose sodium, silicon dioxide colloidal, stearic acid, Opadry-YS-1-7027 White (hydroxypropylmethylcellulose), titanium dioxide (E 171), triacetin).

Dosage form. Film coated tablets.
Basic physical and chemical properties: round biconvex tablets coated with white color.


Indications and dosage.

Indications
Symptomatic treatment of pain syndrome and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, as well as other diseases of the musculoskeletal system, accompanied by pain (eg, shoulder-palpation periarthritis or extra-articular rheumatism).
As an analgesic with conditions accompanied by pain (including pain in the lumbar, dental pain and primary (functional) dysmenorrhea).

Dosage:
Diclotol®, film coated tablets, are intended for oral administration and should be washed at least ½ cup liquids. It is desirable to take Diclotol®  with food.
Undesirable effects can be minimized if the duration of the drug is the smallest necessary to control the symptoms (see section "Peculiarities of use").
Adults
The maximum recommended dose is 200 mg per day for 2 doses of 100 mg (1 tablet in the morning and 1 tablet in the evening).
Elderly patients
Such patients should be taken to monitor the condition of, as they are more likely to experience impaired kidney function, liver function, cardiovascular disorders, and they are more likely to receive concomitant therapy with other diseases, which increases the risk of serious adverse reactions. If necessary, the use of NSAIDs should be used in minimal doses and for the shortest possible time. As a rule, no dose reduction is required. Careful observation of patients for the timely detection of gastrointestinal bleeding against the background of NSAID therapy, as well as the recommendations described in the section "Peculiarities of use".
Hepatic failure
For patients with mild or moderate hepatic failure, the dose of aceclofenac should be reduced. The recommended starting dose is 100 mg per day (see section "Peculiarities of use").
Renal failure
There is no information that a dose adjustment of aceclofenac is required in patients with mild renal failure, but these patients should be careful when using the drug (see section "Peculiarities of use").
Children.
DiclotolÒ  is contraindicated in children.

Side effects and drug interactions.

Side effect

  • Gastrointestinal tract: dyspepsia, abdominal pain, nausea, vomiting, blood vomiting, gastritis, gastrointestinal ulcer, flatulence, diarrhea, constipation, melena, hemorrhagic diarrhea, gastrointestinal hemorrhage, gastrointestinal bleeding, perforation of the gastrointestinal tract , exacerbation of Crohn's disease and ulcerative colitis, stomatitis, pancreatitis.
  • Blood system and lymphatic system: anemia, hemolytic anemia, bone marrow suppression, aplastic anemia, granulocytopenia, agranulocytosis, thrombocytopenia, neutropenia, increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
  • Immune system: hypersensitivity reactions; anaphylactic reactions (including shock); pseudoallergic reactions manifested as anaphylactic reactions, reactivity of the airways including asthma, worsening of asthma, bronchospasm or dyspnoea, various skin reactions including rashes of various types, pruritus, urticaria, purpura, anhioedemy, at least - and exfoliative bullous dermatitis (including epidermal necrolysis and erythema multiforme).
  • Metabolism and nutrition: hyperkalaemia.
  • Psychic disorders: depression, unusual dreams, insomnia.
  • Nervous system disorders: dizziness, paresthesia, tremor, drowsiness, headache, dysgeusia (taste disorder), cases of aseptic meningitis (especially in patients with autoimmune disorders such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as numbness ( Rigidity) neck muscles, fever, disorientation, confusion, hallucinations, malaise.
  • Vision disorders: visual impairment, optic neuritis.
  • Acoustic organs and vestibular apparatus: vertigo, ringing in the ears.
  • Cardiovascular system disorders: heart palpitations, heart failure, arterial hypertension, deterioration of arterial hypertension, hyperemia, tides, vasculitis.
  • Respiratory system, the chest and mediastinum: shortness of breath, bronchospasm, stridor.
  • Liver and the biliary system disorders: liver damage (including hepatitis), jaundice.
  • Skin and subcutaneous tissue: itching, rash, dermatitis, urticaria, angioedema, purpura, eczema, severe skin and mucous membrane reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), photosensitization, skin infections, and m 'Which tissues (when using NSAIDs during the sickle of the chickenpox).
  • Kidneys and the urinary system disorders: nephrotic syndrome, renal failure, interstitial nephritis.
  • General disorders and local reactions: edema, increased fatigue, muscle cramps (at the legs).
  • Results of the laboratory tests: increased activity of liver enzymes, increased activity of alkaline phosphatase in the blood, increased urea concentration in the blood, increased creatinine in the blood, increased body mass.

 

Drug interactions
Due to the lack of studies on the pharmacokinetic interaction of aceclofenac, the following information is based on data from other NSAIDs.
Other analgesics, NSAIDs, including selective inhibitors of cyclooxygenase-2.
Concomitant use of two or more NSAIDs (including acetylsalicylic acid) should be avoided because it increases the incidence of side effects, including the risk of gastrointestinal bleeding.
Antihypertensive drugs.
NSAIDs can also reduce the effect of antihypertensive drugs. Concomitant use of ACE inhibitors or angiotensin II receptor antagonists and NSAIDs may lead to renal impairment. The risk of acute renal failure, which is usually reversible, is increasing in some patients with impaired renal function, such as in elderly patients or dehydrated patients. Therefore, caution should be exercised when using NSAIDs at the same time, especially for elderly patients. Patients should consume the required amount of fluid and be under proper supervision (monitoring the function of the kidneys at the beginning of co-administration and periodically during treatment).
Diuretics
Reducing the effect of diuretics. Diuretics may increase the risk of nephrotoxicity when taking NSAIDs. Although the concomitant use with benfrolazid did not affect blood pressure monitoring, interactions with other diuretics should not be excluded. When administered concomitantly with potassium-sparing diuretics, it is necessary to monitor the content of potassium in serum.
Heart glycosides.
NSAIDs can exacerbate heart failure, reduce glomerular filtration rates, and increase levels of glycosides in plasma.
Preparations of lithium and digoxin.
Some NSAIDs inhibit renal clearance of lithium and digoxin, which leads to an increase in blood serum concentrations of both substances. Concomitant use should be avoided unless frequent monitoring of lithium and digoxin concentrations.
Methotrexate.
Reducing elimination of methotrexate. Possible interaction of NSAIDs and methotrexate, even at low doses of methotrexate, especially in patients with impaired kidney function. At the same time, the indicators of kidney function should be monitored. Caution should be taken if NSAIDs and methotrexate are taken within 24 hours, as the concentration of methotrexate may increase, which will increase the toxicity of this drug.
Mifepriston
NSAIDs should not be taken within 8-12 days after taking mifepristone, since NSAIDs can reduce the effect of mifepristone.
Corticosteroids
The risk of ulceration and bleeding from the gastrointestinal tract (GIT) increases (see section "Peculiarities of use").
Anticoagulants
NSAIDs can increase the effect of such anticoagulants such as warfarin. Careful monitoring of the condition of patients receiving combination therapy with anticoagulants and Diclotol is required.
Antibiotics of the quinoline group.
The results of animal experiments indicate that NSAIDs can increase the risk of developing a vessel associated with the administration of antibiotics to the quinolone group. Patients taking NSAIDs and quinolones may have an increased risk of developing the disease.
Antithrombotic agents and selective serotonin reuptake inhibitors (СI33C).
The risk of bleeding from the gastrointestinal tract increases (see section "Peculiarities of use").
Ciclosporin, tacrolimus.
When NSAIDs are co-administered with cyclosporine or tacrolimus, the risk of elevated nephrotoxicity should be taken into account because of a decrease in the formation of renal prostacyclin. Therefore, at the same time, the kidney function should be carefully monitored.
Zidovudin
With the simultaneous administration of NSAIDs and zidovudine, the risk of hematologic toxicity increases. There is evidence of an increased risk of hemarthrosis and hematoma in HIV (+) - patients with hemophilia receiving zidovudine and ibuprofen.
Hypoglycemic agents.
Clinical trials show that diclofenac can be used in conjunction with oral hypoglycemic agents without affecting their clinical effect. However, there are separate reports of hypoglycemic and hyperglycemic effects of the drug. Thus, when taking aceclofenac, dose adjustments should be made which may cause hypoglycemia.

 

Warnings and precautions

The undesirable effects can be minimized by the short-term use of a lower effective dose for symptom control (see below the risks associated with the gastrointestinal tract and the cardiovascular system). Concomitant use of Diclotol and NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Effect on the gastrointestinal tract
Bleeding, ulceration or perforation of the gastrointestinal tract with a lethal effect were observed in the administration of all NSAIDs in any treatment period, both in the presence of and without dangerous symptoms, regardless of the presence of a history of severe acute-intestinal disease.
The risk of bleeding, ulceration and perforation of the gastrointestinal tract increases with an increase in the dose of NSAIDs in patients with a history of ulcer, especially if accompanied by hemorrhage or perforation (see section "Contraindications") and in elderly patients. These patients should receive the minimum effective dose of the drug. They need combined therapy with the use of protective agents (e.g. misoprostol or proton pump inhibitors), and similar therapy is required for patients who use small doses of acetylsalicylic acid (aspirin) or other drugs that have a negative effect on the state of the gastrointestinal tract (see section "Interaction with other medicines and other types of interactions ").
Patients with diseases of the digestive tract, including the elderly, should be informed of any unusual symptoms associated with the gastrointestinal tract (including gastrointestinal bleeding), including the initial stage of treatment. Particular care should be taken in patients taking concomitant medications that increase the risk of bleeding or ulcers, such as systemic corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiagregants (such as acetylsalicylic acid) (see section "Interaction with other medicines and other types of interactions ").
In case of bleeding or ulcers of the gastrointestinal tract in patients taking Diclotol®, treatment should be discontinued.

Cardiovascular and cerebrovascular effects
Appropriate monitoring and special instructions are required for patients with arterial hypertension and / or congestive heart failure of mild to moderate hepatic status, as fluid fluid retention and edema associated with NSAIDs have been reported. Clinical studies and epidemiological data showing that some NSAIDs (particularly at high doses and prolonged use) slightly increased risk of arterial thrombotic events (e.g.  myocardial infarction or stroke).
Patients with heart failure (functional class I for NYHA), with risk factors for cardiovascular (e.g. hypertension, hyperlipidemia, diabetes and smoking) should observe extreme caution when taking aceclofenac. Since the adverse effect on the cardiovascular system increases with increasing dosage and duration of treatment, the minimum effective daily dose should be used as soon as possible. The need for further symptomatic treatment of the patient and the effectiveness of therapy should be periodically reviewed.
Aceclofenac should be used with caution and under close medical supervision for patients under the following conditions (since there is a risk of exacerbation of the disease) (see section "Adverse reactions"):
- symptoms that indicate the presence of a gastrointestinal tract infection, including its upper and lower divisions;
- history of ulceration, bleeding or perforation of the gastrointestinal tract;
- ulcerative colitis;
- Crohn's disease;
- Proliferation to bleeding, SLE (systemic lupus erythematosus), porphyria and haemopoiesis and hemostasis.
Effect on the liver and kidneys
Receiving NSAIDs may cause dose-dependent reduction of prostaglandin formation and sudden renal insufficiency. The importance of prostaglandins for renal blood flow should be taken into account when administering the drug to patients with impaired function of the heart, kidneys or liver, diuretics, patients after surgery, and elderly patients.
Caution should be exercised when using the drug for patients with mild or moderate liver and kidney function, as well as for patients with other conditions that are accompanied by fluid retention in the body. In these patients, the use of NSAIDs may cause renal dysfunction and fluid retention. Caution should also be exercised when Diclotol® is used in patients taking diuretics or those with a high risk of hypovolemia. Requires a minimum effective dose and regular medical monitoring of kidney function. Renal effects usually end after the withdrawal of aceclofenac.
The use of aceclofenac should be discontinued if the liver function deviation is maintained or increased, clinical symptoms of liver disease develop or other manifestations develop (eosinophilia, rash). Hepatitis can develop without prodrome symptoms. The use of NSAIDs in patients with hepatic porphyria may provoke an attack.
Systemic lupus erythematosus and mixed connective tissue disease
Patients with systemic lupus erythematosus and mixed connective tissue diseases increase the risk of aseptic meningitis (see section "Adverse reactions").
Hypersensitivity and skin reactions
Like other NSAIDs, Diclotol® can cause allergic reactions, including anaphylactic/anaphylactoid reactions, even if the drug is taken for the first time. Severe skin reactions (some of which may lead to death), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, were observed very rarely after NSAID administration (see section "Adverse reactions"). The highest risk of these reactions in patients is observed at the beginning of the drug, and the development of these undesirable reactions is observed during the first month of drug administration. In case of skin rash, damage to the mucous membrane of the mouth or other signs of hypersensitivity, you should stop taking aceclofenac.
In special cases, wind wicks may have complications: severe skin and soft tissue infections. At this time, the role of NSAIDs can not be ruled out for the deterioration of the course of these infections. Therefore, the use of Diklotol® with wind wool should be avoided.
Hematologic disorders
Aceclofenac may cause reversible inhibition of platelet aggregation (see section "Adverse reactions").
Respiratory system adverse reactions
Caution should be exercised when taking the drug in patients with bronchial asthma, including in the history, as taking NSAIDs can provoke the development of sudden bronchoconstriction in such patients.
Elderly patients
Caution should be exercised when using the product for the elderly (aged 65 years), since they often have side effects (especially bleeding, perforation of the gastrointestinal tract) when receiving NSAIDs. Complications can be lethal. In addition, older patients are more likely to suffer from diseases of the kidneys, liver or cardiovascular system.
Long-term application
All patients who receive long-term treatment of NSAIDs should be under close medical supervision (general blood tests, functional liver and kidney tests).

 

Overdosage and Contraindications

Overdose
Possible symptoms
Headache, nausea, vomiting, stomach ache, dizziness, drowsiness, irritation of the gastrointestinal tract, gastrointestinal bleeding, diarrhea, disorientation, excitement, coma, ringing in the ears, arterial hypotension, respiratory depression, loss of consciousness, convulsions. In cases of severe poisoning, acute renal failure and damage to the liver function may occur.
Treatment
Treatment of acute poisoning of NSAIDs involves the use of antacids (if necessary) and other maintenance and symptomatic treatment of complications such as arterial hypotension, renal failure, seizures, irritation of the gastrointestinal mucosa and respiratory depression.
Treatment of acute poisoning when taking aceclofenac inside is to prevent absorption of the drug through gastric lavage and the use of activated charcoal (repeated doses) in the shortest possible time after an overdose. Forced diuresis, dialysis, or hemoperfusion may not be sufficiently effective in eliminating NSAIDs due to the high degree of binding of NSAIDs to blood proteins and extensive metabolisms.

Contraindication

    • Hypersensitivity to aceclofenac, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the auxiliary components of the drug;
    • asthma attacks, acute rhinitis, angioneurotic edema, or urticaria caused by acetylsalicylic acid or other NSAIDs;
    • gastrointestinal bleeding or perforation of an ulcer in a history associated with pre-treatment of NSAIDs;
    • peptic ulcer or bleeding, including anamnesis (two or more isolated proven episodes of ulceration or bleeding);
    • acute bleeding or illness accompanied by bleeding (hemophilia or disturbance of blood coagulation);
    • congestive heart failure (functional class II-IV for NYHA); Ischemic heart disease, including angina or transient myocardial infarction; peripheral arterial disease;
    • cerebrovascular disorders or diseases; Stroke or episodes of transient ischemic attacks in history;
    • aortic coronary artery bypass grafting (for the relief of perioperative pain) or use of a device for artificial blood circulation);
    • severe liver failure;
    • Severe renal failure.

Clinical pharmacology.

Pharmacotherapeutic group: Nonsteroidal antiphlogistic and antirheumatic drug.
Derivative from acetic acid and related materials.
АТС Code М01А В16.

Pharmacological properties.
Pharmacodynamics:
Aceclofenac is a non-steroidal anti-inflammatory and analgesic agent. It is believed that the mechanism of action of this drug is based on the inhibition of the synthesis of prostaglandin.

Pharmacokinetics.
Absorption
After oral administration, aceclofenac is rapidly absorbed, its bioavailability is almost 100%. Peak concentration in blood plasma is reached approximately after 1.25-3 hours after taking. Food intake slows down absorption, but does not affect its degree.
Distribution
Aceclofenac is highly bound to plasma proteins (> 99.7%). Aceclofenac penetrates synovial fluid, where concentration reaches approximately 60% of plasma concentration. The volume of distribution is about 30 liters.
Breeding
The average half-life is 4-4.3 hours. Clearance is 5 liters per hour. Approximately two-thirds of the dose is excreted in urine, preferably in the form of conjugated hydroxymetabolites. Only 1% of the single oral dose is excreted unchanged.
Aceclofenac is expected to be metabolised by CYP2C9 to the main metabolite of 4-OH-aceclofenac, whose clinical effect is not significant. Diclofenac and 4-OH-diclofenac were found among many metabolites.
Special populations
No changes in the pharmacokinetics of aceclofenac have been observed in elderly patients.
In patients with reduced liver function, slower withdrawal of aceclofenac after a single dose was observed. In studies with multiple doses of 100 mg daily, there was no difference in pharmacokinetic parameters between patients with cirrhosis of the liver and the middle and healthy volunteers.
In patients with mild or moderate renal insufficiency, no clinically significant differences in pharmacokinetics were observed after single dose administration.

Shelf life3 years.
Storage condition.
Store at a temperature below 25 °C in original package.
Keep it out of reach of children.

Package.
There are 10 tablets in a blister, there are 3 or 10 blisters in a carton box.
There are 14 tablets in a blister, there are 2 blisters in a carton box.
Conditions of supply.
On prescription.

Manufacturer.
KUSUM HEALTHCARE PVT LTD.

Address.
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

 

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780