Vitascience Aceclofenac tablets 100mg, No. 20

- Relief of inflammation and pain in lumbago, toothache, humeral-scapular periarthritis, rheumatic lesions of soft tissues;

- symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

-The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Inside. The tablet should be swallowed whole with plenty of water.

The drug should be taken for as short a period of time as possible. The course of treatment is prescribed by the doctor individually.

Usually, adults are prescribed 1 table. 100 mg 2 times a day (morning and evening).

active substance: aceclofenac

hypersensitivity to aceclofenac or drug components;

erosive and ulcerative lesions of the gastrointestinal tract in the acute phase (including ulcerative colitis, Crohn's disease);

gastrointestinal bleeding or suspicion of it;

complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history);

severe liver failure or active liver disease;

disorders of hematopoiesis and coagulation;

severe renal failure (Cl creatinine <30 ml / min), progressive kidney disease, confirmed hyperkalemia;

severe heart failure;

period after coronary artery bypass grafting;

pregnancy;

breastfeeding period;

age up to 18 years.

With care: history of liver, kidney and gastrointestinal tract diseases; presence of Helicobacter pylori infection; bronchial asthma; arterial hypertension; decrease in BCC (including immediately after major surgical interventions); coronary heart disease; chronic renal, hepatic and heart failure; Cl creatinine less than 60 ml / min; history of ulcerative lesions of the gastrointestinal tract; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; smoking; elderly age; long-term use of NSAIDs; alcoholism; severe somatic diseases; defects in hemostasis; the risk of developing cardiovascular thrombosis (myocardial infarction, acute cerebrovascular accident - ischemic, hemorrhagic stroke); systemic lupus erythematosus; long-term use of NSAIDs; taking corticosteroids, anticoagulants, antiplatelet agents,serotonin reuptake inhibitors.

Pharmacological group

Non-steroidal anti-inflammatory drug (NSAID).

Pharmacodynamics

Aceclofenac is a phenylacetic acid derivative that indiscriminately inhibits type I and type II cyclooxygenase. Aceclofenac has anti-inflammatory, analgesic and antipyretic effects. It inhibits the synthesis of prostaglandins and, thus, affects the pathogenesis of inflammation, pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac helps to significantly reduce the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the patient.

Indications

Symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (ankylosing spondylitis) Relief of inflammation and pain in lumbago, toothache, humeral periarthritis, rheumatic soft tissue lesions. The drug is intended to reduce pain and inflammation at the time of use, it does not affect the progression of the disease.

Contraindications

Hypersensitivity (including to other non-steroidal anti-inflammatory drugs (NSAIDs)), complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history), gastrointestinal lesions tract and duodenum, active gastrointestinal bleeding, inflammatory bowel disease; severe renal failure (CC less than 30 ml / min), progressive kidney disease; active liver disease; diseases of the thyroid gland; confirmed hyperkalemia, acute myocardial infarction; the period after coronary artery bypass grafting; hypotension, hypertension; acute disorders of cerebral circulation (ischemic, hemorrhagic stroke);diseases of the bone marrow and blood (leukopenia, including a history of thrombocytopenia, hemophilia), myelosuppression; severe myopathy, severe myasthenia gravis; .pregnancy, breastfeeding period, children's age (up to 18 years)

Carefully

Peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease, history of liver disease, hepatic porphyria, chronic renal failure (CC 30-60 ml / min), chronic heart failure, arterial hypertension, a significant decrease in circulating blood volume (including after surgery), elderly patients (including those receiving diuretics, debilitated patients and patients with low body weight), bronchial asthma, concomitant use of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (in including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxstine, paroxetine, sertraline), ischemic heart disease, cerebrovascular diseases,dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, presence of Helicobacter pylori infection, long-term use of NSAIDs, tuberculosis, severe osteoporosis, alcoholism, severe somatic diseases.

Application during pregnancy and lactation

The drug is contraindicated during pregnancy (see section 'Contraindications'). There is no information available on the use of aceclofenac during pregnancy. Regular use of NSAIDs in the last trimester of pregnancy can lead to decreased tone and weaker uterine contractions. The use of NSAIDs can lead to premature closure of the Botallov's duct in the fetus and, possibly, to prolonged pulmonary hypertension in the newborn, delayed onset of labor and an increase in the duration of labor. In human epidemiological studies, no data has been obtained indicating the toxicity of NSAIDs to the embryo. However, in experiments on rabbits, administration of aceclofenac (10 mg / kg / day) in some cases led to a number of morphological changes in the fetus. There are no data on the presence of a teratogenic effect in rats.Aceclofenac should not be taken while breastfeeding (see section '11 Contraindications'). There are no data on the release of aceclofenac with human milk; when radioactive 14C-aceclofenac was administered to lactating rats, no noticeable transfer of radioactivity into milk was observed,

Method of administration and dosage

To reduce the risk of developing adverse events, the minimum effective dose should be used in the smallest possible short course. Inside. The tablets should be swallowed whole with plenty of liquid. It is preferable to take aceclofenac with or after meals. Usually, adults are prescribed 100 mg 2 times a day, morning and evening.

Elderly patients:

Elderly patients do not need to change the daily dose of aceclofenac or the frequency of its use.

Patients with renal impairment:

There is no information about that. that a change in the daily dose of aceclofenac is required when used in patients with renal insufficiency. But, as with other NSAIDs, caution is required when using aceclofenac.

Patients with hepatic impairment:

The initial dose of aceclofenac in patients with hepatic impairment is 100 mg per day. The duration of therapy, without consulting a doctor, should not exceed 7 days.

Side effects

The frequency of the side effects listed below was determined according to the following (classification of the World Health Organization): very often (more than 10%), often (more than 1% and less than 10%), infrequently (more than 0.1% and less than 1%), rarely (more than 0.01% and less than 0.1%), very rarely (less than 0.01%), including individual messages; the frequency is unknown (cannot be estimated using available tributes).

From the gastrointestinal tract:

often - nausea, vomiting, diarrhea, epigastric pain, intestinal colic, dyspepsia, flatulence, anorexia, constipation; in rare cases - noted the occurrence of erosive and ulcerative lesions, bleeding and perforations of the gastrointestinal tract (bloody vomiting, melena), stomatitis (including aphthous), pancreatitis.

From the nervous system:

rarely - headache, dizziness, sleep disturbances (insomnia or drowsiness), agitation; in some cases, violations of sensitivity were noted,

disorientation, impaired memory, vision, hearing, taste, tinnitus, convulsions, irritability, tremors, depression, anxiety, vertigo. aseptic meningitis, paresthesia.

Allergic reactions:

infrequent skin rash; rarely - urticaria, bronchospasm, systemic anaphylactic reactions; very rarely - vasculitis, pneumonitis, Stevens-Johnson syndrome and Lyell's syndrome, anaphylactic shock, discoid lupus erythematosus; isolated cases of eczema, polymorphic erythema, erythroderma were noted.

From the kidneys and urinary tract:

rarely peripheral edema; very rarely - acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria.

From the liver and biliary tract:

Rarely - hepatitis; very rarely - fulminant hepatitis.

From the side of the hematopoietic organs:

very rarely - leukopenia; individual cases of thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, neutropenia are described.

On the part of the cardiovascular system:

isolated cases of tachycardia, arterial hypertension, congestive heart failure, ischemic heart disease (IHD) were noted.

Respiratory system disorders:

rarely - shortness of breath, pulmonary edema;

very rarely bronchospasm.

Musculoskeletal and connective tissue disorders:

there have been isolated cases of leg cramps,

Laboratory indicators:

often - a transient increase in the activity of transaminases in the blood; infrequently - an increase in the concentration of urea and creatinine in the blood; very rarely, an increase in the level of alkaline phosphatase in the blood.

Overdose

Symptoms

The clinical picture is determined by disorders of the central nervous system (headache, dizziness, hyperventilation phenomena with increased convulsive readiness) and gastrointestinal disorders (abdominal pain, nausea, vomiting).

Treatment:

In case of an overdose, gastric lavage, the introduction of activated charcoal, symptomatic therapy are shaken. There is no specific antidote. Forced diuresis, hemodialysis, blood transfusion are ineffective.

Interaction

With the simultaneous use of aceclofenac and:

• digoxin, phenytoin or lithium preparations - plasma levels of these drugs may increase;

• diuretics and antihypertensive drugs - the effect of these drugs may be weakened;

• potassium-sparing diuretics - can lead to the development of hyperglycemia and hyperkalemia. With this combination of funds, it is necessary to control the level of cadium and blood plasma.

• other HDPs or oral glucocorticosteroids (prednisolone) - the risk of side effects from the gastrointestinal tract increases;

• selective serotonin reuptake inhibitors (cntalopram, fluoxetine, paroxetine, sertraline) - the risk of gastrointestinal bleeding increases;

• cyclosporine and tacrolimus - the toxic effect of kidney drugs may increase;

• antidiabetic agents - can cause both hypo- and hyperglycemia. With this combination of funds, blood sugar control is necessary;

• methotrexate within 24 hours before or after taking it - can lead to an increase in the concentration of methotrexate and to an increase in its toxic effect;

• acetylsalicylic acid - the concentration of aceclofenac in the blood decreases;

• antiplatelet agents and anticoagulants (warfarin, clopidogrel) - the risk of bleeding increases (regular monitoring of blood clotting is required);

• mifepristone - aceclofenac, like other NSAIDs, should not be taken within 8-12 days after using mifepristone due to the risk of reducing its effect;

• quinolone antibiotics - an increased risk of seizures;

• zidovudine - the risk of bleeding increases, hemarthrosis and hematomas may appear.

special instructions

During the period of drug treatment, systematic monitoring of the picture of peripheral blood, liver and kidney function, examination of feces for the presence of spill should be carried out. Patients taking the drug should refrain from activities that require increased attention and rapid mental and motor reactions. Drinking alcohol should be avoided during treatment. If signs of liver damage appear (itching, jaundice, nausea, vomiting, abdominal pain, dark urine, increased activity of 'liver' transaminases), stop taking the drug and consult your doctor. In patients with hepatic impairment, kinetics and metabolism differ from those in patients with normal liver function. The drug should not be used concomitantly with other NSAIDs. The drug can change the properties of platelets,however, it does not replace the prophylactic action of acetylsalicylic acid in cardiovascular diseases. The use of the drug may adversely affect female fertility and is not recommended for women planning a pregnancy. In patients with infertility (including those undergoing examination), it is recommended to cancel the drug. Due to the important role of prostaglandins in maintaining renal blood flow, special care should be taken when prescribing to patients with heart or renal failure, the elderly taking diuretics, and patients with a reduced volume of circulating blood (for example, after major surgery). If aceclofenac is prescribed in such cases, it is recommended to monitor renal function.To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used in the shortest possible short course.