Diclofenac 50 mg instructions for use. Diclofenac tablets: instructions for use. Effects on concentration

Identification and classification

Registration number

International non-proprietary name

diclofenac

Dosage form

Enteric film-coated tablets

Composition

One enteric film-coated tablet contains:

active substance: diclofenac sodium 50 mg;

Excipients: lactose monohydrate, corn starch, povidone K-30, sodium lauryl sulfate, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate; shell: methacrylic acid and ethyl acrylate copolymer, macrogol 6000, talc, titanium dioxide E 171 CI 77891, sunset yellow dye.

Description

Round, biconvex, orange-coated tablets with a break from white to almost white.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID)

Pharmacological properties

Pharmacodynamics

A non-steroidal anti-inflammatory drug (NSAID) derived from phenylacetic acid. Diclofenac has anti-inflammatory, analgesic, antiplatelet and antipyretic effects. By indiscriminately inhibiting cyclooxygenase 1 and 2 (COX1 and COX2), it disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the inflammation focus. Most effective for inflammatory pain.

In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant decrease in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. In trauma, in the postoperative period, diclofenac reduces pain and inflammatory edema.

Pharmacokinetics

Absorption is fast and complete, food slows down the absorption rate by 1–4 hours and reduces the maximum concentration (C max) by 40%. After oral administration of 50 mg, the maximum concentration (C max) of 1.5 μg / ml is achieved in 2-3 hours. Plasma concentration is linearly dependent on the size of the administered dose.

There were no changes in the pharmacokinetics of diclofenac against the background of repeated administration. Does not cumulate if the recommended interval between doses is observed. Bioavailability is 50%. The connection with plasma proteins is more than 99% (most of it binds to albumin). Penetrates into synovial fluid; Cmax in synovial fluid is observed 2-4 hours later than in plasma. The half-life (T½) from the synovial fluid is 3-6 hours (the concentration of the active substance in the synovial fluid 4-6 hours after administration of the drug is higher than in plasma, and remains higher for another 12 hours). The relationship between the concentration of the drug in the synovial fluid and the clinical efficacy of the drug has not been clarified.

Metabolism: 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. The isoenzyme CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.

Systemic clearance is about 260 ± 50 ml / min, volume of distribution is 550 ml / kg. T½ from plasma averages about 2.5 hours. 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites in the bile.

In patients with severe renal failure (creatinine clearance (CC) less than 10 ml / min), the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed.

In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac do not change.

Diclofenac passes into breast milk.

Indications for use

Symptomatic treatment of diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis); gouty arthritis, rheumatic lesions of soft tissues, osteoarthritis of the peripheral joints and spine, including with radicular syndrome, tendinitis ...

The drug relieves or reduces pain and inflammation during the treatment period, without affecting the progression of the disease.

Pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboischialgia, post-traumatic pain syndrome accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache.

Contraindications

• Hypersensitivity to diclofenac and any other components of the drug;
• Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history);
• Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum 12, active gastrointestinal bleeding;
• Inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the acute phase;
• The period after coronary artery bypass grafting;
• III trimester of pregnancy, breastfeeding period;
• Confirmed chronic heart failure (NYHA functional class II-IV);
• Clinically proven coronary artery disease;
• Lesion of peripheral arteries or cerebrovascular disorders;
• Increased risk of arterial thrombosis and thromboembolism;
• Uncontrolled arterial hypertension;
• Hematopoiesis disorders, hemostasis disorders (including hemophilia);
• Severe liver failure or active liver disease;
• Severe renal failure (creatinine clearance less than 30 ml / min); progressive kidney disease;
• Confirmed hyperkalemia;
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug contains lactose);
• Children up to age 14.

Carefully

Anemia, bronchial asthma, confirmed NYHA functional class I chronic heart failure, arterial hypertension, edematous syndrome, hepatic or renal failure (creatinine clearance 30-60 ml / min), dyslipidemia, hyperlipoproteinemia, diabetes mellitus, smoking, inflammatory bowel diseases, condition after major surgical interventions, induced porphyria, diverticulitis, systemic connective tissue diseases, pregnancy I-II trimester.

Anamnestic data on the development of gastrointestinal ulcer disease, the presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases.

Concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine serlinetra, paroxetine).

In patients with seasonal allergic rhinitis, swelling of the nasal mucosa (including nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with allergic rhinitis-like symptoms), allergies to other drugs, in patients with a significant decrease in the volume of circulating blood, diclofenac should be used with caution.

Application during pregnancy and during breastfeeding

There is insufficient data on the safety of using diclofenac in pregnant women. Therefore, diclofenac should be prescribed in the I and II trimesters of pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac, like other inhibitors of prostaglandin synthesis, is contraindicated in the last 3 months of pregnancy (suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus is possible).

Diclofenac passes into breast milk in small amounts. To prevent unwanted effects on the child, the drug should not be administered to lactating women. If necessary, the use of the drug, breastfeeding should be discontinued.

Method of administration and dosage

The dose of the drug is selected individually, while in order to reduce the risk of side effects, it is recommended to use the minimum effective dose, if possible, with the shortest possible treatment period in accordance with the purpose of treatment and the patient's condition.

The tablets should be swallowed whole with a liquid, preferably before meals. Do not divide or chew tablets.

Adults and adolescents from the age of 14. The recommended dose is 100-150 mg / day. The daily dose should be divided into several doses. To relieve night pain or morning stiffness, in addition to taking the drug during the day, diclofenac is used in the form of rectal suppositories at bedtime; in this case, the total daily dose should not exceed 150 mg.

With primary dysmenorrhea the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, during several menstrual cycles, it can be increased to 150 mg / day. The drug should be taken when the first symptoms appear. Depending on the dynamics of clinical symptoms, treatment can be continued for several days.

For the treatment of rheumatoid arthritis the daily dose can be maximally increased to 3 mg / kg (in divided doses). The maximum daily dose should not exceed 150 mg.

Elderly patients (≥ 65 years)

Initial dose adjustment is generally not required in patients 65 years of age or older. However, for general medical reasons, caution should be exercised in debilitated elderly patients or patients with low body weight.

Patients with cardiovascular disease or a high risk of cardiovascular disease

The drug should be used with extreme caution in patients with diseases of the cardiovascular system or a high risk of developing diseases of the cardiovascular system. If long-term therapy is necessary (more than 4 weeks) in such patients, the drug should be used in a daily dose not exceeding 100 mg.

Patients with impaired renal function

There is no data on the need for dose adjustment when using the drug in patients with impaired renal function due to the lack of safety studies of the drug in patients of this category. Caution should be exercised when using the drug in patients with impaired renal function.

The use of the drug in patients with renal insufficiency (creatinine clearance less than 30 ml / min) is contraindicated (see section "Contraindications").

Patients with impaired liver function

There is no data on the need for dose adjustment when using the drug in patients with mild and moderate hepatic dysfunction due to the lack of safety studies of the drug in this category of patients.

The use of the drug in patients with severe liver dysfunction is contraindicated (see section "Contraindications").

Side effect

Criteria for assessing the frequency of adverse reactions: very often (> 1/10), often (≥1 / 100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000); частота неизвестна - по имеющимся данным установить частоту возникновения не представляется возможным.

Gastrointestinal disorders: often - epigastric pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia; rarely - gastritis, proctitis, bleeding from the gastrointestinal tract (GIT) (vomiting with blood, melena, diarrhea mixed with blood), gastrointestinal ulcers (with or without bleeding or perforation); very rarely - stomatitis, glossitis, esophagitis, nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease, the occurrence of diaphragmatic strictures in the intestine, constipation, pancreatitis; frequency unknown - ischemic colitis.

Liver and biliary tract disorders: often - an increase in the activity of aminotransferases; rarely - hepatitis, jaundice, liver dysfunction; very rarely - fulminant hepatitis, liver necrosis, liver failure.

Nervous system disorders: often - headache, dizziness; rarely - drowsiness; very rarely - impaired sensitivity, incl. paresthesias, memory disorders, tremors, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis.

Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.

Sensory disorders: often - vertigo; very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, impaired taste.

Kidney and urinary tract disorders: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

Blood and lymphatic system disorders: very rarely - thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis, eosinophilia.

Immune system disorders: anaphylactic / anaphylactoid reactions, including a marked decrease in blood pressure (BP) and shock; very rarely - angioedema (including the face).

Cardiovascular disorders: very rarely - palpitations, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.

Respiratory, chest and mediastinal disorders: rarely - exacerbation of bronchial asthma, cough, laryngeal edema; very rarely - pneumonitis.

Skin and subcutaneous tissue disorders: often - skin rash; rarely - urticaria; very rarely - bullous rashes, eczema, incl. multiforme and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, pruritus, hair loss, photosensitivity, purpura, incl. allergic.

General disorders and disorders at the injection site: rarely - edema.

Overdose

Symptoms: nausea, vomiting, epigastric pain, bleeding from the gastrointestinal tract, diarrhea, dizziness, headache, tinnitus, convulsions, decreased blood pressure, respiratory depression, with a significant overdose - acute renal failure, hepatotoxic effect.

Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating arterial hypotension, renal dysfunction, seizures, gastrointestinal tract damage, respiratory depression. Forced diuresis, hemodialysis are ineffective (due to the significant connection with proteins and intensive metabolism).

Interaction with other medicinal products

Lithium preparations, digoxin: diclofenac may increase plasma concentrations of lithium and digoxin. It is recommended to monitor the concentration of lithium and digoxin in plasma while using it with diclofenac.

Methotrexate: caution is needed when prescribing diclofenac less than 24 hours before or 24 hours after taking methotrexate, because in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may increase.

Cyclosporine: the effect of diclofenac on the synthesis of prostaglandins in the kidneys may increase the nephrotoxicity of cyclosporine. Therefore, the doses of diclofenac used should be lower than in patients not using cyclosporine.

Diuretic and antihypertensive drugs: diclofenac can reduce the hypotensive effect of diuretic and antihypertensive drugs (for example, beta-blockers, angiotensin-converting enzyme inhibitors - ACE). Patients, especially the elderly, should be prescribed these combinations with caution and regularly monitor blood pressure. Patients must be adequately hydrated. After initiation and periodically during treatment, especially with the simultaneous administration of diuretics and ACE inhibitors, it is necessary to monitor renal function due to the increased risk of nephrotoxicity.

Drugs that can cause hyperkalemia: the simultaneous use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim can lead to an increase in the concentration of potassium in the blood serum (in the case of using such a combination of drugs, this indicator should be monitored regularly).

Antibacterial agents - quinolone derivatives: there are isolated reports of the development of seizures in patients receiving both quinolone derivatives and diclofenac.

Anticoagulants and antiplatelet agents: it is necessary to carefully combine diclofenac with drugs of these groups because of the risk of bleeding. Although clinical studies have not established the effect of diclofenac on the effect of anticoagulants, there are isolated reports of an increased risk of bleeding in patients taking this combination of drugs. Therefore, in the case of such a combination of drugs, regular and careful monitoring of patients is recommended. Like other NSAIDs, diclofenac in high doses can reversibly inhibit platelet aggregation.

Acetylsalicylic acid reduces the concentration of diclofenac in the blood.

NSAIDs and corticosteroids: simultaneous systemic use of diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of side effects (in particular, from the gastrointestinal tract).

Selective serotonin reuptake inhibitors (SSRIs): the simultaneous use of diclofenac and drugs from the SSRI group increases the risk of gastrointestinal bleeding.

Hypoglycemic drugs: in clinical studies it was found that when used together, diclofenac does not affect the effectiveness of hypoglycemic drugs. However, there are isolated reports of the development in such cases of both hypoglycemia and hyperglycemia, which required a change in the dose of hypoglycemic drugs during diclofenac therapy. Therefore, during the combined use of diclofenac and hypoglycemic drugs, it is recommended to monitor the blood glucose concentration.

Phenytoin: with the simultaneous use of phenytoin and diclofenac, it is necessary to control the concentration of phenytoin in the blood plasma due to the possible increase in its systemic effect.

Tacrolimus: it is possible to increase nephrotoxicity when used simultaneously with diclofenac.

Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.

The effect of diclofenac on the synthesis of prostaglandins in the kidneys may increase the toxic effect preparations of gold. Concomitant use with ethanol, colchicine, corticotropin and St. John's wort preparations increases the risk of bleeding in the gastrointestinal tract.

Potent inhibitors of the isoenzyme CYP2C9: caution should be exercised when concomitant administration of diclofenac and potent inhibitors of the CYP2C9 isoenzyme (such as voriconazole) due to a possible increase in the concentration of diclofenac in the blood serum and an increase in systemic action.

special instructions

In order to reduce the risk of adverse events, the drug should be used in the lowest effective dose for the shortest period necessary to relieve symptoms.

Therapy with NSAIDs, including diclofenac, in particular long-term therapy and therapy using high doses, may be associated with a slight increase in the risk of serious cardiovascular thrombotic complications (including myocardial infarction and stroke).

In patients with significant risk factors for cardiovascular events (for example, arterial hypertension, hyperlipoproteinemia, diabetes mellitus and smoking), treatment with drugs containing diclofenac should be started only after a thorough examination and analysis.

Due to the important role of prostaglandins in maintaining renal blood flow, special care should be taken when prescribing the drug to patients with heart or renal failure, hypertension, elderly patients, patients taking diuretics or other drugs that affect renal function, as well as patients who have for any reason, there is a decrease in the volume of circulating blood (for example, after major surgery). If diclofenac is prescribed in such cases, it is recommended to monitor renal function as a precautionary measure. After discontinuation of drug therapy, normalization of renal function indicators to baseline values ​​is usually noted.

With the use of diclofenac, such phenomena as bleeding or ulceration / perforation of the gastrointestinal tract were noted, in some cases with a fatal outcome. These phenomena can occur at any time when using the drug in patients with the presence or absence of previous symptoms and a history of serious gastrointestinal diseases or without them. In elderly patients, these complications can have serious consequences. If bleeding or ulceration of the gastrointestinal tract develops in patients receiving diclofenac, the drug should be discontinued. To reduce the risk of toxic effects on the gastrointestinal tract, the drug should be used in the minimum effective dose for the shortest possible time, especially in patients with gastrointestinal ulceration, especially complicated by bleeding or perforation in history, as well as in elderly patients.

Patients with an increased risk of gastrointestinal complications, as well as receiving therapy with low doses of acetylsalicylic acid or other drugs that can increase the risk of gastrointestinal tract damage, should take gastroprotective agents.

Patients with a history of gastrointestinal tract involvement, especially the elderly, should inform the doctor about all symptoms of the digestive system.

During long-term therapy, it is necessary to monitor liver function, peripheral blood picture, and fecal occult blood test.

With prolonged use of diclofenac, there may be an increase in the activity of one or more "liver" enzymes. If liver dysfunction persists and progresses or signs of liver disease or other symptoms appear (for example, eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis against the background of the use of diclofenac can develop without prodromal phenomena.

Caution must be observed when using diclofenac in patients with hepatic porphyria, since the drug can provoke attacks of porphyria. Diclofenac can reversibly inhibit platelet aggregation, therefore, in patients with impaired hemostasis with prolonged use, it is necessary to carefully monitor the appropriate laboratory parameters.

In patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa (including with nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with allergic rhinitis-like symptoms), as well as in patients with allergies to other medications (rash, itching, urticaria) when prescribing diclofenac, special care should be taken (readiness for resuscitation).

With the use of diclofenac, severe, in some cases fatal, skin reactions have been reported very rarely, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. The highest risk and incidence of severe dermatological reactions were observed in the first month of diclofenac treatment. When the first signs of skin rash, mucosal lesions or other symptoms of hypersensitivity develop in patients receiving the drug, diclofenac should be discontinued.

The anti-inflammatory effect of NSAIDs, including diclofenac, can complicate the diagnosis of infectious processes.

Due to the negative effect on fertility, the drug is not recommended for women planning pregnancy. In patients with infertility (including those undergoing examination), it is recommended to cancel the drug.

Influence on the ability to drive vehicles and work with mechanisms

Diclofenac 50 mg is an effective antipyretic and analgesic agent from the group of non-steroidal anti-inflammatory drugs.

Diclofenac 50 mg is an effective antipyretic and analgesic agent.

Release form, composition and packaging

Pills

Intestinal-coated tablets, 25 and 50 mg each.

Sustained-release tablets, coated with a coating, soluble in the intestine, 100 mg each.

Candles

Rectal suppositories, 50 and 100 mg.

Gel

Gel for external use 1% in an aluminum tube of 30 and 40 g.

Gel for external use 5% in an aluminum tube of 30, 50 and 100 g.

pharmachologic effect

Pharmacological effects: anti-inflammatory, antipyretic, antiplatelet, analgesic.

The action consists in non-selective inhibition of the enzyme cyclooxygenase 1 and 2, disrupting the metabolism of arachidonic acid, as a result of which the synthesis of pro-inflammatory cytokines (prostagladins, leukotrienes) decreases, platelet aggregation decreases due to blocking of thromboxane A2, the amount of anti-inflammatory substances (prostacyclins) increases.

With prolonged use, it improves metabolism in cartilage tissue, slows down the progression of bone tissue destruction due to the normalization of proteoglycan metabolism.

Clinical effects include a decrease in pain at rest and during physical exertion on the joints, a decrease in the time of stiffness in movements in the morning, a decrease in swelling and swelling of the joints. In the post-traumatic period and after surgery, it reduces pain and inflammatory edema.

After oral administration, it is completely absorbed in the gastrointestinal tract, the maximum concentration of the drug in the blood plasma is reached after 1-2 hours. It binds to blood proteins and penetrates into the joint fluid, where it reaches its maximum concentration 4 hours after ingestion. Metabolized through the liver.

With rectal administration, absorption is slower, but the concentration peak occurs after 1 hour.

It is excreted through the intestines with feces and bile and through the kidneys with urine.

In patients with severe renal dysfunction (glomerular filtration rate less than 10 ml / min), it is excreted mainly in the bile.

With cirrhosis of the liver and liver failure, the metabolism of the drug and the concentration of the active substance does not change.

The elimination half-life from blood plasma is 1-2 hours, from articular fluid - 3-6 hours.

When used in the form of a gel, it penetrates the skin, does not enter the circulation in therapeutic concentrations and does not take part in systemic side effects.

Indications for use of Diclofenac 50

Inflammatory and degenerative diseases of the musculoskeletal system:

• acute rheumatic fever with articular syndrome;
• rheumatoid arthritis;
• ankylosing spondylitis;
• gouty arthritis and acute gout attack;
• inflammation of the joint capsules and tendons;
• deforming osteoarthritis of the joints.

Inflammatory diseases of the neuromuscular system:

• lumbodynia, sciatica;
• neuralgia, myalgia;
• migraine.

Pain syndrome of various etiologies:

• traumatic;
• postoperative (including coronary artery bypass grafting);
• menstrual pain;
• diseases of the pelvic organs of an infectious origin;
• colic of renal and hepatic etiology;
• hearing infections.

The preparation in the form of a gel is used for topical application in case of:

• sprains, dislocations, bruises (for pain relief);
• rheumatic lesions of soft tissues.

Diclofenac 50 dosage regimen

Tablets of 50 mg are taken orally, without chewing, 1 tablet 2-3 times a day (100-150 mg / day).

The dose for use in children is calculated according to the formula 1-2 mg per 1 kg of body weight per day, divided into 2-3 doses.

The gel is applied externally to the site of the lesion, rubbing slightly, 2-4 g 2-3 times a day.

Rectal suppositories are injected into the anus, 1 suppository 2-3 times a day.

The maximum permitted dose is 150 mg per day.

Side effect

Digestive system: nausea, vomiting, stool disturbances, loss of appetite, hemorrhages, erosion and stomach ulcers, bleeding from the gastrointestinal tract, increased activity of liver enzymes, drug-induced hepatitis, inflammation of the pancreas.

Urinary system: tubulointerstitial nephritis, nephrotic syndrome, glomerular necrosis, acute renal dysfunction, edema.

Nervous system: pain in the temporal region, fatigue, irritability, insomnia, non-bacterial meningitis, convulsive syndrome.

Allergies: skin rash, Stevens-Johnson syndrome, aseptic eosinophilic pneumonia, Lyell's syndrome, anaphylactic shock.

Skin: increased sensitivity to ultraviolet light, alopecia.

Blood system: a decrease in the number of granulocytes, platelets, leukocytes.

Cardiovascular system: hypertension.

When applying the form of the gel, it is possible to develop skin itching, rashes, redness.

When using rectal suppositories - itching, pain during the act of defecation, the appearance of streaks of blood from the anus after administration, the appearance of occult blood during the analysis of feces.

With intramuscular injection - infiltration, abscess, necrosis in the puncture area.

Contraindications to the use of Diclofenac 50

• intolerance (including other NSAIDs);
• unspecified pathology of the hematopoietic system;
• congenital disorders of the blood coagulation system (hemophilia);
• ulcers of the stomach and duodenum in the acute stage;
• chronic kidney disease with a glomerular filtration rate of less than 30 ml / min;
• intestinal diseases with a high risk of bleeding in the acute phase;
• aspirin asthma;
• age up to 6 years;
• III trimester of pregnancy;
• lactation period.

special instructions

During the entire period of taking the drug, you must refrain from driving motor vehicles.

Application during pregnancy and lactation

The use is allowed for women up to 30 weeks of pregnancy if the benefits of taking it outweigh the possible risk to the mother and fetus.

Use in the third trimester of pregnancy is prohibited.

Prohibited for use during lactation.

Application in children

The use is limited in children under 6 years of age (there is no evidence base for the safety of admission).

In children and adolescents from 6 to 18 years old, the daily dose is calculated according to the formula 1-2 mg per 1 kg of body weight, it is prescribed in 2-3 doses.

Application for impaired renal function

Overdose

Clinical picture: frequent and shallow breathing, clouding of consciousness, convulsive syndrome, abdominal pain, nausea and vomiting, acute bleeding from the gastrointestinal tract, impaired sensitivity of the upper and lower extremities, increased blood pressure.

Therapy: gastric lavage (specific antidote has not been developed), oral administration of adsorbing drugs, antihypertensive, anticonvulsant, antiemetic therapy. In case of acute bleeding, hospitalization in a surgical hospital is indicated.

Drug interactions

The simultaneous administration of lithium preparations, cardiac glycosides, quinolone derivatives leads to an increase in the concentration of these substances in the blood.

The use in conjunction with oral hypoglycemic drugs increases the risk of hypoglycemia.

Concomitant therapy with anticoagulants (warfarin) can lead to a high risk of bleeding in the gastrointestinal tract.

Use with caution together with glucocorticosteroids, cytostatics (possibly increased toxicity, increased frequency of side effects).

The risk of electrolyte disturbances (hyperkalemia) increases when combined with potassium-sparing diuretics (spironolactone, eplerenone).

The concentration of the drug in the blood decreases with the simultaneous use of acetylsalicylic acid.

Storage conditions and periods

Store in a dry, dark place, out of reach of children, at a temperature not exceeding + 25 ° C.

The shelf life of enteric coated tablets is 3 years, suppositories - 4 years, gel for external use - 3 years.

Conditions of dispensing from pharmacies

Available without a prescription.

Price

Tablets 50 mg 30 pcs - 120-236 rubles.

Rectal suppositories 50 mg 10 pcs - 289-376 rubles.

Gel for external use 5% 50 mg - 56-98 rubles.

Analogs

Voltaren, Diclofen, Diclovit, Diclobene, Diklomax, Ortofen, Feloran, Flector, Diclofenac Ratiopharm 100 mg.

NSAIDs, a derivative of phenylacetic acid. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system). Inhibits the synthesis of proteoglycan in cartilage. In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase the range of motion. Reduces post-traumatic and postoperative pain and inflammatory edema. Suppresses platelet aggregation. With prolonged use, it has a desensitizing effect. When applied topically in ophthalmology, it reduces swelling and pain in inflammatory processes of non-infectious etiology.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract. Food intake slows down the rate of absorption, while the degree of absorption does not change. About 50% of the active substance is metabolized during the "first pass" through the liver. With rectal administration, absorption is slower. The time to reach Cmax in plasma after oral administration is 2-4 hours, depending on the dosage form used, after rectal administration - 1 hour, intramuscular administration - 20 minutes. The concentration of the active substance in the plasma is linearly dependent on the size of the applied dose. Does not cumulate. Plasma protein binding is 99.7% (mainly with albumin). Penetrates into synovial fluid, Cmax is reached 2-4 hours later than in plasma. It is metabolized to a large extent with the formation of several metabolites, among which two are pharmacologically active, but to a lesser extent than diclofenac. The systemic clearance of the active substance is approximately 263 ml / min. T1 / 2 from plasma is 1-2 hours, from synovial fluid - 3-6 hours. Approximately 60% of the dose is excreted in the form of metabolites by the kidneys, less than 1% is excreted in the urine unchanged, the rest is excreted in the form of metabolites in the bile.

Indications

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathy), post-traumatic inflammation of soft tissues and musculoskeletal system (sprains, bruises). Spinal pain, neuralgia, myalgia, arthralgia, pain syndrome and inflammation after operations and injuries, pain syndrome with gout, migraine, algomenorrhea, pain syndrome with adnexitis, proctitis, colic (biliary and renal), pain syndrome with infectious and inflammatory diseases of the ENT - bodies. For local use: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with removal and implantation of the lens, inflammatory processes of the eye of a non-infectious nature, post-traumatic inflammatory process with penetrating and non-penetrating wounds of the eyeball.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, "aspirin triad", hematopoietic disorders of unknown etiology, hypersensitivity to diclofenac and the components of the dosage form used, or other NSAIDs.

Application during pregnancy and lactation

Application during pregnancy and lactation is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus or newborn.

Method of administration and dosage

For oral administration for adults, a single dose is 25-50 mg 2-3 times / day. The frequency of admission depends on the dosage form used, the severity of the course of the disease and is 1-3 times / day, rectally - 1 time / day. For the treatment of acute conditions or relief of an exacerbation of a chronic process, an intramuscular dose of 75 mg is used. For children over 6 years of age and adolescents, the daily dose is 2 mg / kg. Topically applied in a dose of 2-4 g (depending on the area of ​​the painful area) to the affected area 3-4 times / day. When used in ophthalmology, the frequency and duration of administration are determined individually. The maximum daily oral dose for adults is 150 mg / day.

Side effects

From the digestive system: nausea, vomiting, anorexia, pain and discomfort in the epigastric region, flatulence, constipation, diarrhea; in some cases - erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract; rarely - liver dysfunction. With rectal administration, in isolated cases, there was inflammation of the colon with bleeding, exacerbation of ulcerative colitis. From the side of the central nervous system and peripheral nervous system: dizziness, headache, agitation, insomnia, irritability, fatigue; rarely - paresthesia, visual disturbances (blurred, diplopia), tinnitus, sleep disorders, convulsions, irritability, tremors, mental disorders, depression. From the hematopoietic system: rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis. From the urinary system: rarely - impaired renal function; edema is possible in predisposed patients. Dermatological reactions: rarely - hair loss. Allergic reactions: skin rash, itching; when applied in the form of eye drops - itching, redness, photosensitivity. Local reactions: at the place of intramuscular injection, burning is possible, in some cases - the formation of infiltration, abscess, necrosis of adipose tissue; with rectal administration, local irritation, the appearance of mucous secretions mixed with blood, painful bowel movements are possible; when applied externally in rare cases - itching, redness, rash, burning; when applied topically in ophthalmology, a transient burning sensation and / or temporary blurred vision may occur immediately after instillation. With prolonged external use and / or application to extensive body surfaces, systemic side effects are possible due to the resorptive action of diclofenac.

Overdose

Symptoms: vomiting, bleeding from the gastrointestinal tract, diarrhea, dizziness, tinnitus, convulsions, increased blood pressure, respiratory depression, with a significant overdose - acute renal failure, hepatotoxic effect. Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating an increase in blood pressure, impaired renal function, seizures, gastrointestinal tract damage, respiratory depression. Forced diuresis, hemodialysis are ineffective (due to the significant connection with proteins and intensive metabolism).

Interaction with other drugs

With the simultaneous use of antihypertensive drugs with diclofenac, their effect may be weakened. There are isolated reports of seizures in patients taking both NSAIDs and quinolone antibacterial drugs. With simultaneous use with GCS, the risk of side effects from the digestive system increases. With the simultaneous use of diuretics, it is possible to reduce the diuretic effect. With simultaneous use with potassium-sparing diuretics, an increase in the concentration of potassium in the blood is possible. With simultaneous use with other NSAIDs, the risk of side effects may increase. There are reports of the development of hypoglycemia or hyperglycemia in patients with diabetes mellitus who used diclofenac simultaneously with hypoglycemic drugs. With simultaneous use with acetylsalicylic acid, it is possible to reduce the concentration of diclofenac in blood plasma. Although clinical studies have not established the effect of diclofenac on the action of anticoagulants, isolated cases of bleeding have been described with the simultaneous use of diclofenac and warfarin. With simultaneous use, it is possible to increase the concentration of digoxin, lithium and phenytoin in the blood plasma. The absorption of diclofenac from the gastrointestinal tract decreases with simultaneous use with cholestyramine, to a lesser extent with colestipol. With simultaneous use, it is possible to increase the concentration of methotrexate in the blood plasma and increase its toxicity. With the simultaneous use of diclofenac may not affect the bioavailability of morphine, however, the concentration of the active metabolite of morphine may remain elevated in the presence of diclofenac, which increases the risk of side effects of the morphine metabolite, incl. respiratory depression. With simultaneous use with pentazocine, a case of the development of a large convulsive seizure has been described; with rifampicin - a decrease in the concentration of diclofenac in blood plasma is possible; with ceftriaxone - increased excretion of ceftriaxone with bile; with cyclosporine - an increase in the nephrotoxicity of cyclosporine is possible.

special instructions

It is used with extreme caution in case of liver, kidney, gastrointestinal tract diseases in history, dyspeptic symptoms, bronchial asthma, arterial hypertension, heart failure, immediately after major surgical interventions, as well as in elderly patients. If there is a history of allergic reactions to NSAIDs and sulfites, diclofenac is used only in urgent cases. In the course of treatment, systematic monitoring of the function of the liver and kidneys, and the picture of peripheral blood is necessary. Rectal administration is not recommended in patients with a history of anorectal disease or anorectal bleeding. Externally should be used only on intact skin. Avoid getting diclofenac in the eyes (with the exception of eye drops) or on mucous membranes. Patients using contact lenses should apply eye drops no earlier than 5 minutes after removing the lenses. Not recommended for use in children under 6 years of age. During the period of treatment with dosage forms for systemic use, alcohol is not recommended. Influence on the ability to drive vehicles and control mechanisms During the treatment period, a decrease in the speed of psychomotor reactions is possible. If the clarity of vision deteriorates after using the eye drops, do not drive or engage in other potentially hazardous activities.

Instructions

Tradename

Diclofenac

International non-proprietary name

Diclofenac

Dosage form

Rectal suppositories 50 mg, 100 mg

Composition

One suppository contains

a active substance sodium diclofenac 50 mg or 100 mg,

Excipients - alcohol cetyl,

suppository base (for 100 mg) - semi-synthetic glycerides (Hard fat),

suppository base (for 50 mg) - suppository AM (solid fat).

Description

White or white with a yellowish tinge, suppositories of a cylindrical conical shape. On the cut, the presence of an air and porous rod and a funnel-shaped depression is allowed.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs. Acetic acid derivatives.

ATC code M01AB05.

Pharmacological properties

Pharmacokinetics

Absorption - fast and complete, with rectal administration - 30 minutes. The concentration of the drug in plasma is linearly dependent on the size of the administered dose. The connection with blood plasma proteins is more than 99%. Penetrates into breast milk, synovial fluid. The maximum concentration in the synovial fluid is reached 2 to 4 hours later than in the blood plasma. The half-life from plasma is 1-2 hours, from synovial fluid - 3-6 hours. It is metabolized in the liver. Subject to the recommended interval between doses, the drug does not cumulate. About 60% of the administered dose is excreted as metabolites through the kidneys; less than 1% is excreted unchanged, the rest is excreted as metabolites in the bile. In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac are the same as in patients without liver disease. In patients with severe renal failure (CC less than 10 ml / min), the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed.

Pharmacodynamics

Diclofenac indiscriminately inhibits the activity of COX1 and COX2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever; inhibits the synthesis of inflammatory mediators and reduces pain sensitivity in the inflammation focus. Reduces capillary permeability, inhibits platelet aggregation, restores disturbed microcirculation. In rheumatic diseases, anti-inflammatory and analgesic properties cause a reduction in pain, especially joint pain at rest and during movement, a decrease in morning stiffness, joint swelling, and improvement in motor activity. It has a pronounced analgesic effect for moderate to severe pain. In inflammatory processes that occur after operations and injuries, it quickly relieves both spontaneous pain and pain during movement, and reduces inflammatory edema at the site of the wound. In primary dysmenorrhea, the drug may relieve pain. The anti-inflammatory effect occurs by the end of the first week of treatment.

Indications for use

Inflammatory and degenerative rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis)

Pain syndromes in diseases of the spine

Rheumatic diseases of extra-articular soft tissues

Acute gout attack

Post-traumatic and postoperative pain syndromes accompanied by inflammation and edema

Severe migraine attacks

Renal and biliary colic

Gynecological diseases accompanied by pain and inflammation (primary algomenorrhea and adnexitis)

As an adjuvant for severe diseases of the ear, throat and nose, accompanied by pain (pharyngitis, tonsillitis, otitis media).

Method of administration and dosage

Rectally.

Adults: 1 suppository of 100 mg - 1 time per day, 1 suppository of 50 mg - 2-3 times a day. The daily dose is 100-150 mg. The maximum daily dose of the drug should not exceed 150 mg.

In mild cases and with prolonged therapy, the daily dose is 50-100 mg per day. The duration of the course of therapy is set individually.

With primary algodismenorrhea(when the first symptoms appear): 50-100 mg per day, if necessary, the dose can be increased to 150 mg.

With a migraine attack: 100 mg at the first signs of an attack, if necessary, the dose can be increased to 150 mg.

Teenagers from 16under 18 years old: 50 mg 1-2 times a day.

Suppositories should be injected into the rectum as deeply as possible, preferably after cleansing the intestines. Suppositories should not be cut into pieces, since such a change in the storage conditions of the drug can lead to a violation of the distribution of the active substance.

Side effects

- local reactions: irritation, mucous discharge mixed with blood, pain during bowel movements, local allergic reactions.

With prolonged use, it is possible systemic reactions:

Pain in the epigastric region, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased aminotransferase activity

Headache, dizziness

Visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, impaired taste

Skin rash

Gastritis

Gastrointestinal bleeding (bloody vomiting, melena, bloody diarrhea)

Ulcers of the stomach and intestines, with or without bleeding or perforation

Hepatitis (including fulminant hepatitis), jaundice, liver dysfunction

Drowsiness

Hives

Severe bronchospasm, angioedema, systemic anaphylactic / anaphylactoid reactions including hypotension and shock

Palpitations, chest pain, arterial hypertension, vasculitis, heart failure, myocardial infarction

Bronchial asthma, pneumonitis

Edema, hyperkalemia

In some cases:

Aphthous stomatitis, glossitis, esophagitis

The appearance of diaphragm-like strictures in the intestine

Lower bowel disorders such as nonspecific hemorrhagic colitis, worsening ulcerative colitis, or Crohn's disease

Pancreatitis

Proctitis, exacerbation of hemorrhoids

Sensory disturbances, including paresthesias, memory disturbances, tremors, seizures, anxiety, cerebrovascular disorders, disorientation, insomnia, irritability, depression, anxiety, nightmares, mental disorders, aseptic meningitis

Bullous rash, erythema multiforme, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermal necrolysis), erythroderma (exfoliative dermatitis), pruritus, hair loss, photosensitivity, purpura, including allergic

Acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis

Thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis

Contraindications

Hypersensitivity to diclofenac and / or components of the drug and other nonsteroidal anti-inflammatory drugs (NSAIDs), attacks of bronchial asthma, urticaria, a history of acute rhinitis, arising in response to taking acetylsalicylic acid or other NSAIDs

Erosions and ulcers, as well as inflammatory diseases of the gastrointestinal tract in the acute phase

Active gastrointestinal bleeding, incl. rectal

Violation of hematopoiesis of unknown etiology

Severe liver failure, active liver disease

Severe renal failure (CC less than 30 ml / min)

Severe heart failure

Confirmed hyperkalemia

Proctitis, hemorrhoids in the acute stage

III trimester of pregnancy (suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus is possible) and lactation period

Children and adolescents up to 16 years old.

Drug interactions

Diclofenac, when used together, increases the plasma concentration of lithium, digoxin, indirect anticoagulants, oral antidiabetic drugs (both hypo- and hyperglycemia are possible), quinolones.

Increases the toxicity of methotrexate, cyclosporine, increases the likelihood of side effects of glucocorticoids (gastrointestinal bleeding), the risk of hyperkalemia against the background of potassium-sparing diuretics, reduces the effect of diuretics. The concentration of diclofenac in plasma decreases with the simultaneous use of acetylsalicylic acid.

special instructions

Carefully used for erosive and ulcerative lesions of the gastrointestinal tract in the anamnesis, the presence of infection Helicobacter pylori; history of liver disease, hepatic porphyria, chronic renal failure; bronchial asthma, allergic rhinitis, polyps of the nasal mucosa, with obstructive respiratory diseases; arterial hypertension, chronic heart failure, coronary heart disease, a significant decrease in the volume of circulating blood; immediately after surgery; with cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease; in elderly patients (including those receiving diuretics, debilitated patients and with low body weight), with indications of a history of allergic reactions (urticaria, Quincke's edema, etc.), while taking glucocorticosteroid drugs (incl. prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), long-term use of non-steroidal drugs, alcoholism, severe somatic diseases.

During long-term therapy, it is necessary to monitor liver function, peripheral blood picture, and fecal occult blood test.

Concomitant administration with ethanol increases the risk of bleeding in the gastrointestinal tract.

When side effects appear, the drug is discontinued.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used in the smallest possible short course.

Pregnancy and lactation

The use of the drug in the I and II trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the possible risk to the fetus. If it is necessary to prescribe the drug to women during lactation, the issue of stopping breastfeeding should be resolved.

Features of the effect of the drug on the ability to drive a vehicle orpotentially dangerousmechanisms

Patients who feel dizziness or visual impairment during the use of Diclofenac should not drive a vehicle or potentially dangerous machinery. .

Overdose

Symptoms: headache, dizziness, loss of consciousness, abdominal pain, nausea, vomiting, disorders of the gastrointestinal tract, including bleeding; arterial hypotension, acute renal failure, convulsions, respiratory depression.

Treatment: supportive and symptomatic therapy.

Forced diuresis and hemodialysis are ineffective.

Release form and packaging

Rectal suppositories containing 100 mg of diclofenac: 5 or 6 suppositories in blisters made of polyvinyl chloride film laminated with polyethylene.

1 or 2 blister packs, together with instructions for use in the state and Russian languages, are put into a cardboard pack.

Rectal suppositories containing 50 mg of diclofenac: 6 suppositories in blisters made of polyvinyl chloride film laminated with polyethylene.

1 blister packs, together with instructions for medical use in the state and Russian languages, are put into a cardboard box.

Storage conditions

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Storage period

Do not use after the expiration date.

Conditions of dispensing from pharmacies

On prescription

Manufacturer

Rectal suppositories containing 50 mg of diclofenac

LLC "PHARMAPRIM"

MD-4829, Republic of Moldova,

st. Krinilor, 5, p. Porumbeni, district Criuleni,

tel .: (+ 373-22) -28-18-45, tel / fax: (+ 373-22) -28-18-46,

www.farmaprim.md

Rectal suppositories containing 100 mg of diclofenac

LLC "PHARMAPRIM"

MD-2028, Republic of Moldova,

Chisinau, st. G. Tudor, 3

tel / fax: (+37322) 20-86-72

www.farmaprim.md

Marketing Authorization Holder

LLC "PHARMAPRIM", Moldova

The address of the organization that accepts claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan:

Representative office of LLC "Pharmaprim" in the Republic of Kazakhstan, Almaty, st. Gogol, 86, office 528, tel. 8-727-2796518, [email protected]

Attached files

Release form

film-coated tablets.

1 tablet contains 50 mg diclofenac sodium.

Package

pharmachologic effect

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It has anti-inflammatory, analgesic and antipyretic effects. Inhibits the COX enzyme in the cascade of arachidonic acid metabolism and disrupts the biosynthesis of prostaglandins.
When applied externally, it has anti-inflammatory and analgesic effects. Reduces and relieves pain at the site of application of the ointment (including joint pain at rest and during movement), reduces morning stiffness and swelling of the joints. Promotes increased range of motion.

Indications

Inflammatory and inflammation-activated degenerative forms of rheumatism:
- chronic polyarthritis;
- ankylosing spondylitis (ankylosing spondylitis);
- arthrosis;
- spondyloarthrosis;
- neuritis and neuralgia, such as cervical syndrome, lumbago (lumbago), sciatica;
- acute attacks of gout.
Rheumatic lesions of soft tissues.
Painful swelling or inflammation after injury or surgery.
Non-rheumatic inflammatory pain conditions.

Contraindications

Hypersensitivity. Amnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or another NSAID. Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum 12, active gastrointestinal bleeding. Inflammatory bowel disease. The period after coronary artery bypass grafting. III trimester of pregnancy, lactation period. Decompensated heart failure. Cerebrovascular bleeding or other bleeding and hemostasis disorders. Severe hepatic and renal failure. Children up to age 14. Hereditary lactose intolerance, lactase deficiency or impaired absorption of glucose and galactose.

Method of administration and dosage

Inside, without chewing, during or after meals, with a little water. Adults and adolescents from 14 years old - 50 mg 2-3 times a day. When the optimal therapeutic effect is achieved, the dose is gradually reduced and a maintenance treatment is switched on at a dose of 50 mg / day. The maximum daily dose is 150 mg.

Side effects

Side effects depend on individual sensitivity, the size of the dose used and the duration of treatment.
From the digestive system: nausea, vomiting, epigastric pain, anorexia, flatulence, constipation, gastritis up to erosive with bleeding, increased transaminase activity, drug hepatitis, pancreatitis.
From the urinary system: interstitial nephritis.
From the side of the central nervous system: headache, dizziness, disorientation, agitation, insomnia, irritability, fatigue, aseptic meningitis.
From the respiratory system: bronchospasm.
From the hematopoietic system: anemia, thrombocytopenia, leukopenia, agranulocytosis.
Dermatological reactions: exanthema, erythema, eczema, hyperemia, erythroderma, photosensitization.
Allergic reactions: erythema multiforme, Lyell's syndrome, Stevens-Johnson syndrome, anaphylactic reactions, including shock.
Local reactions: burning sensation, infiltration, necrosis of adipose tissue are possible at the injection site.
Others: fluid retention in the body, edema, increased blood pressure.

special instructions

Use the drug with caution at the same time as other NSAIDs.
Use in pediatrics
If necessary, use the drug in the form of an ointment at

children under 6 years old

Doctor's supervision is required.
Influence on the ability to drive a car and use mechanisms
Due to the fact that when using the drug in high doses, side effects such as dizziness and fatigue may develop, in some cases, the ability to drive a car or other moving objects is impaired. These phenomena are exacerbated by the simultaneous intake of alcohol.

Drug interactions

With the simultaneous use of the drug Diclofenac with digoxin, phenytoin or lithium preparations, an increase in plasma concentrations of these drugs is possible; with diuretics and antihypertensive drugs - it is possible to reduce the effect of these drugs; with potassium-sparing diuretics - the development of hyperkalemia is possible; with acetisalicylic acid - a decrease in the concentration of diclofenac in the blood plasma and an increase in the risk of side effects.
Diclofenac may increase the toxic effect of cyclosporine on the kidneys.
Diclofenc can cause hypo- or hyperglycemia, therefore, when used simultaneously with hypoglycemic agents, control of blood glucose concentration is required.
When using methotrexate within 24 hours before or after taking Diclofenac, it is possible to increase the concentration of methotrexate and increase its toxic effect.
With simultaneous use with anticoagulants, regular monitoring of blood coagulation indicators is necessary.