Diclofenac - instructions for use, dose, side effects, contraindications

Name of components	Amount (g / suppository)
Name of components	50 mg	100 mg
active substance
Diclofenac sodium	0,050	0,100
Excipients
Silica colloidal dioxide	0,011	0,022
Medium chain triglycerides (glyceryl caprylcaprate)	0,0525	0,1050
Fat hard (Vitessol H_]5)	up to 1,000	up to 2,000

Description:Suppositories from white to white with a yellowish hue of color, having the form of a cylinder with a pointed end.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Mechanism of action

Diclofenac is an inhibitor of cyclooxygenases 1 and 2, which leads to inhibition synthesis of prostaglandins. Diclofenac in vitro in concentrations equivalent to those used in clinical practice, does not inhibit the biosynthesis of proteoglycans in the cartilaginous tissue. Diclofenac has anti-rheumatic, anti-inflammatory, analgesic and antipyretic effects. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant reduction in the severity of pain, both at rest and during exercise, morning stiffness, swelling of the joints, improving overall physical well-being. Diclofenac quickly alleviates posttraumatic and postoperative pain both at rest and caused by physical exertion, and also reduces inflammation and swelling of damaged tissues.

Pharmacokinetics:

Suction

Diclofenac is rapidly absorbed by rectal administration, although the rate of absorption is lower compared to oral use. In rectal administration, the maximum serum concentration is observed after about 1 hour and reaches 2/3 of the concentration value when taken orally at the equivalent dose. Values of pharmacokinetic parameters of diclofenac do not change with prolonged use. When used in the recommended doses diclofenac does not accumulate in the body.

Distribution

The connection with blood plasma proteins is 99.7%, with the most part (99.4%) being associated with albumins. Diclofenac penetrates into the synovial fluid, the maximum concentration in the synovial fluid is observed 2-4 hours later than in the blood plasma. One of the nursing mothers in breast milk had a low concentration of diclofenac (100ng / ml). The approximate amount that got into the body of a child fed is equivalent to 0.03 mg / kg / day dose (see the section on "Application during pregnancy and during breastfeeding").

Metabolism

Biotransformation of diclofenac is carried out in part by glucuronidation of the whole molecule, but mostly by single and multiple hydroxylation and methoxylation, resulting in the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac. Excretion

The half-life of the synovial fluid is 3-6 hours. Two hours after reaching a peak concentration in the blood plasma, the concentration of the active substance in the synovial fluid exceeds the concentration in the blood plasma and remains higher up to 12 hours.

The total systemic clearance of diclofenac in blood plasma is 263 ± 56 ml / min. The final half-life of plasma is 1-2 hours. The half-life of four metabolites, including two active metabolites, is 1-3 hours. About 60% of the injected yuzes are excreted by the kidneys in the form of glucuronide conjugates in the form of an entire molecule and in the form of metabolites, most of which are also converted to glucuronidium conjugates. Less than 1% is displayed unchanged; the rest of the dose is excreted as metabolites with bile through the intestine.

Special categories of patients

Elderly patients

In elderly patients, there is no change in absorption, metabolism, and excretion of diclofenac.

Patients with impaired renal function

In patients with renal insufficiency, when diclofenac is used in the recommended doses, cumulation of the active substance is not observed, however, minimum effective doses and monitoring of renal function are necessary. In patients with severe renal insufficiency (creatinine clearance less than 10 ml / min), the concentration of hydroxylated metabolites of diclofenac in blood plasma is 4 times higher than the corresponding concentration in healthy individuals. However, metabolites are ultimately derived from bile.

Patients with impaired hepatic function

In patients with chronic hepatitis or inactive cirrhosis of the liver, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

Indications:

- Diseases of the musculoskeletal system:

- rheumatoid arthritis;

- psoriatic arthritis;

- juvenile idiopathic arthritis;

- ankylosing spondylitis;

- an acute attack of gout;

- periarthritis (for example, humeropathy periarthritis);

- tendonitis;

- rheumatic soft tissue damage;

- osteoarthrosis of peripheral joints and spine, incl. with radicular syndrome;

- tenosynovitis;

- bursitis.

- Pain syndrome of mild or moderate severity:

- neuralgia;

- myalgia;

- sciatica;

- post-traumatic pain syndrome, including fractures, back pain, dislocations, stretching, displacement, pain syndrome in orthopedic, dental and other small surgical interventions;

- headache;

- migraine;

- algodismenorea;

- adnexitis;

- toothache.

- In the complex therapy of infectious and inflammatory diseases of the ear, throat, nose, accompanied by severe pain syndrome (pharyngitis, tonsillitis, otitis).

The drug is designed to reduce the severity of the pain syndrome and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Hypersensitivity to diclofenac or any other component of the drug;

- exacerbation of peptic ulcer of stomach and duodenum, bleeding or perforation;

- gastrointestinal bleeding or history of perforation associated with previous NSAID use;

- acute or recurring episodes of peptic ulcer and / or bleeding in an anamnesis (two or more confirmed episodes);

- inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation;

- pregnancy (III trimester) (see the section "Application during pregnancy and during breast-feeding");

- severe renal failure (creatinine clearance less than 30 ml / min), severe hepatic or decompensated heart failure (see section "Special instructions");

- progressive kidney disease;

- active liver disease;

- hemophilia and other bleeding disorders;

- Postoperative period after coronary artery bypass grafting;

- chronic heart failure (Class II-IV according to the functional classification of chronic heart failure of the New York Heart Association (NYHA));

- cardiac ischemia;

- diseases of peripheral arteries;

- cerebrovascular diseases;

- complete or incomplete combination of intolerance to acetylsalicylic acid, nasal polyposis and bronchial asthma (including history), as well as history of asthma attacks, angioedema, hives, acute rhinitis, which were provoked by the use of acetylsalicylic acid or other NSAIDs (for example, ibuprofen );

- confirmed hyperkalemia;

- children under 15 years for suppositories 50 mg, children under 18 years for suppositories 100 mg;

- proctitis.

Carefully:Careful medical supervision is required for patients with complaints indicating gastrointestinal disease, suspected gastric or intestinal ulcer in history, ulcerative colitis (without exacerbation), Crohn's disease (without exacerbation), liver disease in the history, hepatic porphyria, arterial hypertension, anemia, a significant decrease in the volume of circulating blood (incl.after extensive surgical intervention); also requires careful medical supervision of elderly patients, patients receiving diuretics, weakened patients and patients with low body weight, with bronchial asthma, simultaneous intake of glucocorticosteroid agents (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective inhibitors of serotonin reuptake (including citalopram, fluoxetine, paroxetine, sertraline), dyslipidemia or hyperlipidemia, diabetes mellitus, smoking, chrono (creatinine clearance 30-60 ml / min), presence of infection caused by Helicobacter pylori, prolonged use of NSAIDs, alcoholism, severe somatic diseases, edematous syndrome, condition after extensive surgical interventions, diverticulitis, systemic connective diseases tissue, pregnancy (I and II trimesters).

Pregnancy and lactation:

Fertility

The use of diclofenac, like other NSAIDs, can lead to impaired fertility in women, so it is not recommended for women planning a pregnancy.Women who have problems with conception or who are being examined for infertility should consider the possibility of diclofenac cancellation.

Pregnancy

The use of diclofenac is contraindicated in the third trimester of pregnancy (see section "Contraindications").

If the drug is prescribed to women planning a pregnancy, or during the first trimester of pregnancy, then a minimum dose should be used with the minimum possible short course.

Inhibitors of prostaglandic synthesis may adversely affect the course of pregnancy and / or the development of an embryo or fetus. Data from epidemiological studies indicate an increased risk of abortion and the formation of heart defects and gastroschisis with the use of inhibitors of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of cardiovascular malformations increases from less than 1% to approximately 1.5% and is presumably associated with the dose and duration of diclofenac. In animals, the use of inhibitors of prostaglandin synthesis led to an increase in the number of pre- and postimplantation intrauterine deaths of the embryo and fetus,and their application in the period of organogenesis - to an increase in the number of cases of formation of various developmental anomalies, including cardiovascular. During the III trimester of variability, all inhibitors of prostaglandin synthesis can affect the fetus, causing:

- cardiopulmonary toxicity (with premature closure of the arterial duct and development of pulmonary hypertension);

- renal dysfunction, which can progress up to the development of renal failure and oligohydramnion.

The use of any inhibitors of prostaglandin synthesis in the III trimester of pregnancy can affect the pregnant woman and the fetus, causing:

- possible increase in bleeding time - anti-aggregation effect, which can be observed even when very low doses are used;

- Suppression of uterine contractions, leading to delayed or prolonged labor.

Breastfeeding period

Diclofenac, like other NSAIDs, penetrates into milk in small amounts. Diclofenac should be avoided during breastfeeding in order to avoid the development of unwanted reactions in infants.

Dosing and Administration:

Rectally.

It is recommended to use the lowest effective dose of the drug, allowing to control the symptoms, since this can minimize the number of undesirable reactions (see section "Special instructions").

Suppositories should be injected deep into the rectum, possibly after defecation.

The maximum daily intake for adults is 150 mg. Suppositories can be used in combination with other forms of diclofenac release.

Suppositories 50 mg. Adults and adolescents aged 15 and younger are prescribed 1 suppository 2-3 times a day.

Suppositories 100mg. Adults are assigned but 1 suppository once a day. When used concomitantly with oral diclofenac forms, it is rational to use suppositories once a day at night for 50 or 100 mg (in this case, the evening intake of oral forms of diclofenac is excluded).

To ease night pain and morning stiffness, treatment with a tablet form in day time can be supplemented by the use of a suppository before bed (not exceeding the total maximum daily dose of 150 mg). Duration of the drug - no more than 7 days.

Special patient groups

Children

It is not recommended to use suppositories with a dosage of 50 mg and 100 mg in children.

Elderly patients

Dose adjustment for elderly patients is not required.

Despite the fact that in elderly patients the pharmacokinetics of diclofenac does not change to a clinically significant extent, such patients are usually more prone to manifesting undesirable reactions, therefore NSAIDs they should be used with extreme caution. In particular, in weakened elderly patients or in patients with low body weight (see section "Special instructions") it is recommended to use the lowest effective dose and patients should be observed within 4 weeks from the initiation of therapy with NSAIDs to detect gastrointestinal bleeding.

Patients with impaired renal function

Diclofenac is contraindicated in patients with severe renal failure (see "Contraindications"), No special studies have been conducted with patients with renal insufficiency, thus, no specific recommendations for dose adjustment can be made. Care should be taken when using diclofenac in patients with mild to moderate renal failure (see "Contraindications", "Special instructions").

Patients with impaired hepatic function

Diclofenac is contraindicated in patients with severe hepatic impairment, see "Contraindications"). There have not been any special studies involving patients with hepatic insufficiency, thus, there are no definite recommendations for dose adjustment. Caution should be exercised when using diclofenac in patients with mild to moderate hepatic impairment (see "Contraindications", "Special instructions").

Side effects:

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: Often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1 000 and <1/100), rarely (> 1/10 000 and <1/1 000), rarely (<1/10 000), including individual cases, unknown (can not be estimated from the data available). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

The undesirable reactions described below include reports of reactions observed both with short-term and long-term use of the drug.

Frequency of occurrence of undesirable reactions

Violations of the blood and lymphatic system

Very rarely: anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, agranulocytosis.

Immune system disorders

Rarely: hypersensitivity, anaphylactic and anaphylactoid

reactions (including a marked decrease in blood pressure and shock),

Very rarely: angioedema (including swelling of the face).

Disorders of the psyche

Very rarely: disorientation, depression, insomnia, nightmares, irritability, psychotic disorders.

Disturbances from the nervous system

Often: headache, dizziness.

Rarely: drowsiness, fatigue.

Very rarely: memory impairment, paresthesia, seizures, tremor, anxiety,

aseptic meningitis, a taste disorder, a stroke.

Unknown: confusion, hallucinations, impaired perception, malaise.

Disturbances on the part of the organ of sight

Very rarely: blurred vision, reduced visual acuity, diplopia.

Unknown: retrobulbar neuritis.

Hearing disorders and labyrinthine disorders

Often: vertigo.

Very rarely: hearing impairment, tinnitus.

Heart Disease

Ochep rarely: heart failure, heart palpitations, chest pain, myocardial infarction.

Vascular disorders

Very rarely: increasing and lowering blood pressure, vasculitis.

Disturbances from the respiratory system, chest and mediastinal organs

Rarely: bronchospasm (including shortness of breath).

Very rarely: nnevmonit.

Disorders from the gastrointestinal tract

Often: abdominal pain, indigestion, bloating, diarrhea, nausea, vomiting,

anorexia.

Rarely: gastritis, gastrointestinal ulcers (with bleeding and perforations or without them, sometimes fatal, especially in elderly patients), gastrointestinal bleeding, bloody vomiting, melena, diarrhea with blood.

Very rarely: colitis (including hemorrhagic colitis, exacerbation of ulcerative colitis and Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal damage, diaphragm-like intestinal stricture, pancreatitis.

Disturbances from the liver and bile ducts

Often: increased activity of "liver" transaminases.

Rare: hepatitis, jaundice, abnormal liver function.

Very rare: fulminant hepatitis, gepatonekroz, liver failure.

Disturbances from the skin and subcutaneous tissues

Often: skin rash,

caustically: urticaria.

Very rare: alopecia, eczema, erythema, bullous eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, purpura (including allergic purpura), exfoliative dermatitis, pruritus.

Disorders from the kidneys and urinary tract

Very rare: nephrotic syndrome, proteinuria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure.

Violations of the genitals and mammary gland

Very rarely: impotence.

General disorders and disorders at the site of administration

Rarely: swelling, irritation at the injection site.

Data from clinical studies and epidemiological observations show that the use of diclofenac, particularly at high doses (150mg / day) and long courses, may be associated with an increased risk of arterial thrombosis (including the development of myocardial infarction or stroke) (see. the sections "Contra", "Special instructions ").

Overdose:

Symptoms

There is no specific clinical picture of an overdose of diclofenac. Symptoms such as epigastric pain, nausea, vomiting, diarrhea, gastrointestinal bleeding, dizziness, headache, agitation, drowsiness, tinnitus, impaired orientation, coma, fainting, or convulsions may occur. In case of significant poisoning, acute renal failure and liver damage are possible.

Treatment

Treatment for acute intoxication of NSAID1, including diclofenac, symptomatic and should be aimed at maintaining vital body functions and fighting with hypotension, impaired renal function, convulsions, gastrointestinal disorders and respiratory depression. Specific therapies, such as forced diuresis, dialysis or hemoperfusion, probably do not contribute to the elimination of -NHAP, including diclofenac, due to their high binding to serum proteins and extensive metabolism. The use of activated charcoal and the removal of stomach contents (eg, vomiting) can be justified after accidentally ingesting diclofenac in the dosage form of the suppository.

Interaction:

Lipsy

With simultaneous application diclofenac can increase the concentration of lithium in blood plasma. It is recommended to monitor the concentration of lithium in the blood plasma.

Cardiac glycosides (including digoksii)

The simultaneous use of cardiac glycosides and NSAIDs can cause decompensation of heart failure, reduce glomerular filtration rate and increase the concentration in plasma glycosides.

With simultaneous application diclofenac can increase the concentration of digoxin in the blood plasma. It is recommended to monitor the concentration of digoxin in the blood plasma.

Diuretics and antihypertensives

As with other NSAIDs, the simultaneous application of diclofenac with diuretics or antigipertenzivnymm agents (e.g., beta-blockers, ingibi tori aigiotenzin prevraschayushego-enzyme (ACE) inhibitors) may cause a decrease antigiperteizivnogo their effect by inhibiting the synthesis of prostaglandin vasodilator. Therefore, this sequence should be used with caution, and patients, especially the elderly, should periodically monitor blood pressure.It is necessary to consider monitoring the function of the kidneys after the onset of concomitant therapy and periodically thereafter, especially for diuretics and ACE inhibitors because of the increased risk of nephrotoxicity. Patients receiving diclofenac, should receive a sufficient amount of liquid.

Means that cause hyperkalemia

Simultaneous use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in serum potassium concentration, so it is often necessary to monitor its concentration.

Other NSAIDs, including selective inhibitors of cyclooxygenase 2 and glucocorticosteroids

Simultaneous use with other NV1VP for systemic use, including with elective inhibitors of cyclooxygenase 2 and glucocorticosteroids, may increase the risk of ulcers and gastrointestinal bleeding. Avoid concurrent use of two or more NSAIDs (see section "Special instructions").

Anticoagulants and antiplatelet agents

It is recommended to be careful when using diclofenac and anticoagulants and antiplatelet agentsbecause simultaneous use may increase the risk of bleeding (see section "Special instructions"). Although clinical studies do not indicate that diclofenac affects the effect of anticoagulants, there are some reports of an increased risk of bleeding in patients who are simultaneously receiving diclofenac and anticoagulant drugs. Therefore, to ensure that there is no need to change the dosage of anticoagulants, careful monitoring of the condition of such patients should be carried out. Like other NSAIDs. diclofenac in high doses can reversibly inhibit platelet aggregation. Selective serotonin reuptake inhibitors (SSRIs)

Simultaneous use with selective serotonin reuptake inhibitors

may increase the risk of gastrointestinal hemorrhage (see section "Special instructions"),

IProducts with diabetes

Clinical studies have shown that diclofenac can be used concomitantly with oral hypoglycemic drugs without affecting their clinical effectiveness. However, there are data on hypoglycemic and hyperglycemic effects, which require correction of the dose of antidiabetic drugs against the background of simultaneous diclofenac.As a precautionary measure, it is recommended to monitor the concentration of glucose in the blood during simultaneous therapy.

Methotrexate

Diclofenac can suppress tubular renal clearance of methotrexate, increasing the concentration of methotrexate. Caution should be exercised if the patient has received NSAIDs (including diclofenac) in any dosage form less than 24 hours before the application of methotrexate; in this case, an increase in the concentration of methotrexate in the blood and an increase in its toxic effect. Cases of severe toxicity with methotrexate and NSAIDs, including diclofenac, were reported within 24 hours before or after each use. This interaction is explained by the accumulation of methotrexate as a result of impaired renal impairment in the presence of NSAIDs.

Cyclosporin

NSAIDs, including diclofenac, can increase the nephrotoxicity of cyclosporine, affecting prostaglandins in the kidneys. In patients receiving ciclosporin, the dose of diclofenac should be reduced.

Tacrolimus

Possible increased risk of nephrotoxicity in the application of NSAIDs with tacrolimus.This can be caused by the anti-prostaglandin effects of both NSAIDs and a calcineurin inhibitor.

Quinolones

The interaction of NSAIDs and quinolones can lead to seizures. They can occur in patients with both the presence and absence of seizures or epilepsy in the anamnesis. Therefore, care should be taken when administering quinolones to patients already taking NSAIDs.

Phenytoin

With simultaneous application with phenytoin it is recommended to monitor the concentration of phenytoin in the blood plasma in connection with the expected increase in the duration of its action.

Cholestyramine and cholestyramine

Colestipol and cholestyramine can delay or reduce the absorption of diclofenac. Therefore, it is recommended that diclofenac, at least 1 hour before or 4-6 hours after taking colestipol or cholestyramine.

Mifepristone

NSAIDs should not be taken within 8-12 days after the administration of mifepristone, because NSAIDs may reduce the effect of mifepristone.

Strong inhibitors of cytochrome CYP2C9

It is advisable to use caution when using diclofenac and strong cytochrome inhibitors CYP2C9, such as a voric range, since it can grivetize to a significant increase in the peak concentration of diclofenac in the blood plasma and increase the duration of its action due to the inhibition of its metabolism.

Special instructions:

The likelihood of developing unwanted reactions can be minimized by applying the minimum effective dose during the shortest course of treatment necessary for relief of symptoms.

3 period of treatment with the drug should be monitored by the picture of peripheral timing, liver function, kidney, feces for blood, as possible exacerbation of diseases.

The simultaneous use of diclofenac with NSAIDs for systemic use

The simultaneous use of diclofenac with other NSAIDs for systemic use, including selective inhibitors of cyclooxygenase 2, should be avoided, due to the lack of data on the synergistic effect and the increased risk of developing adverse reactions (see "Interactions with Other Drugs").

Elderly patients

In elderly patients, the likelihood of unwanted reactions is increased when taking NSAIDs.In particular, the lowest effective dose is recommended for weakened elderly patients or patients with low body weight.

Allergic reactions

As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid, can occur without previous use of the drug (see "Side effect" section).

Infeccess

To not other NSAIDs, diclofenac can mask subjective symptoms and objective signs of infection due to its pharmacodynamic properties.

Disorders from the gastrointestinal tract

Gastrointestinal bleeding (bloody vomiting, melena), ulcers and perforations of the gastrointestinal tract, which can cause death, were observed against the background of the use of any NSAID, including diclofenac, and can appear at any time of the course of therapy, both in the presence of gastrointestinal pathology in the anamnesis, and without it, both with the development of symptoms-precursors, and without them. The risk of these adverse events increases with increasing doses of NSAIDs, including diclofenac, as well as in patients with a history of peptic ulcer, especially complicated by bleeding and perforation, and in the elderly. Diclofenac should be abolished with the development of gastrointestinal bleeding or ulcers.

When all NSAIDs, including diclofenac, are used, careful medical attention is needed and special care is taken in the administration of diclofenac to patients with symptoms of gastrointestinal disturbances, either with a stomach ulcer or intestinal ulcer, bleeding or perforating in an anamnesis (see "Side effect "). Older patients are more likely to develop unwanted reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can cause death.

To reduce the risk of gastrointestinal toxicity, such patients should be initiated and treated with the lowest effective dose, and consider the possibility of simultaneous use of gastroprotective drugs (such as misoprostol or proton pump inhibitors). The same applies to patients who receive low doses of acetylsalicylic acid or other drugs that increase the risk of gastrointestinal bleeding (see "Interactions with Other Drugs"). Patients with unwanted reactions from the gastrointestinal tract in history, especially the elderly,should inform the attending physician of all cases of gastrointestinal symptoms, especially gastrointestinal bleeding.

Caution should be given to patients who are simultaneously receiving drugs that increase the risk of gastrointestinal bleeding and ulceration, including. glucocorticosteroids for systemic use, anticoagulants (eg, warfarin), antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (see "Interaction with

other medicinal products ").

Patients with ulcerative colitis and Crohn's disease diclofenac should be used with caution and careful monitoring of treatment, as against the background of diclofenac, their condition may worsen (see section "Side effect").

Dysfunction of the liver

It is necessary to conduct careful medical supervision of patients with hepatic insufficiency, since the use of diclofenac can aggravate the severity of the course of the process.

When using NSAIDs, including diclofenac, one or more liver enzymes may increase.During prolonged use of diclofenac as a precautionary measure, regular monitoring of liver function is necessary. If pathological changes in functional liver samples persist or worsen during treatment, if there are clinical symptoms of liver damage or other manifestations (eg, eosinophilia, rash), diclofenac treatment should be discontinued. The development of hepatitis can take place without prodromal symptoms. Patients with hepatic porphyria use diclofenac with caution, since diclofenac can be a trigger for the aggravation of the disease.

Renal impairment

Since taking NSAIDs, including diclofenac, fluid retention and swelling were observed, caution should be exercised in patients with impaired renal function, in elderly patients, in patients receiving diuretics or drugs that may have a significant effect on kidney function, as well as in patients with a significant decrease in the volume of intercellular fluid, caused by any cause, for example, before or after extensive surgical intervention.As a precaution, it is recommended to monitor kidney function in such patients with diclofenac. After the abolition of therapy, there is usually a return to the initial state. Disturbances from the skin and subcutaneous tissues

Very rarely the intake of NSAIDs including diclofenac, severe skin reactions are observed, sometimes fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (see. The section "Side effect"). The risk of these unwanted reactions is highest at the beginning of therapy: in most cases they appear during the first month of application of the drug. The drug should be stopped immediately if the first signs of a rash, mucous membranes or any other signs of hypersensitivity occur.

Risk of cardiovascular complications Patients with increased risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes and smoking), treatment with the drug should be used only if the benefits of the drug outweigh the risks for cardiovascular complications.Since the risk of developing cardiovascular complications may increase depending on the dose and duration of application, the lowest possible course of treatment and the lowest effective daily dose should be used. Periodic reassessment of the need for symptomatic therapy with the drug and the effectiveness of therapy should be carried out (see "Contraindications", "Side effect"). On the background of therapy with NSAIDs, including diclofenac, fluid retention and edema were observed, therefore special control over the condition of patients with a history of arterial hypertension and / or chronic heart failure from mild to moderate severity is required.

Blood disorders

With prolonged use of diclofenac, as well as other NSAIDs, it is recommended to control the general blood test.

Diclofenac can reversibly inhibit the aggregation of platelets. Patients with hemostasis defects, hemorrhagic diathesis or hematological pathology require special monitoring and careful monitoring.

Bronchial asthma

In patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa, polyposis,chronic obstructive pulmonary disease or chronic infections of the respiratory tract (especially accompanied by symptoms similar to allergic rhinitis), NSAIDs can cause such reactions, asthma exacerbation (so-called analgesic intolerance - aspirin asthma), Quincke's edema or urticaria more often than in other patients . Therefore, such patients are advised to take special care (emergency preparedness). This also applies to patients with allergies to other substances, manifested, for example, by a reaction from the skin, the appearance of pruritus or urticaria. Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can cause bronchospasm when used by patients with bronchial asthma or when indicating the presence of bronchial asthma in an anamnesis.

Systemic lupus erythematosus and mixed connective tissue diseases

In patients with systemic lupus erythematosus and mixed connective tissue diseases, the risk of developing aseptic meningitis may increase (see section "Side effect").

Effect on the ability to drive transp. cf. and fur:During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from driving transport and occupations with other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Suppositories rectal, 50 mg, 100 mg.

Packaging:For 5 suppositories in a blister of polvvinilhlorida / polyethylene. 2 blisters together with instructions for medical use in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012013 / 01

Date of registration:21.06.2010

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Pharmaceuticals, S.A. Poland

Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO

Information update date: & nbsp17.02.2016

Illustrated instructions

Instructions

Diclofenac (Diclofenac)