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

Excipients: silicon dioxide colloidal anhydrous 6.0 / 6.0 mg, microcrystalline cellulose 10.0 / 10.0 mg, lactose monohydrate 16.0 / 25.0 mg, magnesium stearate 1.0 / 1.5 mg, corn starch 50 , 0 / 74.5 mg, povidone K 30 2.0 / 3.0 mg, sodium carboxymethyl starch 20.0 / 20.0 mg;

shell: hypromellose 1.90 / 3.29 mg, macrogol glyceryl hydroxy stearate 0.09 / 0.15 mg, iron dye red oxide - / 0.02 mg, iron oxide dye yellow 0.18 / 0.31 mg, talc 1.70 / 2.92 mg, titanium dioxide 0.13 / 0.31 mg;

enteric membrane - methacrylic acid and ethyl acrylate copolymer [1: 1] 8.28 / 12.42 mg, macrogol 8000 0.83 / 1.24 mg, silicone antifoaming emulsion SE 2 0.06 / 0.10 mg, talc 0.83 / 1.24 mg;

painted casing - hypromellose 0,95 / 1,41 mg, macrogol glyceryl hydroxy stearate 0.04 / 0.07 mg, iron dye red oxide - / 0.01 mg, iron oxide dye oxide 0.09 / 0.13 mg, talc 0.85 / 1.25 mg, titanium dioxide 0.07 / 0.13 mg.

Description:

Tablets 25 mg: round, biconcave, yellow, with a bevel. On one side of the tablet is squeezed out "CG", on the other side - "BZ".

50 mg tablets: round, biconvex, light brown in color, with a bevel. On one side of the tablet is squeezed out "CG", on the other side - "GT".

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Voltaren® contains diclofenac sodium, a substance of a nonsteroidal structure, has a pronounced anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action of diclofenac, established in studies, is inhibition of biosynthesis of prostaglandins. Prostaglandins play an important role in the genesis of inflammation, pain and fever.

In vitro diclofenac sodium in concentrations equivalent to those that are achieved when used in humans, does not inhibit the biosynthesis of proteoglycans of cartilaginous tissue.

In rheumatic diseases, the anti-inflammatory and analgesic properties of the drug provide a clinical effect characterized by a significant decrease in the severity of such manifestations as pain at rest and during movement, morning stiffness and swelling of the joints,as well as improving the functional state.

With post-traumatic and postoperative inflammatory phenomena diclofenac quickly reduces pain (both at rest and during movement), reduces inflammatory edema and swelling of the postoperative wound.

With the use of the drug marked pronounced analgesic effect with moderate and severe pain of non-rheumatic origin.

It was also found that diclofenac can reduce pain and reduce blood loss in primary dysmenorrhea.

Pharmacokinetics:

Suction

After ingestion of tablets coated with enteric coating, diclofenac completely absorbed in the intestine. Absorption occurs quickly, but its onset can be delayed due to the presence of the tablet intestine-soluble shell. After a single dose of 50 mg of the drug, the maximum concentration in the blood plasma (FROM_m_Oh) is observed on average after 2 hours and is 1.5 μg / ml (5 μmol / L). The amount of absorbable active substance is in direct proportion to the dose value of the preparation.

In the case of taking the medication tablet during or after a meal, passing it through the stomach slows down (compared to an empty stomach), but the amount of absorbable diclofenac does not change.

Since about half of diclofenac is metabolized during the first passage through the liver ("first-pass effect"), the area under the "concentration-time" curve (AUC) in the case of using the drug inside or rectally, it is almost 2 times less than in the case of parenteral administration of the drug in an equivalent dose.

After repeated administration of the drug, pharmacokinetics do not change. When observing the recommended dosage regimen of the drug, cumulation is not noted.

Distribution

The connection with serum proteins is 99.7%, mainly with albumin (99.4%). The apparent volume of distribution is 0.12-0.17 l / kg.

Diclofenac penetrates into the synovial fluid, where its maximum concentration is reached 2-4 hours later than in the blood plasma. The apparent half-life of the synovial fluid is 3-6 hours. Two hours after reaching the maximum concentration in the blood plasma, the concentration of diclofenac in the synovial fluid is higher than in the blood plasma, and its values remain higher for a period of up to 12 hours.

Diclofenac was detected in low concentrations (100 ng / ml) in the breast milk of one of the nursing mothers.The estimated amount of diclofenac, ingested with breast milk in the baby's body is equivalent to 0.03 mg / kg / day.

Biotransformation / Metabolism

Metabolism of diclofenac is achieved partly by glucuronidation unmodified molecule, but preferably, by single and multiple hydroxylation and methoxylation, that leads to formation of several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5-hydroxy-, 4 ' 5-dihydroxy- and 3'-hydroxy-4'-metoksidiklofenaka), most of which is converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Excretion

The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min. The final half-life is 1-2 hours. The half-life of 4 metabolites, including two pharmacologically active metabolites, is also short-lived and is 1-3 hours. One of the metabolites. 3'-hydroxy-4'-methoxy-diclofenac, has a longer half-life, but this metabolite is completely inactive.

About 60% of the dose is excreted by the kidneys in the form of glucuronic conjugates of unaltered active substance, as well as in the form of metabolites, most of which are also glucuronic conjugates.Unchanged, less than 1% of diclofenac is excreted. The rest of the dose is excreted as metabolites with bile. The concentration of the active substance in the blood plasma depends linearly on the value of the dose taken.

Pharmacokinetics in specific patient groups

Absorption, metabolism and excretion of diclofenac are independent of age. In children, the concentration of diclofenac in plasma with equivalent doses of the drug (mg / kg body weight) is similar to that in adults. However, in some elderly patients, after a 15-minute intravenous infusion, an increase in plasma diclofenac concentration by 50% was observed compared with that in healthy volunteers of a younger age.

In patients with impaired renal function, when the recommended dosing regimen of cumulation of unchanged active substance is not noted. When creatinine clearance is less than 10 ml / min, the calculated equilibrium concentrations of diclofenac hydroxy metabolites are approximately 4 times higher than in healthy volunteers, with the metabolites being excreted exclusively with bile.

In patients with chronic hepatitis or compensated cirrhosis, the pharmacokinetics of diclofenac are similar to those in patients with preserved liver function.

Indications:

- Inflammatory and degenerative diseases of the musculoskeletal system including:

rheumatoid, juvenile chronic arthritis;
ankylosing spondylitis and other spondyloarthropathies;
osteoarthritis;
gouty arthritis;
bursitis, tendovaginitis.

- Pain syndromes from the side of the spine (lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, sciatica).

- Post-traumatic and post-operative pain syndrome, accompanied by inflammation, for example, in dentistry and orthopedics.

- Algodismenorea; inflammatory processes in the small pelvis, including adnexitis.

- Infectious and inflammatory diseases of the ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media.

Isolated fever is not an indication for the use of the drug.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of application, the progression of the disease is not affected.

Contraindications:

- Exacerbation of peptic ulcer of the stomach and duodenum, bleeding from the organs of the gastrointestinal tract (GI tract), perforation of the gastrointestinal tract.

- Hypersensitivity to diclofenac and any other components preparation.

- III trimester of pregnancy.

- Like other NSAIDs, the preparation Voltaren® is contraindicated in patients with complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis).

- Dysfunction of the liver of severe severity, renal failure (GFR less than 15 ml / min / 1.73 m²), chronic heart failure (IV functional class by classification NYHA).

- Conditions accompanied by a risk of bleeding.

- Confirmed hyperkalemia.

- Aortocoronary bypass surgery (perioperative period).

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

- Active liver disease.

- Breastfeeding period.

- Hereditary severe lactose intolerance, insufficiency of lactase and glucose-galactose malabsorption (because the dosage form contains lactose).

- It is not recommended to use Voltaren®, tablets, coated enteric coating, 25 mg, in children under the age of 6 years.

- It is not recommended to use Voltaren®, tablets, coated enteric-coated, 50 mg, in children under the age of 14 years.

Carefully:

When using Voltaren® and other NSAIDs, care must be taken to carefully observe patients with symptoms / signs indicating a gastrointestinal lesion / disease or with anamnestic data suggestive of ulceration of the stomach or intestines, bleeding or perforation; patients with infection Helicobacter pylori in the anamnesis, ulcerative colitis, Crohn's disease, with a history of liver failure, and patients with complaints that allow suspected GIT diseases. The risk of developing gastrointestinal bleeding increases with an increase in the dose of NSAIDs or in the presence of a history of ulcerative lesions, especially bleeding and perforation of the ulcer and in elderly patients. Special care should be taken when using Voltaren® in patients receiving drugs that increase the risk of gastrointestinal hemorrhage: systemic glucocorticosteroids (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid) or selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Caution is required when using Voltaren^® in patients with mild to moderate liver function, as well as in patients with hepatic porphyria, since the drug can provoke porphyria attacks.

It should be used with caution in patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa (including nasal polyps), chronic obstructive pulmonary disease, chronic respiratory infections (especially associated with allergic rhinitis-like symptoms).

Particular care is required in the treatment of patients with cardiovascular diseases (including coronary heart disease, cerebrovascular disease, compensated heart failure, peripheral vascular disease), renal dysfunction, including chronic kidney failure (GFR 15-60 ml / min / 1.73 m²), dyslipidemia / hyperlipidemia, diabetes mellitus, hypertensive disease, in the treatment of smokers or alcohol abusers in the treatment of elderly patients, patients receiving diuretics or other drugs affecting the function of the kidneys, as well as patients with a significant decrease in the volume of circulating blood (BCC) of any etiology, for example, in periods before and after massive surgical interventions.

It should be used with caution Voltaren^® in patients with defects in the hemostasis system. Care should be taken when using Voltaren^® in patients with a risk of developing cardiovascular thrombosis (including myocardial infarction and strokes).

Care should be taken when using Voltaren^® in elderly patients. This is especially true for weakened or low-weight elderly people in this category of patients, it is recommended to use the drug in the lowest effective dose.

Pregnancy and lactation:

Insufficient data on the safety of diclofenac in pregnant women, and therefore use the drug Voltaren^® in the I and II trimesters of pregnancy should only be in cases where the expected benefit to the mother exceeds the potential risk to the fetus. The preparation Voltaren^®, like other NSAIDs (inhibitors of prostaglandin synthesis), is contraindicated in the last 3 months of pregnancy (suppression of uterine contractility, impaired renal function in the fetus, followed by malnutrition (oligohydroamnion) and / or premature closure of the arterial duct in the fetus).

Despite the fact that the drug Voltaren^®, like other NSAIDs, penetrates into breast milk in small quantities, the drug should not be used during breastfeeding in order to avoid undesirable effects on the child. If it is necessary to use the drug in a woman during this period, breastfeeding is discontinued.

Since the preparation Voltaren^®, like other NSAIDs, can have a negative effect on fertility, women planning a pregnancy are not recommended to take the drug.

In patients undergoing examination and treatment for infertility, the drug should be canceled.

Dosing and Administration:

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

Tablets should be swallowed whole, washed down with liquid, preferably before meals. You can not divide or chew tablets.

Adults. The recommended initial dose is 100-150 mg / day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg per day is sufficient. The daily dose should be divided into several receptions. To alleviate night pain or morning stiffness, in addition to taking the drug throughout the day, apply diclofenac in the form of rectal suppositories before bed; while the total daily dose should not exceed 150 mg.

When primary dysmenorrhea daily dose is selected individually; it is usually 50-150 mg. The initial dose should be 50-100 mg; if necessary for several menstrual cycles, it can be increased to 200 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.

Children aged 6 years and over Voltaren^® in the form of tablets coated with enteric coating, 25 mg, is used at the rate of 0.5-2 mg / kg body weight per day (the daily dose, depending on the severity of the manifestations of the disease should be divided into 2-3 single doses).

Children under the age of 6 years the drug should be used in another dosage form.

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

Elderly patients (≥65 years of age)

Correction of the initial dose in patients aged 65 years and older, as a rule, is not required. However, based on general medical considerations, caution should be exercised in attenuated elderly patients or patients with low body weight.

Patients with diseases of the cardiovascular system or a high risk of diseases of the cardiovascular system

It should be used with extreme caution in patients with cardiovascular disease (including uncontrolled hypertension) or a high risk of developing cardiovascular diseases. If you need long-term therapy (more than 4 weeks) in such patients should use the drug in a daily dose, not exceeding 100 mg.

Patients with impaired renal function

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

The use of the drug in patients with renal insufficiency (GFR less than 15 ml / min / 1.73 m²), is contraindicated (see section "Contraindications").

Patients with impaired liver function of mild to moderate severity

There is no data on the need for dosage adjustment in the use of the drug in patients with impaired liver function of mild and moderate severity due to the lack of safety studies for the use of the drug in this category of patients.

Side effects:

Below are the undesirable phenomena (AEs) that were identified during clinical trials, as well as the use of diclofenac in clinical practice.

The following criteria were used to estimate the frequency of EW: "very often" (≥1 / 10); "often" (≥1 / 100, <1/10); "infrequently" (≥1 / 1000. <1/100); "rarely" (≥1 / 10,000, <1/1000); "very rarely" (<1/10 000).

AEs are grouped according to the system-organ class of the medical dictionary for regulatory activities MedDRA, Within each class, the AHs are listed in descending order of frequency, within each group allocated according to the frequency of occurrence, the AEs are distributed in order of decreasing importance.

Violations of the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.

Immune system disorders: rarely - hypersensitivity, anaphylactic / anaphylactoid reactions, including lowering blood pressure (BP) and shock; very rarely - angioedema (including face swelling).

Disorders of the psyche: very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.

Disturbances from the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - disorders of sensitivity, including paresthesia, memory disorders, tremors, convulsions, anxiety, acute disorders of cerebral circulation, aseptic meningitis.

Disturbances on the part of the organ of sight: very rarely - visual impairment (blurred vision), diplopia.

Hearing disorders and labyrinthine disorders: often - vertigo; very rarely - hearing impairment, tinnitus.

Heart Disease: infrequently, myocardial infarction, heart failure, palpitation, chest pain.

Vascular disorders: very rarely - increased blood pressure, vasculitis.

Disturbances from the respiratory system, chest and mediastinal organs: rarely - bronchial asthma (including dyspnea); very rarely - pneumonitis.

Disorders from the gastrointestinal tract: often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, decreased appetite; rarely - gastritis, gastrointestinal bleeding, vomiting of blood, melena, diarrhea with blood, ulcers of the stomach and intestines (with or without bleeding, stenosis or perforation, with possible development of peritonitis); very rarely - stomatitis, glossitis, damage to the esophagus, the appearance of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, ischemic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis.

Disturbances from the liver and bile ducts: often - increased activity of aminotransferases in blood plasma; rarely - hepatitis, jaundice, liver dysfunction; very rarely - fulminant hepatitis, liver necrosis, liver failure.

Disturbances from the skin and subcutaneous tissues: often - skin rash; rarely - hives; very rarely - bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, pruritus, alopecia, photosensitivity reactions, purpura, purpura Shenlaine-Genocha.

Disorders from the kidneys and urinary tract: very rarely - acute kidney damage (acute renal failure), hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.

General disorders and disorders at the site of administration: rarely - swelling.

Disorders from the cardiovascular system

Clinical studies indicate a slight increase in the risk of developing cardiovascular thrombotic complications (eg, myocardial infarction), especially with prolonged use of diclofenac in high doses (daily dose of more than 150 mg).

Visual disorders

Visual disorders such as visual impairment, blurred vision, or diplopia appear to be class effects of NSAIDs, and are reversible after discontinuation. A possible mechanism for the development of such disorders is the inhibition of the synthesis of prostaglandins and other related substances, which changes the regulation of blood flow in the retina, which is manifested by potential visual disorders. With the development of such symptoms with diclofenac therapy should consider the possibility of ophthalmic examination to exclude any other reasons.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, convulsions. In case of significant poisoning, it is possible to develop acute renal failure and liver damage.

Treatment: supporting and symptomatic treatment is indicated in such complications as a decrease in blood pressure, renal failure, convulsions, gastrointestinal disturbances and respiratory depression. Forced diuresis, hemodialysis or hemoperfusion for the induction of NSAIDs, incl.diclofenac, are ineffective from the body, since the active substances of these preparations are largely bound to blood plasma proteins and are subject to intensive metabolism.

In case of a life-threatening overdose when taking the drug inside to quickly prevent absorption of diclofenac, you should wash the stomach and prescribe Activated carbon.

Interaction:

Identified interactions

Inhibitor inhibitors CYP2C9. Caution should be exercised when diclofenac and isozyme inhibitors are used concomitantly CYP2C9 (such as voriconazole) because of a possible increase in the concentration of diclofenac in the blood serum and its exposure.

Lithium, digoxin. Diclofenac can increase the content of lithium and the concentration of digoxin in the blood plasma. It is recommended to monitor the content of lithium and the concentration of digoxin in the blood serum.

Diuretic and antihypertensives. When used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, angiotensin-converting enzyme-ACE inhibitors) diclofenac can reduce their hypotensive effect.In connection with the above, in patients, especially the elderly, with simultaneous use of diclofenac and diuretics or antihypertensives, blood pressure should be regularly monitored, kidney function and degree of hydration should be monitored (due to increased risk of nephrotoxicity).

Cyclosporine and tacrolimus. The effect of diclofenac on prostaglandin activity in the kidneys can enhance the nephrotoxicity of cyclosporin and tacrolimus. In connection with the foregoing, the dose of diclofenac in patients receiving ciclosporin or tacrolimus, should be lower than in patients who do not receive these drugs.

Drugs that can cause hyperkalemia. Simultaneous use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus and trimethoprim may lead to an increase in the potassium content in the blood plasma (in the case of such simultaneous application, this indicator should be frequently monitored).

Antibacterial agents are derivatives of quinolone. There are some reports of seizures in patients receiving both quinolone derivatives and diclofenac.

Intended interactions

NSAIDs and glucocorticosteroids. Simultaneous systemic use of diclofenac and other systemic NSAIDs or glucocorticosteroids may increase the incidence NL (in particular, from the gastrointestinal tract).

Anticoagulants and antiaggregants. It is necessary to use caution diclofenac with the drugs of these groups because of the risk of bleeding. Although clinical studies have not established the effect of diclofenac on the action of anticoagulants, there are some reports of an increased risk of bleeding in patients taking this combination of drugs. It should be carefully monitored patients receiving simultaneous treatment with these drugs.

Selective serotonin reuptake inhibitors. Simultaneous use of diclofenac with selective serotonin reuptake inhibitors increases the risk of developing gastrointestinal bleeding.

Hypoglycemic drugs. In clinical studies, it has been established that simultaneous use of diclofenac and hypoglycemic drugs is possible, while the efficacy of the latter does not change.However, some reports of development in such cases as hypoglycemia and hyperglycemia are known, which necessitated a change in the dose of hypoglycemic drugs against diclofenac. In connection with the above, during the simultaneous use of diclofenac and hypoglycemic drugs, it is recommended to monitor the concentration of glucose in the blood.

Separate reports on the development of metabolic acidosis with the simultaneous use of diclofenac with metformin, in particular in patients with impaired renal function, have been obtained.

Methotrexate. Caution should be exercised when using diclofenac less than 24 hours before or 24 hours after taking methotrexate, as in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may increase.

Phenytoin. With the simultaneous use of phenytoin and diclofenac, it is necessary to monitor the concentration of phenytoin in the blood plasma because of the possible increase in its systemic effect.

Inductors of isoenzyme CYP2C9. Caution should be exercised when using diclofenac concurrently with inducers of the isoenzyme CYP2C9 (such as rifampicin), since this can lead to a significant decrease in the concentration of diclofenac in the blood plasma and a decrease in its exposure.

Special instructions:

GI tract infection

With the use of diclofenac, as well as other NSAIDs, such phenomena as bleeding or ulceration / perforation of the gastrointestinal tract, in some cases fatal. These phenomena can occur at any time with the application of these drugs with or without previous symptoms or serious diseases of the gastrointestinal tract in history. In elderly patients, such complications can have serious consequences. When developing in patients receiving the drug Voltaren^®, bleeding or ulceration of the gastrointestinal tract should be discarded.

To reduce the risk of toxic effects on the digestive tract in patients with gastroesophageal ulcer, especially complicated bleeding or perforating in the history, as well as in elderly patients, the drug should be applied at the lowest effective dose.

In patients with an increased risk of developing gastrointestinal complications, as well as in patients receiving therapy with low doses of acetylsalicylic acid, against the background of drug therapy should be used gastroprotectors (proton pump inhibitors or misoprostol), or other medications to reduce the risk of unwanted effects on the digestive tract.

Patients with a history of gastrointestinal disease, especially the elderly, should be informed of all abdominal symptoms.

Patients with bronchial asthma

Exacerbation of asthma (intolerance to NSAID / asthma provoked by NSAID), angioneurotic edema, and urticaria most frequently reported in patients with bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic infectious respiratory diseases (particularly associated with allergic rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other medications (skin rash and itching or urticaria) with the use of Voltaren^® special care must be taken (readiness for resuscitation).

Skin Reactions

Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, have been very rare with diclofenac.The greatest risk and frequency of severe dermatological reactions were observed in the first month of treatment with diclofenac. When developing in a patient receiving Voltaren^®, the first signs of skin rashes, lesions of mucous membranes or other symptoms of hypersensitivity, the drug should be discarded.

In rare cases with the use of the drug Voltaren^®, as well as other NSAIDs, anaphylactic / anaphylactoid reactions may develop in patients who have not previously received diclofenac.

Effects on the liver

Since the period of application of the drug Voltaren^® there may be an increase in the activity of one or more "hepatic" enzymes, while prolonged therapy with the drug as a precautionary measure shows control of liver function. With the preservation and progression of violations of the liver function or the appearance of signs of liver disease or other symptoms (eg, eosinophilia, rash, etc.), the drug should be withdrawn. It should be borne in mind that hepatitis against the background of the drug Voltaren^® can develop without prodromal phenomena.

Effects on the kidneys

Against the background of therapy with Voltaren^® it is recommended that kidney function should be monitored in patients with hypertension, cardiac or renal dysfunction, elderly patients, patients receiving diuretics or other drugs that affect kidney function, as well as patients with a significant decrease in extracellular fluid volume of any etiology, for example, before and after massive surgical interventions. After discontinuation of therapy with the drug, normalization of renal function to normal values is usually noted.

Effects on the cardiovascular system

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

Patients with cardiovascular diseases and a high risk of developing cardiovascular diseases (eg, hypertension, hyperlipidemia, diabetes, smokers) should be treated with extreme caution, at the lowest effective dose with the minimum possible duration of treatment,since the risk of thrombotic complications increases with increasing dose and duration of treatment. With prolonged therapy (more than 4 weeks), the daily dose of diclofenac in such patients should not exceed 100 mg. Periodic evaluation of the effectiveness of treatment and the patient's need for symptomatic therapy should be carried out, especially when the duration is more than 4 weeks. When the first symptoms of thrombotic disorders appear (for example, chest pain, feelings of lack of air, weakness, speech impairment), the patient should immediately seek medical help.

Effects on the hematopoietic system

The preparation Voltaren^® can temporarily inhibit platelet aggregation, therefore, in patients with hemostasis disorders, it is necessary to carefully monitor the relevant laboratory parameters.

With prolonged use of Voltaren^® it is recommended to conduct regular clinical analysis of peripheral blood.

Masking the signs of the infectious process

Anti-inflammatory effect of the drug Voltaren^® can make it difficult to diagnose infectious processes.

Application simultaneously with other NSAIDs

Do not use Voltaren^® concurrent with other NSAIDs, including selective COX-2 inhibitors because of the risk of adverse events.

Effect on the ability to drive transp. cf. and fur:

Patients who, with the use of the drug Voltaren^® there are visual disturbances, dizziness, drowsiness, vertigo or other disturbances from the central nervous system should not be managed by vehicles and work with mechanisms.

Form release / dosage:Tablets coated with enteric coating, 25 mg or 50 mg.

Packaging:

10 tablets in a blister (PVC, PVDC, PE / Al.).

For 2 or 3 blisters with instructions in a cardboard box.

Storage conditions:

Store in a dry place, at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015266 / 01

Date of registration:16.08.2011

Expiration Date:Unlimited

The owner of the registration certificate:Novartis Pharma, LLC Novartis Pharma, LLC Russia

Manufacturer: & nbsp

NOVARTIS FARMA, S.p.A. Italy

NOVARTIS Saglik Gida ve Tarim Urunlery Sanayi ve Ticaret, A.S. Turkey

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp25.03.2017

Illustrated instructions

Instructions

Voltaren® (Voltaren®)