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

Excipients: silicon dioxide colloidal anhydrous - 3,000 mg, cetyl alcohol - 59,000 mg, magnesium stearate - 3,000 mg, povidone K30 - 6,000 mg, sucrose - 119,000 mg; sheath: hypromellose - 4,242 mg, iron dye red oxide (E 172) - 0,039 mg, polysorbate-80 - 0,195 mg, talc - 3,768 mg, titanium dioxide - 0,754 mg; polishing components: macrogol 8000, crystalline sucrose, labeling ink, black (pharmaceutical glaze [shellac solution in ethanol], iron oxide black [E 172], propylene glycol [E 1520], ammonium hydroxide 28% [E 527]).

Description:Long-acting tablets, film coated, 100 mg: round, biconcave tablets, covered with a film shell of pink color, with a bevel. On one side of the tablet is marked with black ink marking "CG", on the other side - "CGC".

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

The preparation Voltaren^® contains diclofenac sodium, the substance of the nonsteroidal structure, which 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 diclofenac 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 an improvement in 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.

This dosage form is particularly useful in patients who require long-term use of the drug at a dose of 100 mg per day.

Pharmacokinetics:

Suction

Judging by the amount of unchanged diclofenac and its hydroxylated metabolites output by the kidneys, after taking a prolonged-action tablet coated with a film coat, the same amount of active substance is released and absorbed from it, as from a conventional enteric coated tablet. Nevertheless, the systemic bioavailability of diclofenac released from sustained-release tablets coated with a film coat is on average 82% of the same value after taking tablets coated with the same dose. This is due, perhaps, to another manifestation of the effect of "first passage" through the liver for dosage forms with sustained release of the active substance.Since the active substance is released more slowly from a prolonged-action tablet coated with a film coat, the maximum concentration of diclofenac in the blood plasma is lower than in the case of a tablet coated with an enteric-coated membrane.

After taking a prolonged-action tablet coated with a film coat, 100 mg, the maximum concentration of diclofenac in plasma is achieved on average after 4 hours; its average value is 0.5 μg / ml (1.6 μmol / l).

Eating does not have a clinically significant effect on the absorption of the active ingredient from prolonged-action tablets coated with a film coat and its systemic bioavailability.

Within 24 hours of observation after taking a sustained-release tablet coated with a film coat, 100 mg diclofenac plasma concentration averages 13 ng / ml (40 nmol / L). The amount of absorbable active substance is in direct proportion to the dose value of the preparation. Since at the "first passage" through the liver about half the amount of diclofenac is metabolized, AUC after taking long-acting tablets coated with a film coat, approximately 2 times less than in the case of parenteral administration of an equivalent dose of the drug.

After repeated administration of the drug, the pharmacokinetic parameters do not change. Subject to the recommended dosing regimen, cumulation is not noted. The basal concentration of diclofenac, determined in the morning before taking the next dose, is about 22 ng / ml (70 nmol / l) during treatment with Voltaren® in the form of prolonged-action tablets coated with a film membrane at a dose of 100 mg once a day.

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 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

The metabolism of diclofenac is partly due to the glucuronization of the unmodified molecule, but mainly through single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5'-hydroxy-, 4', 5-dihydroxy and 3'-hydroxy-4'-methoxydiclofenac), most of which are 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'-methoxydiclofenac, 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,while metabolites are 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 arthritis;
ankylosing spondylitis and other spondyloarthropathies;
osteoarthritis;
bursitis, tendovaginitis.

- Painful syndromes from the side of the spine (lumbago, sciatica, osalgia, 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.

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 gastric ulcer and duodenal ulcer, organ bleeding (GIT), perforation of the gastrointestinal tract.

- Hypersensitivity to diclofenac or to any other component of the drug or to other NSAIDs.

- III trimester of pregnancy.

- Like other NSAIDs, Voltaren^® is contraindicated in patients with asthma attacks, hives or acute rhinitis, which are provoked by the use of acetylsalicylic acid or other NSAIDs.

- 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 intolerance to fructose, glucose-galactose malabsorption and sugarazo-isomaltaznaya insufficiency, as the composition of the drug includes sucrose.

- The drug should not be used in children and adolescents under 18 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 anamnesis, ulcerative colitis, Crohn's disease, with a history of liver failure, and in patients with complaints that allow suspected GIT diseases.

The risk of developing gastrointestinal bleeding increases with increasing diclofenac dose 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 bleeding: 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 impaired liver function of mild and moderate degree, 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 those with 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 renal failure (GFR 15-60 ml / min / 1.73 m²), dyslipidemia / hyperlipidemia, diabetes mellitus, hypertension, in the treatment of smoking patients 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 in weakened or low-weight elderly people; in patients in this category, 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^®, as well as other 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 maltreatment (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 apply the drug to a breastfeeding woman, 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, and in order to reduce 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, preferably with food. You can not divide or chew tablets.

Adults

The recommended initial dose is 100 mg (1 tablet of prolonged action, coated with a coating) per day. The same daily dose is used for moderately symptomatic symptoms, as well as for prolonged therapy.In those cases when the symptoms of the disease are most pronounced at night or in the morning, prolonged-action tablets coated with a film membrane, it is desirable to take at night.

Children and teenagers under 18 years of age

The drug in this dosage should not be used in children and adolescents under 18 years of age.

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 arterial 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 when the drug is usedin patients with impaired renal function of mild and moderate severity, 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 / 10000, <1/1000); "very rarely" (<1/10000). AEs are grouped according to the system-organ class of the medical dictionary for regulatory activities MedDRA, within each class of HH are listed in order of decreasing frequency of occurrence, within the limits of each group allocated according to the frequency of occurrence, 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, organs of the chest and mediastinum: 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, dysgeusia.

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 instruction are aggravated, or you notice any other side effects, not specified 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 using diclofenac and CYP2C9 isoenzyme inhibitors (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 and 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.

Preparations, capable of causing 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 - quinolone derivatives. 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 of AEs (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 simultaneous application of diclofenac with metformin have been obtained. especially in patients with impaired renal function.

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 simultaneously 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 in the patient at any time with the application of these drugs with or without previous symptoms or serious diseases of the gastrointestinal tract in an anamnesis. In elderly patients, such complications can have serious consequences. When developing in a patient receiving Voltaren^® bleeding or ulcerative lesion of the gastrointestinal tract drug 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 or other drugmeans that can increase the risk of engaging the gastrointestinal tract, against the background of drug therapy should be used gastroprotectors (for example, proton pump inhibitors or misoprostol) 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 symptoms from the digestive system.

Patients with bronchial asthma

Exacerbation of asthma (intolerance to NSAID / asthma provoked by NSAID), angioneurotic edema, and urticaria most frequently observed in patients suffering from bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic infectious respiratory diseases (particularly related to 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 to monitor renal function in patients with hypertension, cardiac or renal function disorders, the elderly, patients receiving diuretics or other drugs that affect kidney function, and in 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

NSAID therapy, including diclofenac, in particular 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).

In patients with diseases of the cardiovascular system and a high risk of developing cardiovascular diseases (for example,hypertension, hyperlipidemia, diabetes, smokers), the drug should be used 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. The patient should be instructed to promptly seek medical attention when the first symptoms of thrombotic disorders appear (for example, chest pain, feelings of lack of air, weakness, speech impairment).

Effects on the hematopoietic system

The preparation Voltaren^® can temporarily inhibit platelet aggregation in connection with which 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^® and other NSAIDs may make it difficult to diagnose infectious processes.

Application simultaneously with other NSAIDs

Do not use Voltaren^® together with other NSAIDs, including selective inhibitors of COX-2 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 of prolonged action, film-coated, 100 mg.

Packaging:

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

For 1 or 3 blisters together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C, protect from moisture.

Keep out of the reach of children.

Shelf life:

5 years.

The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011889 / 03

Date of registration:10.05.2011 / 06.09.2013

Expiration Date:Unlimited

Date of cancellation:2018-04-09

The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland

Manufacturer: & nbsp

NOVARTIS PHARMA STEIN, AG Switzerland

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp09.04.2018

Illustrated instructions

Instructions

Voltaren® (Voltaren®)