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

Excipients: activated carbon medical - 0,050 mg, magnesium stearate - 1,000 mg, copolymer of acrylic and methacrylic acids with divinylbenzene and ethylvinibenzene - 2,500 mg; cap capsule: titanium dioxide - 0.380 mg, gelatin - 18.820 mg; Capsule body: ferric iron oxide yellow (E172) 0.290 mg, titanium dioxide 0.290 mg, gelatin 28.220 mg.

Composition of ink: shellac (E904), propylene glycol, concentrated ammonia solution, sodium hydroxide, ferric oxide black oxide (E172).

Description:Hard gelatin capsules No. 3, white lid and yellow body, marked "CG" and "CNC" with black ink on the body. Contents of capsules - from, whitish-gray to yellowish-gray color, easily flowing granular powder, with a sharp odor.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Diclofenac colestramine (diclofenac resinate) - a non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid; has anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action is to inhibit the synthesis of prostaglandins, which play an important role in the pathogenesis of pain, inflammation and fever. By indiscriminately inhibiting the cyclooxygenase COX1 and COX2, it disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the inflammatory focus. The most effective for inflammatory pain. Like all NSAIDs, the drug has antiplatelet activity.

In vitro diclofenac in concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of proteoglycans of the cartilaginous tissue.

The rubber acts on the principle of the cationic ion exchange resin, with which the anion is connected diclofenac. Rubber is not absorbed from the gastrointestinal tract (GIT) and is excreted mainly through the intestine. The dose of resinate in each capsule is approximately 100-200 times lower than the dose recommended for the treatment of various forms of lipodystrophy.

In rheumatic diseases, anti-inflammatory and analgesic effects are manifested by a 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 post-operative inflammatory phenomena, the drug quickly stops pain (both at rest and during movement), reduces inflammatory edema and swelling around the postoperative wound.

With primary dysmenorrhea diclofenac relieves pain and reduces blood loss.

Pharmacokinetics:

Suction

Galenic properties of the preparation Voltaren®-Flotac^® stipulate simultaneous and the rapid onset of action of the drug, and prolonged release Diclofenac from the connection with resinate. After a single dose of the drug diclofenac is determined in a plasma blood after 20 minutes in quantity 0,3 mcg / ml (0,96 μmol / L), the maximum concentration in the plasma (FROM_m_Oh) on average through 1,25 hours and is 0,7 ± 0.22 μg / ml (2.2 ± 0.7 μmol / L). After taking the drug, its concentration in the blood plasma is determined within 12 hours. FROM_m_Oh as well as the area under the concentration-time curve (AUC) is directly proportional to the dose value.

In comparison with the corresponding diclofenac doses in the form of enteric-soluble tablets diclofenac resinate is characterized by more rapid absorption active substances, lower FROM_m_Oh, longer stay in the blood, as well as a lower interindividual variability C_m_Oh and AUC.

It is shown that after oral administration of the drug the whole dose of the substance becomes systemically available, of which about 54% is represented by the active substance in unchanged form, the rest - in the form of partially active metabolites (effect of the first passage). Bioavailability of diclofenac resinate on the average is 78 ± 18% (the average range is 62-117%).

When reuse pharmacokinetic parameters do not change. Provided that the recommended dosage regimen of the drug cumulation is not noted.

Distribution

Connection with serum proteins - 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. 2 hours after reaching the maximum concentration in the plasma blood the concentration of diclofenac in the synovial fluid is higher than in the plasma blood, and its values remain higher for a period of up to 12 hours.

Diclofenac was detected in low concentration (100 ng / ml) in the breast milk of one of the nursing mothers. The estimated amount of the drug that passes through breast milk into the baby's body is equivalent to 0.03 mg / kg / day.

Biotransformation / Metabolism

Biotransformation of diclofenac occurs quickly and almost completely. Metabolites are well known. Biotransformation of diclofenac is carried out in part by 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 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.

Pharmacokinetics in special groups patients

Absorption, metabolism and excretion of the drug do not depend on age. Research in patients from impaired renal function showed that the accumulation of the active substance in them after a single intravenous It is unlikely, but in patients with severe renal dysfunction concentration of hydroxy metabolites, which, according to modern data, is clinically insignificant.

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 apparatus including:

rheumatoid, psoriatic, juvenile chronic arthritis,
ankylosing spondylitis (Bechterew's disease),
osteoarthritis,
gouty arthritis,
bursitis, tendovaginitis.

Pain syndrome:

headache (including migraine),
toothache,
lumbago, ischialgia, ossalgia, neuralgia, myalgia, arthralgia, sciatica,
with oncological diseases,
post-traumatic and post-operative pain, accompanied by inflammation.

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

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

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

Contraindications:

- Hypersensitivity to diclofenac and any other components of the drug.

- Like other NSAIDs, Voltaren^®-Flatak^® 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).

- Erosive and ulcerative changes in the stomach and duodenum, gastrointestinal bleeding, perforation.

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

- Active liver disease.

- Violation of liver function in severe degree, renal failure (GFR less than 15 mL / min / 1.73 m²) and chronic heart failure (IV functional class by classification NYHA).

- Conditions accompanied by a risk of bleeding.

- Confirmed hyperkalemia.

- Aortocoronary bypass surgery (perioperative period).

- III trimester of pregnancy.

- Period breastfeeding.

- Children's age (up to 18 years).

Carefully:

When using the drug Voltaren-Flotac^® and other NSAIDs take care and carefully observe patients with symptoms / signs indicating on lesions / diseases of the digestive tract or with anamnestic data, allowing suspected ulcerative lesions of the stomach or intestines, bleeding or perforation; in patients with infection Helicobacter pylori in the anamnesis, ulcerative colitis, Crohn's disease, with a history of liver function disorder and in patients with complaints that allow suspected diseases GIT.

The risk of developing gastrointestinal bleeding increases with an increase in the dose of NSAIDs, as well as in patients with a history of GI ulcers, especially bleeding and perforation, and in elderly patients.

Special care should be taken when using Voltaren®-Flotac® 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 necessary when application of of the drug Voltaren®-Flotac® to patients with impaired hepatic function light and medium degrees, as well as patients with hepatic porphyria, since the drug can provoke porphyria attacks.

Particular caution is required in the treatment of patients with impaired renal function, including chronic renal failure (GFR 15-60 ml / min / 1.73 m²), cardiovascular diseases (including ischemic heart disease, cerebrovascular disease, compensated heart failure, peripheral vascular disease), 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 that affect the function of the kidneys, patients with defects in the hemostasis system, as well as patients with a significant decrease in of circulating blood (BCC) of any etiology, for example, in periods before and after massive surgical interventions.

Caution should be exercised when using Voltaren®-Flotac® in patients at risk of developing cardiovascular thrombosis (including number of myocardial infarction and stroke).Care should be taken when using the drug Voltaren®-Flotac® in elderly patients, especially in weakened or low-weight elderly people.

Pregnancy and lactation:

There is insufficient data on the safety of diclofenac in pregnant women, in connection with which to apply Voltaren®-Flotac^® 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. A drug Voltaren^®-Flotac®, like other NSAIDs (inhibitors of prostaglandin synthesis), is contraindicated in the last 3 months of pregnancy (possibly suppressing the contractility of the uterus, impaired renal function in the fetus followed by maluvodium (oligohydroamnion) and / or premature closure of the arterial duct in the fetus).

Voltaren®-Flotac^®, like other NSAIDs, in a small amount penetrates into breast milk, the drug should not be apply during breastfeeding to avoid undesirable influence on the child. If it is necessary to use drug in women in this the period of breastfeeding is discontinued.Since the preparation Voltaren^®-Flatak®, 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.

Capsules should be swallowed whole, squeezed with liquid, preferably with food. Do not snap, do not break it.

Recommended dose - 1-2 capsules per day (depending on the condition). The maximum daily dose 150 mg, divided into 2 receptions.

With prolonged use, it is usually enough 75 mg per day.

Elderly patients (≥65 years of age)

Correction of the initial dose in patients aged 65 years and older, usually, not required. However, based on general medical considerations, caution should be exercised in weakened 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 in the relationship with a lack of safety studies for the use of the drug in patients of 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), contraindicated (see section "Contraindications").

Patients with impaired liver function of mild and moderate severity

There is no data on the need for dose adjustment in the use of the drug inpatients with violations of 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:

The following are undesirable phenomena (AE), which were identified during clinical trials, as well as in the application of various forms of diclofenac in clinical practice.

To estimate the frequency NL the following criteria are used: "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 of AH are listed in order of decreasing frequency of occurrence, at limits of each group allocated according to frequency of occurrence, NL 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: 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 disturbance 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 organs and the 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 an admixture of blood, stomach and intestinal ulcers (with or without bleeding, stenosis or perforations, 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: 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 vision impairment, blurred vision or diplopia appear to be the class-effects of NSAIDs, and are reversible after discontinuation of use. A possible mechanism for the development of such disorders is the inhibition of synthesis prostaglandins and other associated substances, which alters 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; rarely - increased blood pressure, acute renal failure, liver damage, respiratory depression, coma.

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 elimination of NSAIDs, incl. diclofenac, from the body are ineffective, since the active substances of these preparations are largely bound to plasma proteins blood and are subjected to intense

metabolism.

In case of an overdose when taking the drug inside, in order to prevent the absorption of diclofenac as soon as possible, it is necessary to wash the stomach with subsequent application 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 plasma and its exposure.

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

Diuretic and antihypertensive agents. When used simultaneously with diuretics and antihypertensive drugs (for example, beta-adrenoblockers, angiotensin-converting enzyme-ACE inhibitors) diclofenac can reduce their hypotensive effect. Therefore, in patients, especially the elderly, with the simultaneous use of diclofenac and diuretics or antihypertensive agents, BP should be regularly monitored, kidney function and degree of hydration monitored (especially when combined with diuretics and ACE inhibitors 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 above, the dose diclofenac in patients receiving ciclosporin or tacrolimus, must be lower than in patients not receiving these drugs.

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

Antibacterial agents quinolone derivatives. There are some reports of seizures in patients receiving both quinolone derivatives and diclofenac. It should be borne in mind that resinate, possessing the properties of a cationic ion exchange resin, is able to reduce the absorption of other drugs taken orally.

Intended interactions

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

Simultaneous use with acetylsalicylic acid helps reduce plasma concentrations of diclofenac without changing its therapeutic effectiveness.

Anticoagulants and antiaggregants. It is necessary to use caution diclofenac with the drugs of these groups because of the risk of bleeding. Despite,that clinical studies have not established the effect of diclofenac on the effect 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 NSAIDs (including 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 application 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.

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.

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

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:

Patients with gastrointestinal tract injury

When using diclofenac, such phenomena as bleeding, ulceration and perforation of the gastrointestinal tract, in some cases with a fatal outcome, were noted.These complications can occur at any time with the use of drugs as in patients with the presence of previous symptoms and serious gastrointestinal diseases in the history, and without them. In elderly patients, such complications are most dangerous. When developing in patients receiving the drug Voltaren-Flotac, bleeding or ulceration of the gastrointestinal tract drug should be discarded.

To reduce the risk of toxic effects on the gastrointestinal tract, patients with ulcerative gastrointestinal lesions, especially complicated bleeding or perforating history, as well as in elderly patients, the drug should be used in the lowest effective dose.

Patients with an increased risk of developing gastrointestinal complications, as well as patients receiving therapy with low doses of acetylsalicylic acid, should take 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 unusual manifestations of the gastrointestinal tract.

Patients with bronchial asthma

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), hypersensitivity reactions to NSAIDs such as exacerbation bronchial asthma (intolerance of NSAIDs / bronchial asthma, provoked by the intake of NSAIDs), angioedema and urticaria, are observed more often.

In this group of patients, and in patients who are allergic to other drugs (rash, itching or hives) while applying the drug-Voltaren® Flotak® should take special care (readiness for resuscitation).

Skin Reactions

Such severe dermatologic reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, against the use of NSAIDs, including diclofenac, occurred very rarely. The greatest risk and frequency of severe dermatological reactions were observed in the first month of treatment with diclofenac.In patients who receive Voltaren-Flotac®, the first signs of skin rash, mucosal lesions or other symptoms of hypersensitivity, the drug should be withdrawn. In rare cases, patients without previous allergies to diclofenac, with the use of the drug Voltaren-Flotac®, anaphylactic / anaphylactoid reactions may develop.

Effects on the liver and biliary tract

During the period of application of the preparation Voltaren-Flotac®, as well as other NSAIDs, an increase in the activity of hepatic enzymes may be noted. With prolonged therapy with the drug, as a precautionary measure, control of liver function is indicated. With the preservation and aggravation of abnormalities of liver tests or the appearance of signs of liver disease, as well as other symptoms (eg, eosinophilia, rash, etc.), the drug should be discontinued. Hepatitis against the background of the use of the drug Voltaren-Flotac® can develop without prodromal phenomena.

Effects on the kidneys

It was reported that during the therapy of NSAIDs, including diclofenac, episodes of fluid retention and edema were observed.On the background of therapy with Voltaren®-Flotac®, it is recommended to monitor renal function in patients with hypertension, with renal dysfunction, in elderly patients, in patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease volume of circulating blood plasma associated with various causes, for example, in the period 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), use the drug 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

Like other NSAIDs, the Voltaren Flotac® preparation can temporarily inhibit platelet aggregation, so patients with hemostatic disorders should be carefully monitored for appropriate laboratory parameters. With prolonged use of the drug Voltaren®-Flotac®, regular clinical analysis of peripheral blood is recommended.

Masking the signs of the infectious process

The anti-inflammatory effect of the Voltaren®-Flotac® preparation may make it difficult to diagnose infectious processes.

Application simultaneously with other NSAIDs

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

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

Patients who, with the use of Voltaren-Flotac®, experience dizziness or other disturbances from the central nervous system, including visual impairment, should not be administered vehicles and work with mechanisms.

Form release / dosage:

Capsules, 75 mg.

Packaging:10 capsules per blister.

2 blisters together with instructions for 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:3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:PL-000911

Date of registration:18.10.2011 / 06.08.2014

Expiration Date:18.10.2016

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

Manufacturer: & nbsp

NOVARTIS PHARMA PRODUCTIONS, GmbH Germany

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp26.03.2017

Illustrated instructions

Instructions

Voltaren®-Flotac® (Voltaren®-Flotac®)