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

active substance: diclofenac potassium 50.0 mg, and Excipients: glyceryl dibehenate 2.0 mg, sodium saccharinate 5.0 mg, anise flavoring 15.0 mg, potassium hydrogen carbonate 22.0 mg, mint flavoring 35.0 mg, aspartame 50.0 mg, mannitol 721.0 mg.

Description:

Homogeneous powder from white to light yellow with a specific smell.

The reconstituted solution is transparent, slightly opalescent with a specific odor.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Voltaren Rapid® contains diclofenac potassium, the substance of the nonsteroidal structure, which has a pronounced analgesic, anti-inflammatory and antipyretic effect.

Due to the rapid onset of action, the use of potassium salt of diclofenac is preferred for the treatment of acute pain and inflammatory conditions. The main mechanism of action diclofenac, set in the research, it is believed inhibition of the synthesis of prostaglandins, which play an important role in the pathogenesis of inflammation, pain and fever.

In vitro diclofenac potassium in concentrations equivalent to those achieved when used in humans, does not inhibit the biosynthesis of proteoglycans of cartilaginous tissue. Diclofenac has a pronounced analgesic effect with a moderate and severe pain syndrome. 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.

In clinical studies it was found that diclofenac Potassium is able to reduce pain and reduce blood loss in primary dysmenorrhea.

When migraine attacks Voltaren Rapids® reduces the severity of headache and associated symptoms such as nausea and vomiting.

Pharmacokinetics:

Suction

Diclofenac is quickly and completely absorbed. After a single dose of the drug inside at a dose of 50 mg, the maximum concentration (C_m_Oh) of potassium diclofenac in blood plasma is achieved in 5-20 minutes and is an average of 5.5 μmol / l for powder for the preparation of a solution for oral administration. When taking the drug during meals, the amount of absorbable diclofenac does not change, although the onset and the rate of absorption can be somewhat slowed down. Absorption of diclofenac is linearly dependent on the dose of the drug. About half the dose of diclofenac is metabolized during the first passage through the liver (the "first pass" effect), the area under the pharmacokinetic "concentration-time" (AUC) curve after oral administration or rectally is about half of the equivalent dose used parenterally. After repeated use of the drug Voltaren Rapid ® 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.

Biotransformation / Metabolism

The metabolism of diclofenac is realized in part by glucuronation 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'-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 unchanged 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 specific patient groups

After taking the drug inside the differences in absorption, metabolism or excretion of the drug, associated with the age of patients, is not noted.

In patients with impaired renal function there is no cumulation of the unchanged active substance under the recommended dosage regimen. 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 of the liver the pharmacokinetics of diclofenac are similar to those in patients with preserved liver function.

Indications:

For short-term treatment of the following acute conditions:

- post-traumatic pain, inflammation and edema, for example, due to ligament damage;

- postoperative pain, inflammation and swelling, for example, after dental or orthopedic surgery;

- pain and / or inflammation accompanying gynecological diseases, for example, primary dysmenorrhea or adnexitis;

- migraine attacks;

- Pain syndromes from the side of the spine;

- rheumatic diseases of extraarticular soft tissues;

- as an auxiliary for infectious inflammatory diseases of the ear, throat and nose, for example, with pharyngotongzillitis, otitis, accompanied by severe pain and inflammation.

In accordance with the generally accepted approaches to the treatment of infectious and inflammatory diseases, etiotropic agents must also be used.

Isolated temperature increase is not an indication for the use of Voltaren Rapid.

Contraindications:

- Exacerbation of peptic ulcer of the stomach and duodenum, ulcerous bleeding, perforation.

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

- Hypersensitivity to diclofenac and any other excipients.

- III trimester of pregnancy.

- Like other NSAIDs, Voltaren Rapid® 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 NSAIDs (including in anamnesis).

- Dysfunction of the liver of a severe degree, renal failure (GFR less than 15 ml / min / 1.73 m²), chronic cardiac insufficiency (IV functional class according to the NYHA classification).

- The drug is not recommended for use during breastfeeding.

- Voltaren Rapid ® in the form of a powder contains a source of phenylalanine, so the drug should not be used in patients with phenylketonuria.

The drug is not recommended for use in children under the age of 14 (due to the difficulty of dosing the drug).

Carefully:

Care should be taken when using Voltaren Rapid ® and other NSAIDs and carefully observe patients with symptoms / signs indicating lesions / diseases of the gastrointestinal tract (GIT) or with anamnestic data, which allows to suspect ulcerative lesions of the stomach or intestines, bleeding or perforation; in patients with infection Helicobacter pylori in anamnesis, ulcerative colitis, Crohn's disease, with a history of liver function disorder and in patients with complaints that make it possible to suspect a gastrointestinal disease. The risk of developing gastrointestinal bleeding increases with an increase in the dose of NSAIDs or in the presence of a history of gastrointestinal ulcer, especially bleeding and perforation of the ulcer and in elderly patients.

Special care should be taken when using Voltaren Rapid® in patients who receive drugs that increase the risk of gastrointestinal bleeding: systemic glucocorticosteroids (incl. prednisolone) anticoagulants (incl. warfarin), antiaggregants (incl. clopidogrel, acetylsalicylic acid) or selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline).

Caution is required when using Voltaren Rapid® in patients with impaired liver function of mild and moderate severity, as well as in patients with hepatic porphyria, since the drug may provoke porphyria attacks.

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 / mn / 1.73 m²), dyslipidemia / hyperlipidemia, diabetes mellitus, hypertension, 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 is necessary to use with caution the preparation Voltaren Rapid ® in patients with defects of the hemostasis system.

Caution should be exercised when using Voltaren Rapid® in patients at risk of developing cardiovascular thrombosis (including myocardial infarction and stroke).

Care should be taken when using Voltaren Rapid® in elderly patientsage. This is especially true in weakened or low-weight elderly people.

Pregnancy and lactation:

Safety data are insufficient use of diclofenac in pregnant women, so use the drug Voltaren Rapid® in I and II trimesters of pregnancy should be only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Rapid® drug Voltaren, like other NSAIDs (prostaglandin synthesis inhibitors), contraindicated in last 3 months of pregnancy (possibly suppressing uterine capacity, impaired kidney function in fetal followed oligohydramnios (oligogidroamnion) and / or premature closure of the ductus arteriosus in the fetus).

Despite the fact that the drug Voltaren Rapid®, like other NSAIDs, passes into breast milk in small amounts, it should not be used during breast-feeding in order to avoid undue influence on the child. Diclofenac was detected in low concentrations (100 ng / ml) in 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.

If it is necessary to apply the drug to a breastfeeding woman, breastfeeding is discontinued. Because Voltaren Rapida®, like other NSAIDs, can have a negative effect on fertility, it is not recommended to use the drug in pregnant women planning pregnancy.

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

Dosing and Administration:

The dose of Voltaren Rapid® should be 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.

Powder for solution for ingestion is preferably taken before meals. The contents of the sachet should be dissolved, stirring, in a glass of water (non-carbonated). The solution may remain slightly turbid, but this does not affect the effectiveness of the drug.

For adults the recommended initial dose of the drug is 100-150 mg per day. In the case of moderate symptoms, it is usually sufficient to use a daily dose of 50-100 mg in the form of a powder to prepare a solution for oral administration. The daily dose should be divided into 3 divided doses.

The maximum daily dose of the drug should not exceed 200 mg / day.

With primary dysmenorrhea, the daily dose of Voltaren Rapid® should be selected individually; it is usually 50-150 mg. The initial dose is 50-100 mg; if necessary for several menstrual cycles, the dose 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.

With a migraine attack, the initial dose for Voltaren Rapid® is 50 mg. The drug should be taken with the first symptoms of an approaching attack. In cases where during 2 hours after taking the first dose there is no relief of pain, it is possible to re-take the drug at a dose of 50 mg. In the future, after every 4-6 hours, an additional supplement of Voltaren Rapid® in a dose of 50 mg is possible. The total dose of the drug should not exceed 200 mg per day (for no more than 2 days).

The effectiveness of Voltaren Rapid ® in the treatment of migraine attacks in children and adolescents is not established.

Adolescents 14 years and older Voltaren Rapid ® is used in a daily dose of 50-100 mg of the drug (at the rate of 0.5-2 mg / kg of body weight per day for the treatment of rheumatoid arthritis the daily dose can be maximally increased to 3 mg / kg).

The daily dose should be divided into 2-3 doses. The maximum daily dose of the drug should not exceed 150 mg / day.

Voltaren Rapid® should not be used in children and adolescents under 14 years of age, if necessary, treatment of this category of patients, Voltaren Rapid ® can be used in suppositories of 25 mg.

Patients over 65 years of age correction of the dose 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 and 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 in the course of clinical studies, as well as the use of diclofenac in clinical practice.

To assess the frequency of AE, the following criteria are used: "often" - ≥1 / 100, <1/10, "infrequently" - ≥ 1/1000, <1/100, "rarely" - ≥ 1/10000, <1/1000, "very rarely" - <1/10000, including individual cases.

AEs are grouped according to the system-organ class of the medical dictionary for the regulatory activities of 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 from 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, sensitivity disorders, including paresthesia, memory disorders, tremors, convulsions, anxiety, acute disorders of cerebral circulation, aseptic meningitis.

Disorders from the side of the organ of vision: very rarely - visual impairment (blurred vision), diplopia.

Hearing disorders and labyrinthine disturbances: 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 of 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 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.

Disorders 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, tubulo-interstitial 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, tell your doctor.

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,disorders of the gastrointestinal tract and respiratory depression. Forced diuresis, hemodialysis or hemoperfusion are ineffective for diclofenac, since nvpp largely bind to blood plasma proteins and undergo intensive metabolism.

In case of a life-threatening overdose when taking the drug inside, in order to prevent as soon as possible the absorption of diclofenac, it is necessary to wash the stomach with the subsequent application of activated charcoal.

Interaction:

The following types of drug interactions were observed with Voltaren Rapid® and / or other dosage forms of diclofenac.

Identified interactions

Inhibitors of the isoenzyme 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. Because the diclofenac can increase the concentration of lithium and digoxin in blood plasma, it is recommended to measure the concentration of lithium and digoxin in the blood with simultaneous application with diclofenac.

Diuretic and antihypertensive agents. When used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, ACE inhibitors) diclofenac, like other NSAIDs, can reduce their hypotensive effect, therefore, patients, especially the elderly, with the simultaneous use of diclofenac and diuretics or antihypertensive drugs should regularly monitor blood pressure, monitor kidney function and the degree of hydration (especially when combined with diuretics and ACE inhibitors due to increased risk of nephrotoxicity).

Cyclosporin 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 simultaneousthis 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.

Supposed interactions of NSAIDs and glucocorticosteroids. Simultaneous systemic use of diclofenac and other systemic NSAIDs or glucocorticosteroids may increase the incidence of AEs from the gastrointestinal tract.

Anticoagulants and antiaggregants. Although clinical studies have not established the effect of diclofenac on the effects 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 trials, it has been established that, while diclofenac does not affect the effectiveness of oral hypoglycemic drugs. However, separate reports on the development of both hypoglycemic and hyperglycemic conditions are known on the background of diclofenac, requiring a change in the dose of hypoglycemic drugs. In patients receiving simultaneous treatment with hypoglycemic drugs and diclofenac, the blood glucose concentration should be measured regularly.

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 NSAIDs, including diclofenac, less than 24 hours before or after taking methotrexate, since in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may be increased.

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:

Lesion of the gastrointestinal tract

When all NSAIDs are used, including diclofenac, there were bleeding or ulceration / perforation of the gastrointestinal tract, in some cases fatal. These phenomena can occur at any period of treatment in patients with or without previous symptoms or gastrointestinal ailments. In elderly patients, such complications can have serious consequences. When developing in patients on the background of using the drug Voltaren Rapid ® bleeding or ulceration of the gastrointestinal tract drug should be discarded.

To reduce the risk of toxic effects on the gastrointestinal tract in patients with gastrointestinal ulcer, especially complicated bleeding or perforating in the history, as well as in elderly patients, the drug should be administered at 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 or other drugs capable of increasing the risk of gastrointestinal damage should be taken by gastroprotectors (eg proton pump inhibitors or misoprostol).

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

Patients with bronchial asthma

Exacerbation of bronchial asthma (NSAID intolerance / bronchial asthma induced by NSAID), angioedema and urticaria are most often noted in patients with bronchial asthma, seasonal allergic rhinitis, nasal mucosa polyps, chronic obstructive pulmonary disease or chronic infectious diseases of the respiratory tract (especially associated with allergic rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria) when applying of the drug Voltaren Rapid® special care must be taken (readiness for resuscitation).

Skin Reactions

Such serious dermatological reactions as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, against the background of NSAIDs, including diclofenac, were very rare. The greatest risk and frequency of severe dermatological reactions were observed in the first month of treatment with diclofenac. When developing patients receiving Voltaren Rapid®, the first signs of skin rashes, mucosal lesions or other symptoms of hypersensitivity, the drug should be canceled. In rare cases, patients who are not allergic to diclofenac, with the use of the drug Voltaren Rapid ® can develop anaphylactic / anaphylactoid reactions.

Effects on the liver and biliary tract

Since during the period of application of Voltaren Rapid ®, as well as other NSAIDs, an increase in the activity of one or more 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 progression of violations of the liver function or the appearance of signs of liver disease,or other symptoms (eg, eosinophilia, rash, etc.), taking Voltaren Rapid® should be discarded. It should be borne in mind that hepatitis against the background of the use of the drug Voltaren Rapid ® can develop without prodromal phenomena.

Effects on the kidneys

On the background of therapy with NSAIDs, including diclofenac fluid retention and swelling were noted, therefore, special care should be taken and renal function monitoring should be performed in patients with essential hypertension, cardiac or renal function disorders, elderly patients, patients receiving diuretics or other drugs that affect renal function, as well as patients with a significant decrease in the volume of circulating blood plasma of any etiology, 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), 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 Rapid®, as well as other NSAIDs, can temporarily inhibit platelet aggregation. Therefore y patients with hemostasis disorders need careful monitoring of relevant laboratory indicators. Voltaren Rapid® is recommended for short-term treatment only, but with continuous use of Voltaren Rapid®, as with other NSAIDs, systematic monitoring of peripheral blood pattern is indicated.

Masking the signs of the infectious process

The anti-inflammatory effect of the drug and other NSAIDs can make it difficult to diagnose infectious processes. Voltaren Rapid®, like other NSAIDs due to its pharmacodynamic properties, can mask manifestations of infectious diseases

Application simultaneously with other NSAIDs

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

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

Patients who experience visual impairment, dizziness, drowsiness, vertigo, or other abnormalities from the central nervous system against the background of Voltaren Rapid® should not drive vehicles and work with mechanisms.

Form release / dosage:Powder for solution for oral administration, 50 mg.

Packaging:

For 900 mg of the drug in hermetically sealed sachets of paper / aluminum / polyethylene.

By 3, 6, 9, 12, 21, 24 or 30 sachets together with instructions for use in a cardboard box.

Storage conditions:

In a dry place, at a temperature of no higher than 25 ° C.

The drug should be stored out of the reach of children.

Shelf life:

2 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002565/07

Date of registration:05.09.2007

Expiration Date:Unlimited

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

Manufacturer: & nbsp

MIPHARM, S.P.A. Italy

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp06.03.2017

Illustrated instructions

Instructions

Voltaren Rapid (Voltaren® Rapid)