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

Excipients: calcium phosphate 110.00 mg, corn starch 45.00 mg, silicon colloidal dioxide 4.00 mg, magnesium stearate 1.00 mg, povidone K 30 2.00 mg, sodium carboxymethyl starch 18.00 mg;

sugar shell: sucrose 67.362 mg, talc 17.872 mg, macrogol 8000 0.993 mg, microcrystalline cellulose 0. 993 mg, povidone K 30 1.489 mg, dispersed red (iron oxide red oxide 30%, titanium dioxide 70%) 1.291 mg.

Description:

Reddish brown, round, biconvex tablets, covered with sugar coating pills. Cross section of the core of the tablet white color.

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 Rapid^® contains diclofenac potassium, substance non-steroidal structure that exerts 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 of diclofenac, established in the studies, it is considered 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.

With migraine attacks diclofenac reduces the severity of the headache and such accompanying symptoms 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 of diclofenac potassium in the blood plasma (FROM_m_Oh) is achieved in 20-60 minutes and is an average of 3.8 μmol / l for tablets coated with a coating. 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. The amount of absorbed active substance is in direct proportion to the dose value of the preparation. Since half of the diclofenac is metabolized during the first passage through the liver (the "first pass" effect), the area under the pharmacokinetic "concentration-time" curve (AUC) after administration or rectally is about half of the equivalent dose used parenterally.

After repeated administration of diclofenac, pharmacokinetics do not change.

When observing the recommended dosage regimen of the drug, cumulation is not noted.

Distribution

Connection with serum proteins - 99,7%, predominantly 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 partly due to the 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'-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 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, no cumulation of the unchanged active substance is observed when the recommended dosage regimen is observed. 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:

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 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.

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

- Active liver disease.

- Full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history).

- Conditions accompanied by a risk of bleeding.

- Confirmed hyperkalemia, the period after aortocoronary bypass surgery.

- Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption, since the dosage form contains sucrose.

- The drug is not recommended for use during breastfeeding (see the section on use during pregnancy and during breastfeeding).

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

Carefully:

When using Voltaren Rapid ® and other NSAIDs take care and carefully observe patients with csigns / signs indicating on lesions / diseases gastro-intestinal tract (GIT) or with anamnestic data, which allows 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, a history of liver function disorder, and patients with complaints that allow suspicion diseases GIT.

The risk of developing gastrointestinal bleeding increases with an increase in the dose of NSAIDs or if available ulcers of the gastrointestinal tract in the anamnesis, especially bleeding and perforation of the ulcer and in elderly patients. Special care should be taken when using the drug Voltaren Rapid^® 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 using the drug Voltaren Rapid® in patients with violations of liver function of mild and moderate severity, and in patients with hepatic porphyria, since the drug can provoke attacks of porphyria.

Since prostaglandins play an important role in the maintenance of renal blood flow, special care is required in the treatment of patients with cardiovascular diseases (including coronary heart disease, cerebrovascular disease, compensated heart failure, peripheral vascular disease), renal dysfunction, including chronic kidney failure (GFR 15 -60 ml / min / 1.73 m²), dyslipidemia / hyperlipidemia, diabetes mellitus, 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, before and after massive surgical interventions. In these cases, during the use of Voltaren Rapid®, it is recommended to monitor kidney function as a precaution. Discontinuation of the drug usually leads to the restoration of kidney function to the baseline level.

Long-term use of high doses of Voltaren Rapid® can lead to a slight increase in the risk of serious cardiovascular complications (including myocardial infarction and stroke). To reduce the risk of such complications, it is necessary to apply the drug at the lowest effective dose and in the least long period of time.

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

Pills preparation Voltaren Rapid® contains sucrose. Patients with hereditary intolerance to fructose, impaired absorption of glucose-galactose, or with insufficiency of isomaltase sugarase are not recommended to take the drug.

Pregnancy and lactation:

Insufficient data on the safety of diclofenac in pregnant women, and therefore use the drug Voltaren Rapid® in the first and second trimesters of pregnancy should be used only when the expected benefit for the mother exceeds the potential risk to the fetus. Voltaren Rapid®, as well as others NSAIDs (inhibitors of prostaglandin synthesis), is contraindicated in the last 3 months of pregnancy (suppression of uterine contractility, impaired renal function in the fetus, followed by malnutrition (oligohydroamnion), and / or premature closure of the arterial duct in the fetus).

Despite the fact that Voltaren Rapid ®, like other NSAIDs, penetrates into breast milk in small amounts, the drug should not apply during breastfeeding to avoid undesirable influence on the child. Diclofenac was found 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.

If it is necessary to apply the drug to a breastfeeding woman, breastfeeding is discontinued.

Because the a drug Voltaren Rapid^®, 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:

Dose of the drug Voltaren Rapid^® should be pick up individually, 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.

The tablets covered with a cover, it is necessary to swallow entirely, without chewing, washing down with a liquid, it is desirable before meal.

For of 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 100 mg. The daily dose should be divided into 2-3 doses.

When primary dysmenorrhea daily dose of Voltaren Rapid^® should be selected individually, usually it is 50-150 mg. The initial dose of 50 mg is usually sufficient to effectively control the symptoms; if necessary the initial dose can be 100 mg / day, during 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.

When a migraine attack the initial dose of the drug Voltaren Rapid^® is 50 mg. The drug should be taken with the first symptoms of an approaching attack. In cases where within 2 hours after taking the first dose there is no relief of pain, it is possible to re-take the drug in a dose 50 mg. Further, every 4-6 hours, an additional dose of Voltaren Rapid® in a dose 50 mg. The total dose of the drug should not exceed 200 mg / day. The effectiveness of Voltaren Rapid ® in the treatment of migraine attacks in children and adolescents is not established.

When primary dysmenorrhea and a migraine attack taking a dose of 200 mg / day should be divided into several doses of the drug, taking this dose should be no more than one day.

Teenagers over 14 years old a drug Voltaren Rapid® is usually prescribed in a daily dose of 50-100 mg.The daily dose should be divided into 2-3 doses (daily dose of 100 mg should be divided into 2 doses). The maximum daily dose of the drug should not exceed 150 mg / day, the maximum daily dose should be divided into 3 divided doses.

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

Patients over 65 years of age dose adjustment, 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 cardiovascular disease or a high risk of cardiovascular disease

It should be used with extreme caution in patients with diseases of the cardiovascular system (including with uncontrolled hypertension) or a high risk of cardiovascular disease-vascular system. 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), 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 AE: "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 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: rarely disorientation, depression, insomnia, nightmares, irritability, mental disorders.

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

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 - noise in the ears, hearing loss.

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

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

Disturbances from the respiratory system, chest and mediastinal organs: rarely - bronchospasm; very rarely - pneumonitis.

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

Disturbances from the liver and bile ducts: often - increased activity of "liver" transaminases; 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, alopecia, photosensitivity reactions, purpura Shenlen-Henoch, itchy skin.

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

Tubulointerstitial nephritis, papillary necrosis.

General disorders and disorders in place introduction of: 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 or with 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. If such symptoms develop with diclofenac therapy, consider ophthalmic examination to exclude any other reasons.

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

Overdose:

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

Treatment: supportive and symptomatic treatment is indicated in such complications as a decrease in blood pressure, renal failure, convulsions, gastrointestinal disturbances and respiratory depression.The effectiveness of forced diuresis, hemodialysis or hemoperfusion is unlikely, since NSAIDs largely bind to blood plasma proteins and undergo intensive metabolism. In case of an overdose, you should designate Activated carbon, with life-threatening conditions, provocation of vomiting and gastric lavage are effective.

Interaction:

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

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. 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 drugs. When used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, ACE inhibitors) diclofenac, like other NSAIDs, can reduce their hypotensive effect.With this combination of drugs, patients, especially the elderly, need to monitor blood pressure. Also, patients receiving this combination should provide adequate hydration and control of kidney function (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 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. The 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 often be monitored).

Antibacterial agents derived from 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 when combined 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 were used, bleeding or ulceration / perforation of the gastrointestinal tract was noted, in some cases fatal. These phenomena can occur at any time with the use of drugs in patients with the presence or absence of previous symptoms and serious gastrointestinal diseases in or without anamnesis. In elderly patients, such complications can have serious consequences. When developing in patients with the use of Voltaren Rapid ® bleeding or ulceration of the gastrointestinal tract, the drug should be discontinued.

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

In patients with an increased risk of developing gastrointestinal complications, as well as patients receiving therapy with low doses of acetylsalicylic acid (Aspirin) or other drugs that can increase the risk of gastrointestinal damage, 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 (intolerance to NSAIDs / bronchial asthma induced by NSAIDs), Quincke's edema and urticaria are most often observed 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) with Voltaren Rapid®, special care should 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.

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 several "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 hepatic 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 edema were noted, therefore, special care should be taken and it is recommended that the functionkidney disease in patients with hypertension, cardiac or renal dysfunction, elderly patients, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma of any etiology, for example, before and after massive surgical interventions. After discontinuation of therapy with the drug, normalization of renal function indicators is usually noted.

Effects on the cardiovascular system

Therapy of NSAIDs, including diclofeac, 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, with hypertension, hyperlipidemia, diabetes, smokers), the drug should be used with extreme caution in 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

Voltaren Rapid ®, as well as other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, patients with hemostasis disorders need careful monitoring of relevant laboratory parameters. 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

Voltaren Rapid ®, like other NSAIDs due to its pharmacodynamic properties, can mask manifestations of infectious diseases.

NSAIDs

Do not use Voltaren Rapid ® along with other NSAIDs, including selective COX-2 inhibitors, because there is no evidence of increased co-therapy effectiveness, and because of the potential increase in adverse events.

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

It is advisable to use caution when driving vehicles and engaging in other potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions. the drug may cause dizziness and other side effects that may affect these abilities.

When these undesirable phenomena appear, one should refrain from performing the specified activities

Form release / dosage:Tablets, coated with a coating, 50 mg.

Packaging:For 10 tablets in a blister of PVC / PE / PVDC / Al.

2 blisters together with instructions for use in a cardboard bundle.

Storage conditions:In a dry place, at a temperature of no higher than 30 ° C.

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

Shelf life:

3 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N016266 / 01

Date of registration:26.12.2012

Expiration Date:Unlimited

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

Manufacturer: & nbsp

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

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp26.03.2017

Illustrated instructions

Instructions

Voltaren Rapid (Voltaren® rapid)