Voltaren 50 mg, 20 coated tablets

The instruction for medical use

of VOLTAREN medicine

the Trade name
of Voltaren

the International unlicensed


name Diclofenac Dosage Form
of the Tablet, covered with a kishechnorastvorimy cover, 50 mg

Structure
One tablet contains
active agent - diclofenac of sodium of 50 mg,
excipients: corn starch, lactoses monohydrate, sodium of starch glikolit (type A), cellulose microcrystalline, silicon dioxide colloidal anhydrous, K30 povidone, magnesium stearate,
structure of a cover: a gipromelloza, talc, ferrous oxide yellow (E172), the titan dioxide (E171), makrogolglitserol hydroxystearate (the polioksilirovanny 40 hydrogenated castor oil), ferrous oxide red 17266 (E 172), 30% copolymer dispersion methacrylic acid - ethyl acrylate (1: 1) / copolymer methacrylic acid, macrogoal 8000 (polyethyleneglycols 8000), silicone defoaming emulsion of SE2.

The description of a dosage form
of the Tablet of round shape, with a biconvex surface, coated, light brown color, with a facet, an engraving of CG on one party and GT on other party.

Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs. Non-steroidal anti-inflammatory drugs. Acetic acid derivatives. Diclofenac.
The ATX M01A B05 code

the Pharmacological

Pharmacokinetics Later properties of intake of the tablets covered with a kishechnorastvorimy cover, diclofenac completely is soaked up after passing through a stomach. In case of reception of a tablet of drug in time or after a meal, its passing through a stomach slows down (in comparison with reception to food), but the amount of the soaking-up diclofenac does not change. After single dose of 50 mg of drug the maximum concentration in plasma is noted in 2 hours and makes 1.5 mkg/ml (5 µmol/l). Extent of absorption is in direct dependence on dose size. After repeated administrations of drug the indicators of pharmacokinetics do not change. Therefore if the recommended intervals between receptions of doses of drug are observed, cumulation is not noted. Linking with serum proteins makes 99.7%. Binding happens mainly to albumine (99.4%). The seeming volume of distribution is 0.12-0.17 l/kg. Diclofenac gets into synovial fluid where its maximum concentration is reached at 2-4 o'clock later, than in blood plasma. The seeming elimination half-life makes 3-6 hours of synovial fluid. In 2 hours after achievement of the maximum concentration in plasma the concentration of diclofenac in synovial fluid is higher, than in plasma, and its values remain higher throughout a span till 12 o'clock.
Metabolism of diclofenac is carried out partially by a glyukuronization of not changed molecule, but, mainly, by means of a single and repeated metoksilirovaniye that leads to formation of several phenolic metabolites (3' - hydroxy, 4 '-hydroxy, 5' - hydroxy, 4', 5-digidroksi- and 3 '-hydroxies-4 '-metoksidiklofenaka), the majority of which turns into glyukuronidny conjugates. Two of these phenolic a metabolite are biologically active, but in much smaller degree, than diclofenac. The general system plasma clearance of diclofenac is 263±56 ml/min. Final elimination half-life makes 1-2 hours. Elimination half-life of 4 metabolites, including two pharmacological active, is also short and makes 1-3 hours. One of pharmacological inactive metabolites, 3 '-hydroxies-4 '-metoksi-diclofenac, has longer elimination half-life.
About 60% of the applied dose of drug are removed with urine in the form of glucuronic conjugates of not changed active agent and also in the form of metabolites, the majority of which is represented by glucuronic conjugates. In not changed look less than 1% of diclofenac are removed. The rest of the applied dose of drug is removed in the form of metabolites through bile, with a stake.
After intake or rectal administration of AUC diclofenac decreases twice as about a half of a dose of diclofenac is metabolized during the first passing through a liver. In plasma at reception of equivalent doses of diclofenac children (body weight mg/kg) had a similar to concentration of drug concentration of drug at adults.
The pharmacokinetics at separate groups of patients
After administration of drug in the differences in absorption, metabolism or removal of drug connected with age patients is not noted.
At patients with a renal failure when prescribing the drug Voltaren® in usual single doses of accumulation of diclofenac it was not noted. In case the clearance of creatinine is less than 10 ml/min., estimated equilibrium concentration of hydroxymetabolites of diclofenac are about 4 times higher, than at healthy patients.
At patients with chronic hepatitis or the compensated cirrhosis the indicators of pharmacokinetics of diclofenac are similar to that at patients without liver diseases.
The pharmacodynamics
of Voltaren® contains sodium diclofenac, the substance of nonsteroid structure rendering the significant antirheumatic, anti-inflammatory, analgeziruyushchy and febrifugal action. The main mechanism of effect of diclofenac is slowing down of biosynthesis of prostaglandins playing an important role in genesis of inflammation, pain and fever.
In rheumatic diseases of Voltaren®, showing anti-inflammatory and analgetic effects, considerably reduces pain at rest and at the movement, morning constraint and a swelling of joints and also improve functions of joints.
Diclofenac of sodium does not suppress biosynthesis of proteoglycans of cartilaginous tissue.
At the posttraumatic and postoperative inflammatory phenomena of Voltaren® kills pain (both spontaneous, and arisen at the movement), reduces inflammatory hypostasis and hypostasis of the postoperative field.
The considerable analgetic effect of drug at the moderate and expressed pain syndrome of not rheumatic genesis is revealed. It is also established that Voltaren® is capable to eliminate pain and to reduce blood loss at primary dysmenorrhea.
Вольтарен®, besides, has favorable effect on manifestations of attacks of migraine.

Indications
- inflammatory and degenerative forms of rheumatic diseases: the pseudorheumatism, a juvenile pseudorheumatism, an osteoarthritis, a spondylarthritis ankylosing a spondylitis (Bekhterev's disease), pain syndromes in diseases of a backbone of rheumatic origin
- bad attacks of gout
- posttraumatic and postoperative pain syndromes
- the gynecologic diseases which are followed by a pain syndrome and inflammation (for example, primary dysmenorrhea and an adnexitis)
- as a part of complex therapy in the serious inflammatory illness of an ear, throat and nose proceeding with the expressed pain syndrome (pharyngitis, tonsillitis, otitis, a frontal sinusitis, antritis)

the Route of administration and doses
Within the general recommendation a dose of drug it has to be appointed individually. Side effects can be minimized by means of use of a minimal effective dose during the minimum period demanded for control over symptoms.
Adults
the Recommended initial dose - 100-150 mg/days. In rather mild cases of a disease and also for long therapy happens rather daily dose of 75-100 mg. The daily dose should be divided into 2 – 3 receptions.
At primary dysmenorrhea the daily dose is selected individually, usually it makes 50-150 mg. The initial dose has to make 50-100 mg, in need of a course of several menstrual cycles it can be raised to 200 mg/days. Administration of drug should be begun at emergence of the first symptoms. Depending on dynamics of clinical symptoms the treatment can be continued within several days.
Children are more senior than 14 years
to Children 14 years are more senior and to teenagers appoint drug in a dose at the rate of 0.5-2 mg/kg of mass of bodies/days (in 2-3 receptions, depending on disease severity). For treatment of a juvenile pseudorheumatism the daily dose can be most increased up to 3 mg/kg a day (in 2-3 receptions).
The maximum daily dose should not exceed 150 mg.
É«½ýÔáÓÑ¡® 50 mg are not recommended to be applied at children 14 years are younger.
The geriatrics (patients at age & gt, 65)
Correction of an initial dose is not required for elderly patients.
The established cardiovascular disease or essential risk factors from a cardiovascular system
As a rule, therapy of the drug Voltaren® is not recommended to patients with the established cardiovascular disease or an uncontrollable hypertension. If necessary, Voltaren® is appointed to patients with the established cardiovascular disease, an uncontrollable hypertension, or essential risk factors of a cardiovascular disease only after careful assessment and only within daily doses ≤ 100 mg in case of therapy lasting over 4 weeks (see. Special instructions).
Patients with impaired renal function
of Voltaren® it is contraindicated to patients with a renal failure (see. Contraindications).
In a type of lack of special researches at patients with impaired renal function, the recommendation about special correction of a dose cannot be provided. It is recommended to be careful at use of the drug Voltaren® for patients with a slight and moderate renal failure (see. Special instructions).
Patients from the liver
of Voltaren® broken by function it is contraindicated to patients with a liver failure (see. Contraindications).
In a type of lack of special researches at patients from the liver broken by function, the recommendation about special correction of a dose cannot be provided. It is recommended to be careful at use of the drug Voltaren® for patients with a slight and moderate abnormal liver function (see. Special instructions).
Tablets should be swallowed entirely, without breaking and without chewing, washing down with liquid, it is desirable to food.

Side effects
Often (from & gt, 1/100 to & lt, 1/10)
- a headache, dizziness
- vertigo
- nausea, vomiting, diarrhea, dyspepsia, abdominal pain, a meteorism, anorexia
- increase in level of transaminases
- rash
Infrequently (≥1/1000 to & lt, 1/100)
- a myocardial infarction, heart failure, a cardiopalmus, a stethalgia
Seldom (from & gt, 1/10000 to & lt, 1/1000)
- reactions of hypersensitivity, anaphylactic/anaphylactoid reactions, including hypotension and shock
- drowsiness
- asthma (including dispnoe)
- gastritis, gastrointestinal bleeding (a hematemesis, a melena, diarrhea with blood impurity), ulcer of stomach and intestines, followed or not followed by bleeding or perforation
- hepatitis, jaundice, an abnormal liver function
- urticaria, irritations of skin
Very seldom (& lt, 1/10000)
- thrombocytopenia, a leukopenia, hemolytic anemia (including hemolytic and aplastic anemia), an agranulocytosis
- a Quincke's disease
- a disorientation, a depression, insomnia, nightmares, irritability, psychotic disorders
- paresthesia, disturbance of memory, a spasm, alarm, a tremor, aseptic meningitis, a dysgeusia, an acute disorder of cerebral circulation
- a disorder of vision, the obscured sight, a diplopia
- a ring in ears, a hearing disorder
- hypertensia, a vasculitis
- pneumonia
- colitis (including hemorrhagic colitis and exacerbation of ulcer colitis or Crohn's disease), a constipation, stomatitis, a glossitis, disturbance from a gullet, intestines diaphragm diseases, pancreatitis
- lightning hepatitis, necrotic hepatitis, a liver failure
- bullous dermatitis, eczema, an erythema, a multiformny erythema, Stephens-Johnson's syndrome, a toxic epidermal necrolysis (Lyell's disease), exfoliative dermatitis, an alopecia, reaction of photosensitivity, purple, purple of Shenleyn-Genokh, an itching
- an acute renal failure, a hamaturia, a proteinuria, a nephrotic syndrome, tubulointerstitsialny nephrite, renal papillary necrosis

of the Contraindication
- hypersensitivity to diclofenac and any other ingredients of drug
- a peptic ulcer of a stomach or intestines in a stage of aggravation, bleeding or perforation
- pregnancy and the period of breastfeeding
- a liver failure
- a renal failure
- heavy heart failure
- existence in the anamnesis of the attacks of asthma, urticaria, acute rhinitis connected with use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
- diseases of the haematogenic system
- treatment of postoperative pain after operation of coronary shunting or use of the cardiopulmonary bypass
- the children's age up to 14 years

Medicinal interactions
Strong CYP2C9 inhibitors
Is recommended to be careful when prescribing diclofenac together with strong CYP2C9 inhibitors (such as vorikonazol) that can lead to significant increase in the maximum concentration in blood plasma and exposure to diclofenac because of diclofenac metabolism inhibition.
Lithium,
Voltaren® digoxin can increase concentration of lithium and digoxin in blood plasma. It is recommended to control the level of lithium and digoxin in blood serum.
Diuretic means
of Voltaren® as well as other non-steroidal anti-inflammatory drugs (NPVP), the expressiveness of diuretic action can reduce. Simultaneous use of kaliysberegayushchy diuretics can lead to increase in level of potassium in blood serum (in case of such combination of medicines this indicator should be controlled regularly).
Medicines which, as we know, cause a hyperpotassemia
the Accompanying treatment by kaliysberegayushchy diuretics cyclosporine, takrolimusy or Trimethoprimum can be associated with the increased potassium levels in serum that, therefore, has to be controlled regularly.
NPVP and corticosteroids
Simultaneous system use of non-steroidal anti-inflammatory drugs (NPVP) can increase the frequency of emergence of the undesirable phenomena.
Anticoagulants
Though in clinical trials it is not established influences of the drug Voltaren® on effect of anticoagulants, there are separate messages about increase in risk of bleedings at the patients accepting at the same time Voltaren® and these drugs. Therefore, in case of such combination of medicines, careful and regular observation of patients is recommended.
The Selective Serotonin Reuptake Inhibitors (SSRI)
Combined use of system NPVS, including diclofenac, and SIOZS can increase risk of gastrointestinal bleeding.
Antidiabetic drugs
At simultaneous use of the drug Voltaren® and antidiabetic drugs, the efficiency of the last does not change. However separate messages about development both a hypoglycemia, and a hyperglycemia, the glucose-lowering drugs demanding need of change of a dose are known during drug Voltaren® use.
Phenytoinum
When using Phenytoinum together with diclofenac, is recommended to carry out monitoring of concentration of Phenytoinum in blood plasma because of the expected increase in extent of exposure to Phenytoinum.
A methotrexate
It is necessary to be careful when prescribing non-steroidal anti-inflammatory drugs (NPVP) less than in 24 hours prior to or after reception of a methotrexate as in such cases the concentration of a methotrexate in blood can increase and amplify its toxic action.
Cyclosporine
Influence of non-steroidal anti-inflammatory drugs (NPVP) on synthesis of prostaglandins in kidneys can increase nephrotoxicity of cyclosporine
Antibacterial agents - derivatives of a hinolon
Are available separate messages about development of spasms in the patients receiving at the same time derivative a hinolon and non-steroidal anti-inflammatory drugs (NPVP).

Special instructions
At use of all NPVP, including diclofenac, are registered cases of gastrointestinal bleedings, formation of an ulcer or perforation which can be fatal and occur at any time in the course of treatment at existence or lack of precautionary symptoms or the previous anamnesis of the serious phenomena from a GIT. These phenomena usually have more serious consequences at patients of advanced age. If at the patients accepting diclofenac note the phenomena of gastrointestinal bleeding or ulceration, use of drug needs to be stopped.
As well as at use of other NPVP, including diclofenac, for patients with the symptoms demonstrating disturbances from a GIT, given about existence in the anamnesis of an ulcer, bleeding or perforation in a GIT the medical observation and extra care is obligatory. The risk of developing of bleeding, ulcer or perforation in a GIT increases with increase in a dose of NPVP, including diclofenac, and patients with presence of the ulcer in the anamnesis which is especially complicated by bleeding and also at elderly people. To reduce risk of such toxic impact on a GIT, treatment should be begun and supported by minimal effective doses.
For such patients and also those who need the accompanying use of the medicines containing low doses of acetylsalicylic acid or other medicines which probably increase risk of undesirable action on a GIT it is necessary to consider a question of use of combination therapy using protective equipment (for example inhibitors of a proton pomp or mizoprostol).
Patients with gastrointestinal toxicity in the anamnesis, especially advanced age, have to report about any unusual abdominal symptoms (especially bleedings in a GIT). The precaution is also required for the patients receiving at the same time medicines which can increase risk of developing of an ulcer or bleeding, such as system corticosteroids, anticoagulants, antithrombocytic means or selective serotonin reuptake inhibitors.
During therapy by drug it is necessary to carry out careful medical observation and to be careful at patients with ulcer colitis or Crohn's disease as their state can become aggravated.
Impact on the cardiovascular
Therapy system using NPVP, including diclofenac, in particular when using high doses and duration can be connected with slight increase of risk of heavy cardiovascular trombotichesky processes (including a myocardial infarction and a stroke).
As a rule, therapy by the drug Voltaren® is not recommended to patients with the established cardiovascular disease (stagnant heart failure, coronary heart disease, a peripheral arterial disease) or an uncontrollable hypertension. In need of Voltaren® it is appointed to patients with the established cardiovascular disease, an uncontrollable hypertension, or essential risk factors of a cardiovascular disease (hypertensia, a lipidemia, diabetes and smoking) only after careful assessment and only within daily doses ≤ 100 mg in case of therapy lasting over 4 weeks.
In view of possible increase in risks from a cardiovascular system as a result of a dosage and duration of exposure, it is necessary to use a diclofenac minimal effective dose during the minimum period. It is required to carry out periodically the repeated assessment of need for relief of symptoms and the response to therapy of the patient, in particular lasting therapy over 4 weeks.
Patients have to be informed concerning risk of emergence of the serious trombotichesky phenomena (stethalgia, short wind, weakness, disturbance of the speech) which can arise without precautionary symptoms at any time. In this case it is necessary to see a doctor immediately.
Influence on hematologic indicators
When prescribing this drug to the long period is recommended (as well as for other NPVP) regularly to control a gemogramma. Diclofenac, as well as other NPVP, can temporarily inhibit aggregation of thrombocytes therefore it is necessary to control carefully a condition of patients with disturbances of a hemostasis.
Influence on a respiratory system (asthma in the anamnesis)
At patients with asthma, seasonal allergic rhinitis, a rhinedema (for example nasal polyps), chronic obstructive diseases of lungs or persistent infections of a respiratory path (especially with the manifestations similar to symptoms of allergic rhinitis) at reception of NPVP more often than other patients, have such side effects as exacerbation of asthma (so-called intolerance of analgetics or analgetic asthma), a Quincke's edema or urticaria. In this regard special precautionary measures (readiness for rendering emergency aid) are necessary for such patients. The above also concerns patients with allergic manifestations at use of other drugs, for example rash, an itching or urticaria. Impact on a liver
Careful medical observation is required in case Voltaren® is appointed to patients with an abnormal liver function as their state can worsen. As well as at use of other NPVP, including diclofenac, the level of one or several enzymes
of a liver can increase.
During long-term treatment the regular observation of function of a liver and level of liver enzymes as a precautionary measure is appointed the drug Voltaren®. If abnormal liver functions remain or worsen and if clinical signs or symptoms can be connected with the progressing diseases of a liver or if other manifestations are noted (for example an eosinophilia, rash), use of the drug Voltaren® should be stopped. The course of diseases, such as hepatitis, can pass without prodromal symptoms. Cautions are necessary if Voltaren® is applied at patients with a hepatic porphyria, because of the probability of provoking of an attack.
Skin reactions
Due to the use of NPVP, including the drug Voltaren®, were seldom or never registered serious reactions from skin (some of them were fatal), including exfoliative dermatitis, Stephens's syndrome — Johnson and a toxic epidermal necrolysis. At patients the high risk of these reactions was revealed at the beginning of a therapy course: emergence of reaction is noted in most cases within the first month of treatment. Use of the drug Voltaren® needs to be stopped at the first appearance of skin rash, damage of a mucous membrane or emergence of any other signs of hypersensitivity.
Influence on kidneys
As at treatment of NPVP, including diclofenac, cases of a delay of liquid and hypostases are registered, special attention should be paid to patients with dysfunctions of heart or the kidneys, AG in the anamnesis, to patients of advanced age, patients receiving therapy by diuretics or drugs which significantly influence function of kidneys and also to patients with significant decrease in extracellular volume of liquid for any reason, for example to or after serious surgical intervention. In such cases as a precautionary measure the monitoring of function of kidneys is recommended. The therapy termination usually leads to return to a state which preceded treatment.
Use for elderly people
It is necessary to use with care drug at elderly people according to the main medical practice. In particular are recommended to appoint a minimal effective dose the weakened elderly patients or elderly patients with insufficient body weight.
Interaction with NPVP
It is necessary to avoid simultaneous use of the drug Voltaren® with system NPVP, including selection TsOG-2 inhibitors, in a type of undesirable influence.
Masking of manifestation of infectious diseases
of Voltaren®, as well as other NPVP, thanks to the pharmakodinamichesky properties can mask manifestations and symptoms of infectious diseases.
Drug should not be used to persons with hereditary intolerance of fructose, deficiency of Lappa lactase, glucose malabsorption – galactoses.
Pregnancy and the period of breastfeeding
Use of diclofenac for pregnant women was not studied. Therefore Voltaren® should not appoint the first two trimesters of pregnancy if only the advantage of its use does not exceed risks for a fruit. As well as for other NPVP, use of drug throughout the third trimester of pregnancy is contraindicated owing to risk of development of weakness of patrimonial activity of a uterus and/or premature closing of an arterial channel.
As well as other NPVP, diclofenac in small amounts are allocated in breast milk. Thus, Voltaren® should not be applied during feeding by a breast to prevent undesirable reactions at the child.
As well as other NPVP, Voltaren® can have negative effect on female fertility therefore the women planning pregnancy are not recommended to appoint drug. For women who have problems with conception or pass a research on an infertility occasion, it is necessary to consider expediency of drug withdrawal of Voltaren®.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
to the Patients who are feeling dizzy during time administration of drug Voltaren® or other unpleasant feelings from the central nervous system, including disorders of vision, should not run vehicles or to work with difficult mechanisms.

Overdose
Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, sonitus or spasms. In case of a serious poisoning the development of an acute renal failure and injury of a liver is possible.
Treatment: the supporting and symptomatic therapy. Use of an artificial diuresis, hemodialysis or hemoperfusion are ineffective for removal of non-steroidal anti-inflammatory drugs (NPVP) as active agents of these drugs substantially contact proteins of plasma and are exposed to intensive metabolism. It is possible to consider the possibility of use of activated carbon at drug overdose and also gastric decontamination (for example, vomiting, gastric lavage).

The form of release and packing
On 10 tablets place in blister strip packaging from a transparent colourless film polyvinylchloride/polyethylene/polyvinylidene chloride and the printing aluminum foil varnished.
On 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard pack.


To Store storage conditions at a temperature below 30 wasps, to protect from moisture influence.
To store out of children's reach!


3 years
not to apply a period of storage after the expiry date specified on packing.

Prescription status
According to the prescription



the Producer Novartis Urunleri Kurtkoy,
34912 Istanbul Turkey

the Name and the country of the owner of the registration certificate
of Novartis Pharm AG, Switzerland
the Address of the organization accepting claims from the consumer on quality of a product (goods) and responsible for post-registration observation of safety of medicine in the territory of the Republic of KazahstanFilial Novartis Pharm Servisez AG in Almaty, Luganskogo St., 96 Kazakhstane050051 ph.: (727) 258-24-47 fax: (727) 244-26-51e-mail:
To Develop drugsafety.cis@novartis.com