Voltarenum

Voltarenum – nonsteroid drug of the expressed analgeziruyushchy, febrifugal and antiinflammatory action.

Form of release and structure

Dosage forms of Voltarenum:

• Tablets: round, biconvex in a kishechnorastvorimy cover with a facet and an engraving of "CG" on one of the parties; on other party an engraving of "BZ" – a cover of yellow color, "GT" – light brown (on 10 pieces in blisters, 2 or 3 blisters in a cardboard pack);
• Tablets of the prolonged action: round, biconvex, film coated pink color, with a facet, on one of the parties marking by black CG ink, on another – "CGC" (on 10 pieces in blisters, 1 or 3 blisters in a cardboard pack);
• Solution for intramuscular introduction (in oil): light yellow or colourless liquid (on 3 ml in glass ampoules with a point of a break or a ring of a break, on 5 pieces in a cardboard pack);
• Suppositories rectal: a torpedo-shaped form, from color, white to white with a yellow shade, with smooth or a little uneven surface and a slight smell (on 5 pieces in blisters, in a cardboard pack – 1 or 2 blisters);
• Spray for external use: transparent liquid of yellow color with a smell of mint and isopropanol (on 15 or 30 ml in glass dark bottles with the portioning device, in a cardboard pack 1 bottle);
• The plaster is transdermalny: the beige rectangle from polyester, is applied on one of surfaces adherent layer of light yellow color, with a slight smell, covered with a transparent film (on 2, 5, 7 or 10 pieces in packages from aluminum foil, in cardboard packs on 1 package).

The operating component – sodium diclofenac, its contents depending on a dosage form:

• 1 tablet of yellow color with an engraving of "BZ" – 25 mg;
• 1 tablet of light brown color with an engraving of "GT" – 50 mg;
• 1 tablet of the prolonged action of pink color with an engraving of "CGC" – 100 mg;
• 1 suppository – 25, 50 or 100 mg;
• 1 ampoule – 75 mg;
• 1 dose of spray – 8 mg;
• Transdermalny plaster of 7 by 10 cm – 15 mg;
• Transdermalny plaster of 10 by 14 cm – 30 mg.

Excipients:

• Tablets in a kishechnorastvorimy cover: cellulose microcrystallic, magnesium stearate, silicon dioxide colloid anhydrous, lactoses monohydrate, sodium carboxymethylstarch, starch corn, K30 povidone;
• Tablets of the prolonged action: magnesium stearate, silicon dioxide colloid anhydrous, sucrose, cetyl alcohol, K30 povidone;
• Solution for introduction in oil: benzyl alcohol, a mannitol (free from pyrogens), sodium the bisulphite, propylene glycol distilled sodium hydroxide and water for injections;
• Suppositories: fat firm;
• Spray for external use: ethanol, propylene glycol, hydrophosphate sodium dodecahydrate, isopropanol, dinatrium эдетат, lecithin soy, dihydrophosphate sodium a dihydrate, was offended by palmitate, oil of leaves of a peppermint, water;
• The plaster is transdermalny: polyisobutylene, left menthol, изопренстирол copolymer, метилпирролидон, mercaptobenzimidazole, propilenglikolevy ethers of fatty acids, citric acid, butyl hydroxytoluene, gum efirizirovanny, liquid paraffin, a basis and a protective film from polyester.

In addition as a part of tablets:

• The painted kishechnorastvorimy cover: a macrogoal 8000, copolymer of methacrylic acid and ethyl acrylate (1:1), the silicone antimaking foam emulsion of SE2, a gipromelloz, titanium dioxide, a macrogoal глицерилгидроксистеарат, talc, dye ferrous oxide yellow and red;
• The cover is film: gipromelloza, polysorbate 80, dye ferrous oxide red (E172), talc, titanium dioxide;
• Polish: sucrose crystal, a macrogoal 8000, ink black (shellac solution in ethanol), dye ferrous oxide black (E172), ammonium hydroxide of 28% (E527), propylene glycol (E1520).

Indications to use

Voltarenum is shown for symptomatic therapy of painful and inflammatory processes:

• Joints: inflammatory diseases (chronic gouty arthritis, the pseudorheumatism ankylosing a spondylitis, rheumatism), degenerative diseases (the osteochondrosis deforming an osteoarthrosis);
• Backbone: lumbago, radiculitis, sciatica, mialgiya, ossalgiya, neuralgia, arthralgia;
• Extraarticular fabrics: bursitis, tendovaginitis, rheumatic defeat of soft tissues;
• Bad attack of gout;
• Hepatic and renal colic;
• The postoperative and posttraumatic pain syndrome which is followed by an inflammation;
• Inflammatory processes in a small basin, an adnexitis, primary дисальгоменорея;
• Migraine attack;
• Infectious inflammation of ENT organs with the expressed pain syndrome: pharyngitis, tonsillitis, otitis;
• Residual phenomena of pneumonia.

Use of Voltarenum does not influence progressing of a disease.

Contraindications

• The urticaria, acute rhinitis, attacks of bronchial asthma arising against the background of reception of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NPVS) (in the anamnesis);
• III trimester of pregnancy;
• Breastfeeding period;
• Hypersensitivity to drug components.

Contraindications to use of tablets, solution and suppositories Voltarenum:

• Peptic ulcer of a stomach and duodenum in an aggravation phase (internal bleedings, perforation);
• Disease Krone, ulcer colitis and other destructive and inflammatory diseases of intestines in an aggravation phase;
• Severe form of renal, liver, heart failure;
• Active diseases of a liver;
• Aortocoronary shunting (perioperatsionny period);
• The hyperpotassemia (diagnosed);
• The states which are followed by risk of development of bleedings.

It is not recommended to apply Voltarenum in the form of tablets to patients with glyukozo-galaktozny malabsorption, a heavy lactose intolerance, hereditary intolerance of a galactose.

It is impossible to appoint solution for injections in oil during pregnancy.

Use of suppositories at a proctitis is contraindicated.

Under careful medical control it is necessary to use drugs in the form of tablets, solution and suppositories at patients with bronchial asthma, cardiovascular diseases or high risk of their development, seasonal allergic rhinitis, chronic infectious pathologies of respiratory system, a rhinedema (including at polyps), a diabetes mellitus, arterial hypertension, a dislipidemiya or a lipidemia, disturbances of system of a hemostasis, alcohol and/or tobacco addiction.

With extra care apply diclofenac at treatment of patients of advanced age.

It is impossible to apply spray and a plaster on sites with the broken integrity of an integument.

With care apply:

• Spray and plaster: at heavy abnormal liver functions and kidneys, erosive cankers of a stomach and/or intestines;
• Plaster: at chronic heart failure, a hepatic porphyria (in an aggravation stage), bronchial asthma, at advanced age;
• Spray: at hemorrhagic diathesis, a round ulcer, in I and II trimesters of pregnancy.

Use of Voltarenum aged is contraindicated:

• Up to 18 years in the form of tablets of the prolonged action and solution;
• Up to 15 years in the form of a transdermalny plaster and spray;
• Up to 14 years in the form of tablets in a kishechnorastvorimy cover on 50 mg;
• Up to 6 years in the form of tablets in a kishechnorastvorimy cover on 25 mg.

Route of administration and dosage

• Pill in a kishechnorastvorimy cover is taken inside to food, without chewing, washing down with water. The recommended initial dose on 50 mg 2-3 times a day, at easy degree of a disease or need of prolonged treatment is enough 75-100 mg a day. Therapy of primary dysmenorrhea is recommended to be begun with the moment of emergence of pain in a daily dose 50-100 mg. In case of need, after several menstrual cycles, about 150 mg a day are allowed to raise a dose;
• Tablets of the prolonged action are swallowed entirely during food. The recommended initial dose – 100 mg a day, adhere to it at long therapy or moderately expressed symptomatology;
• Solution is used by deep slow intramuscular introduction for primary removal of a strong pain syndrome. The recommended dose – 75 mg of 1 times a day. In hard cases, including at severe gripes, 2 injections on 75 mg a day with a break in several hours are allowed;
• Suppositories are applied rektalno, it is desirable after bowel emptying. Dosing for adult patients of 100-150 mg a day, with frequency rate of introduction 2-3 times. At long use and pathologies in easy forms appoint 75-100 mg a day. For treatment of an attack of migraine the initial dose is recommended of 100 mg, it is necessary to use drug at the first symptoms of a disease. In case of need long therapy (more than 4 weeks) to patients with diseases of cardiovascular system or with high risk of development of this pathology should use drug in a daily dose no more than 100 mg. To children aged till 1 year the dose is defined at the rate of 0,5-2 mg on 1 kg of weight of the child a day, with frequency rate of introduction 2-3 times. At treatment of a juvenile pseudorheumatism increase in a dose up to 3 mg at 1 kg of weight in days is allowed;
• Spray is sprayed on the site of skin in the field of defeat, then it it is necessary to rub and allow to dry out. Depending on the size of the painful site 4-5 pressing the bottle doser are made. 3 times a day with uniform breaks are recommended to hold the procedure. The maximum daily dose – 120 mg or 15 pressing the sprayer;
• The Transdermalny plaster is applied outwardly in the form of applications on skin over painful area of a body. It is allowed to put 1 application a day, the size of a plaster is selected individually, depending on the size of a painful zone. It is recommended to apply no more than 14 days at treatment of soft tissues and no more than 21 day – at diseases of joints and muscles. At deterioration in health or in case of lack of therapeutic effect after 7 days of treatment it is necessary to see a doctor. For patients of advanced age dosing does not change.

Use of drug is recommended during the short period in a minimal effective dose.

The doctor appoints dosage forms, a dose and the period of treatment individually, considering a condition of the patient and clinical indications.

In case of the combined use of various dosage forms of Voltarenum the maximum total dose of diclofenac should not exceed 150 mg a day.

Side effects

Voltarenum in the form of tablets, solution and candles can cause the following side effects:

• From digestive tract: often – a loss of appetite, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, a meteorism. Seldom – gastritis, gastrointestinal bleeding, vomiting blood, diarrhea with blood impurity, a melena, stomach ulcers and intestines (are possible bleeding or perforation). Very seldom – pancreatitis, stomatitis, colitis (nonspecific hemorrhagic colitis, an exacerbation of ulcer colitis or a disease Krone), a glossitis, injuries of a gullet, emergence of diafragmopodobny strictures to intestines, a lock, a dysgeusia;
• From a liver and biliary tract: often – increase in activity of aminotransferases in a blood plasma. Seldom – abnormal liver functions, hepatitis, jaundice. Very seldom – a liver failure, fulminant hepatitis, a liver necrosis;
• From a nervous system: often – dizziness, a headache; seldom – drowsiness. Very seldom – disturbances of sensitivity, paresthesia, acute disorders of cerebral circulation, a dysmnesia, a tremor, feeling of alarm, a spasm, aseptic meningitis. Sometimes mental disorders in the form of a disorientation, depressions, sleeplessnesses, dreadful dreams, irritability;
• From skin and hypodermic fabrics: often – skin rash; seldom – a small tortoiseshell. Very seldom – violent rashes, a mnogoformny exudative erythema, eczema, Stephens-Johnson's syndrome, an itch, a toxic epidermal necrolysis, exfoliative dermatitis, a hair loss, a purpura, photosensitivity reactions;
• From sense bodys: often – вертиго; very seldom – sight misting, a diplopia, a dysgeusia, a hearing disorder, a sonitus;
• From cardiovascular system: very seldom – stethalgias, a heart consciousness, increase in the arterial pressure (AP), a vasculitis, heart failure, a myocardial infarction;
• From urinogenital system: very seldom – tubulointerstitsialny nephrite, an acute renal failure, a proteinuria, a hamaturia, a nephrotic syndrome, a papillary necrosis;
• From respiratory system: seldom – asthma; very seldom – pneumonites;
• Allergic reactions: seldom – hypersensitivity, anaphylactic or anaphylactoid reactions, decrease in the ABP and shock. Very seldom – a Quincke's disease (including a face edema);
• From system of a hemopoiesis: very seldom – thrombocytopenia, hemolitic anemia, a leukopenia, an agranulocytosis, aplastic anemia;
• Local reactions: often – pain, consolidation in the place of an injection or irritation in a candle injection site; seldom – hypostases, a necrosis in a drug injection site (for solution).

Side effects of use of spray Voltarenum: a skin itch and development of system reactions at long use and/or drawing to extensive area of skin; most often: abdominal pain, renal failure, bronchial asthma, reactions of hypersensitivity, disturbance of system of digestion.

The temporary and moderately expressed skin manifestations on the site of gluing are characteristic of applications of a plaster:

• Local reactions: often – an erythema, dermatitis, eczema; seldom – violent dermatitis. Very seldom – pustular rashes;
• System reactions: very seldom – generalized skin rash, allergic reactions.

At emergence of signs of side effects it is necessary to see a doctor urgently.

Special instructions

Treatment by Voltarenum has to correspond to all recommendations of the doctor strictly.

In I and II trimesters of pregnancy drug is appointed only if the expected advantage for mother exceeds potential risk for a fruit.

Strongly weakened and the patient with low body weight it is recommended to appoint the minimum dose of diclofenac.

No more than 2 days in a row are recommended to apply injections.

Solution is used right after opening of an ampoule, mixing with other drugs in one syringe is not allowed.

It is reasonable to apply a combination therapy: to appoint tablets during the day, and suppositories – before going to bed.

It is not required to patients of advanced age of correction of an initial dose of suppositories.

1 dose of spray corresponds to single pressing the portioning device of a bottle.

Patients who against the background of therapy by Voltarenum feel drowsiness, visual disturbances, dizziness, вертиго and other changes from the central nervous system are recommended to refrain from control of vehicles.

Medicinal interaction

The concomitant use of drug with CYP2C9 inhibitors increases concentration of diclofenac in blood.

Voltarenum can increase the content of digoxin and lithium in a blood plasma.

Drug reduces action of hypotensive and diuretic means.

The diclofenac combination to anticoagulants, antiagregant, inhibitors of the return serotonin reuptake increases risk of bleedings at patients.

Simultaneous use with other non-steroidal anti-inflammatory drugs (NPVP) increases risk of development of side effects.

Drug is recommended to take with caution not later than in 24 hours prior to and not earlier, than in 24 hours after reception of a methotrexate.

Combined use with hypoglycemic means at regular control of concentration of glucose in blood is allowed.

The concomitant use with kaliysberegayushchy diuretics can cause increase in level of potassium in blood.

It is not recommended to use drug with derivatives of a hinolon.

Voltarenum increases nephrotoxicity of cyclosporine and system influence of Phenytoinum.

Terms and storage conditions

To store in the dark dry place unavailable to children, at a temperature:

• Tablets, solution, suppositories – it is not above 30 °C;
• Spray, plaster – is not above 25 °C.

Period of validity:

• Tablets of the prolonged action – 5 years;
• Tablets in a kishechnorastvorimy cover, suppository, spray – 3 years;
• Solution, plaster – 2 years.

After opening of a bottle spray is good for use – 6 months.