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Active ingredient and dosage form

Solution for i / m administration
1 ml of solution contains Diclofenac (in the form of sodium salt) - 25 mg (1 ampoule - 75 mg);
Excipients: mannitol, sodium disulfite, benzyl alcohol, propylene glycol, water d / i, sodium hydroxide.
3 ml in ampoules, 5 ampoules in a carton box.

Enteric-Coated Tablets
1 pill contains diclofenac (in the form of sodium salt) - 25 or 50 mg;
Excipients: airgel, silicon dioxide, microcrystalline cellulose, lactose, Magnesium stearate, corn starch, polyvidone, sodium carboxymethyl starch, hydroxypropylmethyl cellulose, glyceryl polyethylene glycol stearate, ferric oxide yellow (E172), talc, titan teacher, and a student’s accentant classant, and a student’s classant’s classantist will be a classant student who will be a non-accentant student who will be a non-accentant student who will be a non-accentant student who will be a non-accentant student who will be a non-acterate student will not be a member of a student’s class to use a non-one, you will be able to use a non-accentric student to use a non-standardized student.
10 pieces. in blisters, 2 or 3 blisters in a carton box.

Film Retard Tablets
1 pill contains diclofenac (in the form of sodium salt) - 100 mg;
Excipients: silicon airgel, cetyl alcohol, magnesium stearate, polyvidone, sucrose, hydroxypropyl methyl cellulose, polysorbate 80, talc, titanium dioxide, iron red oxide (E172), macrogol 8000.
10 pieces. in blisters, 3 blisters in a carton box.

1 suppository contains diclofenac (in the form of sodium salt) - 25, 50 or 100 mg;
Excipients: solid fats.
25, 50 mg: 5 pcs. in blisters, 2 blisters in a carton box
100 mg: 5 pcs. in blister, 1 blister in a carton box.

Film Coated Tablets white color, oblong.
1 pill contains diclofenac potassium - 12.5 mg;
Excipients: anhydrous colloidal silicon, lactose, corn starch, glycol starch sodium salt, polyvidone, microcrystalline cellulose, magnesium stearate.
Shell composition: methylhydroxypropylcellulose, titanium dioxide, macrogol, polysorbate, maltodextrin.
10 pieces. in blisters, 1, 2 blisters in a cardboard box.

Gel for external use 1%
100 g of gel contain diclofenac diethylamine 1.16 g, respectively. 1 g of diclofenac sodium;
The basis of the gel: fat emulsion in an aqueous gel supplemented with isopropanol and propylene glycol.
Other ingredients: diethylamine, acrylic acid polymer, cetomacrogol 1000, caprylic / capric acid ester, isopropyl alcohol, propylene glycol, liquid paraffin, flavoring, water.
20 g or 50 g in aluminum tubes, 1 tube in a carton box.

rr d / in / m of the introduction of 75 mg / 3 ml - P №011889 / 04, 03/30/05
tabl. by. solution./ intestinal - №015266 / 01, 18.09.2003
tab. retard, pokr pl about. - P No. 011889 / 03-2000, 04/25/05
supp. rekt 25 mg - №013066 / 01-2001, 15.06.2001
VOLTAREN ACT tab. square about. - P No. 014201 / 01-2002 07/17/02
VOLTAREN EMULGEL gel d / external. approx. 1% - П №016030/01 08.19.05

Mechanism of action

NSAIDs. It has a pronounced analgesic, anti-inflammatory and antipyretic effect.
The main mechanism of action of diclofenac, established in the experimental conditions, is the inhibition of the biosynthesis of prostaglandins. Prostaglandins play an important role in the genesis of inflammation, pain and fever.
In vitro, diclofenac sodium at concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of cartilage proteoglycans.
In rheumatic diseases, anti-inflammatory and analgesic properties of Voltaren provide a clinical effect characterized by a significant decrease in the severity of such manifestations of diseases as pain at rest and on movement, morning stiffness and swelling of the joints, as well as an improvement in functional status.
In post-traumatic and postoperative inflammatory events, Voltaren quickly relieves pain (arising both at rest and when moving), reduces inflammatory swelling and swelling of a postoperative wound.
When using Voltaren in pills and suppositories, a marked analgesic effect of the drug was noted with moderate and severe pain of non-rheumatic origin. It was also found that Voltaren is able to reduce pain and reduce blood loss in primary dysmenorrhea.
In addition, Voltaren eases migraine attacks (when used in suppositories).

Indications and usage

- inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, osteoarthritis;
- diseases of the spine, accompanied by pain;
- rheumatic diseases of extra-articular soft tissues;
- acute attack of gout (only for enteric-coated tablets);
- post-traumatic and postoperative pain syndromes, accompanied by inflammation and swelling;
- gynecological diseases accompanied by pain and inflammation (for example, primary algodimenorrhea, adnexitis);
- as an additional remedy for severe infectious and inflammatory diseases of the ear, nose and throat, occurring with severe pain, for example, pharyngitis, tonsillitis, otitis media (except for retard tablets). The main treatment of the disease is carried out in accordance with generally accepted principles, incl. with the use of etiotropic therapy. Isolated fever is not an indication for the use of the drug;
- migraine attacks (only for suppositories).

Removal and reduction of pain sensations of various origins, including:
- headache and toothache;
- pain during menstruation;
- Pain in the muscles and various parts of the spine.
Removal and reduction of symptoms of cold, flu and tonsillitis, including painful sensations in these conditions.
To reduce body temperature.

- post-traumatic inflammation of tendons, ligaments, muscles and joints (sprain, overload, bruises);
- localized forms of rheumatic soft tissue diseases (including tendovaginitis, shoulder-brush syndrome, bursitis, periarthritis);
- Osteoarthritis of the peripheral joints and joints of the spine.


- a stomach or intestinal ulcer;
- Anamnestic information about attacks of asthma, urticaria, acute rhinitis associated with the use of Acetylsalicylic acid or other NSAIDs, as well as any drugs that suppress the production of prostaglandins;
- proctitis (only for suppositories);
- violations of blood formation;
- children's age up to 14 years;
- Hypersensitivity to diclofenac and any other ingredients of the drug.
The drug is not recommended for use in the III trimester of pregnancy / possible suppression of uterine contractility and premature closure of the arterial duct in the fetus /).

Dosage and administration

Enteric-Coated Tablets
Tablets should be swallowed whole with a liquid, preferably before meals.
For adults The recommended initial dose is 100-150 mg / day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg / day is sufficient. The daily dose should be divided into several doses. If necessary, to influence night pain or morning stiffness in addition to taking the drug during the day, Voltaren is prescribed in the form of suppositories at bedtime; at the same time, the total daily dose should not exceed 150 mg.
Primary dysmenorrhea daily dose picked individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, for several menstrual cycles, it can be increased to 150 mg / day. The drug should be started when the first symptoms appear. Depending on the dynamics of the clinical symptoms, treatment can be continued for several days.
Children weighing 25 kg or more prescribe the drug in a dose rate of 0.5-2 mg / kg of body weight / day (in 2-3 doses, depending on the severity of the disease).
For the treatment of rheumatoid arthritis The daily dose can be maximized to 3 mg / kg (in several doses).
Use enteric-coated tablets, 50 mg at children Not recommended.
Film Retard Tablets
Tablets should be swallowed whole, preferably with meals.
For adults The recommended initial dose is 100 mg (1 tab. Retard) / day. The same dose is used in relatively mild cases of the disease, as well as for long-term therapy. In cases where the symptoms of the disease are most pronounced at night or in the morning, it is advisable to take retard pills at night.
Do not prescribe retard pills for children.
For adults The recommended initial dose is 100-150 mg / day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg / day is sufficient. Frequency of use - 2-3 times. To relieve night pain or morning stiffness, Voltaren is prescribed in suppositories at bedtime, in addition to using the drug in pill form throughout the day; at the same time, the total daily dose should not exceed 150 mg.
Primary dysmenorrhea daily dose picked individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, for several menstrual cycles, it can be increased to 150 mg / day. Treatment should begin when the first symptoms appear. Depending on the dynamics of the clinical symptoms, treatment can be continued for several days.
With a migraine attack the initial dose is 100 mg. The drug is prescribed at the first symptoms of an approaching attack. If necessary, on the same day, you can additionally apply Voltaren in suppositories in a dose of up to 100 mg. If it is necessary to continue treatment in the following days, the daily dose of the drug should not exceed 150 mg (in several injections).
Children weighing 25 kg or more prescribe the drug at a dose rate of 0.5-2 mg / kg body weight / day (daily dose, depending on the severity of the disease, should be divided into 2-3 single doses). For the treatment of juvenile rheumatoid arthritis The daily dose may be maximized to 3 mg / kg (in several injections).
Use suppositories 50 mg and 100 mg. at children Not recommended.

The drug is administered intramuscularly by deep injection into the gluteal region. Do not use injections Voltaren more than 2 days in a row. If necessary, treatment can be continued with Voltaren pills or rectal suppositories.
When conducting intramuscular injection in order to avoid damage to the nerves or other tissues at the injection site, it is recommended to adhere to the following rules.
The drug should be administered deep intramuscularly in the upper outer quadrant of the gluteal region. The dose is usually 75 mg (contents of 1 ampoule) 1 time per day. In severe cases (for example, with colic) as an exception, 2 injections of 75 mg can be given, with an interval of several hours (the second injection should be carried out in the opposite gluteal region). Alternatively, one injection of the drug per day (75 mg) can be combined with taking other Voltaren dosage forms (tablets, rectal suppositories), with a maximum daily dose of 150 mg.

For adults and adolescents over 14 years old The initial dose is 2 pills followed by 1-2 pills every 4-6 hours as needed.
The maximum daily dose is 6 pills (75 mg).
Tablets should be taken whole, without chewing and drinking water. To achieve the maximum therapeutic effect of the drug should be taken before meals.
Without a prescription, the duration of Voltaren Akti is 3 days for fever, and 5 days for pain syndrome.

The amount of drug used depends on the size of the painful area. For example, 2-4 g of Voltaren Emulgel (which is comparable in volume, respectively, with the size of a cherry or walnut) is sufficient for application to an area of ​​400-800 cm2. The drug is applied to the skin 3-4 times / day and lightly rubbed.
After application of the drug, the hands should be washed, unless this area is treated.
The duration of treatment depends on the indications and the effectiveness of therapy. Indications for continuation of treatment are recommended to be reviewed after 2 weeks.

When assessing the frequency of occurrence of various adverse reactions, the following gradations were used: often -> 10%, sometimes -> 1-10%, rarely -> 0.001-1%, in some cases - <0.001%.
From the digestive system: sometimes - pain in the epigastric region, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia; rarely, Gastrointestinal bleeding (vomiting of blood, melena, diarrhea with blood), stomach and intestinal ulcers, accompanied or not accompanied by bleeding or perforation; in some cases - aphthous stomatitis, glossitis, damage to the esophagus, the occurrence of diaphragm-like strictures in the intestines, disorders of the distal colon, such as nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn’s disease, constipation, pancreatitis; sometimes - increased levels of aminotransferases in the serum; rarely, hepatitis, with or without jaundice; in some cases, fulminant hepatitis.
From the side of the central nervous system and peripheral nervous system: sometimes - headache, dizziness; rarely - drowsiness; in some cases, sensitivity disorders, including paresthesias, memory disorders, disorientation, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions, aseptic meningitis .
From the senses: in some cases - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, taste disturbances.
Since the cardiovascular system: in some cases - a feeling of heartbeat, chest pain, increased blood pressure, aggravation of congestive heart failure .
Dermatological reactions: sometimes skin rashes; rarely - urticaria; in some cases - bullous rashes, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermal necrolysis), erythroderma (exfoliative dermatitis), hair loss, photosensitivity reactions; purpura, incl. allergic.
From the urinary system: rarely swelling; in some cases - acute renal failure, hematuria, proteinuria, interstitial nephritis; nephrotic syndrome; papillary necrosis.
From the hemopoietic system: in some cases - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.
Hypersensitivity Reactions: rarely, bronchospasm, systemic anaphylactic / anaphylactoid reactions, including hypotension; in some cases - vasculitis, pneumonitis.
Local reactions: with the use of suppositories - local reactions, exacerbation of hemorrhoids.

Voltaren use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. The drug is prescribed in the minimum effective dose. As in the case of the use of other prostaglandin synthetase inhibitors, these recommendations are especially important in the third trimester of pregnancy (suppression of uterine contractility and premature closure of the arterial duct in the fetus are possible).
When Voltarena is taken orally at a dose of 50 mg every 8 hours, diclofenac passes into breast milk, but in such a small amount that there is no reason to expect any undesirable effects in a breastfed baby.
If necessary, the appointment of Voltaren in lactation should decide on the termination of breastfeeding.

During the application of Voltaren, careful medical supervision of those patients who have complaints pointing to gastrointestinal diseases is necessary; having a history of ulcerative lesions of the stomach or intestines; suffering from ulcerative colitis or Crohn's disease, as well as having impaired liver function.
During the use of Voltaren, as well as other NSAIDs, the level of one or more liver enzymes may increase. Therefore, during prolonged therapy with Voltaren, monitoring of liver function is shown as a precautionary measure.If abnormalities in the functional parameters of the liver persist or worsen, or if clinical manifestations of liver disease or other symptoms occur (for example, eosinophilia, rash, etc.), Voltaren should be abolished. It should be borne in mind that hepatitis against the background of the use of Voltaren can occur without prodromal phenomena.
Caution is needed when Voltaren is prescribed to patients with hepatic porphyria, since The drug may provoke attacks of porphyria.
Since prostaglandins play an important role in maintaining renal blood flow, special care is required when treating patients with impaired heart or kidney function, patients receiving diuretics, as well as patients who have a significant decrease in circulating blood plasma of any etiology, for example, before and after massive surgical interventions. In these cases, during the use of Voltaren, monitoring of renal function is recommended as a precautionary measure. Discontinuation of the drug usually leads to the restoration of renal function to its original level.
Caution must be exercised when applying Voltaren in elderly patients. This is especially true for weakened or low-weight older people; they are recommended to prescribe the drug in the minimum effective dose.
Against the background of Voltaren's use, gastrointestinal bleeding may occur (for the first time or again) or develop ulceration / perforation of the gastrointestinal tract, accompanied by or not accompanied by precursor symptoms. More serious consequences of these complications may occur in elderly patients. In those rare cases where these complications develop in patients receiving Voltaren, the drug should be discontinued.
The first use of Voltaren, as well as other NSAIDs, in rare cases may develop allergic reactions, including anaphylactic and anaphylactoid reactions.
Voltaren, due to its pharmacodynamic properties, can mask the manifestations of infectious diseases.
Voltaren, as well as other NSAIDs, can temporarily inhibit platelet aggregation. Therefore, in patients with impaired hemostasis, careful monitoring of relevant laboratory parameters is necessary.
With long-term use of Voltaren, like other NSAIDs, systematic monitoring of the pattern of peripheral blood is shown.
Influence on ability to drive motor transport and control mechanisms
Patients who develop dizziness or other disorders of the central nervous system, including visual impairment during the use of Voltaren, should not drive a car or operate machinery during the period of use of the drug.

The typical clinical picture, peculiar to an overdose of Voltaren, does not exist.
Treatment of acute poisoning with NSAIDs includes supportive and symptomatic therapy. Supporting and symptomatic treatment is indicated for such complications as lowering blood pressure, renal failure, convulsions, gastrointestinal disturbances and respiratory depression. It is unlikely that forced diuresis, hemodialysis or hemoperfusion will be useful for removing NSAIDs, because The active substances of these drugs are largely associated with plasma proteins and are extensively metabolized.
In the event of an overdose while taking the drug inside, in order to quickly prevent the absorption of diclofenac, it is necessary to wash the stomach and appoint activated charcoal.

Voltaren can increase the concentration of lithium and Digoxin in the plasma while using it with these drugs.
Voltaren, like other NSAIDs, can reduce the effect of diuretics. The simultaneous use of Voltaren with potassium-sparing diuretics can lead to an increase in the level of potassium in the blood (in the case of such a combination of drugs, this indicator should often be monitored).
Simultaneous use of Voltaren with other NSAIDs may increase the risk of side effects.
Although clinical studies have not established the effect of Voltaren on the effect of anticoagulants, there are some reports of an increased risk of bleeding in cases of their joint use. Careful observation of patients receiving these drugs at the same time is recommended.
Voltaren can be prescribed together with oral hypoglycemic drugs and at the same time the effectiveness of the latter does not change.However, there are individual reports of the development in such cases of both hypoglycemia and hyperglycemia, which necessitated a change in the dose of hypoglycemic drugs during the use of Voltaren.
Caution should be exercised when using NSAIDs less than 24 hours before the start of application or after the end of therapy with Methotrexate, because its blood level (and therefore toxicity) may increase.
The effect of NSAIDs on kidney prostaglandin activity may increase cyclosporine nephrotoxicity.
There are isolated reports of seizures in patients who took both NSAIDs and quinolone antibacterial drugs.

Tablets, enteric-coated, should be stored out of the reach of children at a temperature not above 30 ° C. Shelf life - 5 years.
Suppositories and gel should be kept out of reach of children at a temperature not higher than 30 ° C. Shelf life - 3 years.
Pharmacy sales terms
The drug is available on prescription.


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