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Instruction for use: Naklofen Duo

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Active substance Diclofenac

ATX Code M01AB05 Diclofenac

Pharmacological group

Non-steroidal anti-inflammatory drug (NSAID) [NSAIDs - Acetic acid derivatives and related compounds]

Nosological classification (ICD-10)

G43 Migraine

The pain of migraine, Migraine, hemiplegic migraine, Migraine headache, A migraine attack, Continuous headache, hemicranias

H60 Otitis externa

Infections of ENT organs, Infections of the external auditory canal, Infectious-inflammatory diseases of the ear, Acute catarrhal inflammation of the external auditory canal, Infections of the external ear

H66 Suppurative and unspecified otitis media

Bacterial ear infections, Inflammation of the middle ear, Infections of the upper respiratory tract, Infectious-inflammatory diseases of ENT organs, Infectious-inflammatory diseases of upper respiratory tract, Infectious-inflammatory diseases of the ear, Infectious diseases of ENT organs with marked pain syndrome, ear Infection, Otitis media infection, Persistent inflammation of the middle ear in children, Ear pain of otitis

J02.9 Acute pharyngitis, unspecified

purulent pharyngitis, Acute nasopharyngitis,Limfonodulyarny pharyngitis

J03.9 Acute tonsillitis, unspecified (angina agranulocytic)

Sore throat infections, Acute tonsillitis, Angina, Follicular tonsillitis, Angina alimentary-hemorrhagic, Secondary sore throat, Sore throat primary, Angina follicular, Angina, Inflammatory diseases of the tonsils, Catarrhal angina, Lacunar angina, Acute Sore Throat, Tonsillitis, Tonsillitis acute, Tonsillar angina, Follicular sore throat, Bacterial tonsillitis

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M02.3 Reiter's Disease

Reiter's syndrome, Arthritis is infectious-allergic, Arthritis Reactive, Urethro-oculo-synovial syndrome

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M07.3 Other psoriatic arthropathies (L40.5 +)

Arthritis psoriatic, The generalized form of psoriatic arthritis, Psoriatic arthritis

M08 Juvenile [juvenile] Arthritis

Juvenile arthritis, Juvenile chronic polyarthritis, Juvenile chronic arthritis, Juvenile rheumatoid arthritis, Arthritis juvenile chronic

M10.9 Gout, unspecified

Arthritis Gouty, Acute gouty arthritis, Acute attack of gout, Gouty Arthritis, Articular syndrome with exacerbation of gout, Articular syndrome with gout, Urarturia, Chronic arthritic arthritis, Acute gout, Salt diathesis

M19 Other arthrosis

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M35.3 Rheumatic polymyalgia

Pseudoarthritis rhizomelic, Rheumatic polymyalgia, Pain syndrome in rheumatic diseases, Muscle pain with rheumatism, Extra-articular rheumatism, Extra-articular rheumatic syndrome, Extra-articular rheumatic diseases, Extra-articular rheumatic soft tissue injury, Extra-articular forms of rheumatism, Rheumatic soft tissue damage, Rheumatism of soft tissues, Rheumatic diseases of soft tissues, Rheumatic diseases of the periarticular soft tissues, Rheumatic affections of soft tissues, Rheumatic collagen diseases

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M54.1 Radiculopathy

Acute sciatica, Radiculopathy, Radiculitis, Radiculitis with radicular syndrome, Acute radiculopathy, Pain syndrome with radiculitis, Subacute radiculitis, Radiculitis, Chronic radiculitis, Diseases of the spinal column

M54.4 Lumbago with sciatica

Pain in the lumbosacral spine, Lumbago, Sciatica, Lumbar syndrome

M54.9 Dorsalgia, unspecified

Pain syndrome with radiculitis, Pain syndrome in the back,Pain with radiculitis, Degenerative changes in the spine, Degenerative and dystrophic disease of the spine and joints, Degenerative disease of the spine, Osteoarthrosis of the spine, Painful lesions of the spine

M60 Myositis

Myositis, Fibrositis Fibromyositis, Inflammatory disease of soft tissues

M65 Synovitis and tendosynovitis

Acute tenosynovitis, Tendovaginitis (tenovaginitis), Tendosinovit (tenosynovitis), Tendovaginitis, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Nonspecific tenosynovitis, Tendosinovit

M65.9 Synovitis and tendosynovitis, unspecified

Synovitis, Inflammation of the tendon sheath, Acute nonspecific tenosynovitis, Reactive synovitis

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

N23 Renal colic unspecified

Pain in renal colic, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), renal Colic, ureteral colic, Renal colic, Renal colic with urolithiasis, Kidney disease, Spasm of smooth muscle in diseases of the urinary system, The spasm of the urinary tract, The spasm of the ureter, The spasm of the ureters, Spasms of the urinary tract, Spasms of the urinary tract

N70 Salpingitis and oophoritis

Adnexitis, Inflammatory diseases of female genitalia, Inflammatory diseases of female genital organs, Infection of the genitals, Oophoritis, Acute adnexitis, Salpingitis, Salpingo-oophoritis, Chronic inflammatory diseases of the ovaries, Inflammation of the ovaries

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R50.0 Fever with chills

High fever, Heat, Chills, elevated temperature, hyperthermia, Prolonged fever, Feverish syndrome, Fervescence, Increased body temperature in infectious and inflammatory diseases, fever Symptoms, febrile syndrome, Febrile state, Fever, Fever in infectious and inflammatory diseases, Fever with SARS, Fever with cold, Fever for colds, febrility, Feverish condition with flu, Feverish state in infectious and inflammatory diseases , Feverish state of infectious diseases and in the postoperative period, Feverish condition for colds, Febrile of different genesis, Feverish syndrome on the background of infectious diseases, Feverish syndrome in infectious and inflammatory diseases, Feverish syndrome with colds, Feverish syndrome of different genesis, Increased temperature for colds, Increased temperature at catarrhal and infectious and inflammatory diseases, Increased body temperature in cold, etc., Increased body temperature in cold and other infectious and inflammatory diseases, Increased body temperature in cold and other infectious and inflammatory diseases, Fever during pregnancy, Fever with thrombocytopenia, Febrile reaction in blood transfusion

R51 Headache

Pain in the head, Cephalgia, Pain with sinusitis, Pain in the back of the head, Painful headache, Headache of vasomotor genesis, Headache of vasomotor origin, Headache with vasomotor disorders, Headache, Neurological headache, Serial headache

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T14 Injury of unspecified site

Pain syndrome with injuries and after surgical interventions, Injuries, Extensive trauma to the skin and soft tissues, Muscle and ligament injuries, Injuries, Fibroma traumatic, Acute sport injuries

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Composition

Capsules with modified release 1 caps.

water-soluble pellets

active substance:

diclofenac sodium 25 mg

auxiliary substances: sugar spheres (the content of sucrose is not more than 92%); giprolose (hydroxypropyl cellulose); hypromellose; magnesium carbonate is heavy; methacrylic acid and ethyl acrylate copolymer (1: 1) dispersion 30%; triethyl citrate; talc; titanium dioxide; sodium carboxymethylcellulose; macrogol; sodium hydroxide

pellets with prolonged release

active substance:

diclofenac sodium 50 mg

auxiliary substances: sugar spheres (the content of sucrose is not more than 92%); giprolose (hydroxypropyl cellulose); methacrylate ammonium copolymer (type B); methacrylate ammonium copolymer (type A); triethyl citrate; talc

composition of the contents of the capsule: enteric-soluble pellets; pellets with prolonged release; talc (0.2% talc is mixed with pellets before filling into capsules, talc prevents the appearance of electrostatic charge of pellets during the filling of capsules)

Capsule shell composition

body capsules: gelatin EP; titanium dioxide (E171)

cap capsule: gelatin EP; titanium dioxide (E171), indigo carmine dye FD & C Blue2 (E132)

Description of dosage form

Capsules number 2, filled with pellets from white to yellowish color. The body of the capsule is white, the cap of the capsule is blue.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

Diclofenac sodium is an NSAID with analgesic, anti-inflammatory and antipyretic effects. The main mechanism of its action and related side effects are indiscriminate inhibition of the activity of the enzymes COX-1 and COX-2, which leads to a disruption of the metabolism of arachidonic acid, a decrease in the synthesis of PG, prostacyclin and thromboxane. The level of various PG in urine, gastric mucosa and synovial fluid decreases.

The most effective for inflammatory pain. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac significantly reduces the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. In injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema. Like all NSAIDs, diclofenac has antiaggregant activity. In therapeutic doses, diclofenac sodium has virtually no effect on bleeding time. With prolonged treatment, the analgesic effect of diclofenac sodium does not decrease.

Pharmacokinetics

Absorption is fast and complete. Diclofenac is contained in capsules of Naklofen Duo in the form of enteric-soluble pellets and pellets with prolonged release, so Naklofen Duo capsules have a quick and prolonged effect.

Cmax in plasma is noted 30-60 min after administration. The therapeutic concentration is maintained twice as long as when using tablets coated with enteric film coating. The concentration in the plasma is linear depending on the amount of the dose taken. Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not noted. Do not cumulate while respecting the recommended interval between doses. Bioavailability - 50%. Binding to plasma proteins is more than 99% (most are associated with albumins). Penetrates into the synovial fluid; Cmax in the synovial fluid is observed 2-4 hours later than in plasma. Diclofenac is more slowly excreted from the synovial fluid than from the plasma.

Metabolism: 50% of the active substance undergoes metabolism during the first passage through the liver. Metabolism occurs as a result of multiple or one-time hydroxylation and conjugation with glucuronic acid. The enzyme system P450CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.

System Cl is 260 ml / min, the volume of distribution is 550 ml / kg. T1 / 2 from plasma - 2 hours. About 70% of the administered dose is excreted as pharmacologically inactive metabolites by the kidneys; less than 1% - unchanged, the rest of the dose - in the form of metabolites with bile.

In patients with severe renal insufficiency (Cl creatinine less than 10 ml / min), the excretion of metabolites with bile is increased, while there is no increase in their concentration in the blood.

In patients with chronic hepatitis or compensated cirrhosis of the liver, as well as elderly patients, the pharmacokinetic parameters of diclofenac do not change. Diclofenac penetrates into breast milk.

Indications

inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease), gouty arthritis, arthritis in Reiter's disease, rheumatic soft tissue damage, osteoarthritis of peripheral joints and spine, incl. with a radicular syndrome, tendovaginitis, periarthritis, bursitis, myositis, synovitis);

pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboschialgia, posttraumatic pain syndrome accompanied by inflammation, postoperative pain, headache, migraine, algodismenorea, adnexitis, proctitis, toothache, renal and biliary colic;

in the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis);

febrile syndrome.

Diclofenac is intended for symptomatic therapy and does not affect the progression of the disease.

Contraindications

hypersensitivity to diclofenac; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in the anamnesis);

period after aortocoronary shunting;

erosive and ulcerative changes in the mucosa of the stomach or duodenum, active gastrointestinal bleeding;

inflammatory bowel disease, in the phase of exacerbation (nonspecific ulcerative colitis - NJC, Crohn's disease);

cerebrovascular bleeding or other bleeding and hemostasis disorders;

severe hepatic impairment or active liver disease;

marked renal failure (Cl creatinine less than 30 ml / min), incl. confirmed hyperkalemia, progressive kidney disease;

Decompensated heart failure;

oppression of bone marrow hematopoiesis;

III trimester of pregnancy, the period of breastfeeding;

children's age (under 18 years).

With caution: IHD, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, Cl creatinine less than 60 ml / min; anamnestic data on the development of ulcerative lesions of the digestive tract, the presence of Helicobacter pylori infection, old age, prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, induced porphyria, epilepsy, diverticulitis, systemic connective tissue diseases, massive surgical intervention), elderly patients (prescribed in lower doses) (including those receiving diuretics, weakened patients and patients with low body weight), I-II trimester of pregnancy; concomitant therapy with the following drugs: anticoagulants (eg warfarin), antiaggregants (eg acetylsalicylic acid, clopidogrel), oral GCS (eg prednisolone), selective serotonin reuptake inhibitors (eg citalopram, fluoxetine, paroxetine, sertraline).

pregnancy and lactation

The use of diclofenac in pregnant women is possible only when the expected benefit exceeds the potential risk to the fetus. Diclofenac is not recommended for use during the last trimester of pregnancy.

Despite the fact that diclofenac is found in breast milk in small amounts, its use during breast-feeding is not recommended.

Side effects

Often - 1-10%; sometimes 0.1-1%; rarely - 0,01-0,1%; very rarely - less than 0.01%, including individual cases.

On the part of the digestive system: often - epigastric pain, abdominal cramps, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases; rarely - gastritis, bleeding from the gastrointestinal tract (vomiting with blood, melena, diarrhea with a trace of blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, impaired liver function; very rarely - stomatitis, glossitis, dryness of the mucous membranes (including the mouth), damage to the esophagus, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis.

From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - a violation of sensitivity, incl. paresthesia, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmares, irritability, agitation, mental disorders.

From the senses: often - vertigo; very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, a violation of taste sensations.

From the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis, edema.

On the part of the organs of hematopoiesis: very rarely - thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis.

Allergic reactions: anaphylactic / anaphylactoid reactions, including a marked decrease in blood pressure and shock; very rarely - angioedema (including face). The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions.

From the cardiovascular system: very rarely - palpitations, tachycardia, extrasystole, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.

On the part of the respiratory system: rarely - cough, bronchial asthma (including dyspnea); very rarely - pneumonitis, laryngeal edema.

On the part of the skin: often - skin rash; rarely - hives; very rarely - bullous eruptions, eczema, incl. multiform and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, skin itching, hair loss, photosensitivity, purpura, incl. allergic.

Interaction

Increases the concentration in the plasma digoxin, methotrexate, lithium and cyclosporine. Reduces the effect of diuretics; against the background of potassium-sparing diuretics, the risk of hyperkalemia increases; against the background of anticoagulants, antiplatelet agents and thrombolytic drugs (alteplase, streptokinase, urokinase) increases the risk of bleeding (more gastrointestinal).

Reduces the effect of hypotensive and hypnotic drugs. Increases the likelihood of side effects of other NSAIDs and GCS (bleeding from the gastrointestinal tract), toxicity of methotrexate and nephrotoxicity of cyclosporine.

Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.

Hypoglycemic agents - hypo- or hyperglycemia can be observed. With this combination of funds, blood sugar levels need to be monitored.

Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.

Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of PG in the kidneys, which is manifested by increased nephrotoxicity.

Selective serotonin reuptake inhibitors increase the risk of bleeding from the digestive tract.

Simultaneous administration with ethanol, colchicine, corticotropin and preparations of St. John's wort increases the risk of bleeding in the digestive tract.

Drugs that cause photosensitivity, increase the sensitizing effect of diclofenac to UV radiation.

LS, which block tubular secretion, increase the concentration in the plasma of diclofenac, thereby increasing its toxicity.

Antibacterial drugs from the quinolone group - the risk of seizures.

Dosing and Administration

Inside, the capsule should be swallowed whole, washed down with water at the end or after eating, usually in the mornings. It is prescribed individually, taking into account the severity of the disease. Adults usually appoint 1 caps. 75 mg 1-2 times a day. The maximum daily dose is 150 mg.

Overdose

Symptoms: vomiting, nausea, abdominal pain, bleeding from the gastrointestinal tract, diarrhea, headache, dizziness, tinnitus, increased excitability, hyperventilation with increased convulsive readiness, convulsions, with a significant overdose - acute renal failure, hepatotoxic effect.

Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating blood pressure increase, renal dysfunction, seizures, gastrointestinal irritation, respiratory depression. Forced diuresis, hemodialysis are ineffective (significant association with proteins and intensive metabolism).

special instructions

In order to quickly achieve the desired therapeutic effect, take the drug 30 minutes before meals. In other cases, take before, during or after a meal wholly, with plenty of water.

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

Caution should be used for ulcerative colitis and Crohn's disease because of a possible exacerbation of the disease.

With long-term use of diclofenac, it is possible, although in rare cases, the development of serious hepatotoxic reactions, and therefore it is recommended to regularly examine liver function.

Because of the important role of GHG in maintaining renal blood flow, care should be taken when administering the drug to patients with cardiac or renal insufficiency, as well as for the treatment of elderly people taking diuretics, and patients who, for whatever reason, are experiencing a decrease in BCC (for example after major surgery). If diclofenac is prescribed in such cases, it is recommended to monitor kidney function as a precautionary measure.

Caution should be given to diclofenac in patients with impaired blood clotting, porphyria, epilepsy, as well as in patients receiving anticoagulants or fibrinolytics.

When carrying out long-term therapy, it is necessary to monitor the picture of peripheral blood, to conduct a fecal occult blood test.

In connection with the negative effect on fertility, women who want to become pregnant, the drug is not recommended. In patients with infertility (including those undergoing examination) it is recommended to cancel the drug.

Patients taking the drug should refrain from drinking alcohol.

In infectious diseases, the anti-inflammatory and antipyretic effects of diclofenac sodium can mask the symptoms of these diseases.

The amount of sucrose contained in the preparation does not affect patients with the following conditions: lactase enzyme deficiency, galactosemia, and glucose / galactose uptake syndrome.

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form of issue

Capsules with modified release, 75 mg. For 10 caps. with modified release in blister; in cardboard packs 2 blisters.

Conditions of leave from pharmacies

On prescription.

storage conditions

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.

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