Instruction for use: Rapten rapid

Active substance Diclofenac

ATX Code M01AB05 Diclofenac

Pharmacological group

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

K62.8.1 * Proctitis

Atrophic proctitis, Anusitis

K80.5 stones of bile duct without cholangitis or cholecystitis

Obstruction of common bile duct, Stones of the common bile duct, biliary colic, Colic liver, Hepatic colic, Cholesterol gallstones in the common bile duct

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M54 Dorsalgia

Pain in the back area, Pain in the spine, Back pain, Pain in different parts of the spine, Backache, Painful pain syndrome in the spine, Pain in the musculoskeletal system

M54.3 Sciatica

Ishialgia, Neuralgia of the sciatic nerve, Sciatic neuritis

M54.4 Lumbago with sciatica

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

M65 Synovitis and tendosynovitis

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

M71 Other bursopathies

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

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

R50.9 Fever unstable

Symptoms of fever, Increased body temperature, Unexplained feverish conditions

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.2 Other constant pain

Pain syndrome, rheumatic origin, Pain at vertebral lesions, Pain in the chamber, Pain for burns, Pain syndrome weak or moderate, Perioperative pain,Moderate to severe pain, Moderately or weakly expressed pain syndrome, Moderate to severe pain, Ear pain of otitis, Neuropathic pain, neuropathic pain

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

Z100 * CLASS XXII Surgical practice

Abdominal surgery, adenomectomy, Amputation, Coronary angioplasty, Angioplasty of the carotid arteries, Antiseptic skin treatment for wounds, Antiseptic Hand, Appendectomy, atherectomy, Balloon coronary angioplasty, Vaginal hysterectomy, The coronary bypass, Interventions in the vagina and cervix, Interventions on the bladder, Intervention in the mouth, Restoration and reconstructive surgery, Hand hygiene of medical personnel, Gynecologic surgery, Gynecological intervention, Gynecological surgery, Hypovolemic shock during operations, Disinfection of purulent wounds, Disinfection of wounds edges, Diagnostic intervention, Diagnostic procedures, Cervical Diathermocoagulation, Long-surgery, Replacing the fistula catheters, Infection in orthopedic surgery, Artificial heart valve, cystectomy, Short-term outpatient surgery, Short-term operation, Short surgical procedures, Krikotireotomiya, Blood loss during surgery, Bleeding during surgery and in the postoperative period, Kuldotsentez, laser photocoagulation, laser coagulation, retinal laser coagulation, Laparoscopy, Laparoscopy in Gynecology, CSF fistula, Small gynecological operations, Small surgical procedures, Mastectomy and subsequent plastic, mediastinotomy, Microsurgical operations on the ear, Mukogingivalnye operation, suturing, Minor surgery, neurosurgical operation, Immobilization of the eyeball in ophthalmic surgery, testectomy, pancreatectomy, Perikardektomiya, The period of rehabilitation after surgery, The period of, convalescence after surgery, Percutaneous transluminal coronary angioplasty, Pleural thoracentesis, Pneumonia postoperative and posttraumatic, Preparation for surgical procedures, Preparation for surgery, Preparation of the surgeon's hands before surgery, Preparation of the colon for surgical procedures, Postoperative aspiration pneumonia in neurosurgical and thoracic surgery, Postoperative nausea, Postoperative bleeding, postoperative granuloma, postoperative shock, The early postoperative period, myocardial revascularization, Radiectomy, gastric Resection, bowel resection, uterine Resection, liver Resection, enterectomy, Resection of part of the stomach, Reocclusion of the operated vessel, Bonding tissues during surgical procedures, Removal of sutures, Condition after eye surgery, Condition after surgery, Condition after surgery in the nasal cavity, Condition after gastrectomy, Status after resection of the small intestine, Condition after tonsillectomy, Condition after removal of the duodenum, Condition after phlebectomy, Vascular surgery, Splenectomy, Sterilization of surgical instruments, Sterilization of surgical instruments, sternotomy, Dental surgery, Dental intervention in periodontal tissues, strumectomy, Tonsillectomy, Thoracic surgery, total gastrectomy, Transdermal intravascular coronary angioplasty, Transurethral resection, Turbinektomiya, Removal of a tooth, cataract surgery, Removal of cysts, tonsillectomy, Removal of fibroids, Removing the mobile primary teeth, Removing polyps, Removing broken tooth, Removal of the uterus body, Removal of sutures, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, Surgery, The surgery in the anal area, The surgery on the colon, Surgical practice, The surgical procedure, Surgical interventions, Surgery on the gastrointestinal tract, Surgical procedures on the urinary tract, Surgical procedures on the urinary system, Surgical intervention of the genitourinary system, Surgical procedures on the heart, Surgical manipulation, surgery, Surgery on the veins, Surgical intervention, Vascular surgery, Surgical treatment of thrombosis, cholecystectomy, Partial gastric resection, transabdominal hysterectomy, Percutaneous transluminal coronary angioplasty, Percutaneous transluminal angioplasty, Coronary artery bypass, tooth Extirpation, Extirpation of milk teeth, pulpectomy, pulsative cardiopulmonary bypass, tooth Extraction, teeth Extraction, cataract extraction, Electrocoagulation, endourological intervention, episiotomy, Etmoidotomiya, Complications after tooth extraction

Composition and form of release

Tablets, covered with sugar shell 1 tab.

diclofenac potassium 12.5 mg

auxiliary substances: calcium hydrophosphate; corn starch; sodium carboxymethyl starch (type A); silicon dioxide colloid (anhydrous); povidone 30; magnesium stearate

sugar shell composition: sucrose; talc; the dye is a crimson "Ponceau" E124; acacia gum; povidone 25; titanium dioxide E171; macrogol 6000

in a blister of 10 pcs .; in a pack of cardboard 1 blister.

Tablets, coated with a coating.

diclofenac potassium 50 mg

auxiliary substances: silicon dioxide colloidal anhydrous; calcium hydrophosphate anhydrous; corn starch; povidone K30; magnesium stearate; sodium carboxymethyl starch; gum arabic; sucrose; sucrose powder; talc; cochineal red varnish Å124; Povidone K25; macrogol 6000

in the package of a contiguous cell 10 units; in a pack of cardboard 1 package.

Description of dosage form

Tablets covered with sugar coating, 12.5 mg: round biconvex, covered with a sugar coat of red color, with small impregnations of a lighter color.

The tablets covered with a cover, 50 mg: round biconcave, covered by a cover of red color, on a break - from white up to almost white color.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

Rapten Rapid, containing potassium diclofenac as an active ingredient, is an NSAID, has a strong anti-inflammatory, analgesic and antipyretic effect. It is caused by inhibition of the synthesis of PG, the main sources of pain, inflammation and fever, by inhibiting the activity of COX-1 and -2.

Given that potassium diclofenac is absorbed very quickly from the digestive tract, Rapten Rapid is most effective in treating acute pain and inflammatory conditions, in which a rapid initial effect is most important. The drug relieves pain and lowers the temperature within the first 30 minutes after administration, and the effect lasts for 4-6 hours.

It leads to a reduction in the pain syndrome (at rest and movement), to a reduction in edema in the joint region and morning stiffness in rheumatic pain.

Pharmacokinetics

When ingestion is rapidly absorbed from the digestive tract, Cmax is reached 40 minutes after administration and is 1.3 μg / ml. The concentration in the plasma is linear in the dose of the drug administered. Changes in pharmacokinetics against a background of repeated administration do not occur. T1 / 2 from the plasma is 1-2 hours. If the interval between doses is observed, cumulation of the drug does not occur.

Rapidly distributed in tissues and body fluids. Penetrates into the synovial fluid. In this case, Cmax in the synovial fluid is noted 2-4 hours later than in the plasma. T1 / 2 from the synovial fluid is 3-6 hours, and its concentration in the synovial fluid 4-6 hours after the administration of the drug remains higher than in the plasma for another 12 hours.

Binding to plasma proteins is about 99% and most are associated with albumins.

Metabolised in the liver. 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation. The enzyme system P450 CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac potassium.

It is excreted mainly by the kidneys. The system Cl is 260 ml / min. About 60% of the administered dose is excreted through the kidneys in the form of metabolites and less than 1% - unchanged; the rest - in the form of metabolites with bile. The pharmacokinetics of the drug does not change with age.

In patients with severe renal dysfunction (Cl creatinine <10 ml / min), the time of excretion of metabolites with bile increases, but no increase in blood concentration is observed.

In patients with chronic hepatitis or compensated liver cirrhosis, pharmacokinetic parameters are similar to those in patients without liver disease.

Indications

Tablets coated with sugar, 12.5 mg

Pain syndrome of different origin:

pain in muscles and joints (including pain in different parts of the spine, etc.);

headache and toothache;

pain during menstruation.

Elimination of symptoms of colds and flu:

pain in the muscles and joints;

headache associated with colds and flu;

pain in the throat.

With an increase in body temperature.

Tablets coated with a coating, 50 mg

inflammatory diseases of the musculoskeletal system; post-traumatic pain syndromes accompanied by inflammation; postoperative pain (short-term - up to 7 days treatment of pain syndrome);

lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis;

toothache; migraine;

inflammatory diseases of the pelvic organs; primary algodismenorea; proctitis; renal or biliary colic;

Infectious-inflammatory diseases of ENT organs with severe pain syndrome (pharyngitis, tonsillitis, otitis) - as part of complex therapy;

febrile syndrome.

Contraindications

Tablets coated with sugar, 12.5 mg

increased sensitivity to diclofenac and other components that make up the drug;

attacks of bronchial asthma, urticaria, or a history of acute rhinitis in response to taking acetylsalicylic acid or other NSAIDs (eg ibuprofen);

period after aortocoronary shunting;

gastric ulcer, inflammatory bowel disease in the stage of exacerbation (ulcerative colitis, Crohn's disease), ulcerous bleeding or perforation;

III trimester of pregnancy;

severe hepatic, renal (Cl creatinine <30 ml / min) or heart failure;

progressive kidney disease;

confirmed hyperkalemia;

violation of hematopoiesis;

various violations of hemostasis;

damage to the bone marrow;

children's age till 14 years.

Carefully:

IHD;

cerebrovascular diseases;

congestive heart failure;

dyslipidemia / hyperlipidemia;

diabetes;

peripheral arterial disease;

smoking;

Cl creatinine <60 ml / min;

anamnestic data on the development of gastrointestinal ulcer;

elderly age;

long-term use of NSAIDs;

frequent use of alcohol;

severe physical illness.

Tablets coated with a coating, 50 mg

hypersensitivity to NSAIDs (including to acetylsalicylic acid), "aspirin" asthma;

erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

bleeding from the digestive tract;

disorders of hematopoiesis;

various violations of hemostasis (including hemophilia);

pregnancy;

lactation period;

children's age (up to 15 years).

Carefully:

severe violations of the liver and kidneys in history;

hepatic porphyria;

anemia;

bronchial asthma;

arterial hypertension;

congestive heart failure;

edematous syndrome;

erosive and ulcerative diseases of the gastrointestinal tract without exacerbation;

alcoholism;

diverticulitis;

diabetes;

postoperative period;

elderly age.

pregnancy and lactation

Sugar-coated tablets, 12.5 mg: in the I and II trimesters of pregnancy, the drug is prescribed only if the potential benefit to the mother's health exceeds the risk to the fetus. The use of diclofenac, like other NSAIDs, is contraindicated in the third trimester of pregnancy because of possible atony of the uterus and / or premature closure of the arteriosus ductus (ductus arteriosus).

Diclofenac, like other NSAIDs, penetrates into breast milk in small amounts. Therefore Rapten Rapid is not recommended for breastfeeding to prevent unwanted effects in the child.

Coated tablets, 50 mg: contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.

Side effects

Tablets coated with sugar, 12.5 mg

Often -> 1/100; sometimes - <1/100, but> 1/1000; rarely - <1/1000, but> 1/10000; very rarely - frequency <1/10000.

On the part of the blood system and lymphatic system: very rarely - thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.

On the part of the immune system: rarely - hypersensitivity, anaphylactic and anaphylactoid reactions (including arterial hypotension and shock); very rarely - angioedema (including swelling of the face).

Psychoemotional disorders: very rarely - loss of orientation; depression; insomnia; nightmares; irritability; psychotic disorders.

Violations of the function of the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular disorders.

From the side of the vision system: very rarely - visual disturbances (blurred vision, diplopia).

From the ENT organs: often - dizziness; very rarely - ringing in the ears, hearing impairment.

From the cardiovascular system: very rarely - palpitations, chest pain, heart failure, myocardial infarction, hypertension, vasculitis.

On the part of the respiratory system: rarely - bronchial asthma (including dyspnea); very rarely - pneumonia.

From the gastrointestinal tract: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, increased levels of hepatic transaminases; rarely - gastritis, gastrointestinal bleeding, bloody vomiting, diarrhea, melena with blood, stomach ulcers or intestines (with or without bleeding or perforation), hepatitis, jaundice; very rarely - colitis (including with blood, exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal pathology, stricture of the esophageal opening of the diaphragm, pancreatitis, fulminant hepatitis.

From the skin and subcutaneous tissues: often - a rash; rarely - hives; very rarely - rash in the form of blisters, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), hair loss, photosensitive reactions - purpura, including allergic purpura.

From the side of the kidneys and urinary tract: very rarely - acute renal failure, hematuria and proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

Common disorders: rarely - edema.

Tablets coated with a coating, 50 mg

Adverse reactions that develop often -> 1/100; sometimes - <1 / 100-> 1/1000; rarely - <1/1000.

On the part of the gastrointestinal tract: often - NSAID-gastropathy (gastralgia and discomfort in the epigastric region, nausea, a feeling of stomach overflow, belching, heartburn, diarrhea, abdominal pain, flatulence), erosive and ulcerative lesions of the gastrointestinal tract; perforation of the intestinal wall; bleeding from the gastrointestinal tract; dry mouth; constipation; pancreatitis; toxic hepatitis; sometimes vomiting; decreased appetite or anorexia; stomatitis, glossitis.

From the nervous system: often - headache, dizziness; sometimes cramps, aseptic meningitis, memory loss, depression, psychotic reactions, peripheral polyneuropathy (hypesesia, tremor, pain or weakness in the muscles of the hands and feet), drowsiness, irritability, nervousness, fear, insomnia, weakness and fatigue.

From the senses: sometimes - toxic damage to the optic nerve, reduced visual acuity, diplopia, scotoma, hearing loss, ringing and tinnitus.

From the skin: often - skin itching, skin rash (mainly erythematous and urticaria), ecchymosis, skin hyperemia; sometimes - multi-form exudative erythema, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), photodermatitis.

On the part of the genitourinary system: often - fluid retention; sometimes - dysmenorrhea, hematuria, cystitis, pollakiuria, proteinuria, interstitial nephritis, nephrotic syndrome, oliguria or anuria, acute renal failure, peripheral edema.

On the part of the organs of hematopoiesis: sometimes - agranulocytosis, hemolytic anemia, aplastic anemia, anemia, associated with internal bleeding, leukopenia, neutropenia, thrombocytopenia with or without purpura.

From the respiratory system: sometimes - shortness of breath.

From the cardiovascular system: often - increased blood pressure; sometimes - arrhythmia, cardialgia, decreased blood pressure; rarely - chest pain, nasal bleeding, aggravation of congestive heart failure.

Endocrine disorders: rarely - weight loss.

Allergic reactions: rarely - anaphylaxis and anaphylactoid reactions, anaphylactic shock (usually develops rapidly), bronchospastic allergic reactions.

Other: rarely - changes in the results of laboratory tests.

Interaction

Tablets coated with sugar, 12.5 mg

Lithium, digoxin: with simultaneous use of diclofenac, potassium can increase the concentration of lithium or digoxin in the blood plasma.

Diuretic and antihypertensive drugs: diclofenac potassium, as well as other NSAIDs, while taking with diuretic or antihypertensive agents (eg beta-blockers, ACE inhibitors) can reduce the severity of antihypertensive action. Simultaneous use of potassium-sparing diuretics can lead to an increase in serum potassium levels.

NSAIDs and corticosteroids: simultaneous use of potassium diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of adverse events on the part of the gastrointestinal tract.

Anticoagulants and inhibitors of platelet aggregation: special care is required, since with the simultaneous administration of potassium diclofenac with these drugs, the risk of bleeding increases.

Antidiabetic drugs: in clinical studies it has been established that simultaneous use of diclofenac and oral antidiabetic drugs is possible, while the efficacy of the latter does not change. However, individual cases of development, both hypoglycemia and hyperglycemia, are known, which required a change in the dose of antidiabetic drugs during the application of potassium diclofenac.

Methotrexate: caution should be exercised in appointing NSAIDs less than 24 hours before or after taking methotrexate, in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may be increased.

Cyclosporine: the effect of NSAIDs on the synthesis of PG in the kidneys can enhance the nephrotoxicity of cyclosporine.

Antibacterial agents, quinolone derivatives: there are separate reports on the development of seizures in patients who received concurrently derivatives of quinolone and NSAIDs.

Antacids (for example, aluminum hydroxide and magnesium hydroxide): can slow the absorption of potassium diclofenac, but do not affect the total amount of the absorbed drug.

Selective serotonin reuptake inhibitors: concomitant therapy with selective serotonin reuptake inhibitors (eg citalopram, fluoxetine, paroxetine, sertraline), is accompanied by an increased risk of developing gastrointestinal bleeding.

Interactions with food: the level of absorption of diclofenac potassium decreases when taken with food. For this reason, it is not recommended to take the drug during or immediately after a meal.

Tablets coated with a coating, 50 mg

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

Increases the likelihood of side effects of other NSAIDs and SCS (bleeding in the gastrointestinal tract), toxicity of methotrexate and nephrotoxicity of cyclosporine (due to increased potassium diclofenac's influence on the synthesis of PG in the kidneys).

Acetylsalicylic acid reduces the concentration of the drug in the plasma.

Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of potassium diclofenac.

Reduces the effect of hypoglycemic agents.

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

Gold preparations increase the effect of potassium diclofenac on the synthesis of PG in the kidneys, which increases nephrotoxicity.

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

Diclofenac potassium enhances the effect of drugs that cause photosensitivity.

Drugs that block tubular secretion, increase the concentration of diclofenac potassium in the plasma, thereby increasing its toxicity.

Dosing and Administration

Inside, before eating (to achieve maximum therapeutic effect), whole, not liquid, squeezed with water.

Tablets coated with sugar, 12.5 mg

Adults and children over 14 years of age: the initial dose is 2 tablets, if necessary - 1-2 tablets. every 4-6 hours.

The maximum daily dose is 6 tablets. per day (75 mg).

Without consultation with a doctor, the drug should be taken no more than 3 days to reduce body temperature and not more than 5 days for the treatment of pain. If the temperature does not decrease within the specified time and the pain persists, you should immediately call your doctor!

Tablets coated with a coating, 50 mg

Adults in a daily dose of 100-150 mg in 2-3 divided doses; the maximum is 200 mg. Children over 15 years of age daily dose is 100 mg in 2-3 divided doses.

Elderly people (especially debilitated and debilitated) are recommended a minimum effective dose.

Overdose

Tablets coated with sugar 12.5 mg

Symptoms: symptomatology on the part of the gastrointestinal tract, arterial hypotension, nephrotoxicity (up to acute renal failure), dizziness, headache, hyperventilation of the lungs, confusion; in children - myoclonic cramps, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.

Treatment: symptomatic and supportive, aimed at eliminating symptoms.

Tablets coated with a coating, 50 mg

Symptoms: dizziness, headache, dyspnea, turbidity, in children - myoclonic cramps, nausea, vomiting, abdominal pain, bleeding, impaired liver function, kidney function.

Treatment: gastric lavage, the appointment of activated charcoal, the conduct of symptomatic therapy.

Forced diuresis and hemodialysis are ineffective.

Precautionary measures

Tablets coated with a coating, 50 mg

During the period of treatment should be monitored peripheral blood picture, liver function, kidney function, examination of feces for the presence of blood.

It should refrain from driving, working with appliances and machinery, drinking alcohol.

special instructions

Tablets coated with sugar, 12.5 mg

When taking NSAIDs, there is a possibility of developing gastrointestinal bleeding, gastrointestinal ulcers, sometimes complicated by perforation, without previous symptoms or the presence of such attacks in the patient's anamnesis. These complications can have serious consequences, especially for the elderly. If these symptoms occur, the drug should be immediately discontinued.

The risk of developing gastrointestinal bleeding increases with increasing doses of NSAIDs in patients with a history of peptic ulcer, especially if the disease is complicated by bleeding and perforation, as well as in elderly patients. To reduce the risk of complications, therapy should be initiated and maintained at the lowest effective dose level, taking into account the possibility of using combination therapy with protector drugs (eg proton pump inhibitors or misoprostol).

When prescribing diclofenac potassium, patients with an existing pathology of the digestive tract (ulcer, bleeding, perforation) in a history should be treated with careful medical supervision and observance of special care.

Caution is recommended for patients who simultaneously take medications that may increase the risk of ulcers or bleeding of the gastrointestinal tract, such as systemic corticosteroids, anticoagulants, platelet aggregation inhibitors, or selective serotonin reuptake inhibitors.

Patients suffering from ulcerative colitis or Crohn's disease should be treated under close medical supervision. as a result of the use of diclofenac potassium, there may be an exacerbation of these diseases.

The use of diclofenac potassium should be discontinued at the first signs of skin rash, mucous membranes and other signs of hypersensitivity.

In the application of diclofenac potassium, as well as other NSAIDs, in rare cases, allergies may occur, including. anaphylactic / anaphylactoid reactions in patients who did not previously use diclofenac potassium.

Diclofenac potassium, as well as other NSAIDs, in connection with its pharmacological properties can mask the symptoms characteristic of infectious diseases.

Simultaneous use of potassium diclofenac with systemic NSAIDs (including selective COX-2 inhibitors) should be avoided, since there is no evidence of a beneficial effect as a result of synergy, and there are no data on possible side effects.

Care should be taken when using the drug in elderly patients. Weak or low-fat elderly people are recommended to prescribe the drug at the lowest effective dose.

In patients suffering from bronchial asthma, seasonal allergic rhinitis, nasal mucosa edema (polygons of the nasal mucosa), COPD or chronic infection of the respiratory tract (especially associated with allergic rhinitis-like symptoms), reactions to drugs from the NSAID group in the form of asthma attacks, edema Quincke or urticaria develop more often than usual. Such patients are advised to take special care (readiness for urgent medical measures).

When administering diclofenac potassium, patients with impaired liver function should be closely monitored, as the condition of such patients may worsen. During the application of Rapten Rapid, like other NSAIDs, the level of one or more liver enzymes may increase. Therefore, long-term therapy with the drug shows a regular study of liver function.

If abnormalities from the liver functional indicators persist or worsen, or if complaints or symptoms that indicate liver disease develop, and if other side effects occur (eg, eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis against the background of diclofenac potassium can occur without prodromal phenomena. Care should be taken in patients with hepatic porphyria, as taking diclofenac potassium can provoke an attack.

Since the use of NSAIDs reported fluid retention and the appearance of edema, special care should be taken in patients with impaired renal and cardiac function, history of arterial hypertension, elderly patients, concurrent administration of diuretics or drugs that have a significant effect on kidney function, and also patients who have a significant reduction in the volume of circulating blood plasma of any etiology, for example, before or after extensive surgical interventions. In such cases, when using diclofenac potassium as a precautionary measure, monitoring of renal function is recommended. After discontinuation of therapy, the baseline parameters are usually restored.

Rapten Rapid is recommended for several days. With the appointment of the drug for a long time, systematic monitoring of the pattern of peripheral blood, liver function, kidney function, and feces for the presence of blood are shown.

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

Diclofenac potassium can have a negative effect on female fertility, so it is not recommended to use the drug for women planning a pregnancy.

Influence on ability of driving of vehicles and management of mechanisms

During the period of treatment, a slight decrease in the rate of psychomotor reactions is possible. In this regard, patients taking the drug should refrain from activities that require increased attention and rapid mental and motor reactions, as well as the use of alcohol.

storage conditions

In dry, the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf-life of Rapten Rapid

tablets covered with sugar coating 12.5 mg - 2 years.

tablets coated with 50 mg - 3 years.

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