Rx Prescription information
DICLOFENAC– BELMED
(User’s information)
Trade name: Diclofenac-Belmed.
International nonproprietary name: Diclofenac.
Appearance : yellow-orange to dark orange enteric-coated tablets. In cross section 2 layers are visible.
Composition: each tablet contains active ingredient: diclofenac – 25.0 mg; excipients: sugar, lactose monohydrate, povidone K - 25 (E - 1201), calcium stearate (E - 470), potato starch, 93A acrylic (methacrylic acid copolymer, talc (E - 553), titanium dioxide (E - 171), colloidal silicon dioxide anhydrous (E - 551), sodium bicarbonate (E - 500), orange yellow (E-PO), yellow iron oxide (E - 172), sodium lauryl sulfate (E - 487), triethyl citrate (E - 1505).
Pharmaceutical form: 25 mg enteric-coated tablets.
Pharmacological group: Non-steroidal anti-inflammatory and anti-rheumatic agents. Acetic acid derivatives and their analogues.
Pharmacological characteristics
The product has anti-inflammatory, analgesic and antipyretic effect. Nonselectively inhibiting cyclooxygenase 1 and 2, it interferes with the metabolism of arachidonic acid, and reduces the amount of prostaglandins (Pg) in inflammation area. It is most effective in pain of inflammatory character. As all NSAIDs, the product has antiplatelet activity.
Indications
Inflammatory diseases of musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, gouty arthritis, rheumatic injury of soft tissues).
Degenerative diseases of musculoskeletal system (deforming osteoarthritis, osteochondrosis).
Algodysmenorrhea, inflammatory processes of the pelvis, including adnexitis.
Pain syndrome: headache (including migraine), and tooth pain, bursitis, tendonitis, lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, radiculitis, in oncological diseases, post-traumatic and postoperative pain syndrome with inflammation.
In the combined therapy in infectious and inflammatory diseases of ENT organs with marked pain syndrome: pharyngitis, tonsillitis, otitis. Feverish syndrome with "cold" and infectious diseases.
Dosage and mode administration
Orally after meal without chewing and drinking with plenty of fluid (1/2-1 glass of water). Upon reaching optimal therapeutic effect gradually reduce the dose and shift to maintenance therapy at a dose of 50 mg/day. Maximum daily dose is 150 mg.
Adults.
In symptomatic treatment of inflammatory diseases of musculoskeletal system (rheumatoid arthritis) 1-2 tablets 2-3 times a day. Average daily dose is 100 mg (4 tablets), maximum daily dose is 150 mg (6 tablets). Duration of treatment is determined by a doctor, but not more than 6 weeks.
In symptomatic treatment of diseases of musculoskeletal system (deforming osteoarthritis, osteochondrosis) 1-2 tablets 2-3 times a day. Average daily dose is 100 mg (4 tablets), maximum daily dose is 150 mg (6 tablets). Duration of treatment is determined by a doctor, but not more than 6 weeks.
In symptomatic treatment of ankylosing spondylitis - 1 tablet 4 times a day, if necessary additionally one 25 mg tablet at bedtime. Average daily dose is 100 - 125 mg (4-5 tablets).
For analgesia in primary algodysmenorrhea 1-2 tablets 3 times a day, if necessary initial dose may be increased to 100 mg (4 tablets). Treatment is continued for a few days depending on the duration of symptoms.
Children aged 6 to 15 years.
For postoperative pain relief 1-2 tablets 1-2 times a day, dose calculation based on 1 -2 mg per kg of body weight of the child per day, as monotherapy or in combination with opioid analgesics, treatment course is no longer than 4 days.
As an analgesic or antipyretic agent in combined therapy 1-2 tablets 1-2 times a day, daily dose calculation based on 1 -2 mg per kg of body weight of the child per day, treatment course is no longer than 4 days.
In symptomatic treatment of juvenile arthritis 1-2 tablets 1-2 times a day, daily dose calculation based on 1 -2 mg per kg of body weight of the child per day. Duration of treatment is determined by a doctor, but not more than 4 weeks.
Side effects
Common - 1-10%; uncommon – 0.1-1%; rare – 0.01-0.1%; very rare – less than 0.001%, including individual cases.
Gastrointestinal disorders: common - NSAID gastropathy (stomachalgia, nausea, vomiting, diarrhea, abdominal pain, flatulence), anorexia; uncommon - gastritis, proctitis, gastrointestinal bleeding (vomiting blood, melena, bloody diarrhea), ulcers of the gastrointestinal tract (with or without bleeding or perforation), non-specific colitis with bleeding, dry mouth; very rare -stomatitis, glossitis, esophagus lesions, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis.
Nervous system disorders: common - headache, dizziness, fatigue; rare - somnolence; very rare - sensitivity disturbance, including paresthesias, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, disorientation, depression, insomnia, "nightmares", irritability, mental disorders, aseptic meningitis.
Sensory organ disorders: common - vertigo; very rare - blurred vision, diplopia, scotoma, decreased hearing, tinnitus.
Skin disorders: common – skin itching; rare - urticaria; very rare - hematomas, bullous rash, eczema, including multiform and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, pruritus, alopecia, photosensitization, purpura.
Urinary tract disorders: common - nephrotic syndrome (swelling); very rare - acute renal failure, hematuria, proteinuria, oliguria, interstitial nephritis, papillary necrosis, cystitis, electrolyte imbalance as a syndrome resembling inappropriate secretion of antidiuretic hormone, spontaneous hyponatraemia.
Hemopoietic organ disorders: rare - thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis, local spontaneous bleeding and inhibition of platelet aggregation, prolonged bleeding.
Cardiovascular disorders: very rare - palpitations, chest pain, increased blood pressure, hypotension, vasculitis, heart failure, myocardial infarction.
Respiratory disorders: rare - bronchial asthma (including wheezing), very rare - pneumonitis.
Endocrine disorders: very rare - impotency.
Allergic reactions: very rare - anaphylactic/anaphylactoid reactions, including accentuated decrease in blood pressure and shock, angioneurotic edema (including facial).
Contraindications
Hypersensitivity (including to other NSAIDs); erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), bronchial asthma (risk of exacerbation), urticaria or acute rhinitis provoked by administration of aspirin or other non-steroidal anti-inflammatory drugs, severe renal/hepatic and heart insufficiency, disorders of hematopoiesis, pregnancy, pediatric use (under 6 years), lactation period.
Cautiously: peptic and duodenal ulcer, ulcerative colitis, Crohn's disease, history of hepatic diseases, hepatic porphyria, chronic renal failure, chronic heart failure, hypertension, significant decrease in circulating blood volume (including after massive surgery), children aged 6 to 15 years, elderly patients over 65 years (including receiving diuretics, fragile patients and patients with reduced body weight), bronchial asthma (risk of exacerbation), concomitant administration of glucocorticoids , anticoagulants, antiplatelet agents , selective serotonin reuptake inhibitors.
Overdose
Symptoms: dizziness, headache, pulmonary hyperventilation, mental confusion, myoclonic seizures, nausea, vomiting, abdominal pain, bleeding, compromised hepatic and renal function.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy aimed at eliminating increased blood pressure, renal impairment, convulsions, gastrointestinal irritation, respiratory depression.
Interaction with other drug products
The drug increases plasma concentrations of digoxin, methotrexate, lithium agents and cyclosporine.
It reduces the effect of diuretics, on the background of potassium-sparing diuretics administration the risk of hyperkalemia increases; on the background of anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase) - risk of bleeding (usually from the gastrointestinal tract). It reduces the effects of antihypertensive and hypnotic agents.
It increases the possibility of side effects of other NSAIDs and glucocorticoid agents (bleeding in the gastrointestinal tract), methotrexate toxicity and cyclosporine nephrotoxicity.
Acetylsalicylic acid reduces blood concentration of diclofenac.
Simultaneous administration with paracetamol increases risk of nephrotoxic effects of diclofenac.
It reduces the effect of hypoglycemic agents.
Cefamandole, cefoperazone, cefotetan, valproic acid, and plicamycin increase the frequency of hypoprothrombinemia.
Cyclosporine and gold drug products increase the influence of diclofenac on the synthesis of prostaglandins in the kidneys which is manifested by increased nephrotoxicity.
Simultaneous prescription of ethanol, colchicine, corticotropin and hypericum drug products increases the risk of bleeding in the gastrointestinal tract.
Drug products causing photosensitivity increase the sensitizing effect of diclofenac to UV irradiation.
Drug products blocking tubular secretion increase diclofenac plasma concentration, thereby increasing its activity and toxicity.
Antibacterial drug products of quinolones group increase the risk of seizures.
Administration details
During prolonged treatment it is required to monitor patterns of peripheral blood and functional state of the liver and kidneys. If symptoms of gastropathy appear, careful medical control is indicated comprising performing of esophagogastroduodenoscopy, blood test with hemoglobin and hematocrit estimation, and fecal occult blood test. When the visual impairment occurs, the dose should be reduced or administration should be discontinued.
Due to the adverse effect on fertility, the product is contraindicated in women planning pregnancy. In patients with infertility (including undergoing the tests) administration should be discontinued.
Precautions
Due to the important role of prostaglandins in maintaining renal blood flow a special cautiousness is required when the product is prescribed to patients with cardiac or renal insufficiency, as well as in the treatment of elderly patients administering diuretics, and patients that, for any reason, have significant decrease in circulating blood volume (e.g., after massive surgery). If in such cases diclofenac is prescribed, renal function monitoring is recommended as a precautionary measure.
In case of prolonged use at high doses the risk of gastrointestinal ulcerations and bleeding (gastrointestinal, gingival, uterine, hemorrhoidal) increases.
Use during pregnancy. The product is contraindicated during pregnancy and lactation.
Effect on ability to drive vehicles and use potentially dangerous machines. During treatment period a patient should refrain from driving vehicles and other potentially dangerous activities that require high concentration and speed of psychomotor reactions.
Storage conditions
Store in protected from light and moisture place at temperature below 25 °С. Keep out of reach of children.
Shelf life
3 years.
Do not use after expiration of a shelf life indicated on the package.
Package
10 tablets in a blister, 1 or 3 blisters together with leaflet are placed in a cardboard pack.
Prescription status
Over-the-counter.
Manufacturer:
“Belmedpreparaty” RUE,
Republic of Belarus,
Minsk, 220007,
30, Fabritsius str.
