Diclo-Denk 50 20 ტაბლეტი

Full description:

• Diclo-Denk 50 is a pain-relieving and anti-inflammatory drug and belongs to the class of non-steroidal antiphlogistic/antirheumatic agents (NSAIDs).
• Symptomatic treatment of pain and inflammation in case of:
• acute joint inflammation (acute arthritides) including gout attack
• chronic joint inflammation (chronic arthritides), especially in case of rheumatoid arthritis (chronic polyarthritis)
• Bechterew’s disease (ankylosing spondylitis) and other inflammatory rheumatoid disorders of the spine
• acute inflammatory condition of degenerative joint or spinal disorders (arthroses and spondylarthroses)
• inflammatory soft tissue rheumatisms
• painful swelling or inflammation after injuries.
• Since there may be delayed release of the active ingredient diclofenac from Diclo-Denk 50, there may be a delayed onset of effect. Diclo-Denk 50 should therefore not be used for initiating therapy in patients where a rapid onset of effect is required.
• What Diclo-Denk 50 contains:
• The active substance is diclofenac sodium. Each enteric coated tablet contains 50 mg diclofenac sodium.
• The other ingredients are: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, poly(methacrylic acid-co-ethyl acrylate), polysorbate 80, macrogol 6000, talc, titanium dioxide, ferric oxides.
• Possible side effects:
• Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of adverse drug reactions is classified as follows:
• Very common: may affect more than 1 in 10 people
• Common: may affect up to 1 in 10 people
• Uncommon: may affect up to 1 in 100 people
• Rare: may affect up to 1 in 1,000 people
• Very rare: may affect up to 1 in 10,000 people
• Not known: frequency cannot be estimated from the available data
• Possible side effects
• The following side effects include those reported with diclofenac enteric coated tablets and/or other pharmaceutical forms of diclofenac during both short-term and long-term use.
• Please note that the following adverse drug reactions are mostly dose-dependent and may differ from individual to individual. The most common adverse drug reactions affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, vomiting of blood, ulcerative inflammation of the oral mucous membranes (ulcerative stomatitis), exacerbation of colitis and Crohn’s disease have been reported after use. Gastritis is less common.
• Fluid retention (oedema), high blood pressure and heart failure have been reported in association with NSAID therapy, including Diclo-Denk 50.
• Medicinal products such as Diclo-Denk 50 are associated with a slightly increased risk of heart attacks (“myocardial infarction”) or strokes, above all at high doses and during prolonged treatment.
• Cardiac disorders
• These side effects may occur in uncommon cases, especially if diclofenac is taken for prolonged periods at high doses (150mg/day): heart attack, weakness of heart muscles (heart failure), palpitations, chest pain.
• Very rare: Fluid retention (oedema).
• Blood and lymphatic system disorders
• Very rare: Impaired haemopoiesis (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may be: fever, sore throat, superficial lesions in the mouth, influenza-like complaints, severe lassitude, nose bleeding and dermatorrhagia.
• In such cases this medication is to be discontinued immediately and a doctor has to be consulted.
• Patients should not self-medicate with analgesics or antipyretics. The blood count should be monitored regularly during long-term therapy.
• Very rare: Haemolytic anaemia (anaemia resulting from accelerated degradation of red blood cells) or aplastic anaemia due to impaired blood production) may occur.
• Nervous system disorders
• Common: Central nervous symptoms such as headache, vertigo, light-headedness, state of excitement, irritability or fatigue.
• Very rare: Sensory disturbances, distortion of taste, impaired memory, disorientation, seizures, tremor, stroke.
• Eye disorders
• Very rare: Impaired vision (blurred and double vision).
• Disorders of the ear and labyrinth
• Common: Dizziness.
• Very rare: Ringing in the ears (tinnitus), transitory impaired hearing.
• Gastrointestinal disorders
• Very common: Gastrointestinal complaints, such as nausea, vomiting and diarrhoea and minor gastrointestinal bleeding, which in individual cases may cause anaemia.
• Common: Indigestion (dyspepsia), flatulence, abdominal pain, abdominal cramps, loss of appetite as well as gastric or intestinal ulcers (sometimes with bleeding and perforation).
• Uncommon: Vomiting of blood (hematemesis), bloody stool or bloody diarrhea, melaena.
• Rare: Gastritis.
• Very rare: Inflammation of the oral mucosa (including mouth ulcers), glossitis, oesophagus lesions, constipation as well as lower abdominal complaints such as inflammation of the colon (colitis), haemorrhaging inflammation of the colon (haemorrhagic colitis), exacerbation of Crohn’s disease or ulcerative colitis (specific inflammation of the colon associated with ulcers), membranous narrowing of the intestine (intestinal strictures), inflammation of the pancreas (pancreatitis).
• In cases of severe upper abdominal pain, vomiting of blood, black discolouration of the stool or blood in stool, you must stop taking Diclo-Denk 50 and inform your doctor immediately. Stop using Diclo-Denk 50 and tell your doctor straight away if you notice mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclo-Denk 50 and followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
• Renal and urinary disorders
• Uncommon: Development of oedema (fluid retention in the body) especially in patients with high blood pressure or impaired kidney function.
• Very rare: Renal tissue damage (interstitial nephritis, papillary necrosis) that may be associated with acute renal dysfunction (renal insufficiency), protein in urine (proteinuria) and/or blood in urine (haematuria); nephrotic syndrome (fluid retention in the body [oedema] and excretion of large amounts of protein in urine), acute renal failure.
• Reduced urinary output, accumulation of water in the body (oedema) as well as general malaise may be symptoms of kidney disease ranging to kidney failure. If the mentioned symptoms occur or worsen, you must stop taking Diclo-Denk 50 and consult your doctor immediately.
• Skin and subcutaneous tissue disorders
• Common: Inflammatory skin lesions.
• Uncommon: Alopecia.
• Very rare: Skin rashes associated with reddening (eczema, erythema, exanthema), hypersensitivity to light, purpura, severe skin reactions such as rash with blistering (e.g Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome), inflammatory skin disease with redness, formation of large scales, swelling, itching, feeling of tension and shivering (exfoliative dermatitis), inflammatory reddening (erythroderma).
• Infections and parasitic diseases
• In very rare cases associated with the use of special anti-inflammatory drugs (NSAIDs to which Diclo-Denk 50 also belongs) an exacerbation of infective inflammations (e.g. development of necrotic fasciitis) has been reported. If signs of an infection (e.g. reddening, swelling, hyperthermia, pain, fever) occur or worsen during treatment with Diclo-Denk 50, a doctor should be consulted immediately.
• In very rare cases, the use of diclofenac has been associated with the symptoms of non-infectious inflammation of the meninges (aseptic meningitis) such as severe headache, nausea, vomiting, fever, stiff neck or clouding of consciousness.
• Patients already suffering from certain autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disorder, appear to be at increased risk.
• Vascular disorders
• Very rare: High blood pressure (hypertension), inflammation of blood vessels.
• Immune system disorders
• Common: Hypersensitivity reactions such as skin rash and itching.
• Uncommon: Hives (urticaria).
• Rare: hypersensitivity reactions (including low blood pressure and shock).
• Very rare: Severe general hypersensitivity reactions that may be manifested by: angioedema including swelling of the face, tongue and internal swelling of the larynx with constriction of the respiratory tract, laboured breathing, palpitations, drop in blood pressure and eventually life-threatening shock. If any of these symptoms occur, and this is possible following the first application, immediate medical attention is required.
• In such cases, the medicine is to be discontinued immediately and a doctor has to be consulted.
• In very rare cases, allergic inflammation of the blood vessels (vasculitis) and lungs (pneumonitis) was observed.
• Hepatobiliary disorders
• Common: An increase in blood liver enzymes.
• Uncommon: Liver damage, especially during longterm therapy, acute hepatitis with or without icterus (in individual cases very severe [fulminant] course, sometimes without prodromal symptoms).
• Very rare: Liver failure, liver disease accompanied by destruction
• of liver cells (liver cell necrosis).
• Regular monitoring of liver parameters is therefore necessary during long-term therapy.
• Psychiatric disorders
• Very rare: Psychotic reactions, depression, feeling of anxiety, nightmares, insomnia.
• Respiratory disorders
• Rare: Asthma (including breathlessness).
• Very rare: Interstitial lung inflammation (pneumonitis).
• Follow the instructions listed above if adverse drug reactions occur.
• How to take: Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose is:
• The dose of diclofenac depends on the severity of the illness. The recommended daily dose for adults is between 50 and 150 mg of diclofenac sodium divided into 1–3 single doses.