Diclo-Denk 100 Retard 100 ტაბლეტი

Full description:

• Diclo-Denk 100 Retard 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.
• Due to the delayed release of the active ingredient diclofenac, Diclo-Denk 100 Retard is not suitable for initiating therapy in patients where a rapid onset of effect is required.
• What Diclo-Denk 100 Retard contains:
• The active substance is diclofenac sodium. Each prolonged-release tablet contains 100 mg diclofenac sodium.
• The other ingredients are: sucrose, cetyl alcohol, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, polysorbate 80, macrogol 6000, talc, titanium dioxide, ferric oxide.
• 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
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• Possible side effects
• The following side effects include those reported with diclofenac suppositories 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 (see section 2). 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 (see section 2) 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 100 Rectal.
• Medicinal products such as Diclo-Denk 100 Rectal are associated with an increased risk of heart attacks (“myocardial infarction”) or strokes, above all at high doses and during prolonged treatment.
• Tell your doctor immediately if you notice any of the following: Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
• Cardiac disorders
• These side effects may occur in uncommon cases, especially if diclofenac is used for prolonged periods at high doses (150 mg/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 (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).
• Ear and labyrinth disorders
• 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: Proctitis, 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), haemorrhoids, inflammation of the pancreas (pancreatitis), membranous narrowing of the intestine (intestinal strictures).
• In cases of severe upper abdominal pain, black discolouration of the stool or blood in stool, you must stop using Diclo-Denk 100 Rectal and inform your doctor immediately.
• Stop using Diclo-Denk 100 Rectal 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 100 Rectal and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
• General disorders and administration site conditions
• Suppositories may often cause local signs of irritation, bloody mucous secretion or painful defecation.
• 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 using Diclo-Denk 100 Rectal 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 100 Rectal 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 100 Rectal, 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 long-term 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:
• Swallow Diclo-Denk 100 Retard whole with plenty of fluids. Do not break the tablets in halves. If you have a sensitive stomach it is advisable to take Diclo-Denk 100 Retard with your meals.
• Your doctor will decide about the duration of treatment. Long-term treatment with Diclo-Denk 100 Retard may be required for patients with rheumatic disease.