not be
Used for: hypersensitivity to Diclofenac (Lertus CD) and / or other components of the formula; unexplained hematologic dysfunction, patients sensitive to aspirin or other drugs with inhibitory activity of prostaglandin synthetase with acute asthma, skin reactions or inflammation nasal mucosa, patients with gastrointestinal ulcers, during the first and last trimester of pregnancy, postpartum and in case of induction of porphyria.
Occasional: epigastric pain, gastrointestinal disturbances such as nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia.
Rare: gastrointestinal bleeding (hematemesis, melena, bloody diarrhea), stomach or intestinal ulcers with or without bleeding or perforation. Isolated cases: aphthous stomatitis, glossitis, oesophageal lesions, intestinal stenosis, diaphragmatic lower colon disturbances, such as non-specific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease, constipation and pancreatitis.
Central nervous system: Occasional: headache, dizziness or vertigo. Rare: drowsiness.
Isolated cases: disturbances of sensation, including paresthesia, memory disturbances, insomnia, irritability, seizures, depression, anxiety, nightmares, tremor, psychotic reactions, aseptic meningitis.
Sensory Organs: Isolated cases: disturbances of vision (blurred vision, diplopia), impaired hearing, tinnitus and taste disturbances.
Skin: Uncommon: rash.
Rare: urticaria.
Isolated cases: erythroderma (exfoliative dermatitis), hair loss, photosensitivity reaction, purpura, including purpura allergic rash with blisters, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome (acute toxic epidermolysis).
Urogenital system: Rare: edema.
Isolated cases: acute renal failure, urinary disturbances, such as hematuria and proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
Liver: Occasional: elevated serum aminotransferase enzymes.
Rare: hepatitis, with or without jaundice. Isolated cases: fulminant hepatitis.
Blood: Isolated cases: thrombocytopenia, leukopenia, anemia (hemolytic and aplastic), agranulocytosis.
Hypersensitivity: rare cases hypersensitivity reactions such as asthma, systemic reactions, anaphylactic / anaphylactoid reactions, including hypotension.
Isolated cases: vasculitis, pneumonia.
Cardiovascular system: Isolated cases: palpitation, chest pain, hypertension, congestive heart failure.
Inflammatory joint diseases (including acute attacks of gout).
Chronic inflammatory joint diseases, particularly rheumatoid arthritis (chronic polyarthritis).
Osteoarthritis.
Ankylosing spondylitis and other rheumatic inflammation of the spine.
Irritation resulting from degenerative joint disease and pain syndromes of the spine (osteoarthritis activated and espondilartrosis, cervical syndrome, lumbago, sciatica).
Non-articular rheumatism.
Painful post-traumatic and postoperative swellings and bruises and swelling after surgery.
Primary dysmenorrhea.
Adnexitis acute or subacute.
Pain due to cancer, particularly osteo-skeletal origin of peritumoral edema or inflammation.
As an adjunct in the treatment of serious infectious processes, accompanied by pain.
Inflammation of the ear, nose or throat, for example, in pharyngitis and otitis, respecting the general treatment principles where the basic disease should be treated properly. There is an indication of only fever.
Lithium, digoxin:this medicine may increase plasma concentrations of lithium and digoxin.
Diuretics: As with other NSAIDs this medicine may inhibit the activity of diuretics.
Concomitant treatment with potassium-sparing diuretics may be associated with elevated serum potassium levels, which should be monitored.
NSAIDs: Concomitant administration of systemic NSAIDs may increase the frequency of adverse reactions.
Anticoagulants: Although clinical investigations do not suggest that this medicine present influence on the effect of anticoagulants, there are reports of elevation in the risk of bleeding with the combined use of Diclofenac (Lertus CD) and anticoagulant therapy.
Consequently, in such cases, we recommend monitoring of patients.
Antidiabetic: Clinical studies showed that this medicine can be administered simultaneously with oral antidiabetic agents without influencing their clinical effects. However, there are isolated reports of hypo-and hyperglycemic effects that require dose adjustments of hypoglycemic agents during treatment with this medicine
Methotrexate: Caution should be exercised when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since the serum concentration of the drug may rise, thus increasing their toxicity.
Cyclosporine: The effects of NSAIDs on renal prostaglandins may increase the nephrotoxicity of cyclosporine.
Quinolone antibacterials: There have been isolated reports of convulsions which may be associated with concomitant use of quinolones and NSAIDs.
Concomitant administration of corticosteroids or other anti-inflammatory medications increases the risk of gastrointestinal bleeding. Medication administration assistant aspirin causes decreased serum concentrations of Diclofenac (Lertus CD).
