Ramazodef Film Coated Tablets
Usage and indications:
Ramazodef is indicated in:
Dosage and administration:
The dosage should be adjusted to the severity of the disorder and the complaints of the patient. During chronic administration, the dosage should be adjusted to the lowest maintenance dose that provides adequate control of symptoms.
Ramazodef film coated tablets can be taken with or without a meal. In general NSAIDs (non-steroidal anti-inflammatory drugs) are preferably taken with food to reduce gastrointestinal irritation, particularly during chronic use. However, a later onset of action in some patients may be anticipated when the tablets are taken with or directly after a meal.
-The recommended dosage is 600 to 900mg dexibuprofen daily, divided in up to three single doses.
For the treatment of mild to moderate pain:
In children and adolescents (<18 years):
Dexibuprofen has not been studied. Safety and efficacy have not been established and therefore it is not recommended in these age groups.
In elderly patients:
It is recommended to start the therapy at the lower end of the dosage range.
The dosage may be increased to that recommended for general population only after good general tolerance has been ascertained.
Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses and be closely monitored. Dexibuprofen should not be used in patients with severe hepatic dysfunction.
The initial dosage should be reduced in patients with mild to moderate impaired renal function. Dexibuprofen should not be used in patients with severe renal dysfunction.
Very common (>1/10): Dyspepsia, diarrhea.
Common (>1/100, <1/10): Nausea, vomiting, abdominal pain.
Uncommon (>1/1,000, <1/100): Gastrointestinal ulcers and bleeding, ulcerative stomatitis.
Rare (>1/10,000, <1/1,000): Gastrointestinal perforation, flatulence, constipation, esophagitis, and esophageal strictures. Exacerbation of diverticular disease, unspecific haemorrhagic colitis, colitis ulcerosa or Crohn's disease.
If gastrointestinal blood loss occurs, this may cause anaemia and haematemesis.
Skin and hypersensitivity reaction:
Uncommon: Urticaria, pruritus, purpura (including allergic purpura), angiooedema, rhinitis, bronchospasm.
Rare: Anaphylactic reaction
Very rare (<1/10,000): Erythema multiforme, epidermal necrolysis, systemic lupus erythematosus, alopecia, photosensitivity reactions, severe skin reactions like Stevens-Johnson-Syndrome, acute toxic epidermal necrolysis (Lyell-Syndrome) and allergic vasculitis.
Generalized hypersensitivity reactions have not yet been reported with dexibuprofen but their occurrence cannot be excluded considering the clinical experience with racemic ibuprofen. The symptoms may include fever with rash, abdominal pain, headache, nausea and vomiting, signs of liver injury and even aseptic meningitis. In the majority of cases in which aseptic meningitis has been reported with ibuprofen, some form of underlying auto-immune disease (such as systemic lupus erythematosus or other collagen diseases) was present as a risk factor. In case of a severe generalized hypersensitivity reaction swelling of face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock can occur.
Central nervous system:
Common: Fatigue or drowsiness, headache, dizziness, vertigo.
Uncommon: Insomnia, anxiety, restlessness, visual disturbances, tinnitus.
Rare: Psychotic reaction, agitation, irritability, depression, confusion or disorientation, reversible toxic amblyopia, impaired hearing.
Very rare: Aseptic meningitis (see hypersensitivity reactions).
Bleeding time: may be prolonged.
Rare cases of blood disorders include: Thrombocytopenia, leucopenia, granulocytopenia, pancytopenia, agranulocytosis, aplastic anemia or haemolytic anaemia.
Peripheral edema has been reported in association with dexibuprofen treatment.
Patients with hypertension or renal impairment seem to be predisposed to fluid retention.
Hypertension or cardiac failure (especially in the elderly) may occur.
According to the experience with NSAIDs in general, interstitial nephritis, nephrotic syndrome or renal failure cannot be excluded.
Rare cases of abnormal liver function, hepatitis and jaundice have been observed with racemic ibuprofen.
In very rare cases infection related inflammation may be aggravated.
Warnings and precautions:
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke which can be fatal. This risk may increase with duration of use.
Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs is contraindicated for the treatment of pre-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach or intestine, which can be fatal. These events can occur at any time during use and without warning symptoms.
Elderly patients are at greater risk for serious gastrointestinal events.
In general the habitual use of analgesics, especially the combination of different analgesic drug substances, can lead to lasting renal lesions with the risk of renal failure (analgesic nephropathy). Thus combinations with racemic ibuprofen or other NSAIDs (including OTC products) should be avoided.
The use of dexibuprofen, as with any other drug known to inhibit cyclooxygenase / prostaglandin synthesis, may impair fertility reversibly and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of Ramazodef should be considered.
Data of preclinical studies indicate that inhibition of platelet aggregation by low-dose acetylsalicylic acid may be impaired if ibuprofen is administrated concurrently; this interaction could reduce the cardiovascular-protective effect. Therefore if concomitant administration of low-dose acetylsalicylic acid is indicated special precaution is required if duration of treatment exceeds short term use.
Pack: Carton box containing one or two (AL/ PVC) blisters each of 10 film coated tablets.