MAFENA RETARD *:
Each extended-release tablet contains:
........... 100 mg sodium diclofenac
Excipient cbp 1 tablet ................
Each tablet contains:
........... 50 mg sodium diclofenac
Excipient cbp 1 tablet .................
MAFENA * Injectable solution:
Each vial contains:
........... 75 mg sodium diclofenac
......... qs water for injection 3 ml
MAFENA GEL *:
100 g of gel contain:
Diclofenac diethylammonium .... 1.16 g
Excipient qs 100.0 g ................
Diclofenac sodium is used for anti-inflammatory and analgesic effects in the symptomatic treatment of acute and chronic osteoarthritis and rheumatoid arthritis, ankylosing spondylitis, and other inflammatory conditions, it has also been used for the symptomatic treatment of acute painful shoulder (bursitis and / or tendinitis), sciatica, back pain, myositis, bursitis and radiohumeral (radiohumeral epicondylitis, tennis elbow) for the relief of myofascial pain, is also used for symptomatic relief of postoperative pain (including pain associated with orthopedic surgery, gynecological and oral) and orthopedic pain (including sprains and traumatic common distortions). Diclofenac has also been used for symptomatic relief of post operative pain (including that associated with dental surgery), postpartum, and (voltages including musculoskeletal sprains) orthopedic and visceral pain associated with cancer. Diclofenac sodium in the form of extended release tablets have also been used for symptomatic relief of dysmenorrhoea, and also for its antipyretic effect in the management of fever, usually associated with infections. Diclofenac, topical or oral, has been useful in treating asymptomatic cases of thrombophlebitis.
Patients should be notified as to which diclofenac, as with other NSAIDs is free to give side effects in some cases could cause discomfort, and some other annoyances, and may even cause some severe effects such as myocardial infarction, shock and gastrointestinal bleeding. May even require hospitalization and with a poor prognosis.
Patients should also be informed that the use of NSAIDs, it is also often used in mild conditions. NSAID therapy is considered essential for the management of disorders such as rheumatoid arthritis and also has a role in pain management. Some physicians discuss with their patients about the risk-benefit of therapy with NSAIDs, especially when the use of these drugs is for mild disorders and when therapy is the best option for both.
All NSAIDs (eg, traditional NSAIDs and COX-2 inhibitors) may increase the risk of major thrombotic cardiovascular event. Patients with cardiovascular disease or any kind of cardiovascular risk may be increased by the use of these drugs. To minimize this risk, short-term therapy and small doses is suggested.
Patients should be alerted about the cardiovascular symptoms that could manifest with the use of NSAIDs, such as chest pain, dyspnea, etc., and further instruction on the attitude to be taken in this regard.
Patients receiving NSAIDs and diuretics such as thiazides or loop diuretics may have an incorrect answer diuretic. NSAIDs also be used with caution in patients with hypertension should be monitored and their blood pressure before and during therapy with NSAIDs. It must also be exercised in patients with renal failure and fluid retention as edema has been observed in some patients receiving these drugs.
The potential risk of gastrointestinal effects have been seen in patients receiving diclofenac, particularly in those who have undergone long-term therapy. Diclofenac should be used with caution in patients with a history of acid peptic disease, since both gastrointestinal bleeding such as peptic ulcer have been reported.
That have been developed severe hepatotoxic effects through symptoms of liver dysfunction should be monitored periodically in patients who are using diclofenac. Patients who experience signs and symptoms suggestive of liver dysfunction or who have a abnormal liver function tests after using diclofenac, they should be evaluated for the development of greater hepatic dysfunction. Diclofenac should be discontinued in the presence of abnormal liver tests or for signs and symptoms of liver dysfunction. The patient should be advised as to the symptoms of hepatic dysfunction, such as nausea, anorexia, fatigue, lethargy, itching, pain in the right upper quadrant of the abdomen, etc. And take appropriate action.
Concomitant use of NSAIDs with corticosteroids may increase the risk of gastrointestinal bleeding, despite the concomitant use of NSAIDs and corticosteroids should be with caution. Diclofenac should be used with caution in patients with bleeding disorders or receiving anticoagulant therapy, because the drug can inhibit platelet function. If they had information of anemia during treatment with diclofenac, should be measured hemoglobin and hematocrit.
Renal toxicity has also been observed in patients who renal prostaglandins have a compensatory role in renal perfusion. The administration of NSAIDs in these patients is likely to cause a dose-dependent in prostaglandin formation and precipitate a reduction in renal decompensation. Patients with high risk for this reaction are those with renal, cardiac or hepatic failure, those with decreased extracellular fluid (receiving diuretics) also those using ACE inhibitors or angiotensin II inhibitors concomitantly and in patients geriatric.
anaphylactoid reactions have been reported in patients receiving diclofenac, patients must be instructed as to such reactions such as difficulty breathing swelling of the face, etc. Serious skin reactions also occur at the intake of diclofenac such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis etc. If this occurs, the intake of diclofenac should be discontinued.
Some clinicians mention caution with the use of NSAIDs in patients with systemic lupus erythematosus and disorders that can occur in the CNS as aseptic meningitis and a possible activation of the LES. NSAIDs including diclofenac, are generally contraindicated in patients with asthma, urticaria or any other reaction that can be precipitated by aspirin or other NSAIDs, can occur a severe anaphylactic reaction. Diclofenac should be used with caution in individuals over 60 years.
(Including the effects seen with other forms of administration MAFENA *).
frequent> 10%, occasional> 1-10%, rare> 1% 0,001th in isolated <0.001% cases: the following estimated frequencies are used.
Occasional: epigastric pain, other gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence and anorexia.
Rarely: gastrointestinal bleeding (haematemesis, melena, bloody diarrhea), gastric or intestinal ulcer with or without bleeding or perforation.
Isolated cases: aphthous stomatitis, glossitis, oesophageal lesions, intestinal stricture formation "diaphragms" lower bowel disorders such as non-specific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease, constipation and pancreatitis.
Central Nervous System:
Occasionally: headache, dizziness or vertigo.
In isolated cases: Disturbed sensation, including paresthesia, memory disorders. disorientation, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions, aseptic meningitis.
In isolated cases: disorders of vision (blurred vision, diplopia), hearing loss, tinnitus and taste perversion.
Sometimes: Erythema or rashes.
In isolated cases: bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reaction syndrome; purple and even allergic purpura.
In isolated cases: Acute renal failure, urinary abnormalities such as hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, and papillary necrosis.
Occasionally: Increased serum aminotransferases.
Rarely: Hepatitis with or without jaundice.
In isolated cases: fulminant hepatitis.
Rare: Hypersensitivity reactions such as asthma, systemic anaphylactic and anaphylactoid-including hypotension.
In isolated cases: vasculitis and pneumonitis.
In isolated cases: palpitation, chest pain, hypertension and congestive heart failure.
Other organ systems:
Occasionally: Reactions at the site of intramuscular injection as local pain and hardening.
In isolated cases: local abscesses and necrosis at the intramuscular injection.
MAFENA * 50 mg: Box of 20 tablets.
In extended-release tablets:
MAFENA RETARD * 100 mg: Box of 10 tablets in a package of bubble.
MAFENA RETARD * 100 mg Box with 20 tablets in blister container.
In injectable solution:
MAFENA * Box 2 and 4 vials of 3 ml, 75 mg.
MAFENA GEL *: Box with tube with 60 g.