Fenaren® Enteric coated tablet 50 mg, each enteric coated tablet contains : Diclofenac sodium 50 mg.
Fenaren® contains Diclofenac sodium is available in enteric coated tablet 50 mg and injection 75 mg/3 ml.
Enteric coated tablet :
Fenaren® is indicated for acute and chronic therapy for rheumatoid arthritis, osteoarthritis and ankylosing spondylitis symptoms.
DOSAGE AND ADMINISTRATIONS :
Maximum dose of 100 mg daily (maximum initial dose 150 mg daily on the first day) in divided doses and with as short as possible duration.
If according physician assessment higher doses is required, there should be consideration the benefit-risk properly.
Supportive and symptomatic treatment should be given for complications, such as hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression.
Patients with peptic ulcer.
Hypersensitivity to Diclofenac.
Patients with a history of asthma, urticaria, acute rhinitis and other hypersensitivity reactions associated with the use Acetosal or other NSAIDs.
Contraindicated for patients with diseases : Ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure (New York Heart Association [NYHA] classification II-IV).
WARNINGS AND PRECAUTIONS :
- Cardiovascular thrombotic events
Clinical trials of severe COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal.
All NSAIDs, both COX-2 selective and nonselective, may have similar risk. Patients with known CV disease or risk factor for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the sign and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Acetyl salicylic acid mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of Acetyl salicylic acid and an NSAID does increase the risk of serious GI events (see GI WARNINGS, gastrointestinal (GI) effect – risk of GI ulceration, bleeding and perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
NSAIDs, including Diclofenac sodium can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Diclofenac sodium, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with Diclofenac sodium and throughout the course of therapy.
- Congestive heart failure and oedema
Fluid retention and oedema have been observed in some patients taking NSAIDs. Diclofenac sodium should be used with caution in patients with fluid retention or hearts failure.
GASTROINTESTINAL (GI) EFFECTS
- Risk of GI ulceration, bleeding and perforation
NSAIDs, including Diclofenac sodium, can cause serious gastrointestinal events, including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months and in about 2 – 4% of patients treated for one year. These trends with longer duration of use, increasing the like hood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should prescribed with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factor. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral Corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
Caution should be used in patients with cardiac decompensation or hypertension, Diclofenac sodium can cause fluid retention and edema.
Caution should be used in patients with impaired renal, cardiac, hepatic function, geriatric patients and patients with inflammation or gastrointestinal bleeding.
Caution should be used for the last 3 months of pregnancy, it can cause inhibit uterine contraction and delay partus.
Use in lactation, must be considered the adverse effect although small amount are excreted in breast milk.
Use in children, effectivity and safety have not been established.
Strict accuracy of diagnosis and close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history of gastrointestinal ulceration, with ulcerative colitis or with Crohn’s disease.
The presence of Sodium metabisulfite, especially in patients with bronchial asthma, lead to isolated hypersensitivity reactions, which may become manifest as an acute asthma attack, clouding of consciousness or shock.
Patients experiencing dizziness or other central nervous disturbances should refrain from driving vehicle or operating machines.
DRUG INTERACTIONS :
Concurently use with Acetosal lowers the plasma concentration and AUC values of Diclofenac.
Diclofenac sodium may raise the plasma concentration of Digoxin, Methotrexate, Cyclosporin and Lithium. The toxicity of these substance may increase.
Diclofenac sodium can reduce effect of diuretic drugs.
Concomitant treatment with pottasium-sparing diuretics may be followed with increased serum potassium levels.
Caution should be exercised when non-steroidal anti-inflammatory drug administered less than 24 hours before or after treatment with Methotrexate, since Methotrexate concentration in blood of may rise and toxicity of this drug be increased.
Increases nephrotoxicity of Cyclosporin may occur through effects of non-steroidal anti-inflammatory drugs on renal prostaglandins.
ADVERSE REACTIONS :
Infections and infestations
Very rare : Injection site abscess.
Blood and lymphatic system disorders
Very rare : Thrombocytopenia, leucopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.
Immune system disorders
Rare : Hypersensitivity anaphylactic and anaphylactoid reactions (including hypertension and shock).
Very rare : Angioedema (including face edema).
Very rare : Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders
Common : Headache, dizziness.
Rare : Somnolence.
Very rare : Paresthesia, memory impairment, convulsion, anexiety, tremor, aseptic meningitis , dysgeusia, cerebrovascular accident, drowsiness.
Very rare : Visual impairment, blurred vision, diplopia.
Ear and labyrinth disorders
Common : Vertigo.
Very rare : Tinnitus, impaired hearing.
Uncommon* : Myocardial infarction, cardiac failure, palpitations, chest pain.
Frequency not known : Kounis syndrome.
Very rare : Hypertension, vasculitis, syncope.
Respiratory, thoracic and mediastinal disorders
Rare : Asthma (including dyspnoea).
Very rare : Pneumonitis.
Common : Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, decreased appetite.
Rare : Gastritis, gastrointestinal hemorrhage, hematemesis, melaena, hemorrhagic diarrhea, gastrointestinal ulcer (with or without bleeding, gastrointestinal stenosis or perforation, which may lead to peritonitis).
Very rare : Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis, glossitis, oesophageal disorder, intestinal diaphragm disease, pancreatitis.
Common : Transaminases increased.
Rare : Hepatitis, jaundice, liver disorder.
Very rare : Hepatitis fulminant, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders
Common : Rash.
Rare : Uticaria.
Very rare : Bullous dermatitis, eczema, erythema, erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, Henoch-Schonlein purpura, pruritus.
Renal and urinary disorders
Very rare : Acute kidney injury (acute renal failure), hematuria, proteinuria, nephrolic syndrome, tubulointerstitial nephritis, renal papillary necrolisis.
General disorders and administration site conditions
Common : Injection site reaction, injection site pain, injection site induration.
Rare : Edema, injection site necrosis.
*The frequency reflects data from long-term treatment with a high dose (150 mg/day).
Fenaren® Enteric coated tablet 50 mg Box, 10 strips @ 10 enteric coated tablets
Reg. No. DKL9002314615B1
Fenaren® Enteric coated tablet :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia