Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA
K-FENAK OTC is contraindicated in:
The most frequently observed adverse events are gastrointestinal in nature. Other adverse reactions include nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, and gastritis (see "SIDE EFFECTS").
Treatment with K-FENAK OTC should be started and maintained at the lowest effective dose to reduce the risk of gastrointestinal toxicity in elderly patients and in patients with a history of ulcer, especially if complicated with perforation or haemorrhage (see ʺDOSAGE AND DIRECTIONS FOR USEʺ ).
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be instructed to report any unusual abdominal symptoms, in particular gastrointestinal bleeding. Caution is advised in patients taking K-FENAK OTC concurrently with medicines that may increase the risk of bleeding or ulceration, including anticoagulants, systemic corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet medicines (see ʺINTERACTIONSʺ).
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. K-FENAK OTC should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity (see "SIDE EFFECTSʺ).
Hypersensitivity reactions (such as bronchospasm, anaphylactic/anaphylactoid reactions, including hypotension), vasculitis and pneumonitis may occur less frequently without prior exposure to K-FENAK OTC. Discontinue treatment immediately.
Due to its pharmacodynamic properties, K-FENAK OTC may mask the signs and symptoms of infection.
The bioavailability of both K-FENAK OTC and acetylsalicylic acid (aspirin) may be reduced if used concurrently. Due to the potential for increased side effects and the absence of synergistic benefits, the use of two or more NSAIDs concomitantly, including cyclo-oxygenase-2 selective inhibitors, should be avoided (see ʺINTERACTIONSʺ).
Concomitant use of K-FENAK OTC and methotrexate could result in serious interactions (see ʺINTERACTIONSʺ).
Caution is required in elderly patients on basic medical grounds. A reduction in dosage may be required in the elderly, especially in the very frail or those with a low body mass.
Reactions to K-FENAK OTC, such as asthma exacerbations (so-called analgesics-asthma/intolerance to analgesics), urticaria or angioedema, may occur more frequently in patients with asthma, swelling of the nasal mucosa/nasal polyps, seasonal allergic rhinitis, chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms) or chronic obstructive pulmonary diseases, than in other patients. Special precaution (readiness for emergency) is therefore required in these patients and in patients with allergies to other substances, e.g. with pruritus, skin reactions or urticaria (see ʺCONTRAINDICATIONSʺ).
K-FENAK OTC is contraindicated in patients with hepatic failure (see "CONTRAINDICATIONS").
There may be an increase in the values of one or more liver enzymes. Regular monitoring of liver function is required as a precautionary measure during prolonged treatment with K-FENAK OTC. If abnormal hepatic function tests continue and symptoms of hepatic disease develop, or if other manifestations such as rash or eosinophilia occur, discontinue K-FENAK OTC. Hepatitis may develop with the use of K-FENAK OTC in the absence of prodromal symptoms.
K-FENAK OTC is contraindicated in patients with renal failure. Heart failure may be precipitated in some compromised patients, due to the inherent potential of K-FENAK OTC to cause fluid retention and oedema (see ʺCONTRAINDICATIONSʺ and "SIDE EFFECTSʺ).
Patients suffering from renal or cardiac impairment, patients with a history of hypertension, the elderly, patients being treated with diuretics or medicines that can significantly affect renal function, or patients who have extracellular volume depletion from any cause, e.g. before or after major surgery, should be carefully monitored because of the role of prostaglandins in maintaining renal blood flow. In such cases, monitoring of kidney function is recommended as a precautionary measure when using K-FENAK OTC. Recovery to the pre-treatment state usually follows discontinuation of treatment.
Monitoring of blood counts is indicated during prolonged treatment with K-FENAK OTC. K-FENAK OTC may inhibit aggregation of platelets temporarily. Patients who have defects of haemostasis require careful monitoring.
K-FENAK OTC contains lactose. Patients with rare hereditary problems or a history of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take K-FENAK OTC.
When K-FENAK OTC is administered less than 24 hours before or after treatment with methotrexate, caution is required, since concurrent administration of methotrexate with K-FENAK OTC may result in increased methotrexate blood concentrations and toxicity (see ʺWARNINGS AND SPECIAL PRECAUTIONSʺ).
Raised plasma concentrations of lithium or digoxin may occur if taken together with K-FENAK OTC. It is recommended to monitor the serum levels of lithium or digoxin.
Co-administration of K-FENAK OTC with antihypertensive medicines [e.g. angiotensin converting enzyme (ACE) inhibitors, beta-blockers] or diuretics may cause a decrease in the antihypertensive effect. The combination should, therefore, be given with caution and the patient's blood pressure, particularly that of the elderly, should be monitored periodically. Due to the increased risk of nephrotoxicity, patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concurrent treatment and periodically thereafter, especially for ACE inhibitors and diuretics. Increased serum potassium levels may be associated with concurrent treatment with potassium- sparing medicines; therefore, serum potassium levels should be monitored frequently (see ʺWARNINGS AND SPECIAL PRECAUTIONSʺ).
Gastrointestinal adverse effects may be exacerbated by the concomitant administration of K-FENAK OTC. Concurrent treatment with two or more NSAIDs may increase the risk of adverse effects (see ʺWARNINGS AND SPECIAL PRECAUTIONSʺ).
Oral antidiabetic medicines can be co-administered with K-FENAK OTC without influencing the clinical effects of antidiabetic medicines. K-FENAK OTC may cause both hypo- and hyperglycaemia. Therefore, the dosage of antidiabetic medicines may need to be changed during co-administration with K-FENAK OTC, and blood glucose levels should be monitored as a precautionary measure.
The bioavailability of both K-FENAK OTC and acetylsalicylic acid (aspirin) are reduced if used concurrently (see ʺWARNINGS AND SPECIAL PRECAUTIONSʺ). As there is an increased risk of gastrointestinal bleeding, caution is recommended.
K-FENAK OTC may enhance the effects of anti-coagulants, such as warfarin. There is an increased risk of haemorrhage if K-FENAK OTC is used concurrently with any anticoagulants. Careful monitoring is necessary.
Caution is recommended since there is an increased risk of gastrointestinal bleeding when these medicines are co-administered with K-FENAK OTC.
Nephrotoxicity of ciclosporin may be increased by the effects of K-FENAK OTC on renal prostaglandins. Therefore, in patients receiving ciclosporin K-FENAK OTC should be administered at lower doses than for patients not receiving ciclosporin.
Cases of convulsions have been reported, which may be due to concurrent use of NSAIDs, such as K-FENAK OTC, and quinolone antibiotics.
K-FENAK OTC should not be used during pregnancy, as safety and efficacy in pregnancy and lactation has not been established (see "CONTRAINDICATIONS").
Use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased (see ʺCONTRAINDICATIONSʺ).
Use of NSAIDs, such as K-FENAK OTC, around 20 weeks gestation or later in pregnancy may cause a rare but serious foetal renal dysfunction leading to oligohyramnios and, in some cases, neonatal renal impairment. Complications of prolonged oligohydramnios include limb contractures and delayed lung maturation, which may require invasive procedures such as exchange transfusion or dialysis, in some cases.
A small amount of K-FENAK OTC passes into the breast milk. Therefore, in order to avoid undesirable effects in the infant K-FENAK OTC should not be used during lactation (see ʺCONTRAINDICATIONSʺ).
Administration of K-FENAK OTC is not recommended in women attempting to conceive, as it may impair female fertility. Withdrawal of K-FENAK OTC should be considered in women experiencing difficulties conceiving or who are undergoing investigation of infertility.
Patients who experience dizziness, vertigo, visual disturbances, somnolence, or other central nervous system disturbances while taking K-FENAK OTC, should refrain from driving a vehicle or operating machinery.
Less frequent: Leucopenia, thrombocytopenia, aplastic anaemia, haemolytic anaemia, agranulocytosis.
Less frequent: Hypersensitivity reactions, anaphylactic and anaphylactoid reactions (including shock and hypotension), angioedema (including face oedema), bullous reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome (see ʺSkin and subcutaneous tissue disordersʺ).
Less frequent: Disorientation, insomnia, irritability, depression, nightmares, psychotic reactions.
Frequent: Headache, dizziness, nervousness.
Less frequent: Tiredness, disturbances of sensation (including paraesthesia), memory disturbance, convulsions, anxiety, tremor, aseptic meningitis, somnolence, taste disturbances, cerebrovascular accident.
Less frequent: Disturbances of vision (diplopia, blurred vision).
Frequent: Vertigo.
Less frequent: Impaired hearing, tinnitus.
Less frequent: Palpitation, chest pain, congestive heart failure, oedema, myocardial infarction.
Less frequent: Vasculitis, hypertension.
Less frequent: Asthma (including dyspnoea), pneumonitis.
Frequent: Epigastric pain, nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, eructation, anorexia, local irritation, abdominal pain.
Less frequent: Gastrointestinal bleeding, haematemesis, melaena, bloody diarrhoea, peptic ulcer with or without bleeding or perforation, lower gut disorders such as non-specific haemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's proctocolitis, glossitis, aphthous stomatitis, oesophageal lesions, diaphragm-like intestinal strictures, constipation, pancreatitis, alteration in taste, gastritis, Crohn's disease.
Frequent: Elevated transaminase levels (ALT, AST).
Less frequent: Hepatitis with or without jaundice, fulminant hepatitis, liver disorder, hepatic necrosis, hepatic failure.
Frequent: Rash and skin reactions.
Less frequent: Urticaria, bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute toxic epidermolysis (see ʺImmune system disordersʺ), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reaction, purpura, including allergic purpura, pruritus.
Less frequent: Acute renal failure, urinary abnormalities such as haematuria, proteinuria, interstitial nephritis, nephritic syndrome, papillary necrosis.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.