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Logo K-FENAK (Tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

K-FENAK (Tablets)

COMPOSITION:
Each film-coated tablet contains 50 mg
diclofenac potassium.

PHARMACOLOGICAL CLASSIFICATION:
A.3.1. Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Diclofenac is a non-steroidal anti-inflammatory compound (NSAID) with analgesic, antipyretic and anti-inflammatory activities. It causes decreased formation of prostaglandins and thromboxanes through inhibition of the activity of the enzyme cyclo-oxygenase. Prostaglandins play a major role in the aetiology of inflammation, pain and fever and the inhibition of prostaglandin synthesis may have an important bearing on diclofenac’s mechanism of action. Diclofenac inhibits platelet aggregation in vitro.
Pharmacokinetics:
Diclofenac is well absorbed after oral administration. Peak plasma concentrations are reached within approximately 1 hour. Administration with food slows the rate but does not alter the extent of absorption. There is a substantial first-pass effect (only 50% of diclofenac is available systemically). Diclofenac is extensively bound to plasma proteins (99%) and its plasma half-life is 1 to 2 hours.
Diclofenac is metabolised in the liver by a cytochrome P450 isozyme of the CYP2C subfamily and excreted in the form of metabolites via the kidneys (approximately 60%) and faeces (approximately 30%). Less than 1% is excreted in unchanged form.

INDICATIONS:
K-FENAK
is indicated for a maximum period of 5 days when intended for:
The emergency treatment of acute gout attacks.
The treatment of post-traumatic conditions.

CONTRA-INDICATIONS:
Hypersensitivity to diclofenac or to any of the ingredients in the formulation.
Hypersensitivity to other NSAIDs, including aspirin.
Gastric or duodenal ulcer.
History of gastrointestinal bleeding or perforation (PUB) related to previous NSAIDs.
Active or history of recurrent ulcer/haemorrhage/perforations.
Asthmatic patients in whom asthma attacks, acute rhinitis or urticaria are precipitated by acetylsalicylic acid or by other medicines which inhibit prostaglandin synthetase.
Pregnancy and lactation (see "PREGNANCY AND LACTATION").
Porphyria.
Heart failure.
WARNINGS:
Close medical surveillance and strict accuracy of diagnosis are imperative in patients with:
A case history suggestive of, or symptoms indicative of, gastrointestinal disease.
Ulcerative colitis.
Crohn’s disease.
Impaired hepatic function.
Pre-existing dyshaemopoiesis or disorders of blood coagulation.
K-FENAK should be used with caution in patients with renal or hepatic failure.
Concomitant use of K-FENAK and methotrexate could result in serious interactions (see "INTERACTIONS").
Acetylsalicylic acid/aspirin: the bioavailability of both K-FENAK and acetylsalicylic acid may be reduced if used concurrently.
Regular 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 "PREGNANCY AND LACTATION").
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with K-FENAK therapy (see "SIDE-EFFECTS AND SPECIAL PRECAUTIONS").
The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs), which may be fatal. The risk of gastrointestinal bleeding or perforation is higher with increasing doses of K-FENAK, in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving K-FENAK, treatment with K-FENAK should be stopped. K-FENAK should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated (see "SIDE-EFFECTS AND SPECIAL PRECAUTIONS").
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. K-FENAK should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity (see "SIDE-EFFECTS AND SPECIAL PRECAUTIONS").

INTERACTIONS:
Methotrexate:
Concurrent administration of methotrexate with K-FENAK may result in increased methotrexate toxicity (see "WARNINGS").
Lithium or digoxin:
Raised plasma concentrations of lithium or digoxin may occur if taken together with K-FENAK.
Glucocorticoids:
Gastrointestinal adverse effects may be exacerbated by the concomitant administration of K-FENAK. Co-administration of K-FENAK and corticosteroids increases the risk of gastrointestinal ulceration or bleeding (PUBs).
Antidiabetic medicines:
K-FENAK
may cause either hypo- or hyperglycaemia. Dosage of antidiabetic medicines may need to be changed.
Anticoagulants:
K-FENAK
may enhance the effects of anticoagulants, such as warfarin. There is an increased risk of haemorrhage if K-FENAK is used concurrently with any anticoagulants. Careful monitoring is necessary.
Ciclosporin:
Nephrotoxicity of ciclosporin may be increased through the effects of K-FENAK on renal prostaglandins.
Quinolone antibiotics:
Convulsions, which may have been due to concomitant use of NSAIDs and quinolone antibiotics, have been reported in isolated cases.
NSAIDs:
Use of two or more NSAIDs concomitantly could result in an increase in side-effects.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs):
There is an increased risk of gastrointestinal bleeding when these agents are co-administered with K-FENAK.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation have not been established (see "CONTRA-INDICATIONS").
Regular use of non-steroidal anti-inflammatory medicines, such as K-FENAK, 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 "WARNINGS").

DOSAGE AND DIRECTIONS FOR USE:
Use the lowest effective dose for the shortest possible duration of treatment.
Adults:
Initial daily dose: 100 to 150 mg in two to three divided doses, with a maximum daily dose of 150 mg in divided doses.
Milder cases: 75 to 100 mg in divided doses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects:
Haematological disorders:
Less frequent: Aplastic anaemia, haemolytic anaemia, agranulocytosis, leucopenia, thrombocytopenia.
Neuropsychiatric disorders:
Frequent: Dizziness, headache, nervousness, vertigo.
Less frequent: Aseptic meningitis, tiredness, tremor, convulsions, disturbances of sensation (including paraesthesia), disorientation, insomnia, irritability, memory disturbance, anxiety, depression, nightmares, psychotic reactions.
Visual disorders:
Less frequent: Disturbances of vision (diplopia, blurred vision).
Cardiovascular disorders:
Less frequent: Chest pain, congestive heart failure, hypertension, oedema, palpitations.
Gastrointestinal disorders:
Frequent: Anorexia, local irritation, nausea, vomiting, abdominal cramps, dyspepsia, epigastric pain, eructation, diarrhoea, flatulence (see "Special Precautions").
Less frequent: Alteration in taste, aphthous stomatitis, glossitis, haematemesis, oesophageal lesions, gastrointestinal bleeding, peptic ulcer with or without bleeding or perforation, diaphragm-like intestinal strictures, pancreatitis, lower gut disorders such as non-specific haemorrhagic colitis, exacerbation of ulcerative colitis or Crohn’s proctocolitis, bloody diarrhoea, melaena, constipation.
The following side-effects have been reported and frequencies are unknown:
Ulcerative stomatitis, gastritis.
Hepatobiliary disorders:
Frequent: Elevated transaminase levels (ALT, AST).
Less frequent: Fulminant hepatitis, hepatitis with or without jaundice.
Genitourinary disorders:
Less frequent: Acute renal failure, interstitial nephritis, nephrotic syndrome, papillary necrosis, urinary abnormalities such as haematuria, proteinuria.
Skin and subcutaneous tissue disorders:
Frequent: Rash or other skin reactions.
Less frequent: Bullous eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, eczema, erythema multiforme, erythroderma (exfoliative dermatitis), Lyell’s syndrome (acute toxic epidermolysis), photosensitivity reaction, purpura, including allergic purpura, urticaria, loss of hair.
Other disorders:
Less frequent: Impaired hearing, tinnitus. Hypersensitivity reactions (such as bronchospasm, anaphylactic systemic reactions including hypotension), pneumonitis and vasculitis may occur without prior exposure to K-FENAK. Discontinue treatment immediately.
Special Precautions:
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, have been reported. 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").
Patients who experience dizziness or other central nervous system disturbances while taking K-FENAK should refrain from driving a vehicle or operating machinery.
Due to its pharmacodynamic properties K-FENAK may mask signs and symptoms of infection.
Gastric bleeding may occur at any time during treatment with K-FENAK. Discontinue treatment immediately.
A reduction in dosage may be required in the elderly, especially the very frail or those with a low body mass.
Heart failure may be precipitated in some compromised patients due to the inherent potential of K-FENAK to cause fluid retention.
Patients suffering from renal, hepatic or cardiac impairment or those being treated with diuretics or who have extracellular volume depletion from any cause, should be carefully monitored because of the role of prostaglandins in maintaining renal blood flow.
During prolonged treatment with K-FENAK, blood counts and monitoring of renal and hepatic function are indicated. If abnormal liver function tests persist and symptoms of hepatic disease develop, discontinue K-FENAK.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
(See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS".) Treatment is symptomatic and supportive, especially for convulsions, hypotension, respiratory depression, gastrointestinal irritation and renal failure. Absorption should be prevented as soon as possible after an overdose by means of gastric lavage and activated charcoal.
Specific therapies, such as dialysis, haemoperfusion or forced diuresis are of little value in eliminating K-FENAK because of its extensive metabolism and high protein binding.

IDENTIFICATION:
White, circular, biconvex, film-coated tablets plain on both sides.

PRESENTATION:
Aluminium Strip-packed cartons of 15 tablets.

STORAGE INSTRUCTIONS:
Store in a cool, dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
38/3.1/0651

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Rosen Heights, Pasita Street
Rosen Park, Bellville, 7530 R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 2010

© CIPLA MEDPRO (PTY) LTD

New addition to this site: December 2016
Source: http://www.cipla.co.za/products/over-the-counter/pain/k-fenak

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