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Logo DICLOFLAM BLACKCURRANT

SCHEDULING STATUS:
S3
Except when intended for the emergency treatment of acute gout attacks and when intended for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days.        S2

PROPRIETARY NAME
(and dosage form):

DICLOFLAM BLACKCURRANT
(DISPERSIBLE TABLET)

COMPOSITION
Each DICLOFLAM BLACKCURRANT dispersible tablet contains 46,5 mg of
diclofenac free acid, equivalent to 50,0 mg of diclofenac sodium.

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 causation 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 P-450 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
DICLOFLAM BLACKCURRANT is indicated as short-term treatment in the following acute conditions:
Painful musculoskeletal conditions
Non-articular rheumatism
Acute attacks of gout
Painful post-operative and post-traumatic inflammation and swelling
Pain following dental surgery
Flare-up of osteoarthrosis
Symptomatic treatment of primary dysmenorrhoea
Classical migraine headaches

CONTRA-INDICATIONS
Hypersensitivity to diclofenac or to any of the ingredients.
Hypersensitivity to other NSAIDs including aspirin.
Gastric or intestinal ulcer.
Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicines with prostaglandin- synthetase inhibiting activity.
Pregnancy (see PREGNANCY AND LACTATION)
Porphyria

WARNINGS
Close medical surveillance and strict accuracy of diagnosis are imperative in patients with
Symptoms indicative of gastrointestinal disease
Ulcerative colitis
Crohn’s disease
a case history suggestive of gastro-intestinal disease
impaired hepatic function
Pre-existing dyshaemopoiesis of disorders of blood coagulation.
DICLOFLAM BLACKCURRANT should be used with caution in patients with hepatic or renal failure.
Concomitant use of DICLOFLAM BLACKCURRANT and methotrexate could result in serious interactions. (See INTERACTIONS)
Acetylsalicylic acid/aspirin: The bioavailability of both DICLOFLAM BLACKCURRANT and acetylsalicylic acid may be reduced if used concurrently.

INTERACTIONS
Methotrexate: Concurrent administration of methotrexate with DICLOFLAM BLACKCURRANT may result in increased methotrexate toxicity (see WARNINGS).
Lithium or digoxin: Raised plasma concentrations of lithium or digoxin may occur if taken together with DICLOFLAM BLACKCURRANT.
Glucocorticoids and other NSAIDs: Gastrointestinal adverse effects may be exacerbated by the concomitant administration of DICLOFLAM BLACKCURRANT. Concurrent treatment with two or more NSAIDs may increase the risk of adverse effects.
Antidiabetic medicines: DICLOFLAM BLACKCURRANT may cause both hypo –or hyperglycaemia. Dosage of antidiabetic medicines may need to be changed.
Anticoagulants: There is an increased risk of haemorrhage if DICLOFLAM BLACKCURRANT is used concurrently with any anticoagulants. Careful monitoring is necessary.
Ciclosporin: Nephrotoxicity of ciclosporin may be increased by the effects of DICLOFLAM BLACKCURRANT on renal prostaglandins.
Quinolone antibiotics: There have been isolated reports of convulsions which may have been due to concomitant use of quinolone antibiotics and NSAIDs.

PREGNANCY AND LACTATION
Safety and efficacy in pregnancy and lactation have not been established.
Use of NSAIDs during the third trimester of pregnancy may result in premature closure of the ductus arteriosus in utero and possibly in persistent pulmonary hypertension in the newborn. The onset of labour may be delayed and its duration increased.
(See CONTRA-INDICATIONS).

DOSAGE AND DIRECTIONS FOR USE
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 daily in divided doses.
Primary dysmenorrhoea: 50 to 150 mg daily in divided doses. Dosage should be individually determined. Treatment should be initiated at onset of symptoms and continued for a few days, depending on intensity of pain.
Classical migraine: 50 mg taken at first signs of an impending attack. If pain relief is not sufficient within 2 hours after the first dose, a second dose of 50 mg may be taken. A third dose may be taken after 4 to 6 hours if necessary but the total daily dose of 150 mg must not be exceeded.
The use of DICLOFLAM BLACKCURRANT in migraine attacks has not been established in children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects:
Frequently-occurring:
Nervous system disorders:
Headache
Dizziness
Vertigo
Nervousness
Gastrointestinal disorders:
Epigastric pain
Nausea
Vomiting
Diarrhoea
Abdominal cramps
Dyspepsia
Flatulence
Eructation
Anorexia
Local irritation
Hepatobiliary disorders:
Elevated transaminase levels (ALT, AST)
Skin and subcutaneous tissue disorders:
Rash and skin reactions

Less frequently occurring:
Blood and lymphatic system disorders:
Leucopenia
Thrombocytopenia
Aplastic anaemia
Haemolytic anaemia
Agranulocytosis
Cardiac disorders:
Palpitations
Chest pain
Hypertension
Congestive heart failure
Oedema
Nervous system disorders:
Tiredness
Disturbances of sensation ( including paraesthesia)
Memory disturbance
Disorientation
Insomnia
Irritability
Convulsions
Depression
Anxiety
Nightmares
Tremor
Psychotic reactions
Aseptic meningitis
Gastrointestinal disorders:
Gastrointestinal bleeding
Haematemesis
Melena
Bloody diarrhoea
Peptic ulcer with or without bleeding or perforation
Lower gut disorders such as non-specific haemorrhagic colitis
Exacerbation of ulcerative colitis of Crohn’s proctocolitis
Glossitis
Aphthous stomatitis
Oeasophageal lesions
Diaphragm-like intestinal strictures
Constipation
Pancreatitis
Alteration in taste
Genitourinary disorders:
Acute renal failure
Urinary abnormalities such as haematuria, proteinuria, interstitial nephritis, nephritic syndrome, papillary necrosis
Hepatobiliary disorders:
Hepatitis with or without jaundice
Fulminant hepatitis
Eye disorders:
Disturbances of vision (diplopia, blurred vision)
Skin and subcutaneous tissue disorders:
Urticaria
Bullous eruptions
Eczema
Erythema multiforme
Stevens Johnson syndrome
Lyell’s syndrome (acute toxic epidermolysis)
Erythroderma (exfoliative dermatitis)
Loss of hair
Photosensitivity reaction
Purpura, including allergic purpura
Other:
Impaired hearing
Tinnitus
Hypersensitivity reactions (such as bronchospasm, anaphylactic systemic reactions including hypotension)
Vasculitis and pneumonitis may occur without prior exposure to DICLOFLAM BLACKCURRANT. Discontinue treatment immediately.

Special precautions:
Patients who experience dizziness or other central nervous system disturbances while taking DICLOFLAM BLACKCURRANT should refrain from driving a vehicle or operating machinery.
DICLOFLAM BLACKCURRANT may mask signs and symptoms of infection due to its pharmacodynamic properties.
Gastric bleeding may occur at any time during treatment with DICLOFLAM BLACKCURRANT. 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 DICLOFLAM BLACKCURRANT 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 DICLOFLAM BLACKCURRANT, blood counts and monitoring of hepatic and renal function are indicated. If abnormal liver function tests persist and symptoms of hepatic disease develop, discontinue DICLOFLAM BLACKCURRANT.

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

IDENTIFICATION
A white, diamond-shaped biconvex tablet, bisected on one side with a blackcurrant odour.

PRESENTATION
One strip of 15 tablets in clear plastic pockets containing one tablet in each pocket and sealed with printed aluminium foil. Blister packed into an outer carton of printed cardboard along with a printed package insert.

STORAGE INSTRUCTIONS
Store below 25°C in tightly closed containers.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
37/3.1/0607

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THE PACKAGE INSERT
16 March 2005

        68459
        UNIPRINT

New addition to this site: July 2005
Source: Pharmaceutical Industry

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