INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DICLOFLAM DISPERSIBLE

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 DISPERSIBLE
(DISPERSIBLE TABLET)

COMPOSITION
Each DICLOFLAM DISPERSIBLE 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 DISPERSIBLE 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 or disorders of blood coagulation.

DICLOFLAM DISPERSIBLE should be used with caution in patients with hepatic or renal failure.
Concomitant use of DICLOFLAM DISPERSIBLE and methotrexate could result in serious interactions. (See INTERACTIONS)
Acetylsalicylic acid/aspirin: The bioavailability of both DICLOFLAM DISPERSIBLE and acetylsalicylic acid may be reduced if used concurrently.

INTERACTIONS
Methotrexate: Concurrent administration of methotrexate with DICLOFLAM DISPERSIBLE 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 DISPERSIBLE.
Glucocorticoids and other NSAIDs: Gastrointestinal adverse effects may be exacerbated by the concomitant administration of DICLOFLAM DISPERSIBLE. Concurrent treatment with two or more NSAIDs may increase the risk of adverse effects.
Antidiabetic medicines: DICLOFLAM DISPERSIBLE 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 DISPERSIBLE is used concurrently with any anticoagulants. Careful monitoring is necessary.
Cyclosporin: Nephrotoxicity of cyclosporin may be increased by the effects of DICLOFLAM DISPERSIBLE 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 DISPERSIBLE 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
•	Melaena
•	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 DISPERSIBLE. Discontinue treatment immediately.

Special precautions:
Patients who experience dizziness or other central nervous system disturbances while taking DICLOFLAM DISPERSIBLE should refrain from driving a vehicle or operating machinery.
DICLOFLAM DISPERSIBLE may mask signs and symptoms of infection due to its pharmacodynamic properties.
Gastric bleeding may occur at any time during treatment with DICLOFLAM DISPERSIBLE. 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 DISPERSIBLE 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 DISPERSIBLE, 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 DISPERSIBLE.

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 DISPERSIBLE because of its high protein binding and extensive metabolism.

IDENTIFICATION
A white, diamond-shaped biconvex tablet, bisected on one side, and embossed “P”on the other side

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 25ºC in tightly closed containers.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
A38/3.1/0390

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

574993/050511
UNIVERSAL - POS

New product launch
Source: Pharmaceutical Industry October 2006
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