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

Logo DICLOHEXAL T
DCABP4

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME
(and dosage form):

DICLOHEXAL T

DicloHexal 25 T enteric coated tablets
DicloHexal 50 T enteric coated tablets

COMPOSITION
DicloHexal 25 T (enteric coated tablets) - each tablet contains 25 mg diclofenac sodium.
DicloHexal 50 T (enteric coated tablets) - each tablet contains 50 mg diclofenac sodium.

PHARMACOLOGICAL CLASSIFICATION
A 3.1 Anti-rheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION
Diclofenac is a non steroidal compound with antipyretic, analgesic, anti-inflammatory and antirheumatic properties.
It inhibits cyclo-oxygenase and also has an inhibitory effect on platelet aggregation.
The inhibition of synthesis of prostaglandins is important regarding the mechanism of action of diclofenac, since prostaglandins play a major role in the cause of pain, fever and inflammation.

INDICATIONS
Inflammatory and degenerative forms of rheumatism : rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, spondylarthritis.
Symptomatic treatment of primary dysmenorrhoea.
Post operative or post traumatic pain and inflammation, pain following dental surgery.
Painful musculoskeletal disorders.
Non articular rheumatism.
Acute attacks of gout.

CONTRA INDICATIONS
Hypersensitivity to any of the ingredients.
Peptic ulcers.
Asthmatic patients or those patients in whom asthma attacks, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other medicines which inhibit prostaglandin synthetase.
DicloHexal is contra- indicated in patients suffering from porphyria.
DicloHexal should not be used in pregnancy or in children under the age of 2 years.

WARNINGS
Patients who exhibit symptoms of gastro intestinal disease, who have a case history suggestive of gastro intestinal ulceration, ulcerative colitis, Crohns disease, pre existing dyshaemopoeisis, or disorders of blood coagulation, should be under strict medical supervision.
The concomitant use of diclofenac and methotrexate has lead to serious interactions.
DicloHexal should be administered with caution in patients with hepatic or renal failure.

DOSAGE AND DIRECTIONS FOR USE
Children
2 to 3mg per kg body mass daily in two to three fractional doses.
DicloHexal 50 T tablets are not suitable for use in children.
Adults
DicloHexal 25 T and 50 T tablets
The initial daily dose is 100 mg to 150 mg
In milder cases or in long term therapy 75 mg to 100 mg daily is sufficient. The maximum daily dose is 150 mg, generally supplied in 2 to 3 divided doses.
The tablets should be taken whole with a glass of water.
Primary Dysmenorrhoea - the daily dose of 50 mg to 100 mg should be adapted to suit the individual and treatment should begin upon appearance of the first symptoms and should be continued for a few days.
Adults and children aged 16 years and older:
Do not exceed the maximum daily dosage of 150 mg.
Do not take for longer than 2 weeks without consulting your doctor, since persistent symptoms can indicate other medical problems.
Patients must seek medical advice:
- if symptoms fail to respond
- if symptoms persist after 5 days treatment
- if symptoms recur following self-treatment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
GASTRO-INTESTINAL TRACT
Nausea, vomiting, diarrhoea, abdominal cramps, epigastric pain, cramps, dyspepsia, flatulence, anorexia, local irritation, are common.
Less frequently, gastro intestinal tract ulceration or haemorrhage, haematemesis, malaena, bloody diarrhoea, peptic ulcer with or without bleeding and perforation.
Lower gut disorders may occur.
CENTRAL NERVOUS SYSTEM
Headache, dizziness, vertigo and nervousness, are common. Less frequently, tiredness, sensation disturbances including paraesthesias and memory loss.
Tinnitis, impaired hearing, disorientation, disturbances of vision (diplopia etc.), blurred vision, changes in visual colour perception, toxic amblyopia, aseptic meningitis, insomnia, convulsions, irritability, anxiety, nightmares, tremor, psychotic reactions.
Alteration in taste perception
SKIN
Rash and skin reactions are common. Less common are urticaria, bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), photo sensitivity reaction, purpura including allergic purpura, loss of hair.
KIDNEY
Less frequently: acute renal failure, urinary disorders e.g., haematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
LIVER
More frequently : elevated transaminase levels (SGOT, SGPT).
Less frequently : Hepatitis with or without jaundice, fulminant hepatitis.
BLOOD
Less frequently :dyshaemopoiesis (leucopenia, thrombocytopenia, aplastic anaemia and agranulocytosis)
HYPERSENSITIVITY
Less frequently : hypersensitivity reactions ( bronchospasm anaphalactic/anaphalactoid systemic reactions including hypotension.)
OTHER ORGAN SYSTEMS
Peripheral oedema, impotence, palpitations, chest pain, hypertension and pancreatitis, may occur.

PRECAUTIONS
Gastro intestinal tract bleeding or ulceration/perforation can occur at any time, and the medication should then immediately be withdrawn. The elderly must receive close monitoring, since dosage may have to be reduced.
The lowest effective dose must be given in frail elderly patients or those with a low body mass.
The product has an inherent potential to cause fluid retention, therefore heart failure may be precipitated in compromised patients.
Elevation of the liver enzyme(s) may occur and during treatment, regular blood tests should be performed, as well as renal and hepatic function tests.
If abnormal liver function tests persist or signs and symptoms of liver failure become apparent then DicloHexal T should be discontinued.
Allergic reactions can occur without previous exposure to the medicine.
DicloHexal T may trigger an attack of hepatic porphyria in susceptible patients.
DicloHexal T should be discontinued in patients who experience blurred or diminished vision or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.
Patients experiencing central nervous system effects should refrain from driving or operating dangerous machinery

INTERACTIONS
DicloHexal T may raise the plasma concentrations of digoxin, lithium and methotrexate, when given concomitantly.
Concomitant administration of other non-steroidal anti inflammatory agents as well as glucocorticoids may aggravate gastro intestinal tract side effects or promote the occurrence of side effects.
When DicloHexal T and acetylsalicylic acid are co-administered their bio-availabilities are lowered.
Patients on anti-coagulant therapy may be exposed to increased risk of haemorrhage when taking DicloHexal T.
Hyperglycaemic and hypoglycaemic effects have been observed, with the use of DicloHexal T, which necessitated change in the dosage of hypoglycaemic agents.
The effects of DicloHexal T on renal prostaglandins may cause increased nephrotoxicity of cyclosporin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side effects and special precautions.
There is no specific antidote. Treatment is symptomatic and supportive.
Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating DicloHexal T from the system due to its high protein binding rate and extensive metabolism.
Absorption from tablets should be limited as soon as possible after the overdosage by gastric lavage and treatment with activated charcoal.

IDENTIFICATION
DicloHexal 25 T Brown-yellow film coated tablet, biconvex with plain surface and uniform colour .
6,1mm-6,3mm x 2,9mm-3,2mm
DicloHexal 50 T Brown-yellow film coated tablet, biconvex with facette on both sides, with plain surface and uniform colour. 8,0mm-8,3mm x 3,5mm-3,8mm

PRESENTATION
DicloHexal 25 T White opaque polypropylene securitainers containing 500 tablets
DicloHexal 50 T White opaque PVC/aluminium blisters strips.
10 tablets per blister strip.
2 blister strips per cardboard carton (20).

STORAGE INSTRUCTIONS
Store below 25°C in airtight containers.
Protect from light
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS
DicloHexal 25T         31/3.1/0324
DicloHexal 50T         31/3.1/0351

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hexal Pharma (SA)(PTY)LTD
10 Fangio Road
Mahogany Ridge
Westmead
Pinetown

DATE OF PUBLICATION OF THIS PACKAGE INSERT
June 1998

        DCABP4

New addition to this site: February 2002

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