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

Logo ADCO-DICLOFENAC 25 mg Tablets
ADCO-DICLOFENAC 50 mg Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

ADCO-DICLOFENAC 25 mg Tablets
ADCO-DICLOFENAC 50 mg Tablets

COMPOSITION:
Each enteric-coated tablet contains 25 mg or 50 mg
diclofenac sodium.
Sugar free.

PHARMACOLOGICAL CLASSIFICATION:
A. 3.1 Antirheumatics (Anti-inflammatory Agents)

PHARMACOLOGICAL ACTION:
Diclofenac sodium is a non-steroidal compound, a phenylacetic acid derivative, with analgesic, antipyretic and anti-inflammatory effects. Diclofenac sodium inhibits the biosynthesis and release of prostaglandins, which are known to be implicated in the pathogenesis of inflammation, pain and fever. ADCO-DICLOFENAC Tablets are enteric-coated so that absorption occurs in the gastrointestinal tract to give peak plasma concentrations approximately 2 hours after ingestion. There is at least 99% binding to plasma-proteins and excretion of metabolites is mainly in the urine.

INDICATIONS:
Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteo-arthrosis, painful post-operative and post-traumatic inflammation and swelling and dysmenorrhoea.

CONTRA-INDICATIONS:
Diclofenac sodium is contra-indicated in patients with known hypersensitivity to diclofenac and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions like asthma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contra-indicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.

INTERACTIONS:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.
Blood concentrations of lithium are increased when ADCO-DICLOFENAC is administered concommitantly.

PREGNANCY AND LACTATION:
The safe use of ADCO-DICLOFENAC in pregnancy has not been demonstrated.
Regular use of NSAID’s 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.

DOSAGE AND DIRECTIONS FOR USE:
Usual Adult Dose:
25 to 50 mg taken three times daily. The tablet must be taken whole during or after meals. Initially this dose may be increased to 150 mg daily and may be reduced to 75 to 100 mg daily in milder cases or for long-term and maintenance therapy. Diclofenac sodium is not recommended for use in children as safety and efficacy have not been established.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Gastric or intestinal ulceration with associated bleeding has been reported - ADCO-DICLOFENAC therapy should be discontinued immediately in such cases. Skin rashes and gastro-intestinal disturbances may occur. Headache, dizziness, oedema, nervousness, pruritus, tinnitus, insomnia, blurred vision and other ocular reactions, peripheral oedema, malaise, jaundice, elevated transaminase levels, drowsiness and hypersensitivity reactions (eg. bronchospasm) have occurred. Blood counts and monitoring of hepatic and renal function are advised during prolonged therapy with ADCO-DICLOFENAC as blood dyscrasias have been reported. ADCO-DICLOFENAC should be given with care to patients with bleeding disorders, cardiovascular disease, and in those who are receiving coumarin anticoagulants. Patients who are sensitive to aspirin generally should not be given ADCO-DICLOFENAC.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and special precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
25 mg tablet: Yellow, round enteric-coated.
50 mg tablet: Tan coloured, round, enteric-coated.

PRESENTATION:
ADCO-DICLOFENAC 25 mg Tablets are presented in bottles and securitainers of 30 and 500 tablets.
ADCO-DICLOFENAC 50 mg Tablets are presented in bottles and securitainers of 21 and 500 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER:
ADCO-DICLOFENAC 25 mg: U/3.1/181
ADCO-DICLOFENAC 50 mg: U/3.1/182

NAME AND ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1990

New addition to this site: April 2004
Source: Pharmaceutical Industry

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