FLEXAGEN-25 TABLETS; FLEXAGEN-50 TABLETS

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

FLEXAGEN-25 TABLETS
FLEXAGEN-50 TABLETS

SCHEDULING STATUS:
S3
S2 (See Indications below)

PROPRIETARY NAME
(and dosage form):

FLEXAGEN-25 TABLETS
FLEXAGEN-50 TABLETS

COMPOSITION:
Enteric coated tablet contains either 25 mg or 50 mg diclofenac sodium.

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

PHARMACOLOGICAL ACTION:
Diclofenac sodium is a non-steroidal compound with analgesic, anti-inflammatory, antirheumatic and antipyretic properties.

A single 50 mg dose of enteric coated tablets results in maximum plasma concentrations of about 1500 ng/mL at 1,5 to 2 hours after ingestion.

Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy derivative of diclofenac sodium. The amount excreted in urine accounts for 20 - 30 % of the dose and that in bile for 10 to 20 %. The mean terminal elimination half-life is 1,2 to 1,8 hours.

INDICATIONS:
Schedule 3
Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. Symptomatic treatment of primary dysmenorrhoea.

Schedule 2
Emergency treatment of acute gout attacks. Treatment of post-traumatic conditions such as pain, swelling and inflammation for a maximum period of 5 days.

CONTRA-INDICATIONS:
Patients with porphyria.
Patients with a history of or active gastro-intestinal bleeding or peptic ulceration.
Severe hepatic or renal impairment.
Contra-indicated in aspirin-sensitive patients, and in patients sensitive to any of the ingredients in these products.
Children under the age of two years.
Safety during pregnancy and lactation has not yet been established.

WARNING:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.

DOSAGE AND DIRECTIONS FOR USE:
Flexagen-25 and Flexagen-50 Tablets
In adults, the dosage is 25 to 50 mg three times daily depending on the severity of the condition.
The maintenance dose should be adjusted to the minimum that will provide continuous therapeutic control. The tablets should be swallowed whole, with or after a meal.

The dosage in children is 2 mg per kilogram body mass per day in three divided doses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disorders, including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include vertigo, headache, skin rashes, pruritis, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, oedema, palpitations, blurred vision and other ocular reactions.
Hypersensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed. Dizziness, eczema and haemolytic anaemia may also occur.
Allergic reactions, which include angio-oedema, bronchospasm, urticaria and anaphylactic reactions, have occurred.
It is advisable to perform blood counts in patients undergoing prolonged treatment.
Flexagen should be given with care to patients with cardiovascular disease, bleeding disorders, in those who are receiving coumarin anti-coagulants, and in patients with impaired hepatic or renal function.
Acute allergic reactions have been reported. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of aspirin.
When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations.
Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents may aggravate gastro-intestinal side-effects.
Concurrent administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.
May increase the half-life of probenecid.
Should be used with caution in patients with asthma or bronchoconstriction.
Use with care in elderly patients.
Decreased platelet aggregation with increased bleeding time may occur.
Use with care together with other protein-bound medicines e.g. Tolbutamide, Coumarin and Hydantoin.
In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION:
25 mg Tablet Yellowish-mustard, film-coated, shallow biconvex tablet (which is also enteric-coated).
50 mg Tablet Light brown, film-coated, shallow biconvex tablet (which is enteric coated).

PRESENTATION:
25 mg Tablet Securitainers of 30, 100 and 500 tablets.
50 mg Tablet Securitainers of 21 and 500 tablets.

STORAGE INSTRUCTIONS:
Protect from moisture.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
25 mg Tablet 27/3.1/0314
50 mg Tablet 27/3.1/0315

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

29/4/1993	K886A
	Len 574039 Stop Press