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

Logo A-LENNON DICLOFENAC 25 mg (tablets)
A-LENNON DICLOFENAC 50 mg TABLETS
A-LENNON DICLOFENAC 100 mg SUPPOSITORIES

SCHEDULING STATUS:
S3
S2 (See Indications below)

PROPRIETARY NAME
(and dosage form):

A-LENNON DICLOFENAC 25 mg (tablets)
A-LENNON DICLOFENAC 50 mg TABLETS
A-LENNON DICLOFENAC 100 mg SUPPOSITORIES

COMPOSITION:
Each coated tablet (which is also enteric coated) contains either 25 mg or 50 mg
Diclofenac Sodium.
Each suppository contains 100 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:
Tablets S3
:
Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. Symptomatic treatment of primary dysmenorrhoea.
Suppositories S3:
Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. For use as initial therapy for inflammatory and degenerative rheumatic diseases.
All Dosage forms S2:
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. Children under the age of two years.
Patients with a history of active gastro-intestinal bleeding or peptic ulceration. Severe hepatic or renal impairment. Contra-indicated in aspirin-sensitive patients, patients sensitive to any other non-steroidal anti-inflammatory agent, and in patients sensitive to any of the ingredients in these products.
Safety during pregnancy and lactation has not yet been established.
The use of suppositories is contra-indicated in proctitis.

WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with A-LENNON DICLOFENAC therapy.
Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal.
The risk of gastrointestinal bleeding or perforation (PUBs) is higher with increasing doses of A-LENNON DICLOFENAC, in patients with a history of ulcers, and the elderly.
When gastrointestinal bleeding or ulceration occurs in patients receiving A-LENNON DICLOFENAC, treatment with A-LENNON DICLOFENAC should be stopped.
A-LENNON DICLOFENAC should be given with caution to patients with a history of gastrointestinal disease (eg. ulcerative colitis, Crohn's disease, hiatus hernia, gastro-oesophegeal reflux disease, angiodysplasia) as the condition may be exacerbated.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. A-LENNON DICLOFENAC should be discontinued at the very first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

DOSAGE AND DIRECTIONS FOR USE:
A-LENNON DICLOFENAC 25 mg and A-LENNON DICLOFENAC 50 mg 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 dose in children is 2 mg per kilogram body mass per day in three divided doses.
Suppositories:
Suppositories should never be divided for administration as active substance may be distributed unevenly.

100 mg Suppositories
The average adult dose is 100 mg each evening.

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 may occur and include fever and rashes. Hepatotoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions.
Diclofenac may cause cystitis and haematuria, as well as acute renal failure, interstitial nephritis and nephrotic syndrome.
Other adverse effects include anaemia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis and abnormalities of liver function tests.
Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion or renal insufficiency are at greater risk of developing renal dysfunction due to non-steroidal anti-inflammatory medicine-induced inhibition of renal prostaglandin synthesis.
It is advisable to perform blood counts in patients undergoing prolonged treatment.
A-LENNON DICLOFENAC 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.
Allergic reactions, which include angio-oedema, bronchospasm, urticaria and anaphylactic reactions, have occurred. 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.
Concomitant administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.
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.
May increase the half-life of probenecid.
Use with care 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:                A light brown, film-coated, shallow biconvex tablet (which is also enteric coated).
100 mg Suppository: A large, white, torpedo-shaped suppository.

PRESENTATION:
25 mg Tablet:                Securitainer packs of 30, 100 and 500 tablets.
50 mg Tablet:                Securitainer packs of 21 and 500 tablets.
100 mg Suppository: Packs of 10 suppositories

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
100 mg Suppository: 29/3.1/0257

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 September 1994

1009764

Updated on this site: March 2010
Source: Hospital Pharmacy

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