FORTFEN 100 SIMPLE REGIMEN CAPSULES
SCHEDULING STATUS:
S3.
PROPRIETARY NAME
(and dosage form):
FORTFEN 100 SIMPLE REGIMEN CAPSULES
COMPOSITION:
Each capsule contains 100 mg diclofenac sodium.
PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents).
PHARMACOLOGICAL ACTION:
Diclofenac sodium is a non-steroidal compound with antirheumatic, anti-inflammatory, analgesic and antipyretic properties. In vitro it inhibits prostaglandin synthetase and also has an inhibitory effect on platelet aggregation. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation, pain and fever.
Pharmacokinetics:
Absorption:
Following ingestion of one capsule on an empty stomach, absorption occurs more rapidly than when the capsule is taken during or after a meal, but bioavailability remains the same. The active substance is subject to first-pass metabolism.
Protein binding: 99,7 %
The mean terminal elimination half-life is 1 to 2 hours.
Excretion:
Approximately 60 % of the dose administered is excreted via the kidneys in the form of metabolites, and less than 1 % in unchanged form. About 30 % of the dose is excreted in metabolised form in the faeces.
INDICATIONS:
Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitus, osteoarthrosis and spondylarthritis.
Painful musculoskeletal conditions.
Non-articular rheumatism.
Acute attacks of gout.
Painful post-operative and post-traumatic inflammation and swelling pain following dental surgery.
Symptomatic treatment for primary dysmenorrhoea.
CONTRA-INDICATIONS:
Peptic ulcer. Sensitivity to diclofenac sodium or any other non-steroidal anti-inflammatory medicine. FORTFEN 100 SIMPLE REGIMEN Capsules are also contraindicated in asthmatic patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or by other medicine with prostaglandin synthetase inhibiting activity. Strict accuracy of diagnosis and close medical surveillance is imperative in patients with symptoms indicative of gastro-intestinal disease, with a history suggestive of gastro-intestinal ulceration, with ulcerative colitis, with Crohn's disease or with pre-existing dyshaemopoiesis or disorders of blood coagulation. FORTFEN 100 SIMPLE REGIMEN capsules should not be used in patients with porphyria. Pregnancy and lactation.
WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac. Patients with gastro-intestinal symptoms or with severe hepatic or renal damage should be kept under close surveillance.
DOSAGE AND DIRECTIONS FOR USE:
Children:
FORTFEN 100 SIMPLE REGIMEN capsules is not recommended in children below the age of 14 years.
Adults:
1 capsule daily.
FORTFEN 100 SIMPLE REGIMEN capsules should be taken with a glass of water, preferably at mealtimes. Where the symptoms are most pronounced during the night or in the morning, FORTFEN 100 SIMPLE REGIMEN capsules should preferably be taken in the evening.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Epigastric pain, eructation, nausea and diarrhoea, headache or dizziness. Peripheral oedema and skin reactions, such as rash and eczema, have also been encountered. Central nervous system side-effects, such as tiredness, insomnia or irritability, have occurred. Gastro-intestinal ulceration or haemorrhage may occur. Hypersensitivity reactions (e.g. bronchospasm, anaphylactic/anaphylactoid systemic reactions), elevated transaminase levels, jaundice, hepatitis, renal failure and nephrotic syndrome, may occur. Dyshemopoiesis (leucopenia, thrombocytopenia, aplastic anaemia) and erythema multiforme have been observed. Agranulocytosis and haemotolytic anaemia have been observed. In view of the products inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Precautions:
Patients suffering from impairment of hepatic, cardiac, or renal function should be carefully monitored.
In the instances where peptic ulceration or gastro-intestinal bleeding occur in patients under treatment with FORTFEN 100 SIMPLE REGIMEN capsules, the medicine should be withdrawn.
Dosage may have to be reduced in the elderly.
During prolonged treatment with FORTFEN 100 SIMPLE REGIMEN capsules blood counts and monitoring of hepatic and renal function are indicated as precautionary measures.
Interactions:
When given together with preparations containing lithium or digoxin, FORTFEN 100 SIMPLE REGIMEN capsules may raise their plasma concentrations. Use with care concomitantly with other protein bound medicines.
Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents, may aggravate gastro-intestinal side-effects.
Concurrent treatment with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.
The bioavailability of FORTFEN 100 SIMPLE REGIMEN capsules is reduced when acetylsalicylic acid is given concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic and supportive.
IDENTIFICATION:
Opaque red-orange and opaque ivory capsules.
PRESENTATION:
Securitainers containing 10, 30 and 100 FORTFEN 100 SIMPLE REGIMEN capsules.
STORAGE INSTRUCTIONS:
Store below 25 °C. Protect from moisture and light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
Y/3.1/189
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Compu Pharmaceutical Products Limited
476 Kings Highway
Lynnwood Pretoria
0081
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1992
F100SRPI 09/93
|
