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

Logo AFLAMIN 25 (capsule)

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME
(and dosage form):

AFLAMIN 25 (capsule)

COMPOSITION:
Each Aflamin 25 capsule contains 25 mg
indomethacin.

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

PHARMACOLOGICAL ACTION:
Indomethacin is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic properties which are mediated through it’s mode of action as an inhibitor of prostaglandin synthesis.

INDICATIONS:
Indomethacin is indicated for the symptomatic treatment of rheumatoid arthritis, ankylosing/spondylitis, osteoarthritis, other musculo-skeletal inflammatory disorders and acute attacks of gout.

CONTRA-INDICATIONS:
Aflamin 25
is contra-indicated in persons hypersensitive to it or to aspirin, persons operating machinery, or patients with psychiatric disorders, epilepsy or Parkinsonism. It is contra-indicated in persons with renal disease or ulcerative lesions of the stomach or intestines.
Aflamin 25 is also contra-indicated in patients with bleeding disorders, active peptic ulcers, gastritis, regional enteritis and ulcerative colitis, as well as in pregnant and nursing women and in children.

WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with indomethacin. The combined use of indomethacin with diflunisal has been associated with fatal gastro-intestinal haemorrhage. Indomethacin and diflunisal should therefore not be used concomitantly.

DOSAGE AND DIRECTIONS FOR USE:
The recommended dosage is 25 mg to 200 mg daily divided in two to four equal doses, given with food, milk or an antacid. Therapy may be initiated with low doses and gradually increasing them where necessary according to the patients’response and requirements.
Bioavailability may be reduced with antacids containing aluminium hydroxide, magnesium carbonate and magnesium hydroxide.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects with indomethacin are gastrointestinal disturbances, headache and dizziness. Gastrointestinal ulceration and bleeding may occur. Other adverse effects may be depression, drowsiness, tinnitus, confusion, light-headedness, insomnia, psychiatric disturbances, syncope, convulsions, coma, peripheral neuropathy, blurred vision, corneal opacities and other ocular effects, oedema and mass gain, hypertension, haematuria, skin rashes, pruritus, urticaria, stomatitis, alopecia and hypersensitivity reactions. Prolonged therapy will require regular ophthalmological examinations. Renal failure may occur. Gastro-intestinal disturbances such as nausea, vomiting, anorexia, abdominal pain and diarrhoea may occur.
Peptic ulceration with perforation and haemorrhage may occur. Anaemia due to blood loss and pancreatitis may also occur.
Leucopenia, purpura, thrombocytopenia, aplastic anaemia, heamolytic anaemia, agranulocytosis, neutropenia, epistaxis, hyperglycaemia, hyperkalaemia and vaginal bleeding have been reported. Hypersensitivity reactions may also occur in aspirin-sensitive patients which may be manifested in states of respiratory distress, dyspnoea and asthma and in skin rashes. Jaundice and hepatitis have been reported in conjunction with the use of indomethacin. Elderly patients may be specially susceptable to the toxic effects of indomethacin. Indomethacin is excreted in the breast milk of breast-feeding mothers. Acute renal failure may result after concomitant use of triamterene.
Concurrent administration of oral anticoagulant agents leads to increased risk of gastrointestinal bleeding. Indomethacin antagonizes the natriuretic and antihypertensive effects of furosemide. The total plasma concentration of indomethacin plus its inactive metabolites is increased by concurrent administration of probenecid.

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

IDENTIFICATION:
Size 3 yellow gelatine capsules containing a white to off-white powder.

PRESENTATION:
Securitainers of 100 and 500 capsules.

STORAGE INSTRUCTIONS:
Store in a dry place, below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
28/3.1/0411

NAME AND ADDRESS OF THE APPLICANT:
HEXAL PHARMA (SA) (PTY) LTD
UNIT A
10 FANGIO ROAD
MAHOGANY RIDGE
WESTMEAD
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 November 1993

Updated on this site: February 2000

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