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

Logo FLAMECID 25 Capsules
FLAMECID 50 Capsules

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

FLAMECID 25 Capsules
FLAMECID 50 Capsules

COMPOSITION:
Each capsule contains:
Indomethacin        25 or 50 mg
Contains sugar

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Connective tissue medicines: Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Indomethacin has analgesic, anti-inflammatory and anti-pyretic properties.
Indomethacin inhibits the biosynthesis of prostaglandins; this action may bethe basis of its anti-inflammatory and antipyretic properties. Indomethacin inhibits motility of polymorphonuclear leucocytes; like salicylates, it uncouples oxidative phosphorylation in cartilaginous and hepatic mitochondria.

INDICATIONS:
Indomethacin is used to relieve the painful symptoms of ankylosing spondylitis and osteoarthritis and to relieve the pain and swelling in gout, rheumatoid arthritis and acute musculoskeletal disorders.

CONTRA-INDICATIONS:
Children, persons operating machinery, patients with psychiatric disorders, epilepsy or parkinsonism, or in individuals with renal disease. Contraindicated in persons hypersensitive to indomethacin or aspirin, nursing mothers and in patients with bleeding disorders.
Indomethacin may mask the signs and symptoms of peptic ulcer. Because indomethacin itself may cause peptic ulceration or irritation of the gastrointestinal tract, it should not be given to patients with active peptic ulcer or with ulcerative lesions of the stomach or intestines, gastritis, regional enteritis and ulcerative colitis.

WARNINGS:
Patients may experience dizziness and, in this event, should not operate motor vehicles and should avoid potentially dangerous activities, which require alertness.

INTERACTIONS:
Patients allergic to aspirin may exhibit cross- reaction to indomethacin. Aspirin and indomethacin should not be administered concurrently and the concurrent administration of indomethacin and probenecid could be hazardous because of the increased risk of gastro-intestinal bleeding. Probenecid inhibits the tubular secretion of indomethacin and thereby increases in plasma level and risk of systemic toxicity. Concurrent administration of oral anticoagulant agents leads to increased risk of gastro-intestinal bleeding.
Serious interactions have been reported after the use of high dose methorexate with indomethacin.

PREGNANCY AND LACTATION:
FLAMECID CAPSULES
are contra-indicated in pregnant women.
Regular use of NSAIDs 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:
In rheumatic disorders the usual dose is 25 mg twice or thrice daily, increased, if required, up to 150 mg daily in divided doses. In acute particular disorders and low back pain 50 mg may be given twice or thrice daily for about 10 days. In acute gout 50 mg may be given three or four times a day. The total daily dose should not generally exceed 200 mg. IT IS RECOMMENDED THAT INDOMETHACIN CAPSULES BE TAKEN WITH FOOD, MILK OR AN ANTACID.

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.
Headache and dizziness occur frequently at the commencement of treatment and may disappear if the dose is reduced. Anorexia, nausea, vomiting, dyspepsia and diarrhoea may occur and are usually unrelated to dosage. Peptic ulceration, possibly with gastro-intestinal haemorrhage may occur and is not always preceded by dyspepsia; there may be oesophageal ulceration. Thrombocytopenia, leucopenia, purpura, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, haematuria, epistaxis, hyperglycaemia, hyperkalaemia, vaginal bleeding and acute pancreatitis have been reported. Renal failure has been reported.
Vertigo, drowsiness, tinnitus, confusion, lightheadedness, insomnia, syncope, convulsions, coma, peripheral neuropathy, oedema and weight gain, hypertension and angioneurotic oedema, stomatitis and alopecia may occur. Severe depression, psychosis, hallucinations and suicide have been reported. Corneal opacities, visual-field changes and pallor of the optic disc have also occurred.
Hypersensitivity reactions are manifested as rashes, itching, urticaria and more seriously, acute attacks of asthma.
Indomethacin should be administered with caution to patients with impaired hepatic function. Elderly patients may be specially susceptible to the toxic effects of indomethacin.
If indomethacin fails to provide benefit in 2 to 3 weeks, alternative therapy must be considered.
Where therapy is prolonged, it is necessary to perform ophthamological examinations at regular intervals.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Central nervous system symptoms include headache and vertigo, gastro-intestinal irritation resulting in anorexia, nausea, vomiting, dyspepsia, peptic ulceration often with bleeding, acute pancreatitis. Treatment is symptomatic and supportive.

IDENTIFICATION:
Size 3 opaque yellow capsules each containing 25 mg indomethacin.
Size 2 opaque yellow capsules each containing 50 mg indomethacin.

PRESENTATION:
Capsules 25 mg - bottles of 100, 500, 1000.
Capsules 50 mg - bottles of 25, 100, 500, 1000.

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

REGISTRATION NUMBER:
25 mg capsules: K/3.1/174.
50 mg capsules: K/3.1/175.

NAME AND BUSINESS 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:
06/02/1978


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

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