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

Logo ADCO-IBUPROFEN 400 mg

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ADCO-IBUPROFEN 400 mg
Tablets

COMPOSITION:
Each sugar-coated tablet contains 400 mg
Ibuprofen.
Contains TARTRAZINE.
Contains Sugar.

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

PHARMACOLOGICAL ACTION:
ADCO-IBUPROFEN
contains ibuprofen, which is a non-steroidal, anti-inflammatory, antipyretic and analgesic agent. It inhibits the synthesis of prostaglandins. Ibuprofen is absorbed from the gastro-intestinal tract producing peak plasma concentrations after one to two hours.

INDICATIONS:
ADCO-IBUPROFEN
is indicated in the treatment of rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis, Still's disease (juvenile rheumatoid arthritis), fibrositis, musculoskeletal pain, swelling and inflammation due to trauma.

CONTRA-INDICATIONS:
It should be given with care to patients with peptic ulceration or a history of such ulceration, bleeding disorders, cardiovascular disease and those on oral anticoagulants. It should not be given to patients who are sensitive to aspirin. ADCO-IBUPROFEN should be administered with care in patients with asthma, especially those who have developed bronchospasm with other non-steroidal agents.

WARNINGS:
Contains tartrazine, which may cause allergic type reactions (including bronchial asthma) in certain individuals. The overall incidence of tartrazine sensitivity is low; it is however frequently seen in patients who also have aspirin sensitivity.

PREGNANCY AND LACTATION:
ADCO-IBUPROFEN
should not be administered during pregnancy and is not recommended for use by breast-feeding 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:
Adults:
600 mg - 1 200 mg daily in divided doses.
Children:
20 mg/kg body mass per day but not to exceed 500 mg per day in children weighing less than 30 kg.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ADCO-IBUPROFEN
may cause nausea, vomiting, dyspepsia, diarrhoea, stomatitis, or gastrointestinal haemorrhage. Headache, dizziness, nervousness and other central nervous system effects, skin rash, thrombocytopenia, agranulocytosis, toxic amblyopia, bronchospasm, oedema, tinnitus, pruritus, depression, drowsiness, insomnia and blurred vision may occur. Abnormalities of liver function tests and impairment of renal function has been observed. Acute reversible renal failure has been reported. Ibuprofen should be used with care in patients with impaired renal function.
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:
The main symptoms of overdosage are epigastric pain, nausea, heartburn and abdominal discomfort.
Treatment:
The stomach should be emptied by inducing emesis or by aspiration and gastric lavage. Blood-electrolyte balance should be maintained. Further treatment is supportive and symptomatic.

IDENTIFICATION:
Green sugar-coated tablets.

PRESENTATION:
Amber glass bottles of 100 tablets and securitainers of 100 and 1000.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
R/3.1/186

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:
19 December 1985

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

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