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

Logo ADCO-MEFENAMIC ACID 250 mg CAPSULES
ADCO-MEFENAMIC ACID 50 mg/5 mL SUSPENSION
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ADCO-MEFENAMIC ACID 250 mg CAPSULES
ADCO-MEFENAMIC ACID 50 mg/5 mL SUSPENSION

COMPOSITION:
ADCO-MEFENAMIC ACID 250 mg CAPSULES: 250 mg Mefenamic acid per capsule
ADCO-MEFENAMIC ACID 50 mg/5 mL SUSPENSION: 50 mg Mefenamic acid per 5 mL
(Preservative): Sodium Benzoate 0,5% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or Anti-pyretic and Anti-inflammatory analgesics

PHARMACOLOGICAL ACTION:
Mefenamic acid has analgesic, anti-inflammatory and anti-pyretic properties. It inhibits the synthesis of prostaglandins. Mefenamic acid shows central and peripheral action and it owes these properties to its capacity to inhibit cyclooxygenase.

INDICATIONS:
Mefenamic acid is used for the relief of mild to moderate pain in acute and chronic conditions including: pain of traumatic, arthritic or muscular origin; dysmenorrhoea; headache and dental pain.
Mefenamic acid reduces blood loss in menorrhagia where menorrhagia is due to ovulatory dysfunctional bleeding. Uterine and other pathology should first be excluded before prescribing Mefenamic acid for this indication. It is also indicated as an anti-pyretic in febrile conditions.
Mefenamic acid is used for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of five days.

CONTRA-INDICATIONS:
Mefenamic acid is contra-indicated in patients with known sensitivity and in patients who respond to aspirin and aspirin-like medicines with sensitivity reactions like bronchoconstriction, skin rashes and urticaria. Mefenamic acid is contra-indicated in patients with peptic ulceration or having a history of gastro-intestinal bleeding and or inflammatory bowel disease.
Safety in pregnancy and lactation has not been established. Do not use in epileptic patients or in patients with impaired hepatic function.

WARNING:
It may enhance the effects of the coumarin anti-coagulants.
Therapy should be discontinued if diarrhoea or skin rash occur.

DOSAGE AND DIRECTION FOR USE:
Adult dose:        500 mg of mefenamic acid three times daily with food.
  The dosage may be reduced to 1 capsule (250 mg) three times daily.
Children: 
6 months to 1 year: 5 mL three times per day
2 - 4 years: 10 mL three times per day
5 - 8 years: 10 mL four times per day
9 - 12 years: 15 mL four times per day
Mefenamic acid should not be used for longer than seven days at a time.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects involve the gastro-intestinal system and include forms of dyspepsia, upper gastro-intestinal discomfort as well as peptic ulceration and gastro-intestinal bleeding. Gastric irritation may be reduced by taking medication during meals. Headache, drowsiness, dizziness, nervousness and visual disturbances have been reported. Therapy should be discontinued if diarrhoea or skin rashes occur. Skin rash may be a sensitivity reaction, and urticaria may also occur.
Reported haematological effects include haemolytic anaemia, agranulocytosis, pancytopenia, thrombocytopenia or thrombocytopenia purpura and bone-marrow aplasia. Allergic glomerulonephritis has occurred as well as abnormalities of hepatic and renal function. Therefore blood counts and monitoring of hepatic and renal function are advised during prolonged therapy with Mefenamic acid. Bronchoconstriction may occur in asthmatic patients with aspirin sensitivity. Mefenamic acid affects platelet function and it may enhance the effect of anti-coagulant therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and Special Precautions.
Mefenamic acid has a marked tendency to induce tonic-clonic (grand-mal) convulsions in overdosage. Acute erosion or ulceration of the gastro-intestinal mucosa may be a delayed manifestation.
Treatment is symptomatic and supportive.

IDENTIFICATION:
ADCO-MEFENAMIC ACID 250 mg CAPSULES:
Capsule with an opaque yellow body and opaque blue cap.
ADCO-MEFENAMIC ACID 50 mg/5 mL SUSPENSION:
Smooth off-white opaque suspension with a fruity odour.

PRESENTATION:
Securitainers and amber glass bottles of18, 30, 100 and 250 capsules.
Amber glass bottles of 100 mL and 200 mL suspension

STORAGE INSTRUCTIONS:
Store below 25°C, in a well closed container. Keep out of reach of children.

REGISTRATION NUMBER:
ADCO-MEFENAMIC ACID 250 mg Capsules:28/2.7/0019
ADCO-MEFENAMIC ACID 50 mg/5 mL Suspension: 28/2.7/0020

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Ave
Bryanston Ext 77        Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
29 November 1996

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

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