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

Logo BIRAL® sugar-coated tablets.
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

BIRAL® sugar-coated tablets.

COMPOSITION:
Each tablet contains:
Valerianae extractum siccum 100,0 mg
Passiflorae extractum siccum 45,0 mg

PHARMACOLOGICAL CLASSIFICATION:
A.2.6 (Tranquillizers).

PHARMACOLOGICAL ACTION:
Biral is a natural product of plant origin which acts on the central nervous system to bring about a mild sedative action. Biral may be used as a day-time sedative since it should not cause drowsiness or impair mental alertness and concentration.

INDICATIONS:
Anxiety, restlessness and minor neuroses characterised by the absence of depression.

CONTRA-INDICATIONS:
There are no known contra-indications.

DOSAGE AND DIRECTIONS FOR USE:
Adults : Unless otherwise directed, initially take 2 tablets with water three times daily after meals. After improvement or in less severe cases, take 1 tablet three times daily after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse reactions with normal therapeutic doses are unknown. Should any adverse reactions occur discontinue medication.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage or prolonged use should not give rise to any toxic effects. However, should any severe symptoms occur following overdosage, consult your doctor or nearest hospital immediately.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
Pale pink sugar-coated tablets.

PRESENTATION:
Available in packs of 40 and 100 tablets.

STORAGE INSTRUCTIONS:
Store in a cool, dry place (below 25°C).
Keep out of reach of children.

REFERENCE NUMBER:
B1503 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BYK MADAUS (PTY) LTD
2nd Road (Cnr. 16th Road)
Randjespark
1685 Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19/08/1993

POSTAL ADDRESS:
BYK MADAUS (PTY) LTD
P.O. Box 3435
1685 Halfway House
                        BPI 05/00/12
                        Britepak

Updated on this site: December 2000

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