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

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BETASLEEP
Capsules

COMPOSITION:
Each capsule contains 50 mg Diphenhydramine HCI.

PHARMACOLOGICAL CLASSIFICATION:
A 2.2. Sedatives, Hypnotics.

PHARMACOLOGICAL ACTION:
Diphenhydramine HCI has the general pharmacological actions of the H¹ - blocking antihistamines. It has pronounced sedative properties.

INDICATIONS:
Betasleep is indicated for the alleviation of temporary insomnia.

CONTRA-INDICATIONS:
Antihistamines are contra-indicated in epileptics, pregnancy and lactation. Not to be taken by children under the age of twelve years.

WARNINGS:
If the condition persists for more than 10 days consult a doctor. The use of this medicine leads to drowsiness, which is aggravated by the simultaneous intake of alcohol and other CNS depressants.
Patients are warned not to drive motor vehicles, climb dangerous heights or operate dangerous machinery as impaired decision making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Take 1 to 2 capsules at night, 20 minutes before retiring. This product is intended for occasional use. Not to be used on successive nights or over periods exceeding several days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Antihistamines may cause lassitude, dizziness, gastro-intestinal disturbances such as nausea, vomiting and gastric pain; headache, blurred vision, tinnitus; dryness of the mouth; muscular weakness and inco-ordination.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
Sedation and CNS depression. Accidental overdosage in children can lead to excitation, hyperpyrexia and convulsions. Use stimulants by injection where large doses have produced severe drowsiness.

IDENTIFICATION:
Orange capsule containing white powder.

PRESENTATION:
12 capsules blister-packed.

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

REGISTRATION NUMBER:
C/2.2/653

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LTD.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 February 1986

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