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

Logo SLEEPEZE-PM TABLETS
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SLEEPEZE-PM TABLETS

COMPOSITION:
Each tablet contains:
Diphenhydramine Hydrochloride 25 mg –Contains TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION:
A.2.2 Sedatives, hypnotics.

PHARMACOLOGICAL ACTION:
Diphenhydramine Hydrochloride is a member of the ethanolamine group of H1-blocking antihistamines. The medicines in this group have a pronounced tendency to induce sedation and, with conventional doses, about half of those treated with these medicines experience somnolence.

INDICATIONS:
SLEEPEZE-PM is indicated for the alleviation of temporary insomnia.

CONTRA-INDICATIONS:
SLEEPEZE-PM is contra-indicated in epileptics and in children under the age of twelve. It should not be taken during pregnancy, nor whilst breastfeeding.

WARNINGS:
The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol and other CNS depressants. Do not use continuously for more than 10 days without consulting your doctor. This product contains tartrazine which have allergy-related reactions (including brochial asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children 12 years and older:
One to two tablets to be taken with water on retiring. This product is designed for occasional use. Not to be used on successive nights or over extended periods.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include 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. If condition persists, consult a doctor.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Sedation and CNS depression. If accidently taken by children, excitation, hyperpyrexia and convulsions may occur. No specific antidote exists. Give general supportive treatment as for antihistamine poisoning.

IDENTIFICATION:
Yellow, uncoated, compressed tablets, with an "S" imprinted on each side.

PRESENTATION:
Blister packed in 12's and 24's in cartons.

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

REGISTRATION NUMBER:
N/2.2/37

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
S.A.D SELF MEDICATION (PTY) LIMITED (Co. Reg. No. 92/04769/07)
Robbie de Lange Road, Wilsonia, EAST LONDON 5201 –P.O. Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1981

Code 308218 A115                LH&SEL-K14164 I96

Updated on this site: October 2001

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