SOMNIL TABLETS
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
SOMNIL TABLETS
COMPOSITION:
Each tablet contains:
Doxylamine Succinate 25,00 mg
PHARMACOLOGICAL CLASSIFICATION:
A 2.2 Sedative, hypnotics,
PHARMACOLOGICAL ACTION:
Doxylamine succinate, a member of the Ethanolamine group of H1 -Blocking Agents, has a pronounced tendency to induce sedation.
INDICATIONS:
Doxylamine succinate is indicated for the alleviation of insomnia.
CONTRA-INDICATIONS:
Doxylamine succinate should not be taken during pregnancy, nor whilst breastfeeding. It is also contra-indicated in epileptics, in patients with severe cardio-vascular disorders, and in patients suffering from an acute asthma attack.
WARNINGS:
This medicine leads to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to take charge of vehicles, other means of transport or machinery where loss of attention may lead to accidents.
DOSAGE AND DIRECTIONS FOR USE:
One to two tablets with water at bedtime.
Not to be administered to children under the age of 12.
This product should be used occasionally and should not be used successively for periods exceeding several days. If insomnia persists consult your doctor.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The most common side-effect is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness and in-coordination.
Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain.
Doxylamine succinate may also produce antimuscarinic effects including blurred vision, difficulty in micturition, dysuria, dryness of the mouth and tightness of the chest. Other central effects include hypotension, muscular weakness, tinnitus, euphoria or depression, headache, irritability and nightmares.
Paradoxical central nervous system stimulation may occur with insomnia, nervousness, tachycardia, tremors and convulsions. Doxylamine succinate may precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex.
Allergic reactions and cross-sensitivity to related medicines may occur.
Blood disorders, including agranulocytosis, leucopenia and haemolytic anemia have been reported.
Special Precautions:
Doxylamine should be used with care in the elderly, and in conditions such as closed-angle glaucoma, urinary retention, liver impairment, prostatic hypertrophy or pyloroduodenal obstruction.
Use with care in cardiac failure, hypertension, oedema and cardiovascular disease.
Interactions:
Doxylamine succinate may enhance the sedative effects of central nervous system depressants including alcohol, tricyclic antidepressants, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
Mono amine oxidase inhibitors may enhance the antimuscarinic effects of doxylamine succinate, and it has additive effects with other antimuscarinic agents, such as atropine and tricyclic antidepressants.
It has been suggested that doxylamine succinate could mask the warning signs of damage caused by ototoxic medicines such as aminoglycoside antibiotics.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In children CNS stimulation, resulting in ataxia, excitement, tremors, psychoses, hallucinations and convulsions, occurs. Hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. Death may occur from respiratory failure.
In adults, CNS depression is more common, with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardio-vascular collapse.
Treatment is supportive and symptomatic.
IDENTIFICATION:
Pale blue, flat, bisected tablets with bevelled edges having a diameter of 7 mm.
PRESENTATION:
Packs of 12 and 24 tablets.
STORAGE INSTRUCTIONS:
Store below 25 °C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBERS:
Q/2.2/186
NAME AND BUSINESS ADDRESS OF 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:
11 April 1985 |
