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

Logo DRAMAMINE TABLETS
DRAMAMINE LIQUID [not marketed]

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form):

DRAMAMINE TABLETS
DRAMAMINE LIQUID [not marketed]

COMPOSITION:
Each DRAMAMINE Tablet contains 50 mg
dimenhydrinate.
DRAMAMINE Tablets contain Tartrazine.

Each 5 mL DRAMAMINE Liquid contains 15,6 mg dimenhydrinate and 5,28% (v/v) ethyl alcohol. It is preserved with methylparaben 0,1% (m/v.)

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.2. Anti-emetics and anti-vertigo preparations.

PHARMACOLOGICAL ACTION:
The action of dimenhydrinate is anti-histaminic (H1 blacker) and is of the ethanolamine class with significant anticholinergic activity and sedative (calming, relaxing or sleep) properties. It is not clear how dimenhydrinate works as an anti-emetic, but it is .thought to block excitatory labyrinthine impulses at cholinergic synapses in the region of the vestibular nuclei.

INDICATIONS:
Prevention and relief of motion sickness and treatment of vertigo (dizziness), nausea or vomiting associated with electroshock therapy, anaesthesia and surgery, labyrinthine disturbances, radiation sickness and postfenestration syndrome.

CONTRA-INDICATIONS:
Patients with known sensitivity (abnormal or allergic reactions) to dimenhydrinate.

WARNINGS:
Safety in pregnancy and lactation (breast feeding) has not been established.

DRAMAMINE Tablets contain FD & C Yellow No. 5 (TARTRAZINE) which may cause allergic-type reactions (including bronchial 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.

Caution should be used when DRAMAMINE is given in conjunction with certain antibiotics which may cause ototoxicity (toxic effects on the nerves of the ear), since DRAMAMINE is capable of masking ototoxic symptoms and an irreversible state may be reached.

This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights as impaired decision making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
DRAMAMINE Tablets:
Adults and children 12 years of age and over:
        50 to 100 mg (1-2 tablets) every 4-6 hours, not to exceed 300 mg (6 tablets) in 24 hours.
Children 6 to under 12 years of age:
        25 to 50 mg (½ to 1 tablet) every 8-12 hours, not to exceed 150 mg (3 tablets) in 24 hours.
Children 2 to under 6 years of age:
        12,5 to 25 mg (¼ - ½ tablet) every 8-12 hours, not to exceed 75 mg ( 1½ tablets) in 24 hours.

DRAMAMINE LIQUID:
Adults and children 12 years of age and over:
        4-7 five mL medicine measuresful every 4-6 hours, not to exceed 20 five mL medicine measuresful in 24 hours.
Children 6 to under 12 years of age:
        2-3 five mL medicine measuresful every 8-12 hours, not to exceed 10 five mL medicine measuresful in 24 hours.
Children 2 to under 6 years of age:
        1-2 five mL medicine measuresful every 8-12 hours, not to exceed 5 five mL medicine measuresful in 24 hours.
Children under two years of age:
        To be administered only on the advice of a physician.

For prevention of motion sickness, the first dose should be given 30 minutes before departure.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect of dimenhydrinate is sedation which can vary from slight drowsiness to deep sleep, and including inability to concentrate, lassitude (lack of energy, fatigue, lethargy), dizziness, hypotension (low blood pressure) muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances (affecting the stomach and intestines) such as nausea, vomiting, diarrhoea or constipation and epigastric pain (pain in the upper, middle region of the stomach). Headache, tinnitus (ringing in the ears), elation and depression, irritability, nightmares, anorexia (lack of appetite), difficulty in micturition (passing of urine), dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may occur. In infants and children it may act as a cerebral (brain) stimulant. Symptoms of stimulation in adults include insomnia (inability to sleep), nervousness, tachycardia (increased rate of heart beat), tremors, muscle twitching and convulsions (seizures and fits).

Large doses may precipitate fits in epileptics. Allergic (unusual sensitivity to medicines) reactions and anaphylaxis (sudden, life threatening severe allergic reaction) may occur. Blood dyscrasias including agranulocytosis (severe decrease in a particular type of white blood cells) and haemolytic anaemia (lack of red blood cells due to destruction of circulating cells) may occur. Dimenhydrinate has anticholinergic properties and should be used with care in conditions such as glaucoma (raised pressure in the eye) and prostatic hypertrophy (enlargement of prostrate gland). The anticholinergic effects of atropine and tricyclic antidepressants may be enhanced by dimenhydrinate.

Dimenhydrinate may mask the warning symptoms of damage caused by ototoxic medicines and may effect the metabolism of other medicines in the liver. It may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms: Convulsions may occur with overdosage. Also coma respiratory depression (abnormally slow and/or shallow breathing). Stimulation may occur in children.
Treatment: Symptomatic and supportive.

IDENTIFICATION:
DRAMAMINE Tablets are yellow, bi-convex uncoated tablets 8.7 mm in diameter, scored on one side and “Searle”above 72 stamped on the other.

DRAMAMINE LIQUID is a red, sweet syrup with a mild cherry flavour.

PRESENTATION:
DRAMAMINE Tablets are packed in foil strips of 4 and 10.
DRAMAMINE LIQUID is packed in 100 mL amber glass bottles.

STORAGE INSTRUCTIONS:
DRAMAMINE Tablets should be stored in a dry place below 30 °C.
DRAMAMINE LIQUID should be stored in a cool place (below 25 °C).
Keep out of reach of children.

REFERENCE/REGISTRATION NUMBERS:
DRAMAMINE Tablets: C619 (Act 101/1965)
DRAMAMINE LIQUID: R/5.7.2/79

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven
Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 November 1984.

CODE: 4106-5-10/90 (IMA 3933-R3)

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