INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
EMDALEN® TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

EMDALEN^® TABLETS

COMPOSITION:
Each Emdalen tablet contains 76,1 mg lofepramine hydrochloride equivalent to 70 mg lofepramine.

PHARMACOLOGICAL CLASSIFICATION:
A 1.2 - Psychoanaleptics (antidepressants).

PHARMACOLOGICAL ACTION:
Emdalen is a tricyclic antidepressant used in the treatment of ambulant depressive patients –it improves the mood, reduces anxiety. As a result of its high lipophilicty, Emdalen is rapidly absorbed. Maximum serum concentrations are reached one hour after oral administration.
Excretion of Emdalen is rapid and occurs via the urine and faeces.
As with other tricyclic antidepressants the mechanism of action in man of Emdalen is not fully understood. However, clinical trials utilising the fact that tricyclic antidepressants inhibit the uptake of tyramine and noradrenaline into peripheral adrenergic nerves have shown Emdalen to have the same qualitative effect as other clinically effective antidepressants. Emdalen is not a monoamine oxidase inhibitor.

INDICATIONS:
Emdalen is used in the treatment of depressive illnesses.

CONTRA-INDICATIONS:
Emdalen is contra-indicated in the acute phase of myocardial infarction.
Emdalen is contra-indicated in patients who have shown prior hypersensitivity to lofepramine.
Emdalen should be prescribed with caution during pregnancy and is not advised during the first trimester unless there are compelling reasons for its use.
Emdalen is contra-indicated in acute alcoholic, hypnotic, analgesic and psychotropic drug poisoning and acute deliria.

WARNINGS:
This medicine should at all times be kept out of reach of children, as even small doses may be fatal to them.

DOSAGE AND DIRECTIONS FOR USE :
Dosage of Emdalen depends on the individual requirements according to the severity of the depression and individual sensitivity of the patient.
Mild to moderate depression: An initial dose of 70 to 140 mg in divided doses is recommended for the first three days. If necessary, this dose can be increased in the course of the first week to 140 to 210 mg per day in divided doses.
Moderately severe to severe depression: A dosage of 140 to 210 mg per day is recommended and should it be necessary in individual cases, a dosage of 210 mg per day may be exceeded.
After onset of the desired effect it is advisable to reduce the dose to a maintenance dose.
Maintenance dose: 70 mg two times daily.
Emdalen tablets are best taken with liquid during or after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Peripheral anticholinergic side-effects, notably dry mouth, constipation, urinary retention and pupillary dilatation with blurred vision and changes in visual accommodation. When anticholinergic effects are severe the medicine should be discontinued or reduced.
Drowsiness or excessive sedation in certain patients. On the other hand disorientation and agitation, insomnia and restlessness can also occur with normal doses. The risk of central nervous system depression is greater when administered together with other central nervous system depressants e.g. alcohol, barbiturates.
NOTE: Elderly patients are more prone to all these effects, and therapy should be initiated at lower than standard doses in the elderly.
Special precautions:

a.	At the time of initiation of therapy patients should be advised not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery for at least several days. In these situations impaired decision making could lead to accidents.
b.	Caution should be observed with patients suffering from a depressive phase of manic depressive psychosis, as occasionally hypomania or mania can be precipitated in such patients. Withdraw the drug if the depression turns into a manic phase.
c.	In elderly male patients suffering from prostatism, urinary retention may be precipitated. Use with caution in patients with severe liver and kidney disorders.
d.	In patients suffering from cardiac disease special caution should be observed because of the occasional problems of tachycardia, dysrythmias, orthostatic hypotension and other unwanted effects on blood pressure, aggravation of condition disturbances, and electrocardiographic abnormalities. Regular cardiological and electrocardiographic examination is advised.
e.	Epilepsy may be aggravated.
f.	The medicine should not usually be given to patients receiving other central nervous system depressants e.g. barbiturates, and to patients receiving monoamine oxidase inhibitors only after a suitable interval (the drugs may be given together if the dosages are carefully controlled, preferably in hospital). The pressor effects of the direct acting sympathomimetic agents, adrenaline and noradrenaline are enhanced, and the use of local anaesthetics containing these vasoconstrictors should be avoided as hypertensive reactions may occur. The simultaneous administration of anticholinergic agents may be dangerous. The hypotensive effect of certain antihypertensive agents may be reduced.
g.	Narrow angle glaucoma may be aggravated.
h.	Withdraw the drug if allergic skin reactions appear.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage and poisoning may be characterised by central nervous system depression or excitation, severe anticholinergic effects and cardiotoxicity. The following symptoms and signs are characteristic of acute overdosage: Drowsiness, restlessness, ataxia, stupor, coma, pyrexia, palpitations, tachycardia, cardiac arrhythmias, hypotension and in severe cases, respiratory depression.
Epileptiform seizures may occur. Mixed poisoning with other central nervous system depressants is not uncommon.
Treatment: The stomach should be emptied by aspiration and lavage. Treatment is symptomatic.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Violet-brown, round slightly convex lacquered tablet, scored on one side, approximately 10 mm in diameter and 4,5 mm thick.

PRESENTATION:
Emdalen is available as 70 mg tablets in bottles of 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep all medicines out of reach of children.

REGISTRATION NUMBER:
N/1.2/205.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd
Reg. No 1970/004059/07
1 Friesland Drive,
Longmeadow Business Estate
Modderfontein 1645

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5 July, 1984.

® = Registered Trade Mark        Highland Print
        F70163
        P09/2002

Updated on this site: December 2004
Source: Community Pharmacy
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