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

Logo CLINIUM® tablets

SCHEDULING STATUS:
Schedule 3.

PROPRIETARY NAME
(and dosage form):

CLINIUM® tablets

COMPOSITION:
Each tablet contains 60 mg of the active substance
lidoflazine.

PHARMACOLOGICAL CLASSIFICATION:
7.1.4 Vascular medicines. Vasodilators –coronary and other medicines used in angina pectoris.

PHARMACOLOGICAL ACTION:
In the light of animal experimentation, it is suggested that Clinium potentiates, by an as yet undetermined mediating mechanism, the intensity and duration of hypoxically induced reactive hyperaemia in the coronary circulation.

INDICATIONS:
Angina pectoris resulting from ischaemic heart disease. Prophylaxis and after-treatment (after the acute phase) of myocardial infarcation.

CONTRA-INDICATIONS:
None.

WARNINGS:
Premenopausal women may only be treated with Clinium tablets if pregnancy has been excluded.
Clinium does not disturb normal heart rhythm, conduction or contractility, yet it may restore sinus rhythm in patients with supra-ventricular arrhythmia such as atrial fibrillation. Since caution should be exercised with any procedure producing conversion of any arrhythmia, it is recommended that the treatment of such patients be started only under strict and continuous medical supervision.
In congestive cardiac failure the effective maintenance dosages of therapy with cardiac glycosides and diuretics should be determined before instituting Clinium treatment.
Combination therapy and Incompatibility:
Incompatibility with other medication which is likely to be prescribed in ischaemic heart disease has not been reported.

DOSAGE AND DIRECTIONS FOR USE:
The dosage ranges between 2 and 4 tablets daily. Dosage should be adapted individually and started gradually as follows:
first week –1 tablet daily.
second week –1 tablet every morning and evening.
third week –1 tablet three times per day.
An appreciable beneficial effect may sometimes be manifest after a few days or weeks of treatment but the full therapeutic result can usually only be assessed after 6 months of treatment.
If no marked improvement is noticeable after 3 months then the dosage may gradually be increased to 6 tablets per day using as guidelines the therapeutic response, possible non-transient side-effects and ECG controls.
Tablets are preferably taken during meals. Gastrointestinal disturbances can be avoided by taking an antacid con-currently. Clinical findings indicate that uninterrupted therapy, at the optimum dosage level, must be maintained indefinitely to consolidate the favourable results.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Gradual institution of therapy very rarely causes side-effects, but headache, vertigo and tinnitus have been encountered although these usually disappear after a few days or following slight adjustment of dosage.
At higher dosages, in some patients, an individual dose-related and characteristic broadening and rounding of the T-wave is seen, and also sometimes a rapidly occurring but stable QTc prolongation. Both effects are reversed if the dose is reduced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS SPECIFIC TREATMENT:
Symptoms of accidental overdosage or poisoning are unknown as this has never occurred. No specific antidote is known. If accidental overdosage or poisoning is suspected, treatment should be along the customary lines of inducing emesis or performing gastric lavage, followed by supportive symptomatic treatment and intensive care nursing.

CONDITIONS OF REGISTRATION:
Not applicable.

IDENTIFICATION:
White, round, flat bevel-edged tablet engraved Clinium and "JANSSEN" on opposite faces.

PRESENTATION:
Blisterpacks in boxes of 50 tablets.

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

REGISTRATION NUMBER
(or reference number):
H566 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
JANSSEN
PHARMACEUTICA
Janssen Pharmaceutica (Pty) Ltd. (Reg. No. 80/11122/07)
15th Road, Halfway House, 1685
© JANSSEN PHARMACEUTICA (PTY) LTD.
SOUTH AFRICA

DATE OF PUBLICATION:
17 December 1980. Code No.: 020030
88G
® Trademark

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