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

Logo ENARAX® TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ENARAX® TABLETS

COMPOSITION:
Each Enarax tablet contains:
  Oxyphencyclimine HCl 5 mg
  Hydroxyzine 2HCl 12,5 mg
PHARMACOLOGICAL CLASSIFICATION:
A 11.2 Gastro-intestinal antispasmodics and cholinolytics (anti-cholinergics).

PHARMACOLOGICAL ACTION:
Enarax is a combination of an inherently long-acting anticholinergic, Oxyphencyclimine HCl with Hydroxyzine 2HCl (Aterax) a non-phenothiazine type of tranquilliser. Apart from its tranquillising sedative actions, Hydroxyzine 2HCl (Aterax) has antihistaminic and unspecific antispasmodic and antisecretory properties.
Hydroxyzine 2HCl is not hepatotoxic and does not cause drug dependence.
Because Hydroxyzine 2HCl per se has the unusual property of decreasing the volume and the acidity of the gastric secretion in patients with gastric hypersecretion, it was possible to take advantage of this property and decrease the dosage of Oxyphencyclimine HCl and thus minimize the side-effects associated with the administration of anticholinergics.

INDICATIONS:
Duodenal and gastric ulcer, irritable colon, cholecystitis, pylorospasm, cardiospasm, duodenitis, ureteral spasm.

CONTRA-INDICATIONS:
Glaucoma, prostatic hypertrophy and in general conditions in which anticholinergics are contra-indicated.

WARNINGS:
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.

DOSAGE AND DIRECTIONS FOR USE:
1 or 2 tablets twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Same as for anticholinergics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Same as for anticholinergics.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
Each scored white tablet is marked "UCB" on the one side and "E/N" on the other.

PRESENTATION:
Packs of 18 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
E947 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
UCB (S.A.) (PTY) LTD
2nd Floor, Pharmacy House
26 Juta Street
BRAAMFONTEIN 2001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8/72

        P611
        L.LTD.L 17408/22463

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