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

Logo ROXIT 75 Film-coated Tablets
ROXIT 150 Film-coated Tablets
SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

ROXIT 75 Film-coated Tablets
ROXIT 150 Film-coated Tablets

COMPOSITION:
ROXIT 75: Each controlled-release film-coated tablet contains 75 mg roxatidine acetate hydrochloride.
ROXIT 150: Each controlled-release film-coated tablet contains 150 mg roxatidine acetate hydrochloride.
Preservative:
Benzyl alcohol 0,4% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3 Antacids: other

PHARMACOLOGICAL ACTION:
ROXIT (Roxatidine acetate HCl) suppresses the effect of histamine on the parietal cells of the stomach (H2-receptor antagonist). This suppressive action is dose-dependent. As a result, the production and secretion, particularly of gastric acid, are reduced.
After oral administration roxatidine acetate HCl is well absorbed and rapidly metabolised to the primary, active desacetyl metabolite. The elimination half-life of the substance is between five and six hours.

INDICATIONS:
Disorders of the upper gastro-intestinal region that are due to an excess of hydrochloric acid in the gastric juice, i.e. duodenal ulcers, benign gastric ulcers.
Prophylaxis of recurrent gastric and duodenal ulcers

CONTRA-INDICATIONS:
Hypersensitivity to roxatidine acetate.
Safety in pregnancy and lactation has not been established.
The use of ROXIT in children cannot be recommended as safety and efficiency have not been established.

WARNING
Malignancy of gastric ulcers should be excluded before treatment with ROXIT.
Since approximately 30 per cent of the active ingredient is metabolised in the liver and there is no experience of use in patients with severe impairment of liver function, treatment of such patients with ROXIT is not recommended. The dose must be reduced in patients with impaired renal function (see dosage and directions for use). Patients with failure of urine production (anuria) must not be treated with ROXIT.
Use with care in geriatric patients.

DOSAGE AND DIRECTIONS FOR USE:
Treatment of acute conditions:
Unless otherwise prescribed by the doctor, adults take one ROXIT 150 mg tablet every evening, without chewing and with a generous amount of liquid.
Treatment of duodenal ulcers must be maintained for four to six weeks and for gastric ulcers up to eight weeks.

Dosage in patients with impaired renal function:
Roxatidine acetate is almost entirely (90 per cent to 99 per cent) excreted via the kidneys, therefore a reduction in the daily dose is recommended for patients with impaired renal function, as below:

Creatinine clearance of 20 to 50 mL/minute
75 mg Roxatidine acetate hydrochloride (one tablet ROXIT 75) per day, in the evening.

Creatinine clearance of less than 20 mL/minute
75 mg Roxatidine acetate hydrochloride (one tablet ROXIT 75) once every two days, in the evening.

Prophylactic treatment
For the prophylaxis of recurrent gastric or duodenal ulcer, one ROXIT 75 tablet taken at night without chewing and with prophylactic treatment with a generous amount of liquid is sufficient.
The duration of treatment is determined by the doctor.

Dosage in patients with impaired renal function:
For prophylactic treatment of patients with impaired renal function, a reduction in the dose is recommended.

SIDE-EFFECTS:
Headaches may occur. There have been reports of diarrhoea, constipation, nausea, vomiting and other gastro-intestinal complaints. Dizziness, troubled sleep, restlessness, drowsiness and visual disturbances have been observed. Skin rashes, itching and pain in muscles and joints occurred sporadically, possibly as hypersensitivity reactions.
Very rarely, changes in pulse rate, e.g. an increase or decrease, have been reported.
A transient impairment of sexual drive has been described.
As a precaution, a possible rise in liver enzyme activity (e.g. serum transaminases) should be borne in mind.
There have been reports of reductions in the number of leucocytes and/or thrombocytes.

INTERACTIONS:
No substance-specific interactions with other agents or medicines are known.
Concomitant ingestion of food or antacids has no effect on the absorption of Roxit. Since Roxit reduces acid secretion in the stomach, other drugs may be absorbed differently and their effects weakened (e.g. ketoconazole) or intensified (e.g. midazolam).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects.
The treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
ROXIT 75: White to yellowish white coated oblong tablet with "NAH" imprinted on the one side and HOECHST logo on the other (10 mm long x 5 mm wide)
ROXIT 150: White to yellowish white coated oblong tablet with "NAL" imprinted on the one side and the HOECHST logo on the other (13 mm long x 6 mm wide)
PRESENTATION:
ROXIT 75 AND ROXIT 150: Cardboard cartons with amber glass bottles each containing 30 controlled-release film-coated tablets.

STORAGE INSTRUCTIONS:
Store below 25°C, in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ROXIT 75:        28/11.4.3/0221
ROXIT 150:        28/11.4.3/0222.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
22 July 1994

ETHIMED
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA
        D381/01

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