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

Logo REMOTROX Gel

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

REMOTROX Gel

COMPOSITION:
Each 5 mL contains:
  Dicyclomine HCl 2,5 mg
  Aluminium hydroxide gel 200,0 mg
  Magnesium oxide 100,0 mg
Preservative: Nipasept 0,08%
PHARMACOLOGICAL CLASSIFICATION:
11.4.2 Acid neutralisers with antispasmodics.

PHARMACOLOGICAL ACTION:
Magnesium oxide has a rapid antacid action and aluminium hydroxide has a prolonged antacid effect. In this combination there is a balanced antacid action with virtually no constipation or diarrhoea. Both aluminium hydroxide and magnesium oxide are poorly absorbed and there is virtually no risk of alkalosis. Balanced antacids inhibit pepsin by raising stomach pH. Aluminium hydroxide has a direct anti-peptic action as well as a demulcent action.

Dicyclomine hydrochloride relieves smooth muscle spasm in the gastro-intestinal tract. It has been shown in-laboratory studies in animals to have a dual mode of action: a neurotropic action which acts to block the effects of acetylcholine at the parasympathetic nerve ending, and a direct musculotropic action on smooth muscle itself. Assuming the same manner of action in man, the result would be effective relief of spasm at doses lower than would cause intolerable anticholinergic side effects. Dicyclomine hydrochloride helps decrease gastric hypermotility and thus tends to keep the other components in the stomach longer.

INDICATIONS:
For the relief of symptoms of gastric hyperacidity with or without pylorospasm in conditions such as oesophagitis, acute and chronic gastritis (including iatrogenic gastritis) and heartburn of pregnancy. In the treatment of peptic ulcer and for prophylaxis in the ulcer-prone patient.

CONTRA-INDICATIONS:
Obstructive uropathy, obstructive disease of gastrointestinal tract, paralytic ileus and intestinal atony, severe ulcerative colitis, myasthenia gravis. Sensitivity to any of the components.

DOSAGE AND DIRECTIONS FOR USE:
2 - 4 Medicine measure (10 - 20 mL) one to two hours after meals and at bedtime or as needed for relief.

Remotrox Gel is not recommended for children.

Shake well before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects are uncommon. When they occur, they are usually related to the dicyclomine hydrochloride which may cause atropine-like side-effects, such as dry mouth, blurred vision or urinary retention. Fatigue, sedation, rash, constipation, thirst, nausea and vomiting, headache, and dizziness also have been reported infrequently by patients taking dicyclomine hydrochloride. Magnesium oxide, as with other magnesium salts, in the presence of renal insufficiency, may cause central nervous system depression. Aluminium hydroxide, in the presence of low phosphorus diets, may cause phosphorus deficiency. Products containing dicyclomine should be used with caution in any patient with, or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate this condition.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms may include dry mouth, blurred vision, dilated pupils, rapid heart rate, restlessness and dry hot skin. Treatment should include gastric lavage, and general supportive measures. If symptoms are mainly related to the effect of dicyclomine, give pilocarpine 10 mg subcutaneously every half hour until the mouth becomes moist. Barbiturates can be considered if sedation is required.

IDENTIFICATION:
A white homogeneous suspension.

PRESENTATION:
In an amber glass bottle of 350 mL.

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

REGISTRATION NUMBER:
G/11.2/179

APPLICANT:
Supramed Ltd
a Division of
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios
Howard Drive
PINELANDS
7405

DATE OF PUBLICATION:
10/90

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