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Logo RIOPONE® Suspension
RIOPONE® Chew Tablets

SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME
(and dosage form):

RIOPONE® Suspension
RIOPONE® Chew Tablets

COMPOSITION:
A. Suspension: Each 5 mL contains 400 mg Magaldrate USP suspended in an aqueous solution.
B. Chew Tablets: Each tablet contains 400 mg Magaldrate USP bulked with sucrose and dextrose.
Not more than 2,5 mg of sodium per teaspoonful (5 mL) suspension/per chew tablet.

PHARMACOLOGICAL CLASSIFICATION:
Category A, 11.4.1 Antacids - Acid Neutralisers.

PHARMACOLOGICAL ACTION:
RIOPONE reacts chemically to neutralize or buffer existing quantities of stomach acid but have no direct effects on its production. This action increases gastric pH, providing symptomatic relief of hyperacidity.

Magaldrate reacts with gastric acid in stages. The hydroxymagnesium is relatively rapidly converted to magnesium ion and the aluminate to hydrated aluminium hydroxide; the magnesium ion rapidly neutralises or buffers existing acid while the aluminium hydroxide reacts more slowly to give a sustained antacid effect.

A small amount of aluminium from aluminium hydroxide is absorbed from the intestine. Approximately 10% of the magnesium in magnesium hydroxide is absorbed from the intestine.

INDICATIONS:
For the symptomatic relief of hyperacidity associated with the diagnosis of peptic ulcer, gastritis, reflux oesophagitis, and gastric hyperacidity.

CONTRA-INDICATIONS:
In patients with symptoms of appendicitis since RIOPONE may increase the danger of perforation or rupture due to the constipating or laxative effects.

In patients with severe renal function impairment due to the increased danger of occurrence of hypermagnesemia.

In patients with hypophosphatemia due to the phosphate binding properties of aluminium salts.

Do not use this product if you are presently taking a prescription antibiotic drug containing any form of tetracycline.

Do not use this product it there is a known history of sensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
5 mL to 10 mL (or equivalent dose if tablets are available) taken 3 to 4 times a day, administered between meals and at bedtime, or as directed by a doctor.

Use in children - Not recommended in children under 6 years of age unless, directed by a doctor.

Do not exceed the recommended dosage of suspension 40 mL (8 medicine measures or 8 tablets) in a 24 hour period. Do not use maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Suspension may be followed by a sip of water, if desired. Chewable tablets should be chewed before swallowing.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aluminium-containing products:
Nausea, vomiting, constipation. Large doses can cause obstruction.
Excessive doses, or normal doses in patients with low phosphate diets may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia.

Osteomalacia, encephalopathy and dementia have occurred in patients with chronic renal failure on high aluminium-dose as a phosphate-binding agent.

Magnesium-containing products:
May cause diarrhoea. Release of carbon dioxide may cause discomfort.

Hypermagneseamia may occur if renal function is impaired.

The use of RIOPONE in patients with mild to moderate renal impairment should be carefully monitored due to a possible increased danger of hypermagnesemia. In patients with chronic renal failure, hyperaluminemia may occur.

Hypophosphataemia may occur with prolonged administration or large doses especially in patients with an inadequate dietary intake of phosphorus.

Laboratory Tests - Serum phosphate levels should be monitored at monthly or bi-monthly intervals in patients on maintenance haemodialysis who are receiving chronic antacid therapy.

Interactions: - The rate and/or extent of absorption of many medicines may be increased or decreased when they are used concurrently with RIOPONE. Therefore, medication should not be taken within one to two hours of RIOPONE, if possible.

An incomplete list of medicines for which the above statement has been shown to apply includes: iron, tetracycline, isoniazid, ethambutol, some anti-muscarinic drugs, benzodiazepines, phenothiazines, ranitidine, indomethacin, phenytoin, nitrofurantoin, vitamin A, fluoride and phosphate.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
A. Suspension : White, mint flavoured suspension.
B. Chew Tablets : Flat, round, white, mint flavoured tablet.
PRESENTATION:
A. Suspension : 150 mL and 350 mL bottles.
B. Chew Tablets : Strip-packed in cartons of 48 tablets.
STORAGE INSTRUCTIONS:
A. Suspension: Shake well before using. Keep tightly closed. Protect from freezing. Store at room temperature (approximately 25 °C).
B. Chew Tablets: Store at room temperature (approximately 25 °C).
Keep out of reach of children.

REGISTRATION NUMBERS:
RIOPONE Chew Tablets - E/11.4.1/1274
RIOPONE Suspension - E/11.4.1/1275

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
AKROMED PRODUCTS
Electron Avenue ISANDO 1600

Trademark and product, under licence from
WYETH AYERST LABORATORIES U S A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 27, 1993

24880 GX401
Davbar Dbn.

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