ACIDEX Oral suspension Ref.[50687] Active ingredients: Alginic acid Calcium carbonate Sodium bicarbonate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

4.1. Therapeutic indications

For the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress.

4.2. Posology and method of administration

Posology

Adults and children over 12 years: 10-20 ml (Two to four 5 ml spoonfuls) after meals and at bedtime. The maximum daily dose is 80 ml.

Children under 12 years: Should only be given on medical advice.

Children 6-12 years: 5-10 ml (One to two 5 ml spoonfuls) after meals and at bedtime. The maximum daily dose is 40 ml.

Children under 6 years of age: Not recommended.

Special patient groups

Elderly: No dosage modification is required in this age group.

Hepatic Impairment: No modifications necessary.

Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).

Method of Administration

For oral administration.

Duration of treatment

If symptoms do not improve after seven days, the clinical situation should be reviewed.

4.9. Overdose

Symptoms

The patient may experience abdominal discomfort and may notice abdominal distension.

Management

In the event of overdose symptomatic treatment should be given.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate.

6.5. Nature and contents of container

Type III amber glass bottles with pilfer proof caps and tamper evident screw caps, in pack sizes of 100ml, 150ml, 200ml, 250ml, 300ml and 500ml.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Shake well before use.

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