Asynta Oral Suspension (500 mg+100 mg)/5 ml

Indications

Treatment of symptoms of gastroesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis.

Therapeutic Class

Antacids

Pharmacology

Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Soodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the food pipe. This relieves the symptoms of reflux such as heartburn.

The mode of action of this preparation is physical and does not depend on absorption into the systemic circulation.The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.

Dosage & Administration

Tablet:

• Adult and child over 12 years: 1-2 tablets daily 4 times, after meals and at bed time.
• Child 6-12 years: 1 tablet daily 4 times, after meals and at bed time.

Suspension:

• Adult and child over 12 years: 5-10 ml daily 4 times, after meals and at bedtime.
• Child 2-12 years: 2.5-5 ml daily 4 times, after meals and at bedtime. This is not recommended for children under 2 years of age.

Interaction

If you are taking other medicines concomitantly, or have just completed another drug treatment, inform your physician in order to prevent hazards or inefficacy arising from drug interactions.

Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipient.

Side Effects

In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician. In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.

Pregnancy & Lactation

• Pregnancy: This combination may be used during pregnancy.
• Breast feeding: No known effect on breast fed infants. Can be used during breast feeding.
• Fertility: No known effect on human fertility.

Precautions & Warnings

Each 10 ml (two teaspoonfuls) or two-tablet dose has a sodium content of 106 mg and a potassium content of 78 mg. This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment or when taking drugs which can increase plasma potassium levels.

Each 10 ml or two-tablet dose contains 200 mg of calcium carbonate. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium containing renal calculi.

There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.

Use in Special Populations

Elderly: No dose modifications necessary for this age group.

Hepatic Impairment: No dose modifications necessary.

Renal Insufficiency: Caution if highly restricted salt diet is necessary.

Overdose Effects

Over dosage with this formulation is a rare case. In case of overdose please consult with a registered physician.

Storage Conditions

Store in a cool place (in room temperature, below 30° C).