Gavilac (Anised) (500 mg+213 mg+325 mg)/10 ml

INDICATIONS

This preparation is indicated in-

Gastric reflux
Heartburn
Indigestion
Flatulence associated with gastric reflux
Heartburn of pregnancy
All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

PHARMACOLOGY

This is the combination of two antacids (Calcium carbonate and Sodium bicarbonate) and an alginate (Sodium alginate). The suspension work in two ways-

Neutralizing excess stomach acid to relieve the pain & discomfort
Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

The mode of action of the product is physical and does not depend on absorption into the systemic circulation. The product is a combination of two antacids (Calcium Carbonate and Sodium Bicarbonate) and an Alginate. On ingestion, the medicinal product reacts rapidly with gastric acid to form a raft of Alginic Acid gel having a near neutral pH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing esophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-esophageal reflux, for up to 4 hours, and protecting the esophagus from Acid, Pepsin and Bile.In severe cases the raft itself may be refluxed into the esophagus, in preference to the stomach contents, and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the esophagus from these gastric components. Calcium Carbonate neutralizes gastric acid to provide fast relief from indigestion and heartburn.This effect is increased by the addition of Sodium Bicarbonate which also has a neutralizing action.

DOSAGE & ADMINISTRATION

For oral suspension:

Adult and children over 12 years:10-20 mL after meals and at bedtime, up to four times a day.
Children 6 to 12 years: 5-10 mL after meals and at bedtime, up to four times a day.
Children under 6 years: Not recommended.
Elderly: No dose modifications necessary.

Chewable Tablet should be taken in oral route after being thoroughly chewed. Recommended dose:

Adults and children 12 years and over: Take two to four tablets after meals and at bedtime, up to four times a day.
Children under 12 years: Tablets should be given only on medical advice.

Hepatic Impairment: No dose modification necessary.Renal Insufficiency: Caution if highly restricted salt diet is necessary.

INTERACTION

A time-interval of 2 hours should be considered between this drug intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphosphonates) and Estramustine.

SIDE EFFECTS

In addition to the desired effect of the drug, some side effects may appear such as: constipation, flatulence, stomach cramp or belching. In these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. In this case, it is advisable to consult a physician.

PREGNANCY & LACTATION

Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate no malformative nor feto/neonatal toxicity of the active ingredients. This drug can be used during pregnancy, if clinically needed.Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This drug can be used during breastfeeding.Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on parental or offspring fertility or reproduction. Clinical data do not suggest that this drug has an effect on human fertility.

PRECAUTIONS & WARNINGS

Each 20 ml of dose has a sodium content of 254.5 mg (11.06 mmol). 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. Each 20 ml contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis, and recurrent calcium containing renal calculi. Treatment of children younger than 12 years of age is not generally recommended, except on medical advice. This combination is considered high in sodium. 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. Each tablet contains 75 mg of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Due to its aspartame content this combination should not be given to patients with phenylketonuria. If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought. Taking this combination can mask the symptoms of other more serious, underlying medical conditions. It should not be used in patients with impaired renal function/insufficiency and with hypophosphatemia. This may cause allergic reactions.

THERAPEUTIC CLASS

Antacids

STORAGE CONDITIONS

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.