Gavilac (Anised)

Indications

Gavilac (Anised) is recommended for the treatment of:

• Gastric reflux
• Heartburn
• Indigestion
• Flatulence associated with gastric reflux
• Heartburn during pregnancy
• Epigastric and retrosternal discomfort caused by gastric reflux

Always follow the guidance of a registered healthcare professional.

Pharmacological Action

Gavilac (Anised) combines two antacids, Calcium Carbonate and Sodium Bicarbonate, with Sodium Alginate to provide dual-action relief:

1. Neutralizing Excess Stomach Acid: This helps alleviate pain and discomfort caused by acidity.
2. Protecting the Esophagus: It forms a protective barrier over the stomach’s contents, soothing the chest-burning sensation associated with reflux.

The mechanism of action is physical rather than systemic, meaning the product doesn’t require absorption into the bloodstream to work. Upon ingestion, the ingredients react with stomach acid to create a gel raft with near-neutral pH. This raft floats on top of stomach contents, reducing acid exposure in the esophagus and preventing gastroesophageal reflux for up to 4 hours. It also provides additional protection from bile and pepsin.

Calcium Carbonate quickly neutralizes acid, while Sodium Bicarbonate enhances the neutralizing effect, offering rapid relief from heartburn and indigestion.

Dosage & Administration

For Oral Suspension:

• Adults & Children Over 12 Years: 10-20 mL after meals and at bedtime, up to 4 times a day.
• Children 6 to 12 Years: 5-10 mL after meals and at bedtime, up to 4 times a day.
• Children Under 6 Years: Not recommended.
• Elderly: No dose modifications needed.

For Chewable Tablets:

• Adults & Children 12 Years and Over: 2-4 tablets after meals and at bedtime, up to 4 times a day.
• Children Under 12 Years: Use only under medical supervision.

Special Considerations:

• Hepatic Impairment: No dose adjustment required.
• Renal Insufficiency: Caution if on a restricted salt diet.

Always use as directed by a healthcare professional.

Drug Interactions

Allow at least 2 hours between taking Gavilac (Anised) and other medications, especially those listed below:

• Tetracyclines, Digoxin, Fluoroquinolones
• Iron salts, Ketoconazole
• Thyroid hormones, Penicillamine
• Beta-blockers, Glucocorticoids
• Chloroquine, Biphosphonates
• Estramustine

Contraindications

Gavilac (Anised) is not suitable for individuals with known allergies to any of its active ingredients or excipients.

Possible Side Effects

While rare, some side effects may include:

• Constipation
• Flatulence
• Stomach cramps or belching

Consult a physician if these symptoms occur. Overdose may cause abdominal distension, in which case medical advice should be sought.

Pregnancy & Lactation

• Pregnancy: Clinical studies involving over 500 pregnant women show no harmful effects on the fetus. Gavilac (Anised) is considered safe during pregnancy when used as needed.
• Breastfeeding: No adverse effects have been reported in breastfed infants. Gavilac (Anised) is safe for use during breastfeeding.
• Fertility: Pre-clinical studies show no negative effects on fertility or reproduction.

Precautions & Warnings

• Each 20 mL dose contains 254.5 mg (11.06 mmol) of sodium, so caution is advised for individuals on a salt-restricted diet, such as those with congestive heart failure or renal impairment.
• Each 20 mL contains 260 mg (6.5 mmol) of calcium. Avoid use in patients with hypercalcemia, nephrocalcinosis, or calcium-containing kidney stones.
• Children under 12 should use only under medical advice.
• Due to its sodium content, Gavilac (Anised) may not be suitable for those on a strict salt-free diet.
• Patients with phenylketonuria should avoid Gavilac (Anised) due to its aspartame content.
• Prolonged use (more than 7 days) or persistent symptoms should be reviewed by a doctor, as it may mask more serious underlying conditions.

Overdose Effects

If overdose occurs, symptomatic treatment should be administered. Patients may experience bloating or abdominal discomfort.

Therapeutic Class

Antacids

Storage Conditions

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