GAVISCON® FORTE PEPPERMINT SUSPENSION

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GAVISCON® FORTE PEPPERMINT SUSPENSION (GAVISCON® FORTE PEPPERMINT SUSPENSION)

Composition:

Active substances:
sodium alginate, potassium bicarbonate;

5 ml of suspension contains 500 mg of sodium alginate, 100 mg of potassium bicarbonate;

Excipients:
calcium carbonate, carbomer 974P, sodium hydroxide, sodium saccharin, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), peppermint flavor, purified water.

Pharmaceutical form.
Oral suspension.

Main physicochemical properties:
almost white, viscous suspension with a minty odor.

Pharmacotherapeutic group.
Drugs for treatment of peptic ulcer and gastroesophageal reflux disease. ATC code A02BX.

Pharmacological properties.

Pharmacodynamics.

After oral administration, Gaviscon® Forte Mint suspension rapidly interacts with gastric juice, forming a layer of alginate gel on its surface with a pH close to neutral. This gel layer suppresses gastroesophageal reflux for up to 4 hours and acts as a protective barrier on the surface of gastric contents, protecting the esophagus from acid, pepsin, and bile. In severe cases, the gel layer enters the esophagus instead of gastric contents and protects the esophageal walls. Furthermore, in vitro data have demonstrated that the gel layer has a secondary effect and is capable of trapping bile and pepsin within its structure, thereby providing additional protection to the esophagus from these components of gastric juice.

Pharmacokinetics.

The mechanism of action of this medicinal product is physical and does not depend on absorption into the systemic circulation.

Clinical characteristics.

Indications.

Gaviscon® Forte Peppermint Suspension is indicated for the treatment of symptoms of gastroesophageal reflux, such as acid regurgitation, heartburn, and digestive disturbances associated with reflux, for example, after meals or during pregnancy, or in patients with symptoms related to reflux oesophagitis.

Contraindications.

The medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).

Special precautions.

If no improvement is observed within 7 days, the clinical situation should be re-evaluated.

Each 5 ml of suspension contains 1.0 mmol (40 mg) of calcium; therefore, the product should be administered with caution in patients with hypercalcaemia, nephrocalcinosis, and recurrent calcium-dependent kidney stones.

The medicinal product contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicinal product contains 57.85 mg (2.5 mmol) of sodium per 5 ml, equivalent to 2.9% of the maximum daily sodium intake recommended by WHO.

The maximum daily dose of this medicinal product is equivalent to 23.14% of the maximum daily sodium intake recommended by WHO. This is based on a dose of 10 ml taken four times daily.

This product has a high sodium content. This should be taken into account in patients on a low-salt diet, for example, in congestive heart failure and impaired renal function, or in patients taking medicinal products that may increase plasma potassium levels.

This product contains 1.0 mmol (39.06 mg) of potassium per 5 ml. This should be taken into consideration in patients with impaired renal function or in patients on a potassium-restricted diet.

Interaction with other medicinal products and other forms of interaction.

Due to the presence of calcium carbonate, which acts as an antacid, at least two hours should elapse between administration of Gaviscon® Forte Peppermint Suspension and administration of other medicinal products, particularly H2-receptor antagonists, tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, bisphosphonates, and estramustine.

Usage Instructions.

Use during pregnancy or breastfeeding.

Clinical studies involving more than 500 pregnant women, as well as extensive post-marketing experience, indicate the absence of toxic effects of the active ingredients on the fetus or newborn, and also show no evidence of teratogenic effects. If clinically necessary, Gaviscon® Forte Mint Suspension can be used during pregnancy.

Breastfeeding.

There are no data available on effects in infants who are breastfed. Gaviscon® Forte Mint Suspension can be used during breastfeeding.

Fertility.

There are no data available on effects on human fertility.

Ability to affect reaction speed when driving or operating machinery.

The medicinal product does not affect the ability to drive or operate other complex machinery.

Method of Administration and Dosage.

For adults and children aged 12 years and older, the medication is administered orally. Take 5–10 ml (1–2 teaspoons) after meals and before bedtime, up to 4 times daily.

Special Patient Categories:

Dosage adjustment is not required for elderly patients.

Hepatic Impairment:
Dosage adjustment is not required.

Renal Impairment:
Use with caution in patients who must follow a low-salt diet.

The medication should not be used for more than 7 days. If symptoms persist or worsen during this period, the patient should consult a physician for diagnosis clarification and treatment regimen adjustment.

Children.

Not recommended for children under 12 years of age.

In children under 12 years of age, the medication may be used only upon a physician's recommendation, when the expected beneficial effect outweighs the potential risk of treatment.

Overdose.

Overdose is very rare and may manifest as abdominal discomfort and bloating.

In case of overdose, discontinue the medication and administer symptomatic treatment.

Side effects

The side effects are listed by frequency according to the following classification: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and frequency not known (cannot be estimated from the available data):

Immune system disorders

Very rare: anaphylactic and anaphylactoid reactions, hypersensitivity reactions such as urticaria.

Respiratory, thoracic and mediastinal disorders

Very rare: respiratory manifestations such as bronchospasm.

Gastrointestinal disorders

Uncommon: diarrhea, nausea, vomiting.
Frequency not known: abdominal distension, constipation.

Shelf life
2 years.

Do not use more than 6 months after first opening the bottle.

Do not use after the expiry date stated on the packaging.

Storage conditions
Keep out of the reach of children. Store at temperatures not exceeding 30 °C.

Do not store in the refrigerator. Do not freeze.

Packaging
150 mL or 300 mL in amber glass bottles with a polypropylene cap with a tamper-evident seal, or 10 mL in sachets made of polyester, aluminum, and polyethylene, with 20 sachets per cardboard box.

Marketing authorization category
Over-the-counter (without prescription).

Manufacturer
Reckitt Benckiser Healthcare (UK) Limited.

Manufacturer's address
Dansom Lane, Hull, HU8 7DS, United Kingdom.