Instructions Gaviscon Forte Mint oral suspension sachet 10 ml No. 20
Composition
active ingredients: sodium alginate, potassium bicarbonate;
5 ml of suspension contain 500 mg of sodium alginate, 100 mg of potassium bicarbonate;
Excipients: calcium carbonate, carbomer 974P, sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), mint flavoring, purified water.
Dosage form
Oral suspension.
Main physicochemical properties: almost white viscous suspension with a mint odor.
Pharmacotherapeutic group
Preparations for the treatment of peptic ulcer and gastroesophageal reflux disease. ATX code A02BX.
Pharmacological properties
Pharmacodynamics
After oral administration, Gaviscon® Forte mint suspension quickly begins to interact with gastric juice, forming a layer of alginic acid gel on its surface, which has a pH close to neutral, 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 walls of the esophagus. In addition, in vitro data have demonstrated that the gel layer has a secondary effect and is able to retain bile and pepsin in its structure and thereby additionally protect the esophagus from these components of gastric juice.
Pharmacokinetics
The mechanism of action of this drug is physical and does not depend on absorption into the systemic bloodstream.
Indication
Symptomatic treatment of gastroesophageal reflux (acid regurgitation, heartburn), reflux esophagitis, gastric dysfunction causing reflux: for example, after gastric surgery, as a result of hiatal hernia, during pregnancy.
Contraindication
The drug is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Special safety precautions
If no improvement is observed after 7 days, the clinical situation should be reviewed.
Each 10 ml of the preparation contains 78 mg (2.0 mmol) of potassium and 106 mg (4.6 mmol) of sodium, equivalent to 5.3% of the maximum daily sodium intake recommended by the WHO.
The maximum daily dose of this drug is equivalent to 21% of the maximum daily sodium intake recommended by the WHO.
This drug belongs to drugs with a high sodium content.
This should be taken into account in patients on a low-salt diet, for example in congestive heart failure and renal impairment, or taking medications that may increase plasma potassium levels.
It should also be noted that 10 ml of suspension contains 200 mg (2.0 mmol) of calcium carbonate, therefore the drug should be prescribed with caution to patients with hypercalcemia, nephrocalcinosis, and recurrent calcium-induced nephrolithiasis.
The medicine contains methylhydroxybenzoate and propylhydroxybenzoate, which may cause allergic reactions (possibly delayed).
Interaction with other medicinal products and other types of interactions
Due to the presence of calcium carbonate, which acts as an antacid, at least two hours should elapse between taking Gaviscon® Forte mint suspension and taking other medications, especially H2-antihistamines, tetracyclines, digoxin, fluoroquinolone, ferric salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoids, chloroquine, diphosphonates and estramustine.
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 substances on the fetus or newborn, as well as their lack of ability to cause congenital malformations. In case of clinical need, Gaviscon® Forte mint suspension can be used during pregnancy.
Breast-feeding.
There are no data on the effects on breastfed infants. Gaviscon® Forte mint suspension can be used during breast-feeding.
Fertility.
There are no data on the effect on fertility in humans.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles and work with other complex mechanisms.
Method of administration and doses
Adults and children over 12 years of age are prescribed the drug orally. Take 5-10 ml (1-2 teaspoons) after meals and before bedtime up to 4 times a day.
Special categories of patients:
No dose adjustment is required for elderly patients.
Hepatic impairment: No dose adjustment is required.
The drug should not be used for more than 7 days. If the symptoms of the disease persist or worsen during this period, the patient should consult a doctor to clarify the diagnosis and adjust the treatment regimen.
Children
Not recommended for children under 12 years of age.
Children under 12 years of age may use the drug only as prescribed by a doctor, when the expected positive effect outweighs the potential risk of taking the drug.
Overdose
Overdose is very rare and may manifest as abdominal discomfort and bloating.
In case of overdose, it is necessary to discontinue use of the drug and conduct symptomatic therapy.
Side effects
Adverse reactions are listed by frequency of occurrence 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 unknown (cannot be estimated from the available data):
From the immune system.
Very rare: anaphylactic and anaphylactoid reactions, hypersensitivity reactions such as urticaria.
On the part of the respiratory system, chest organs and mediastinum.
Very rare: respiratory system manifestations such as bronchospasm.
From the digestive tract.
Frequency unknown: abdominal bloating, constipation.
Expiration date
2 years.
Store no more than 6 months after first opening the bottle.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 ºС.
Do not refrigerate. Do not freeze.
Packaging
150 ml or 300 ml in orange glass bottles with a polypropylene cap with tamper-evident closure or 10 ml in a polyester, aluminum and polyethylene sachet, 20 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
Reckitt Benckiser Healthcare (UK) Limited.
Address
Dansom Lane, East Yorkshire, Hull, HU8 7DS, United Kingdom.
