Gavinium Mint Sugar-Free Chewable Tablets 24 Tablets

$34.95
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Gavinium Mint Sugar-Free Chewable Tablets 24 Tablets

Gavinium Mint Sugar-Free Chewable Tablets 24 Tablets

$34.95
Product Information

Description
Gavinium Mint Sugar-Free Chewable Tablets are a medicine used to relieve symptoms of acid reflux and gastroesophageal reflux disease, including heartburn, acid regurgitation, and difficult digestion. They are especially useful after meals, at bedtime, or during pregnancy when reflux symptoms may occur.

The formula combines sodium alginate, sodium bicarbonate, and calcium carbonate to help neutralize excess stomach acid and form a protective barrier that helps limit acid reflux.

Benefits
Helps relieve heartburn
Helps reduce acid reflux and acid regurgitation
Sugar-free mint flavor
Suitable for adults and adolescents from 12 years old
May be used during pregnancy and breastfeeding, with treatment kept as short as possible

Active Ingredients per Chewable Tablet
Sodium Alginate: 250 mg
Sodium Bicarbonate: 106.5 mg
Calcium Carbonate: 187.5 mg

Directions for Use
For oral use. Chew the tablets thoroughly before swallowing.

Please read the following full disclosure before purchasing or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated: 11/02/2026

1. NAME OF THE MEDICINAL PRODUCT

GAVINIUM MINT SUGAR-FREE, chewable tablet sweetened with aspartame and acesulfame potassium

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains:

Sodium Alginate: 250 mg
Sodium Bicarbonate: 106.5 mg
Calcium Carbonate: 187.5 mg

Excipients with known effect: one chewable tablet contains 5.86 mg of aspartame (E951), 0.375 mg of azorubine aluminum lake (E122), and 55.936 mg of sodium.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablet.

A 15 mm, flat, circular, two-layer chewable tablet with beveled edges. One side of the chewable tablet is pink, slightly speckled, and marked “GDA” on the surface. The other side is white with a surface marking in the shape of a sword and circle.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of symptoms of gastroesophageal reflux related to acidity, such as heartburn, acid regurgitation, and indigestion, for example after meals or during pregnancy.

This medicine is indicated for adults and children aged 12 years and over.

4.2 Dosage and method of administration

Dosage

Adults and children aged 12 years and over: 2 to 4 chewable tablets after main meals and at bedtime, up to 4 times per day.

Pediatric population

Children under 12 years old: treatment of children under 12 years old is not recommended.

Elderly patients

No dose adjustment is required for this population.

Hepatic impairment

No dose adjustment is required.

Renal impairment

Use with caution if a very strict salt-free diet is required. See section 4.4.

Method of administration

Oral use, after being carefully chewed.

Duration of treatment

The maximum recommended duration of use without medical advice is 7 days. If symptoms do not improve after 7 days of treatment, the clinical situation should be reassessed.

4.3 Contraindications

Known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

If symptoms do not improve after 7 days of treatment, the clinical situation should be reassessed.

Prolonged use should be avoided.

As with other antacid products, taking GAVINIUM MINT SUGAR-FREE, chewable tablet sweetened with aspartame and acesulfame potassium may mask the symptoms of other, more serious underlying diseases.

GAVINIUM MINT SUGAR-FREE, chewable tablet sweetened with aspartame and acesulfame potassium should not be used in the following cases:

Patients with severe kidney failure or impaired kidney function.
Patients with hypophosphatemia.

Effectiveness may be reduced in patients with very low levels of stomach acid.

Pediatric population

There is an increased risk of hypernatremia in children with gastroenteritis or suspected kidney failure.

Treatment of children under 12 years old is not recommended.

This medicine contains 223.7 mg, or 9.728 mmol, of sodium per four chewable tablets. This is equivalent to 11.18% of the WHO-recommended maximum daily dietary intake of 2 g sodium for an adult.

The maximum daily dose of this medicine is equivalent to 44.75% of the WHO-recommended maximum daily sodium intake. This medicine is considered to have a high sodium content. This should be taken into particular account for patients following a low-sodium diet, for example in certain cases of congestive heart failure and kidney failure.

Four chewable tablets contain 300 mg, or 7.5 mmol, of calcium. Particular care should be taken when treating patients with hypercalcemia, nephrocalcinosis, or recurrent calcium-containing kidney stones.

This medicine contains azorubine aluminum lake (E122), which may cause an allergic reaction.

This medicine contains 5.86 mg of aspartame per chewable tablet. Due to its aspartame content (E951), this medicine must not be given to patients with phenylketonuria.

4.5 Interaction with other medicinal products and other forms of interaction

Due to the presence of calcium and carbonates, which act as antacids, a 2-hour interval should be observed between taking this medicine and taking other medicines.

This applies in particular to H2 antihistamines, tetracyclines, digoxin, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers such as atenolol, metoprolol, and propranolol, glucocorticoids, chloroquine, estramustine, and bisphosphonates.

See also section 4.4.

4.6 Fertility, pregnancy and breastfeeding

Pregnancy

A moderate amount of data on pregnant women, between 300 and 1,000 pregnancies, has not shown any malformative or fetal/neonatal toxicity of the active substances.

Based on this experience and previous experience, the medicine may be used during pregnancy and breastfeeding if clinically necessary.

However, due to the presence of calcium carbonate, it is recommended to keep the duration of treatment as short as possible.

Breastfeeding

No effects of the active substances have been observed in newborns or infants breastfed by treated women. This medicine may be used during breastfeeding if clinically necessary.

Fertility

Preclinical animal studies have shown that alginate has no negative effect on fertility or reproductive capacity of parents or their offspring.

Clinical data do not suggest that this medicine has any effect on human fertility.

4.7 Effects on ability to drive and use machines

GAVINIUM MINT SUGAR-FREE, chewable tablet sweetened with aspartame and acesulfame potassium has no effect or negligible effect on the ability to drive vehicles and use machines.

4.8 Undesirable effects

The undesirable effects associated with sodium alginate, sodium bicarbonate, and calcium carbonate are listed below by system organ class and frequency.

Frequencies are defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency group, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders
Very rare: anaphylactic and anaphylactoid reactions; hypersensitivity reactions such as urticaria.

Metabolism and nutrition disorders
Frequency not known: alkalosis, hypercalcemia, Burnett’s syndrome.

Respiratory, thoracic and mediastinal disorders
Frequency not known: respiratory effects such as bronchospasm.

Gastrointestinal disorders
Very rare: abdominal pain, acid rebound, diarrhea, nausea, vomiting.
Frequency not known: constipation.

Skin and subcutaneous tissue disorders
Very rare: itchy skin rash.

Description of selected adverse reactions

These effects generally occur after administration of doses higher than those recommended.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.

Website: https://signalement.social-sante.gouv.fr/

4.9 Overdose

Symptoms

Symptoms will probably be minor. The patient may experience abdominal discomfort and may notice abdominal distension.

Treatment

In case of overdose, symptomatic treatment should be given.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other medicines for peptic ulcer and gastroesophageal reflux disease, ATC code: A02BX13.

This medicine is a combination of an alginate and two antacids, calcium carbonate and sodium bicarbonate, providing a protective and neutralizing effect.

Protective effect

After ingestion, this medicine quickly reacts with stomach acid to form a protective barrier, or raft, of alginic acid gel with a pH close to neutral, floating above the stomach contents.

Effective obstruction of gastroesophageal reflux may last up to 4 hours. This means acid regurgitation is mechanically prevented, thereby protecting the esophagus. In cases of severe reflux, the raft itself may be regurgitated into the esophagus instead of the stomach contents. The raft then provides a soothing effect.

Neutralizing effect

Calcium carbonate and sodium bicarbonate react immediately after ingestion to neutralize stomach acid and quickly relieve indigestion and heartburn.

GAVINIUM MINT SUGAR-FREE, chewable tablet sweetened with aspartame and acesulfame potassium neutralizes the post-meal acid pocket.

The total neutralizing capacity of the medicine at the lowest dose of two chewable tablets is approximately 10 mEqH+.

This effect was also demonstrated in an in vivo study using intragastric pH monitoring with a multi-electrode catheter in fasting healthy participants in order to eliminate variability caused by post-meal buffering. The primary endpoint of the study was the percentage of time with intragastric pH ≥ 4 during the 30 minutes following treatment. This endpoint was reached in 50.8% of cases with the sodium alginate-antacid medicine versus 3.5% of cases with placebo, p=0.0051.

5.2 Pharmacokinetic properties

The mode of action of this medicine is mechanical and does not depend on systemic absorption.

5.3 Preclinical safety data

There are no preclinical data relevant to the prescriber in addition to those already included in other sections of the Summary of Product Characteristics.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol, Mannitol (E421), Copovidone, Acesulfame Potassium, Aspartame (E951), Azorubine Aluminum Lake (E122), Magnesium Stearate, Xylitol DC containing Sodium Carmellose, Mint Flavoring containing Maltodextrin and Gum Arabic.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store at a temperature not exceeding 30°C. Store in the original packaging, protected from moisture.

6.5 Nature and contents of container

Transparent laminate blister packs made of PVC/PE/PVDC with aluminum foil lidding, packaged in a box.

Blister pack containing 2, 4, 6, or 8 chewable tablets.

Pack sizes: 4, 6, 8, 12, 16, 24, 32, 48, 60, 64, 80, and 112 chewable tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special disposal requirements.

7. MARKETING AUTHORIZATION HOLDER

RECKITT BENCKISER HEALTHCARE FRANCE
38 Rue Victor Basch
91300 Massy
France

8. MARKETING AUTHORIZATION NUMBER(S)

34009 303 240 2 8: 4 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 240 3 5: 6 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 240 4 2: 8 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 240 5 9: 12 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 240 6 6: 16 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 240 7 3: 24 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 240 9 7: 32 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 241 0 3: 48 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 241 1 0: 60 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 241 2 7: 64 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 241 3 4: 80 chewable tablets in blister pack(s) (PVC/PE/PVDC)
34009 303 241 5 8: 112 chewable tablets in blister pack(s) (PVC/PE/PVDC)

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

To be completed later by the marketing authorization holder.

Date of first authorization: {DD month YYYY}

Date of last renewal: {DD month YYYY}

10. DATE OF REVISION OF THE TEXT

To be completed later by the marketing authorization holder.

{DD month YYYY}

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.

Adults and children aged 12 years and over: take 2 to 4 tablets after meals and at bedtime, up to 4 times per day as needed.

Consult a doctor if symptoms persist for more than 7 days.

Warnings
Do not use if you are allergic to any of the ingredients.
Ask a doctor or pharmacist before use if you have kidney disease, heart disease, electrolyte disorders, hypophosphatemia, reduced stomach acid, or intolerance to certain sugars.
This product contains sodium. Use with caution if you are on a sodium-restricted diet.
Contains aspartame and azorubine aluminum lake.

Ingredients
Sodium Alginate, Sodium Bicarbonate, Calcium Carbonate, Xylitol, Sodium Carmellose, Magnesium Stearate, Macrogol, Mannitol (E421), Copovidone, Acesulfame Potassium, Aspartame (E951), Mint Flavor, Azorubine Aluminum Lake (E122).

Product Details
Brand: Gavinium
Format: Chewable tablets
Flavor: Mint
Sugar-Free: Yes
Quantity: 24 chewable tablets
Recommended Age: Adults and children 12 years and older