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SUMMARY OF PRODUCT CHARACTERISTICS
ANSM – Updated: 17/06/2025
1. NAME OF THE MEDICINAL PRODUCT
GAVINIUM, oral suspension in sachet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium alginate: 500 mg
Sodium bicarbonate: 213 mg
Calcium carbonate: 325 mg
Per 10 ml sachet of oral suspension.
Excipients with known effect: each sachet contains 40 mg of methyl parahydroxybenzoate (E218), 6 mg of propyl parahydroxybenzoate (E216), 5.21 mg of propylene glycol (E1520), and 128 mg of sodium from the excipients, sodium alginate, and sodium bicarbonate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension in sachet.
An off-white to cream-colored suspension with mint odor and flavor.
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: 10–20 ml, equivalent to 1 to 2 sachets, after meals and at bedtime, up to 4 times per day.
Use in 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 for this population.
Renal impairment
Use with caution in patients following a very strict salt-free diet. See section 4.4.
Method of administration
Oral use.
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 this medicine may mask the symptoms of other, more serious underlying diseases.
GAVINIUM oral suspension in sachet should not be used in the following cases:
Patients with 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 128 mg, or 5.56 mmol, of sodium per sachet. This is equivalent to 6% 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 51% 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.
Each sachet contains 130 mg, or 3.25 mmol, of calcium. Particular care should be taken when treating patients with hypercalcemia, nephrocalcinosis, or recurrent calcium-containing kidney stones.
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions, possibly delayed.
This medicine contains 5.21 mg of propylene glycol per sachet.
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 a treated woman. 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 oral suspension in sachet 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
Abdominal distension may be observed.
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. The total neutralizing capacity of the medicine at the lowest 10 ml dose 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 percentage of time with intragastric pH ≥ 4 during the 30 minutes following treatment, the primary endpoint, was 50.8% with a sodium alginate-antacid medicine versus 3.5% 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
Carbomer, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavoring containing flavoring substances and propylene glycol (E1520), sodium hydroxide, purified water.
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. Do not refrigerate or freeze.
6.5 Nature and contents of container
Outer carton containing sachets.
The sachets are composed of polyester/aluminum foil/polyethylene/polyester/polyethylene.
Pack sizes: 4, 5, 6, 8, 10, 12, 16, 24, 48, and multipacks containing 48 sachets, 2 x 24.
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 303 190 4 8: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 4.
34009 303 190 5 5: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 5.
34009 303 190 6 2: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 6.
34009 303 190 7 9: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 8.
34009 303 190 8 6: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 10.
34009 303 190 9 3: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 12.
34009 303 191 0 9: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 16.
34009 303 191 1 6: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 24.
34009 303 191 2 3: 10 ml sachet, polyester/aluminum/PE/polyester/PE, box of 48.
34009 303 191 3 0: 10 ml sachet, polyester/aluminum/PE/polyester/PE, multipack of 48, 2 x 24 sachets.
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
To be completed later by the marketing authorization holder.
Date of first authorization: {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.
