Maalox Syrup - Mint Flavor | Relieves Heartburn & Acid Reflux (250 ml)

For: Teenagers (15+), Adults
Suitable for Pregnant Women: Only on medical advice
Suitable for Breastfeeding Women: Yes
Form: Oral Solution

Product Description:

Maalox® Syrup (250 ml) is an effective oral solution designed to relieve heartburn, acid reflux, and stomach discomfort. It works by neutralizing excess stomach acid, providing fast and lasting relief.

Ideal for adults and adolescents aged 15 and over, this mint-flavored syrup offers a refreshing taste while soothing digestive discomfort.

Active Ingredients:

• Aluminium Hydroxide

• Magnesium Hydroxide

Other Ingredients: Purified water, concentrated hydrochloric acid, citric acid monohydrate, peppermint essential oil, mannitol, domiphene bromide, sodium saccharin, liquid sorbitol (non-crystallising) (E420).

Dosage & Usage:

• Recommended Dose: 1 tablespoon (approx. 15 ml) when experiencing heartburn or acid reflux.

• Maximum Dose: Do not exceed 6 tablespoons (90 ml) per day.

• Duration: Limit use to 10 consecutive days without medical advice.

Important: If you are taking other medications, maintain a 2-hour gap between Maalox and other treatments to prevent interactions.

Precautions for Use:

Do NOT use Maalox Syrup if you:

• Are allergic to any of its ingredients.

• Have severe kidney disease.

Consult a doctor before use if you:

• Experience weight loss, difficulty swallowing, or persistent abdominal discomfort.

• Suffer from digestive disorders, kidney issues, or are undergoing dialysis (risk of aluminum and magnesium accumulation causing neurological issues).

Special Warnings:

• Not recommended for individuals with fructose intolerance due to sorbitol (E420) content.

• Always inform your doctor or pharmacist if you're taking other medications, including over-the-counter products.

Pregnancy & Breastfeeding:

• Pregnant Women: Use only under medical supervision.

• Breastfeeding: Safe to use.

Packaging:

• 250 ml Bottle

Storage:
Keep out of reach of children. Store in a cool, dry place away from direct sunlight.

Consult your healthcare provider if symptoms persist.

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

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 01/07/2023

1. NAME OF THE MEDICINAL PRODUCT

MAALOX STOMACH PAIN

Aluminium Hydroxide/Magnesium Hydroxide 525 mg/600 mg, oral suspension in bottle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

• Aluminium Hydroxide: 3.50 g

• Magnesium Hydroxide: 4.00 g

(Per 100 ml)

Each tablespoon (15 ml) contains 525 mg of aluminium hydroxide and 600 mg of magnesium hydroxide.

Notable excipient: 15 ml of suspension contains 0.15 g of sorbitol (E420) (see section 4.4).

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.

4. CLINICAL DATA

4.1. Therapeutic Indications

Indicated for adults and adolescents over 15 years old for the relief of heartburn and acid reflux.

4.2. Posology and Method of Administration

For Adults and Adolescents (15+):

• Dosage: 1 tablespoon during episodes of heartburn or acid reflux. Do not exceed 6 tablespoons per day.

• Duration: Treatment should not exceed 10 days without medical advice.

Method of Administration: Oral use.

4.3. Contraindications

• Hypersensitivity to active substances or any excipients listed in section 6.1.

• Severe renal impairment due to magnesium content.

4.4. Special Warnings and Precautions for Use

Special Warnings:

Consult a doctor if you experience:

• Unintentional weight loss

• Difficulty swallowing or persistent abdominal discomfort

• Newly occurring or recently changed digestive disorders

• Renal impairment

Potential Side Effects:

• Aluminium hydroxide may cause constipation and worsen intestinal obstruction, especially in high-risk patients (elderly or with renal impairment).

• Magnesium overdose can slow intestinal movement.

Excipients of Note:

• Contains 0.15 g of sorbitol per tablespoon. Sorbitol is a source of fructose and should not be used in patients with hereditary fructose intolerance (HFI).

• Contains less than 1 mmol (23 mg) of sodium per tablespoon, considered "sodium-free."

Precautions for Use:

• Prolonged use can lead to phosphate depletion, bone resorption, and risk of osteomalacia.

• Caution in patients with renal impairment due to accumulation risks.

• Prolonged antacid use in renal impairment should be avoided.

4.5. Interactions with Other Medicinal Products

Antacids can reduce the absorption of certain oral medications. Maintain at least a 2-hour gap between Maalox and other medications (4 hours for fluoroquinolones).

4.6. Fertility, Pregnancy, and Breastfeeding

Pregnancy:

• Limited data available; use only if necessary.

• May cause diarrhea (magnesium salts) or constipation (aluminium salts).

Breastfeeding:

• Considered compatible due to limited maternal absorption.

Fertility:

• No data available.

4.7. Effects on the Ability to Drive and Use Machines

Not applicable.

4.8. Undesirable Effects

• Immune System Disorders: Hypersensitivity reactions (rash, pruritus, urticaria, anaphylactic shock).

• Metabolism Disorders: Hypermagnesemia, hyperaluminemia, hypophosphatemia.

• Gastrointestinal Disorders: Abdominal pain, diarrhea, constipation.

4.9. Overdose

• Magnesium overdose may cause hypotension, nausea, drowsiness, bradycardia, and respiratory depression, especially in renal impairment.

• Treatment includes rehydration and forced diuresis. Calcium gluconate IV may counteract hypermagnesemia.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic Group: Antacids (ATC code: A02AD01)

• Mechanism: Mucosal protector for the esophagus, stomach, and duodenum.

• Absorption: Minimal systemic absorption under normal conditions.

6. PHARMACEUTICAL DATA

6.1. List of Excipients

Hydrochloric acid (10%), citric acid monohydrate, peppermint essential oil, mannitol, domiphen bromide, sodium saccharin, liquid sorbitol (non-crystallising) (E420), hydrogen peroxide, purified water.

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

• 250 ml PET bottle: 3 years

• 250 ml polyethylene & 500 ml brown glass bottles: 2 years

After Opening: Use within 6 months.

6.4. Special Precautions for Storage

Store below 25°C.

6.5. Packaging

• 250 ml (polyethylene or PET bottle)

• 500 ml (brown glass bottle)

Not all pack sizes may be marketed.

6.6. Special Precautions for Disposal

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

OPELLA HEALTHCARE FRANCE SAS
157 Avenue Charles de Gaulle, 92200 Neuilly-sur-Seine

8. MARKETING AUTHORIZATION NUMBERS

• 34009 353 828 9 4: 250 ml (PE bottle)

• 34009 300 076 4 8: 250 ml (PET bottle)

• 34009 353 830 3 7: 500 ml (brown glass bottle)

9. DATE OF FIRST AUTHORIZATION/RENEWAL

[To be completed by the authorization holder]

10. DATE OF TEXT REVISION

[To be completed by the authorization holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS:
Over-the-counter medication.