MAALOX Oral suspension (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Maalox 200mg/175mg per 5ml Oral Suspension.

2. Qualitative and quantitative composition

Each 5 ml of the suspension contains: 200 mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste), 175 mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel). Excipients: Each 5ml also contains ...

3. Pharmaceutical form

Oral Suspension. White, viscous, aqueous oral suspension with a peppermint odour and taste.

4.1. Therapeutic indications

For the relief of the symptoms of dyspepsia.

4.2. Posology and method of administration

The route of administration is oral. Recommended Dosage Adults One to Two x 5 ml spoonfuls taken 20 minutes to one hour after meals and at night as required or as directed by the physician. Children Not ...

4.3. Contraindications

Use in severely debilitated patients or in those suffering from kidney failure. Use in patients who are hypersensitive to the active ingredients or to any of the excipients.

4.4. Special warnings and precautions for use

Aluminium hydroxide may cause constipation and magnesium salts overdose may cause hypomotility of the bowel; large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients ...

4.5. Interaction with other medicinal products and other forms of interaction

Aluminium hydroxide may form complexes with certain drugs, e.g. tetracyclines, digoxin and vitamins, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered. ...

4.6. Pregnancy and lactation

There are no available data on Maalox use in pregnant women. No conclusions can be drawn regarding whether or not Maalox is safe for use during pregnancy. Maalox should be used during pregnancy only if ...

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

Side effects are uncommon at recommended doses Immune system disorders Not known: hypersensitivity reactions, such as pruritus, urticaria, angioedema and anaphylactic reactions. Gastrointestinal ...

4.9. Overdose

SIGNS AND SYMPTOMS Reported symptoms of acute overdose with aluminium hydroxide and magnesium salts combination include diarrhea, abdominal pain, vomiting. Large doses of this product may trigger or aggravate ...

5.1. Pharmacodynamic properties

Maalox is a balanced mixture of two antacids: aluminium hydroxide is a slow acting antacid and magnesium hydroxide is a fast acting one. The two are frequently combined in antacid mixtures. Aluminium hydroxide ...

5.2. Pharmacokinetic properties

The absorption of aluminium and magnesium from antacids is small. Aluminium hydroxide is slowly converted to aluminium chloride in the stomach. Some absorption of soluble aluminium salts occurs in the ...

5.3. Preclinical safety data

Not relevant.

6.1. List of excipients

Domiphen bromide Citric Acid, monohydrate Saccharin sodium Sorbitol liquid (Non-crystallising) (E420) Mannitol (E421) Hydrogen peroxide Peppermint oil Hydrochloric acid Purified water

6.2. Incompatibilities

None known.

6.3. Shelf life

As packaged for sale: 3 years. After first opening the container: this product should be used within 6 months of first opening the bottle.

6.4. Special precautions for storage

Do not store above 25ºC.

6.5. Nature and contents of container

White PET bottles with plastic screw cap: 250 ml and 355 ml. Not all pack sizes are marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

8. Marketing authorization number(s)

PA23180/009/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 19 April 1982 Date of last renewal: 01 October 2009

10. Date of revision of the text

October 2021

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