Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Magnesium hydroxide; Aluminium hydroxide
Opella Healthcare France SAS T/A Sanofi
A02AD; A02AD01
Magnesium hydroxide; Aluminium hydroxide
200mg/175 mg/5ml
Oral suspension
Combinations and complexes of aluminium, calcium and magnesium compounds; ordinary salt combinations
Marketed
1982-04-19
MAALOX® 200MG/175MG PER 5ML ORAL SUSPENSION _magnesium hydroxide _ _aluminium hydroxide _ _ _ READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU This medicine is available without prescription. However, you still need to use Maalox Oral Suspension carefully to get the best results from it. • Keep this leaflet. You may need to read it again • Ask your pharmacist if you need more information or advice • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. • You must talk to a doctor if you do not feel better or if you feel worse after taking this medicine. IN THIS LEAFLET: 1. What Maalox Oral Suspension is and what it is used for 2. What you need to know before you take Maalox Oral Suspension 3. How to take Maalox Oral Suspension 4. Possible side effects 5. How to store Maalox Oral Suspension 6. Contents of the pack and other information 1. WHAT MAALOX ORAL SUSPENSION IS AND WHAT IT IS USED FOR Maalox Oral Suspension contains two different medicines. They are called magnesium hydroxide and aluminium hydroxide. They belong to a group of medicines called antacids. Maalox Oral Suspension is used for: • The relief of indigestion (dyspepsia) Maalox Oral Suspension works by lowering the amount of acid in your stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX ORAL SUSPENSION DO NOT TAKE MAALOX ORAL SUSPENSION IF: • You are allergic (hypersensitive) to aluminium hydroxide or magnesium hydroxide or any of the other ingredients in Maalox Oral Suspension (see Section 6: Contents of the pack and other information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • You are feeling very weak and have no energy (debilitated) • You have kidney problems • You have low levels of phosphate (called “hypophosphataemia”). This is shown up in blood tests Do not take this medicine if any of the above apply to you. If you Read the complete document
Health Products Regulatory Authority 15 November 2023 CRN00DRFC Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 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 71.45mg sorbitol (E420) and 1.59mg sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension White, viscous, aqueous oral suspension with a peppermint odour and taste. 4 CLINICAL PARTICULARS 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 recommended 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 at higher risk such as those with renal impairment, infants less than 2 years, or the elderly.. Aluminium hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low-phosphorus diets or in infants less than 2 years, may lead to phosphate depletion (due to aluminium-phosphate binding) accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Medical advice is recommended in case of long-term use or in patients at Read the complete document