Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Magnesium hydroxide; Aluminium oxide, hydrated
Sanofi-Aventis Ireland Limited T/A SANOFI
A02AD; A02AD01
Magnesium hydroxide; Aluminium oxide, hydrated
400mg/400 milligram(s)
Chewable tablet
Product not subject to medical prescription
Combinations and complexes of aluminium, calcium and magnesium compounds; ordinary salt combinations
Marketed
1982-04-19
PACKAGE LEAFLET: INFORMATION FOR THE USER MAALOX® 400MG/400MG CHEWABLE TABLETS ALUMINIUM OXIDE, HYDRATED 400MG MAGNESIUM HYDROXIDE 400MG IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP 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 Chewable Tablets 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 You must contact a doctor if your symptoms worsen or do not improve If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. WHAT MAALOX CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX CHEWABLE TABLETS 3. HOW TO TAKE MAALOX CHEWABLE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MAALOX CHEWABLE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT MAALOX CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR Maalox Chewable Tablets contain two different Medicines called aluminium oxide, hydrated and magnesium hydroxide. They belong to a group of medicines called antacids. Maalox Chewable Tablets are used for: . The relief of indigestion (dyspepsia) Maalox Chewable Tablets work by lowering the amount of acid in your stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX CHEWABLE TABLETS DO NOT TAKE MAALOX CHEWABLE TABLETS IF: . You are allergic (hypersensitive) to aluminium oxide, hydrated, magnesium hydroxide or any of the other ingredients in Maalox Chewable Tablets (see Section 6: Further 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 th Прочитайте повний документ
Health Products Regulatory Authority 15 March 2021 CRN009V1S Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maalox 400mg/400mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 400 mg of Aluminium oxide, hydrated 400 mg of Magnesium Hydroxide. Excipients: Each tablet contains 192mg confectioners sugar (containing no less than 97% sucrose), 125mg sorbitol (E420) and 59.2 mg sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable Tablet Flat, circular, bevel-edged white chewable tablet of diameter 1.4 cm with 'Mx' engraved on both sides and having an odour of peppermint. 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: 1-2 tablets chewed 4 times daily, taken 20 minutes to 1 hour after meals and at bedtime, or as directed by the physician. A maximum of 8 tablets in a 24 hour period should not be exceeded, nor should the maximum dose continue for more than 2 weeks except under the direction of 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. Health Products Regulatory Authority 15 March 2021 CRN009V1S Page 2 of 5 However, excessive doses or long-term use, or even normal doses in patients with low-p Прочитайте повний документ