Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ALUMINIUM OXIDE HYDRATED, MAGNESIUM HYDROXIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
A02AB10
ALUMINIUM OXIDE HYDRATED, MAGNESIUM HYDROXIDE
460/400 Milligram
Oral Suspension
Oral use
20 sachets each containing 4.3ml of oral suspension
Product not subject to medical prescription
A. Nattermann & Cie GmbH
COMBINATIONS
For the relief of the symptoms of dyspepsia
Authorised
2015-07-10
Reference: 11923 1.3.1.3 - Leaflet Text - PIL - 460mg, 400mg - 2016-04-12 - 0000 - CCDSv3-5 - 540/110/6 1.5 MAALOX SACHETS 460MG/400MG ORAL SUSPENSION _aluminium hydroxide_ _magnesium hydroxide _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Maalox is and what it is used for 2. Before you take Maalox 3. How to take Maalox 4. Possible side effects 5. How to store Maalox 6. Further information 1. WHAT MAALOX IS AND WHAT IT IS USED FOR Maalox Sachets contains two different medicines. They are called Aluminium hydroxide and Magnesium hydroxide. They belong to a group of medicines called antacids. Maalox Sachets are used for: • Heartburn or when your stomach has too much acid (indigestion) • Lowering the amount of acid in your stomach or gut (intestine) when you have an ulcer. Maalox works by lowering the amount of acid in your stomach. 2. BEFORE YOU USE MAALOX DO NOT TAKE MAALOX IF: You are allergic (hypersensitive) to Aluminium hydroxide or Magnesium hydroxide or any of the other ingredients in Maalox Sachets (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. You have severe stomach pain. Your bowel is partial Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maalox Sachets 460mg/400mg Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 460mg Aluminium hydroxide (aluminium oxide hydrated) and 400mg Magnesium hydroxide. Excipients: Each 4.3ml sachet also contains 140mg of sorbitol (E420) and 3144.32 mg of Sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension White to faintly yellow homogeneous suspension 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 sachets taken 20 minutes to one hour after meals and at night as required or as directed by the physician 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 Przeczytaj cały dokument