Land: Malta
Språk: engelsk
Kilde: Medicines Authority
DIMETICONE, ALUMINIUM OXIDE, HYDRATED, MAGNESIUM HYDROXIDE
Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France
A02AF02
DIMETICONE 25 mg ALUMINIUM OXIDE, HYDRATED 200 mg MAGNESIUM HYDROXIDE 200 mg
CHEWABLE TABLET
DIMETICONE 25 mg ALUMINIUM OXIDE, HYDRATED 200 mg MAGNESIUM HYDROXIDE 200 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Authorised
2005-11-04
PACKAGE LEAFLET: INFORMATION FOR THE USER MAALOX® PLUS 200MG/200MG/25MG CHEWABLE TABLETS hydrated aluminium oxide 200mg magnesium hydroxide 200mg dimeticone (as simeticone) 25mg 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 Plus 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 PLUS CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS CHEWABLE TABLETS 3. HOW TO TAKE MAALOX PLUS CHEWABLE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MAALOX PLUS CHEWABLE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT MAALOX PLUS CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR Maalox Plus Chewable Tablets contain three different medicines: • The first two medicines are called hydrated aluminium oxide, and magnesium hydroxide. They belong to a group of medicines called antacids. • The other medicine is called dimeticone (as simeticone). It belongs to a group of medicines called antifoaming agents. Maalox Plus Chewable Tablets are used for: • The relief of indigestion (dyspepsia) • Heartburn • Wind (flatulence) Maalox Plus Chewable Tablets work by lowering the amount of acid in your stomach. The anti- foaming agent in Maalox Plus Chewable Tablets helps to remove gas from your stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS CHEWABLE TABLETS DO NOT TAKE MAALOX PLUS CHEWABLE TABLETS IF: • You are allergic (hypersensitive) to hydrated aluminium oxide, magnesium hydroxide, dimeticone (as simeticone) or any of the other ingredients in Maalox Plus Chewable Tab Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Maalox Plus Chewable Tablets 200mg/200mg/25mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 200 mg of Magnesium Hydroxide (as magnesium hydroxide paste) 200mg of Hydrated Aluminium Oxide 25mg of Dimeticone (as simeticone) Excipients with known effect: Sorbitol (E420) 45 mg Glucose 500.5 mg Sucrose 75 mg Ethanol 0.00004 mg Sulphur dioxide (E220) 13 ppm For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable Tablet. Bi-layered, white/yellow tablets engraved with “Maalox” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of heartburn, indigestion, flatulence and dyspepsia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The route of administration is oral. Recommended Dosage Adults: One to two tablets four times a day (after meals and at bedtime) or as required. Children: Not recommended 4.3 CONTRA-INDICATIONS 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 risk of phosphate depletion. Magnesium salt Les hele dokumentet