البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE
PHARMA SHALOM
A02AD01
SUSPENSION
ALUMINIUM HYDROXIDE 175 MG / 5 ML; MAGNESIUM HYDROXIDE 200 MG / 5 ML
PER OS
Not required
SANOFI S.P.A., ITALY
ORDINARY SALT COMBINATIONS
Antacid.
2020-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed without a doctor’s prescription Name of the preparation and its form: MAALOX SUSPENSION Active ingredients and their quantity per dosage unit: Each teaspoon (5 ml) contains: Aluminium hydroxide 175 mg Magnesium hydroxide 200 mg Inactive ingredients – see section 6 and “Important information about some of the ingredients in this medicine” section. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or pharmacist. Keep this leaflet; you may need to read it again. Take this preparation according to the instructions in the Dosage section in this leaflet or according to the doctor’s instructions. Consult the pharmacist if you need further information. Refer to the doctor if symptoms worsen or are not improving. If one of the side effects worsens or if you suffer from a side effect not mentioned in this leaflet, refer to the doctor or pharmacist. The medicine is not intended for children under 14 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Maalox Suspension contains two different medicines that belong to the group called antacids. The preparation is intended to reduce the amount of gastric acid and to relieve the sensation of heartburn. Therapeutic group: antacids. 2. BEFORE USING THE MEDICINE X DO NOT USE THE MEDICINE IF: • you are allergic to aluminium hydroxide or magnesium hydroxide or to any of the other ingredients of the medicine (see section 6). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue. • you feel severe exhaustion. • you are suffering from kidney problems. Prolonged exposure to high doses of Maalox Suspension may lead to dementia. • you are suffering from severe abdominal pain. • you are suffering from partial or full bowel obstruction. Do not take t اقرأ الوثيقة كاملة
1 NAME OF THE MEDICINAL PRODUCT Maalox Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of the suspension contains: 200 mg of Magnesium Hydroxide and 175 mg of Aluminium Hydroxide. Excipients with known effect: This medicinal product contains 1.4 mg of sodium saccharin and 50 mg of sorbitol per 5 ml dose. For the 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 Antacid 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Recommended Dosage _ _ _ADULTS (INCLUDING THE ELDERLY): _ 10-20 ml taken 20 minutes to one hour after meals and at bedtime or as required. Maalox can be taken with water or milk if required. _CHILDREN: _ Not recommended for children under 14 years. METHOD OF ADMINISTRATION For oral administration: Shake before use 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Maalox should not be used in patients who are severely debilitated or suffering from renal insufficiency, or if there is severe abdominal pain and/or the possibility of bowel obstruction. 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, 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 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 deplet اقرأ الوثيقة كاملة