البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE; SIMETHICONE
PHARMA SHALOM
SUSPENSION
ALUMINIUM HYDROXIDE 175 MG / 5 ML; MAGNESIUM HYDROXIDE 200 MG / 5 ML; SIMETHICONE 25 MG / 5 ML
PER OS
Not required
OPELLA HEALTHCARE INTERNATIONAL SAS, FRANCE
Antacid, antiflatulent, relief of sensation of heatburn.
2022-10-31
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 PLUS SUSPENSION Active ingredients and their quantity per dosage unit: EACH TEASPOON (5 ML) OF SUSPENSION CONTAINS: Aluminium hydroxide 175 mg Magnesium hydroxide 200 mg Simethicone 25 mg Inactive ingredients: see “Important information about some of the ingredients in this medicine” section and section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet; you may need to read it again. Use according to the instructions in the Dosage section in this leaflet. Consult the pharmacist if you need further information. Refer to the doctor if symptoms worsen or are not improving. The medicine is not intended for children under 6 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Maalox Plus contains three different medicines: two that belong to the group called antacids and one which is an anti-foaming agent. Maalox Plus is used as an antacid, anti-flatulence agent and to relieve the sensation of heartburn in the digestive system. THERAPEUTIC GROUP: antacid and anti-flatulence agent in the digestive system. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF YOU: • are sensitive (allergic) to aluminium hydroxide, magnesium hydroxide, simethicone 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. • feel severe exhaustion. • are suffering from kidney problems/kidney failure. • are suffering from severe abdominal pain or partial or full bowel obstruction. • are suffering from a low blood phosphate level (hypophosphatemia). This condition can be identified in your blood tests. Do not take the medicine if o اقرأ الوثيقة كاملة
1. NAME OF THE MEDICINAL PRODUCT Maalox Plus Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5ml of the suspension contains: 175 mg of Aluminum Hydroxide (as aluminium hydroxide gel), 25 mg of simethicone and 200mg of Magnesium Hydroxide Also contains 320 mg of sorbitol liquid 70% per 5 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension White suspension, homogenous after shaking, with the odour and taste of lemon . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antacid, antiflatulent, relief of sensation of heartburn 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults 5-10ml, four times a day, taken 20 minutes to 1 hour after meals and at bedtime or as required. Children Child 6–12 years 5 mL 3–4 times daily Child 12–18 years 5–10 mL 4 times daily, taken 20 minutes to 1 hour after meals and at bedtime when required Elderly The normal adult dose is appropriate. 4.3 CONTRAINDICATIONS Should not be used in patients who are hypersensitive to any of the active substances or excipients, are severely debilitated or suffering from kidney failure, or hypophosphataemia 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 a اقرأ الوثيقة كاملة