PATIENT PACKAGE INSERT IN ACCORDANCE Shake well before use; intended for administration by WITH THE PHARMACISTS’ REGULATIONS mouth. If necessary, the medicine can be taken with (PREPARATIONS) - 1986 water or milk. The medicine is dispensed without The usual dosage for adults, the elderly, and a doctor’s prescription children above 14 years of age: 10-20 ml, 20 minutes to one hour after meals and at Name of the preparation and its form bedtime or according to doctor’s instructions. You must use a measuring spoon or cup meant for Maalox suspension measuring the correct amount of medicine. Do not use a household spoon to measure the amount of medicine. Household spoons differ in size and you Active ingredients and their quantity per dosage may not get the correct amount of medicine. unit: Do not exceed the recommended dose. Each teaspoon (5 ml) contains: If the symptoms do not pass, refer to the doctor. Aluminium hydroxide 175 mg This medicine is not intended for children under Magnesium hydroxide 200 mg 14 years of age. Inactive ingredients - see section 6. Do not take for more than two weeks without instruction from the doctor. Read the package insert carefully in its entirety before using the medicine. Tests and monitoring Keep this leaflet; you may need to read it again. If you have to have diagnostic tests with radioactive Refer to the doctor if symptoms worsen or are not reagents, inform the doctor that you are taking this improving. medicine, as the test results may be affected by the presence of aluminium. If a side effect worsens or if you suffer from a side effect not mentioned in this leaflet, please refer to If you have accidentally taken an overdose or if the doctor or pharmacist. a child has accidentally swallowed the medicine, This leaflet contains concise information about the refer to the doctor or to a hospital emergency room medicine. If you have additional questions, refer to immediately and bring the package of the medicine the doctor or pharmacist. with you. In such a case you may suffer from diarrhea, The medicine is not intended for children under 14 abdominal pain, bloating, vomiting, indigestion, years of age. heartburn, upset stomach, constipation, loss of appetite, dry mouth. These can be caused by intestinal 1. What is the medicine intended for? obstruction. Maalox Suspension contains two different medicines that High dosages of the preparation may cause or worsen belong to the group called antacids. phosphate deficiency, bone problems, increased The preparation is intended to reduce the amount of gastric calcium levels in the urine, rickets. acid and to relieve the sensation of heartburn. Do not take medicines in the dark! Check the label and Therapeutic group: antacids. the dose each time you take medicine. Wear glasses if you need them. 2. Before using the medicine If you have further questions regarding use of this Do not use the medicine if: medicine, consult the doctor or pharmacist. • you are allergic to aluminium hydroxide or 4. Side effects magnesium hydroxide or to any of the other As with all medicines, use of Maalox may cause side components of the medicine (see section 6). Signs effects in some users. Do not be alarmed when reading of an allergic reaction include: rash, swallowing the list of side effects; you may not suffer from any or breathing problems, swelling of the lips, face, of them. throat or tongue • you feel severe exhaustion Stop taking the medicine and refer immediately • you are suffering from kidney problems to the doctor or proceed to a hospital emergency • you are suffering from severe abdominal pain or room if: from partial or full bowel obstruction Side effects of unknown frequency (cannot be evaluated from the available data): Special warnings relating to use of the medicine You suffer from a red and bumpy rash, swelling of the Refer to the doctor or pharmacist before beginning eyelids, face, lips, mouth or tongue, itching, difficulty treatment if you suffer from low blood phosphate level breathing or swallowing. This could be an allergic or are on a low-phosphorus diet. reaction. Do not use this medicine frequently or for a prolonged period without consulting the doctor. Refer to the doctor or pharmacist if any of the following side effects worsens or lasts longer than If you are taking, or have recently taken, other a few days: medicines, including non-prescription medicines and nutritional supplements, inform the doctor or Uncommon side effects: may occur in up to 1 out pharmacist. of 100 users: Maalox suspension, like other antacids containing Diarrhea or constipation. aluminium, can impair the absorption of other Side effects of unknown frequency (cannot be preparations; allow a lapse of at least two hours evaluated from the available data): between taking them and taking Maalox (a lapse of 4 Increased blood magnesium or aluminium levels, hours for fluoroquinolone). decreased blood phosphate level that may, with In particular, inform the doctor or pharmacist if you prolonged use or a high dosage or an appropriate are taking: dosage for patients on a low-phosphorus diet, cause - Antibiotics such as: tetracycline, penicillamine, bone problems, increased calcium levels in the urine, or lincosamide antibiotics (e.g.: clindamycin), or rickets. fluoroquinolone antibiotics (e.g.: ciprofloxacin, If any of the side effects worsen, or when you suffer ofloxacin, levofloxacin), or antibiotics for treating from a side effect not mentioned in the leaflet, consult tuberculosis (e.g.: ethambutol, isoniazid), the doctor. or cephalosporin antibiotics (e.g.: cefdinir, cefpodoxime). Side effects can be reported to the Ministry of Health - H2 antagonists used for treatment of gastric ulcer by clicking on the link “Report Side Effects of Drug (e.g.: cimetidine, ranitidine, famotidine). Treatment” found on the Ministry of Health homepage - bisphosphonates used for the treatment of (www.health.gov.il) that directs you to the online form osteoporosis or Paget’s disease (e.g.: alendronate for reporting side effects, or by entering the link: sodium, etidronate sodium, risedronate sodium) https://forms.gov.il/globaldata/getsequence/getseque - glucocorticoids [email protected] - neuroleptics of the phenothiazine group (e.g.: 5. How should the medicine be stored? fluphenazine, thioridazine) Avoid poisoning! This medicine and all other medicines - preparations containing iron salts should be stored in a closed place out of the reach of - propranolol, metoprolol, atenolol, digoxin children and/or infants in order to avoid poisoning. (preparations for the treatment of cardiac disease/ Do not induce vomiting unless explicitly instructed to blood pressure) do so by a doctor. - chloroquine, hydroxychloroquine, chlorpromazine, Do not use the medicine after the expiry date (exp. rifampicin date) that is indicated on the bottle. The expiry date - diflunisal, indomethacin (analgesics) refers to the last day of that month. In any case of - ketoconazole (antifungal) doubt, consult the pharmacist who dispensed the - sodium fluoride (preparation for prevention of medicine to you. dental caries) Store at a temperature below 25°C. - levothyroxine (for treatment of thyroid gland Do not freeze. Keep the bottle tightly closed. hormone deficiency) After first opening, can be used for 6 months. - rosuvastatin (for lowering blood cholesterol levels) 6. Further information - polystyrene sulfonate (kayexalate - preparation for treatment of potassium excess) In addition to the active ingredients, the medicine - vitamins also contains: - Combined administration with quinidine can cause Sorbitol liquid 70% (non crystallizing) 71.45 mg/5 an increase in blood quinidine levels ml, Hydrochloric acid 10%, Mannitol, Citric acid - Combined administration with preparations monohydrate, Hydrogen peroxide solution 30%, containing citrate can increase aluminium levels, Saccharin sodium 1.4 mg/5 ml, Peppermint oil, particularly in patients suffering from kidney Domiphen bromide 0.211 mg/5 ml, Purified water. dysfunction What the medicine looks like and contents of the Use of the medicine and food pack The medicine can be taken with water or milk. Maalox is a white, mint-flavored and scented Drink the suspension 20 minutes to one hour after suspension packaged in a white bottle. meals and at bedtime. This leaflet does not contain all the information about your medicine. If you have any questions Pregnancy and breastfeeding or are not sure about anything, please ask your Consult the doctor or pharmacist before using this doctor. medicine if: - you are pregnant, may become pregnant, or think License holder and its address: you are pregnant. Do not use the medicine during sanofi-aventis Israel ltd.; the first three months of pregnancy. P.O.B. 8090, Netanya 4250499. - you are breastfeeding or plan to breastfeed. Manufacturer and its address: Important information regarding some of the Sanofi S.p.A, Origgio, Italy. ingredients of the medicine This leaflet was checked and approved by the Ministry The preparation contains sorbitol - if you suffer from a of Health in June 2014. problem tolerating or digesting certain sugars, consult the doctor before using the medicine. Registration number of the medicine in the National Drug Registry of the Ministry of Health: 485924105. 3. How should you use the medicine? Check with the doctor or pharmacist if you are unsure.