البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CALCIUM CARBONATE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
A12AA04
CHEWABLE TABLETS
CALCIUM CARBONATE 1000 MG
PER OS
Not required
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC, USA
CALCIUM CARBONATE
CALCIUM CARBONATE
For relief from heartburn and acidity.
2022-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a doctor’s prescription TUMS ULTRA ASSORTED BERRIES, CHEWABLE TABLETS 1000 MG Each tablet contains calcium carbonate 1000 mg (elemental calcium 400 mg) Acid-neutralizing capacity per tablet: 20 mEq. Inactive and allergenic ingredients in the preparation – please see section 6. READ THE 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. Take the preparation in accordance with the instructions in section 3 “How should you use the medicine?” of this leaflet. Consult a pharmacist if you need further information. Refer to a doctor if the symptoms worsen or are not improving after 14 days. 1. WHAT IS THE MEDICINE INTENDED FOR? For relief of heartburn and stomach acidity. THERAPEUTIC GROUP: ANTACIDS. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to calcium carbonate or to any of the additional ingredients contained in the medicine (listed in section 6) • You have excess calcium in the blood (hypercalcemia) or excess calcium in the urine (hypercalciuria) • You are on a low-phosphate diet • In patients with parathyroid gland function problems • You have impaired kidney function • In patients with Zollinger-Ellison syndrome • You are taking a cardiac glycoside (e.g., digoxin) CHILDREN AND ADOLESCENTS: Do not use the medicine in children under 12 years of age. DRUG INTERACTIONS: IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON- PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST. Especially if you are taking: • Thiazide diuretics • Bisphosphonates for treatment of bone thinning • Tetracyclines and ciprofloxacin (antibiotics). It is recommended to wait between 2 and 3 hours between taking this medicine and taking other oral medicines. PRE اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TUMS ULTRA ASSORTED BERRIES 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Carbonate 1000 mg per tablet. 3 PHARMACEUTICAL FORM Chewable Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief from heartburn and acidity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual dosage for adults and children over the age of 12 is generally: chew 2 to 3 tablets when symptoms occur, or as recommended by the physician. Maximal daily dose is 7 tablets. For pregnant, maximal daily dose is 5 tablets in 24 hours. Do not use the maximum dose for more than two weeks except under the advice and supervision of your physician. Do not use the medicine if the symptoms persist for more than two weeks, unless recommended by the physician. Do not exceed the recommended dose. If you accidentally took a higher dosage, or if a child has accidentally swallowed the medicine, refer immediately to a physician or proceed to a hospital emergency room and bring the package of the medicine with you. Symptoms of overdose may include: anorexia, thirst, nausea, vomiting, constipation, abdominal pains, muscle weakness, tiredness, mental disturbances, excessive thirst, excessive urination, bone pain, renal calcification, nephrolithiasis and, in severe cases, heart rate disturbances. Extreme overdose of calcium may cause coma and death. If you forgot to take this medicine at the designated time, do not take a double dose. Take the next dose at the usual time and consult a physician 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Contraindicated in patients with hypercalcaemia, hypercalciuria, or on a low- phosphate diet. Or those receiving cardiac glycosides or with impaired renal function. Contraindicated in patient with thyroid dysfunction, Zollinger-Ellison syndrome. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use of higher than recommended doses may result in hypercalcaemia and milk alkali s اقرأ الوثيقة كاملة