País: Israel
Idioma: inglés
Fuente: Ministry of Health
CALCIUM CARBONATE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
A12AA04
CHEWABLE TABLETS
CALCIUM CARBONATE 750 MG
PER OS
Not required
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC, USA
CALCIUM CARBONATE
CALCIUM CARBONATE
For relief from heartburn and acidity
2020-06-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a physician's prescription TUMS ™ SMOOTHIES EX BERRY FUSION Chewable tablets Each tablet contains Calcium Carbonate 750 mg (elemental calcium 300 mg) Acid-neutralizing capacity per tablet: 15 mEq. List of the additional ingredients detailed in section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the physician or the pharmacist. 1. WHAT IS THE MEDICINE INTENDED FOR? Relief of heartburn (pyrosis) and sour stomach. THERAPEUTIC GROUP: antacids. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • If you are sensitive (allergic) to the Calcium Carbonate or to any of the additional ingredients contained in the medicine (listed in section 6) • In patients with hypercalcaemia, hypercalciuria • In patients on a low- phosphate diet • In patients with problems with parathyroid glands function • In patients with kidney problems (e.g. kidney stones) • In patients with Zollinger- Ellison Syndrome • In patients taking Digoxin for heart diseases. DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A PHYSICIAN BEFORE STARTING THE TREATMENT: • In children under the age of 12 • If you are suffering from diabetes (the medicine contains sugar). IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER M E D I C I N E S I N C L U D I N G NON-PRESCRIPTION MEDICINES AND FOOD SUPPLEMENTS, TELL THE PHYSICIAN OR THE PHARMACIST. Especially if you are taking: T h i a z i d e d i u r e t i c s , bisphosphonates for treatment of bone loss, tetracyclines and ciprofloxacin (antibiotics). It is recommended to wait 2-3 hours between taking this medicine and taking other oral medicines. PREGNANCY AND BREAST- FEEDING Consult the physician or the pharmacist before using this medicine. See section 3 for the 'usual dosage'. IMPORTANT INFORMATION ABOUT SOME INGREDIENTS OF THE MEDICINE • The medicine contai Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TUMS SMOOTHIES EX BERRY FUSION 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Carbonate 750 mg per tablet. 3 PHARMACEUTICAL FORM Chewable Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual dosage for adults and children over the age of 12 is generally: chew 2 to 4 tablets when symptoms occur, or as recommended by the physician. Maximal daily dose is 10 tablets. For pregnant, maximal daily dose is 6 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 syndr Leer el documento completo