Country: Израел
Језик: Енглески
Извор: Ministry of Health
SODIUM BICARBONATE
REKAH PHARMACEUTICAL INDUSTRY LTD, ISRAEL
B05CB04
TABLETS
SODIUM BICARBONATE 500 MG
PER OS
Not required
REKAH PHARMACEUTICAL INDUSTRY LTD, ISRAEL
SODIUM BICARBONATE
SODIUM BICARBONATE
Antacid.
2021-11-30
Patient package insert according to Pharmacists' Regulations (Preparations) -1986 This medicine can be sold without a physician’s prescription SODIUM BICARBONATE 500 mg, Tablets Composition: Each tablet contains: Sodium Bicarbonate 500 mg. Each tablet contains approximately 137 mg Sodium. Inactive ingredients and allergens in the medicine - see section 6 "Additional information". Read the entire leaflet carefully before using this medicine. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. Take this medicine according to the instructions in section 3 "How to use this medicine?" in this leaflet. Consult the pharmacist if you need additional information. Refer to a doctor if the symptoms of your illness get worse or if they do not improve after 14 days. 1. What is the medicine intended for? The medicine Sodium Bicarbonate 500 mg is intended for relief in cases of hyperacidity in the stomach. Therapeutic group: Antacid. 2. Before using this medicine Do not use this medicine if: • You are hypersensitive (allergic) to the active ingredient (Sodium Bicarbonate) or to any of the other ingredients this medicine contains (see section 6 "Additional information”). Special warnings regarding the use of this medicine Before using Sodium Bicarbonate 500 mg, tell the doctor if: • You have previously suffered from heart failure • You suffer from liver or kidney problems • You have high blood pressure • You are on a low salt diet (each tablet contains approximately 137 mg of Sodium) • You are elderly Children and adolescents: The medicine is not recommended for use in children and infants under 6 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: • Drugs containing Lithium (for depression) • Phenothiazines (to treat anxiety) • Antibiotics (e.g., Rifampicin or Tetracycl Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Bicarbonate 500 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Sodium Bicarbonate 500 mg. Each tablet contains approximately 137 mg Sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white, round biconvex tablet, "REKAH" engraved on one size, plain on the other. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Sodium Bicarbonate is used for relief in cases of hyperacidity in the stomach. 4.2 Posology and method of administration Posology Adults 1-4 tablets, 4 times daily _(_ 0.5g – 8g), as needed. Paediatric population Not recommended for use under 6 years of age. Method of administration Oral. To be swallowed with a glass of water. For ease of swallowing, the tablet may be halved or crushed, for immediate use. No information is available regarding the uniformity of split halves of the tablet. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Avoid in patients on salt restricted diets. Administer with caution in patients suffering from heart failure, hypertension, hepatic or renal impairment. Warning: Do not take more medicine than the label tells you to. Prolonged use should be avoided. Caution advised in elderly patients. Although a reduction of the normal adult dose is not considered necessary, sodium retention could occur if there is concomitant impaired cardiac or renal function. 4.5 Interaction with other medicinal products and other forms of interaction Sodium bicarbonate increases the excretion of lithium, resulting in reduced plasma lithium concentration. Antacids reduce the absorption of antibacterials (eg. tetracycline, rifampicin) and antifungals (itraconazole and ketoconazole). They also reduce the absorption of dipyridamole, phenothiazines, chloroquine, hydroxychloroquine, phenytoin, gabapentin, bisphosphonates, penicillamine, captopril, enalapril and possibly othe Прочитајте комплетан документ