Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Calcium carbonate
Reckitt Benckiser Ireland Ltd
A02AC; A02AC01
Calcium carbonate
800 milligram(s)
Chewable tablet
Calcium compounds; calcium carbonate
Not marketed
1992-10-13
REMEGEL 800 mg Chewable Tablets Calcium Carbonate Soft Chew 24 Tablets in 3 packs Original Mint Fast Effective Relief: Acid indigestion Heartburn Excess Acid 1. What Remegel is and what it is used for: Remegel is a soft, mint flavour chew, that provides fast, effective relief from acid indigestion and heartburn. It can also reduce excess acid in stomach. Each chewable tablet contains Calcium Carbonate 800 mg. 2. Before you use Remegel: Do not take if you are allergic to Remegel or to any of its ingredients, if you have severe kidney disease, have had kidney stones, diabetes, or high levels of calcium or low levels of phosphate in your blood. Contact a doctor or pharmacist before taking Remegel if you are pregnant, under a doctor’s care, taking other medicines particularly tetracycline and quinolone antibiotics, digoxin, estramustrine, on a special diet, or have severe dietary problem (e.g. malnutrition or phosphate deficiency). Remegel contains glucose, sucrose and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking. Glucose and sucrose may be harmful to teeth. 3. How to take Remegel: Adults & Children 12 years and over: Chew 1 or 2 tablets as symptoms occur. Repeat as necessary, up to a maximum of 12 tablets in 24 hours. Not recommended for children under 12. Do not exceed the stated dose except on medical advice. Consult your doctor or pharmacist if your symptoms do not improve after 7 days. If you take more tablets than you should, seek medical advice. 4. Possible Side Effects: If you experience any serious allergic reactions (rash, skin blistering, itchiness, breathing difficulties, swelling), stop takin the medicine and seek medical advice. Constipation, belching, nausea, vomiting, stomach discomfort, diarrhoea, muscle twitching, spasms, muscular weakness or kidney stones due to high levels of calcium may occur. Reporting side effects: If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effe Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 07 March 2019 CRN008RM9 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Remegel 800 mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800mg Calcium Carbonate. Excipients with known effect: each tablet contains 99.71mg sorbitol (E420), 1.47g sucrose and 992.5mg glucose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Light green, soft, chewable squares with bevelled edges and rounded corners. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Remegel tablets are indicated for the relief of stomach upsets due to hyperacidity and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Tablets to be chewed and swallowed. ADULTS AND CHILDREN 12 YEARS AND OVER: One or two tablets of Remegel to be chewed as a single dose, when symptoms occur. Repeat as necessary. Maximum dose: 12 tablets in 24 hours. CHILDREN UNDER 12 YEARS OF AGE: Not recommended. THE ELDERLY: As for adults, see above. HEPATIC DYSFUNCTION: There is no specific information relating to the use of Remegel in hepatic impairment. Normal adult dosage is appropriate. RENAL DYSFUNCTION: Remegel should be used with caution in subjects with mild to moderate renal impairment (see section 4.4). Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia. Use in severe renal impairment is contraindicated (see sections 4.3). 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or any of the excipients, refer to section 6.1 Hypercalcaemia Nephrocalcinosis Patients with renal calculi, or with history of renal calculi Severe renal function impairment (creatinine clearance below 30ml/min) Hypophosphataemia 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 07 March 2019 CRN008RM9 Page 2 of 5 Use with caution in patients with renal dysfunction (see Posology and Method of Administration). Long term uses at high do Διαβάστε το πλήρες έγγραφο