Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium carbonate
Kyowa Kirin International UK NewCo Ltd
A12AA04
Calcium carbonate
1.5gram
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09050101; GTIN: 5038903000136
Package Leaflet: Information for the patient Adcal ® 1500 mg Chewable Tablets Calcium carbonate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. ● Keep this leaflet. You may need to read it again. ● If you have any further questions, ask your doctor or pharmacist. ● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What Adcal is and what it is used for 2. What you need to know before you take Adcal 3. How to take Adcal 4. Possible side effects 5. How to store Adcal 6. Contents of the pack and other information 1. What Adcal is and what it is used for Adcal contains calcium which is essential for healthy bones and teeth. Adcal provides extra calcium to your diet. It is therefore used in conditions where your body’s calcium levels need to be increased. Adcal can be prescribed by doctors for certain bone conditions. 2. Before you take Adcal Do not take Adcal: ● If you are allergic to calcium carbonate or any of the other ingredients of this medicine (listed in Section 6). ● If you have a higher than normal level of calcium in your blood (hypercalcaemia). ● If you have very high levels of calcium in your urine (severe hypercalciuria). ● If you have severe kidney failure and are not being treated by renal dialysis. ● If you have kidney stones. ● If you have osteoporosis due to long-term immobility. Warnings and precautions Talk to your doctor or pharmacist before taking Adcal. Tell your doctor or pharmacist if you: ● have higher than normal levels of calcium in your urine (mild to moderate hypercalciuria). ● have mild to moderate problems with your kidneys. ● have previously been told by your doctor that you have an intolerance to some sugars. ● are taking a Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adcal 1500mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per tablet: Calcium carbonate: 1500mg equivalent to 600mg of elemental calcium 3 PHARMACEUTICAL FORM Chewable Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adcal is a chewable tablet recommended as a supplementary source of calcium when normal requirements are high and in the correction of calcium deficiency in the diet. They can be used in osteoporosis therapy as an adjunct to more specific conventional treatments. Adcal chewable tablets can be used as a phosphate binding agent in the management of renal failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. _Adults, elderly and children _ Dietary deficiency and as an adjunct in osteoporosis therapy; 2 chewable tablets per day, preferably one tablet each morning and evening. For use in binding phosphate in the management of renal failure in patients on renal dialysis, the dose should be adjusted for the individual patient and is dependent on the serum phosphate level. The tablets should be chewed, not swallowed whole and taken just prior to, during or immediately following a meal. 4.3 CONTRAINDICATIONS Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure untreated by renal dialysis. Hypersensitivity to any of the tablet ingredients. Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calc Read the complete document