Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Calcium acetate
Pinewood Laboratories Ltd
A12AA; A12AA12
Calcium acetate
500 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Calcium; calcium acetate anhydrous
Not marketed
1998-01-23
PATIENT INFORMATION LEAFLET CALCIUM ACETATE 500 MG TABLETS CALCIUM ACETATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Calcium acetate tablets are and what they are used for 2. Before you take Calcium acetate tablets 3. How to take Calcium acetate tablets 4. Possible side effects 5. How to store Calcium acetate tablets 6. Further information 1. WHAT CALCIUM ACETATE TABLETS ARE AND WHAT THEY ARE USED FOR Calcium acetate tablets are ‘phosphate binding agents’ and are prescribed as part of the management of kidney failure in patients on regular haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).In kidney failure the phosphate levels in the blood can be high. These tablets control the phosphate levels by removing phosphate from the food in your stomach before it gets into the bloodstream. 2. BEFORE YOU TAKE CALCIUM ACETATE TABLETS DO NOT TAKE THE TABLETS IF YOU: are allergic (hypersensitive) to calcium acetate or any of the other ingredients in the tablets (_see Section 6 and end of Section 2_), have high levels of calcium in your blood or urine, have low levels of phosphate in your blood. TAKE SPECIAL CARE Your doctor will monitor your blood-calcium levels regularly. If your levels are too high, your dose will be reduced or treatment stopped immediately. Long-term high calcium levels in your blood may lead to a build-up of calcium in your blood vessels or soft tissues. Tell your doctor if you have heart problems or are taking medication for heart problems. TAKING OTHER MEDICINES Please tell your doctor if you are taking, or have recently taken any other med Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Acetate 500mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of Calcium Acetate. Excipient: each tablet contains 28.15 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A white 12.5 mm round tablet with bevelled edges and a breakline on one side. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcium Acetate Tablets are recommended in the treatment and prevention of hyperphosphatemia in chronic renal failure particularly for patients on regular haemodialysis therapy and continuous ambulatory peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hyperphosphatemia Dosage must be determined according to the requirements of the individual patient. Usual dose is 1-2 tablets three times daily. In special cases up to 4 tablets can be taken three times a day. 4.3 CONTRAINDICATIONS Hypersensitivity to calcium acetate or to any of the excipients. Hypercalcemia and hypercalciuria. Hypophosphataemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Excessive dosage may induce hypercalcemia. In patients with renal dysfunction the blood-calcium level should be monitored regularly. Should hypercalcemia occur dosage should be reduced or treatment discontinued immediately depending on the severity of the hypercalcemia. Chronic hypercalcemia may lead to vascular calcification, and other soft tissue calcification. Patients with rare hereditary problems of galactose intolerance, the Lapp lastase deficiency or glucose – galactose malabsorption, should not take this medicinal product. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Διαβάστε το πλήρες έγγραφο