国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium carbonate; Colecalciferol
Stirling Anglian Pharmaceuticals Ltd
A12AX
Calcium carbonate; Colecalciferol
2.5gram ; 880unit
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5060384790022
1 PACKAGE LEAFLET: INFORMATION FOR THE USER THEICAL-D 3 1000 MG / 880 IU CHEWABLE TABLETS Calcium and Colecalciferol READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take TheiCal-D 3 1000 mg / 880 IU chewable tablets carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What TheiCal-D 3 1000 mg / 880 IU chewable tablets is and what it is used for 2. Before you take TheiCal-D 3 1000 mg / 880 IU chewable tablets 3. How to take TheiCal-D 3 1000 mg / 880 IU chewable tablets 4. Possible side effects 5. How to store TheiCal-D 3 1000 mg / 880 IU chewable tablets 6. Further information 1. WHAT THEICAL-D 3 1000 MG / 880 IU CHEWABLE TABLETS IS AND WHAT IT IS USED FOR TheiCal-D 3 1000 mg / 880 IU chewable tablets is a calcium-vitamin D 3 -supplement. IT IS USED - to prevent and treat a lack of calcium and vitamin D in the elderly. - for vitamin D- and calcium supplementation as supportive treatment of osteoporosis (brittle bones). 2. BEFORE YOU TAKE THEICAL-D 3 1000 MG / 880 IU CHEWABLE TABLETS DO NOT TAKE THEICAL-D 3 1000 MG / 880 IU CHEWABLE TABLETS - if you are allergic (hypersensitive) to calcium, vitamin D 3 or any of the other ingredients of TheiCal- D 3 1000 mg / 880 IU chewable tablets - if you have high levels of calcium in your blood (hypercalcaemia) - if you have increased excretion of calcium with your urine (hypercalciuria) - if you suffer from overactive parathyroid glands (hyperparathyroidism) - if you suffer from bone marrow cancer (myeloma) - if you suffer from cancer that has affected your bones (bone metastases). - if you have a restraint of the limbs (prolonged 完全なドキュメントを読む
OBJECT 1 THEICAL-D3 1000MG/880 IU CHEWABLE TABLETS Summary of Product Characteristics Updated 14-Jan-2016 | Stirling Anglian Pharmaceuticals Ltd 1. Name of the medicinal product theiCal-D 3 1000 mg / 880 IU chewable tablets 2. Qualitative and quantitative composition Each chewable tablet contains: 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium). 8.8 mg of colecalciferol concentrate (powder form) (equivalent to 22 micrograms of colecalciferol = 880 IU of vitamin D 3 ). Excipients: Each chewable tablet contains 1.00 mg of aspartame (E951), 119.32 mg of sorbitol (E420), 370.00 mg of isomalt (E953) and 1.694 mg of sucrose. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Chewable tablet. Round, white tablet with faultless surface and a breakmark. The tablet can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications Calcium Vitamin D 3 1000 mg / 880 IU chewable tablets is indicated: - for the prevention and treatment of vitamin D and calcium deficiency in the elderly - as vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency 4.2 Posology and method of administration Posology _Adults and elderly_ 1 chewable tablet daily (corresponding to 1,000 mg of calcium and 880 IU of vitamin D 3 ). _Dosage in hepatic impairment_ No dose adjustment is required _Dosage in renal impairment_ Calcium Vitamin D 3 1000 mg / 880 IU chewable tablets should not be used in patients with severe renal impairment (see section 4.3). _Dosage during pregnancy_ During pregnancy the daily intake should not exceed 1,500 mg of calcium and 600 I.U. of vitamin D 3 . Therefore, the daily dose must not exceed half a tablet (see section 4.6). Method of administration Oral use. Calcium Vitamin D 3 1000 mg / 880 IU chewable tablets should be taken at any time, with or without food. The chewable tablets should be chewed and swallowed. Calcium Vitamin D 3 1000 mg / 880 IU chewable tablets are not intended 完全なドキュメントを読む