País: Malta
Língua: inglês
Origem: Medicines Authority
CALCIUM, COLECALCIFEROL
Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France
A12AX
CALCIUM 500 mg COLECALCIFEROL 400 IU
CHEWABLE TABLET
CALCIUM 500 mg COLECALCIFEROL 400 IU
OTC
MINERAL SUPPLEMENTS
Authorised
2006-08-11
1.3.1. Proposed Product Information Malta November 2021 PACKAGE LEAFLET 1.3.1. Proposed Product Information Malta November 2021 PACKAGE LEAFLET: INFORMATION FOR THE USER IDEOS 500 MG/400 IU, CHEWABLE TABLETS Calcium, vitamin D 3 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What IDEOS is and what it is used for 2. What you need to know before you take IDEOS 3. How to take IDEOS 4. Possible side effects 5. How to store IDEOS 6. Contents of the pack and other information 1. WHAT IDEOS IS AND WHAT IT IS USED FOR IDEOS contains two active substances calcium and vitamin D3 (also called cholecalciferol). It belongs to a group of medicines called calcium, combinations with vitamin D and or other drugs. This medicine is used: - in case of vitamin D and calcium deficiency in the elderly, - in association with some treatments of osteoporosis (a condition where bone mass decreases and bone brittleness increases), when there is deficiency or a risk of deficiency in vitamin D and calcium. This medicine is indicated in adults only. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IDEOS 1.3.1. Proposed Product Information Malta November 2021 DO NOT TAKE IDEOS: - if you are allergic (hypersensitive) to calcium, vitamin D or any of the other ingredients of this medicine (listed in section 6), - if you are allergic (hypersensitive) to peanut or soya, due to the presence of hydrogenated soya bean oil, - if you have abnormal high level of calcium in your blood (hypercalcaemia), - if you have high u Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT IDEOS 500 mg/400 IU, chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg of calcium as 1250 mg calcium carbonate and 400 IU of cholecalciferol (vitamin D 3 ) as 4 mg cholecalciferol concentrate (in powder form). Cholecalciferol concentrate in powder form contains among others alpha-tocopherol, hydrogenated soya bean oil, sucrose. Excipients with known effect: Each tablet contains 475.0 mg of sorbitol (E420), 1.52 mg of sucrose, and 0.3 mg of hydrogenated soybean oil. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets Square, white-grey tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IDEOS is indicated only in adults for: - The correction of vitamin D and calcium combined deficiency in elderly people. - Vitamin D and calcium supplementation, as an adjunct to specific therapy for osteoporosis treatment in patients with established or at high risk of vitamin D and calcium combined deficiencies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults One tablet twice a day. Paediatric population There is no relevant use of IDEOS in the paediatric population. Method of administration Oral use. Chew or suck the tablets. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - This product contains hydrogenated soya bean oil. Patients should not take this medicinal product if they are allergic to peanut or soya. - Hypercalcaemia, hypercalciuria, and diseases and/or conditions, which lead to hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism). - Calcium lithiasis, nephrocalcinosis. - Severe renal impairment (glomerular filtration rate < 30 ml/min). In patients with severe renal impairment, vitamin D3 in the form of cholecalciferol is not metabolised in the normal way and other forms of vitamin D3 must be used. - Hypervitaminosis D. 4.4 SPECIAL WARNING Leia o documento completo