Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Calcium carbonate; Cholecalciferol concentrate (powder form)
Rowex Ltd
A12AX
Calcium carbonate; Cholecalciferol concentrate (powder form)
1000mg/880 international unit(s)
Chewable tablet
Product not subject to medical prescription
Calcium, combinations with vitamin D and/or other drugs
Marketed
2012-02-17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CALCIUP D 3 FORTE 1000 MG / 880 IU CHEWABLE TABLETS calcium/colecalciferol (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 Calciup D 3 Forte 1000 mg/880 IU Chewable tablets are and what they are used for 2. What you need to know before you take Calciup D 3 Forte 1000 mg/880 IU Chewable tablets 3. How to take Calciup D 3 Forte 1000 mg/880 IU Chewable tablets 4. Possible side effects 5. How to store Calciup D 3 Forte 1000 mg/880 IU Chewable tablets 6. Contents of the pack and other information 1. WHAT CALCIUP D 3 FORTE 1000 MG/880 IU CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR Calciup D 3 Forte 1000 mg/880 IU Chewable tablets contain the active substances calcium and vitamin D 3 and is a calcium-vitamin D 3 -supplement. CALCIUP D 3 FORTE 1000 MG/880 IU CHEWABLE TABLETS ARE USED - to prevent and treat a lack of calcium and vitamin D in elderly. - for vitamin D- and calcium supplementation as supportive treatment of osteoporosis (brittle bones). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUP D 3 FORTE 1000 MG/880 IU CHEWABLE TABLETS DO NOT TAKE CALCIUP D 3 FORTE 1000 MG/880 IU CHEWABLE TABLETS - if you are allergic to calcium, vitamin D 3 or any of the other ingredients of this medicine (listed in section 6) - if you have high levels of calcium in your blood (hypercalcaemia) - if you have a high level of calcium in the urine (hypercalciuria) - if you suffer from overactive parathyroid glands (hyperparathyro Pročitajte cijeli dokument
Health Products Regulatory Authority 26 May 2022 CRN00CXDH Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calciup D3 Forte 1000mg/880 IU Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 1,000 mg calcium (as calcium carbonate) and 22 micrograms cholecalciferol (vitamin D 3 equivalent to 880 IU as concentrate powder form). Excipient(s) with known effect Each chewable tablet contains 1.00 mg of aspartame (E 951), up to 152.89 mg of sorbitol (E 420), 370.00 mg of isomalt (E 953), 1.694 mg of sucrose and 0.02 mg benzyl alcohol. For the 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 doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calciup 1000 mg / 880 IU chewable tablets is indicated: for the prevention and treatment of vitamin D and calcium deficiency in 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 ). _Hepatic impairment_ No dose adjustment is required _Renal impairment_ Calciup D 3 Forte 1000 mg/ 880 IU Chewable Tablets must not be used in patients with severe renal impairment (see section 4.3). _Pregnant patients_ 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). _Paediatric population_ Calciup D 3 Forte 1000 mg/ 880 IU Chewable Tablets must not be used in children and adolescents below 18 years of age (see section 4.3). Method of administration Health Products Regulatory Authority 26 May 2022 CRN00CXDH Page 2 of 7 Oral use. Calciup D 3 Forte 1000 mg/ 880 IU Chewable Tablets can be taken at any time, with o Pročitajte cijeli dokument