Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Colecalciferol
Aristo Pharma GmbH
A11CC; A11CC05
Colecalciferol
20,000 international unit(s)
Capsule, soft
Product subject to prescription which may be renewed (B)
Vitamin D and analogues; colecalciferol
Not marketed
2018-02-23
PACKAGE LEAFLET: INFORMATION FOR THE USER COLECALCIFEROL ARISTO 20,000 IU SOFT CAPSULES colecalciferol (vitamin D3) 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Colecalciferol Aristo Capsules are and what they are used for 2. What you need to know before you take Colecalciferol Aristo Capsules 3. How to take Colecalciferol Aristo Capsules 4. Possible side effects 5. How to store Colecalciferol Aristo Capsules 6. Contents of the pack and other information 1. WHAT COLECALCIFEROL ARISTO CAPSULES ARE AND WHAT THEY ARE USED FOR Colecalciferol Aristo Capsules contains colecalciferol (vitamin D3). Vitamin D is found in some foods and is also produced in the body when skin is exposed to sunlight. Vitamin D helps the kidneys and intestine absorb calcium and it helps build bones. Colecalciferol Aristo Capsules are used for initial treatment of symptomatic vitamin D deficiency in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL ARISTO CAPSULES DO NOT TAKE COLECALCIFEROL ARISTO CAPSULES: • if you are allergic to colecalciferol or any of the other ingredients of this medicine (listed in section 6) • if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) • if you have a condition which means that your body is resistant to parathyroid hormone (pseudohypoparathyroidism) • if you have high levels of vitamin D in your blood (hypervitaminosis D) • if you have kidney stones, calcification of the kidneys or serious kidney problems. WARNINGS AND PRECAUT Baca dokumen lengkapnya
Health Products Regulatory Authority 11 July 2023 CRN00DLD9 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colecalciferol Aristo 20,000 IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: 500 microgram colecalciferol (vitamin D 3 equivalent to 20,000 IU). Excipients with known effect: Each capsule contains 16.5 milligrams of sorbitol. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Soft capsule Light yellow coloured clear transparent round shaped gelatin capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Initial treatment of symptomatic vitamin D deficiency in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended dose: One capsule (20,000 IU) weekly. After first month, lower doses may be considered, dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and/or the patient´s response to treatment. Alternatively, national posology recommendations in treatment of vitamin D deficiency can be followed. Special populations: _Dosage in hepatic impairment_ No dose adjustment is required. _Dosage in renal impairment_ Colecalciferol Aristo Capsulesmust not be used in patients with severe renal impairment (see section 4.3). _Paediatric population_ Colecalciferol Aristo Capsules are not recommended. Method of administration _Oral_ The capsules should be swallowed whole (not chewed) with water. Patients should be advised to take Colecalciferol Aristo Capsules preferably with meal (see section 5.2 Pharmacokinetic properties -“Absorption”). Health Products Regulatory Authority 11 July 2023 CRN00DLD9 Page 2 of 6 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Diseases or conditions resulting in hypercalcemia and / or hypercalciuria. - Pseudohypoparathyroidism. - Hypervitaminosis D. - Nephrolithiasis. - Nephrocalcinosis. - Severe renal impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Colec Baca dokumen lengkapnya