ประเทศ: มอลตา
ภาษา: อังกฤษ
แหล่งที่มา: Malta Medicines Authority
COLECALCIFEROL
Colonis Pharma Limited Quantum House, Hobson Industrial Estate, Burnopfield, Country, Durham NE16 6EA, United Kingdom
A11CC05
COLECALCIFEROL 800 IU
HARD CAPSULE
COLECALCIFEROL 800 IU
POM
VITAMINS
Withdrawn
2016-03-24
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVITICOL / COLECALCIFEROL 800 IU CAPSULES COLECALCIFEROL 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Aviticol Capsules are and what they are used for 2. What you need to know before you take Aviticol Capsules 3. How to take Aviticol Capsules 4. Possible side effects 5. How to store Aviticol Capsules 6. Contents of the pack and other information 1. WHAT AVITICOL CAPSULES ARE AND WHAT THEY ARE USED FOR Aviticol Capsules contain the active ingredient colecalciferol. Colecalciferol is a form of vitamin D used in the prevention and treatment of vitamin D deficiency conditions. It may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines. Aviticol 800 IU is the equivalent of 20 micrograms vitamin D 3 , which is involved in bone formation. The active ingredient colecalciferol is identical to the Colecalciferol that is found in the human body. It is found in the diet and is also produced in the skin after exposure to the sun. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). IF YOU ARE PLANNING TO GET PREGNANT OR YOU ARE PREGNANT AND YOU REQUIRE EXTRA VITAMIN D DO NOT TAKE IT WITHOUT MEDICAL SUPERVISION. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVITICOL CAPSULES DO NOT TAKE AVITICOL CAPSULES If you are ALLERGIC (hypersensit อ่านเอกสารฉบับเต็ม
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aviticol / Colecalciferol 800 IU Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: 800 IU Colecalciferol (equivalent to 20 micrograms vitamin D 3 ) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, Hard capsule Unprinted, hard gelatin yellow capsule containing clear, slightly yellow oily liquid. Capsule length: 21.7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment and prevention of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. Aviticol 800 IU Capsules is indicated in adolescents and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One capsule contains 800 IU colecalciferol (vitamin D 3 ). ADULT POSOLOGY - Treatment of vitamin D deficiency: 1-5 capsules (800- 4 000 IU) daily for 10 weeks dependent upon the severity of the disease and the patient's response to treatment, followed by maintenance therapy of 1-2 capsules (800- 1 600 IU) daily, as directed by your doctor. Follow-up serum 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved. - Prevention of vitamin D deficiency or treatment of vitamin D insufficiency: 1-2 capsules (800- 1 600 IU) daily. Higher doses may be required in certain populations, see below: CERTAIN POPULATIONS are at high risk of vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D: Page 2 of 8 Institutionalised or hospitalised individuals Dark skinned individuals Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens Patients being evaluated for osteoporosis Obese individuals Use of certain concomitant medications (e.g. anticonvulsant medications glucocorticoids, anti-retrovirals) Those recently treated for vitamin D defici อ่านเอกสารฉบับเต็ม