Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Colecalciferol
Strides Pharma (Cyprus) Limited
A11CC05
Colecalciferol
Capsule, soft
colecalciferol
Not marketed
2023-06-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER COLECALCIFEROL 800 IU CAPSULES, SOFT 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 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 What Colecalciferol Capsules is and what it is used for 2. What you need to know before you take Colecalciferol Capsules 3. How to take Colecalciferol Capsules 4. Possible side effects 5. How to store Colecalciferol Capsules 6. Contents of the pack and other information 1. WHAT COLECALCIFEROL CAPSULES IS AND WHAT IT IS USED FOR Colecalciferol capsules contains the active substance colecalciferol (vitamin D 3). Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Vitamin D3 regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue. Often vitamin D is given in combination with calcium. Colecalciferol capsules may be prescribed by your doctor to treat or prevent vitamin D deficiency. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). Colecalciferol capsules 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. Colecalciferol capsules is used in adults, the elderly and adolescents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL CAPSULES DO NOT TAKE COLECALCIFEROL CAPSULES: • if you are allergic to vitamin D or any of the other ingredients of this med Read the complete document
Health Products Regulatory Authority 01 November 2023 CRN00DX5P Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colecalciferol 800 IU capsules, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 800 IU colecalciferol (equivalent to 20 micrograms vitamin D 3 ) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, soft (capsule) Blue colored translucent oval shaped soft gelatin capsules containing clear yellow oily liquid. Capsule dimensions: diameter: 6.7 +/-0.5 mm and length: 9.6 length +/-0.5 mm. 4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment 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. Colecalciferol is indicated in adults, the elderly and adolescents from 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS _Vitamin D deficiency_ For vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)), 1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment. _Vitamin D insufficiency_ For vitamin D insufficiency in adults and the elderly (serum levels 25 – 50 nmol/l (10-20 ng/mL)), long term maintenance therapy following treatment of deficiency in adults and the elderly and prevention of vitamin D deficiency, 1- 2 Capsules (800-1600 IU) daily. _Osteoporosis_ As an adjunct to specific therapy for osteoporosis, 1 capsule daily. _Dosage in hepatic impairment_ No dose adjustment is required. _Dosage in renal impairment _ Colecalciferol should not be used in patients with severe renal impairment (see section 4.3). Health Products Regulatory Authority 01 November 2023 CRN00DX5P Page 2 of 6 PAEDIATRIC POPULATION _Vitamin D deficiency or insufficiency_ _ _ Vitamin D deficiency or insufficiency in children over 12 years – 1 capsule daily depending on the severity of the disease and the pat Read the complete document