Country: Malta
Language: English
Source: Medicines Authority
Pharmacare Srl Via Marghera, 29 20149, Milan, Italy
A11CC05
COLECALCIFEROL 10000 IU
SOFT CAPSULE
COLECALCIFEROL 10000 IU
POM
VITAMINS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-12-20
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DENZO 10,000 IU, SOFT CAPSULES DENZO 25,000 IU, SOFT CAPSULES Cholecalciferol (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 Denzo soft capsules is and what it is used for 2. What you need to know before you take Denzo soft capsules 3. How to take Denzo soft capsules 4. Possible side effects 5. How to store Denzo soft capsules 6. Contents of the pack and other information 1. WHAT DENZO SOFT CAPSULES IS AND WHAT IT IS USED FOR Denzo soft capsules contains the active substance Cholecalciferol, better known as Vitamin D3. _ _ Denzo soft capsules is indicated for: - Prevention and treatment of vitamin D deficiency in adults. For prevention of vitamin D deficiency Denzo soft capsules 25,000 IU is used in adults only in the cases where therapeutic adherence is not obtained with the daily dosing of low dosages of cholecalciferol. Denzo soft capsules is indicated in adults. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DENZO SOFT CAPSULES DO NOT TAKE DENZO SOFT CAPSULES - If you are allergic to Cholecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6). - if you have high levels of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria) - if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis). PAGE 2 OF 6 - If you have high levels of viamin D in the body (h Read the complete document
PAGE 1 OF 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Denzo 10,000 IU soft capsules Denzo 25,000 IU soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Denzo 10,000 IU soft capsules _ Each soft capsule contains: Cholecalciferol (vitamin D 3 ) 0.250 mg corresponding to 10,000 IU. _Denzo 25,000 IU soft capsules _ Each soft capsule contains: Cholecalciferol (vitamin D 3 ) 0.625 mg corresponding to 25,000 IU. Excipients with known effect: glycerol. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Denzo 10,000 IU soft capsules are bourgogne red, size 2, oblong, soft capsules containing a clear colourless or greenish-yellow transparent solution Denzo 25,000 IU soft capsules are bourgogne red, size 4, oblong, soft capsules containing a clear colourless or greenish-yellow transparent solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Prevention and treatment of vitamin D deficiency in adults. Prevention of vitamin D deficiency for 25,000 IU only in adults with an identified risk when therapeutic adherence (or compliance) is not achieved by daily administration of low cholecalciferol doses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ Recommended dose: 10,000 IU or 25,000 every week. After first month, lower doses may be considered. Following this initial treatment, maintenance therapy may be required with a dose determined individually by the treating doctor. Alternatively, national posology recommendations in treatment of vitamin D deficiency can be followed. _ _ _Adults _ Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. The patient’s dietary habits should be carefully evaluated and artificially added PAGE 2 OF 9 vitamin D content of certain food types should be taken into consideration. Cholecalciferol soft capsules 10,000 IU are suitable for weekly vitamin D supplementation. Cholecalciferol soft capsules 25,000 IU are suitable for weekly (treatment) and monthly (preven Read the complete document