FULTIUM -D 800 IU CAPSULES - GOV.UK

1 UKPAR FULTIUM D3 800 IU CAPSULES PL 40861/0002. FULTIUM -D3 800 IU CAPSULES . (colecalciferol). PL 40861/0002. UKPAR. TABLE OF CONTENTS. Lay Summary Page 2. Scientific Discussion Page 4. Steps Taken for Assessment Page 41. Summary of Product Characteristics Page 42. Patient Information Leaflet Page 43. Labelling Page 44. Steps taken after authorisation - summary Page 47. Annex 1 Page 48. 1. UKPAR FULTIUM D3 800 IU CAPSULES PL 40861/0002. LAY SUMMARY. FULTIUM -D3 800 IU CAPSULES . (colecalciferol). This is a summary of the Public Assessment Report (PAR) for FULTIUM -D3 800 IU CAPSULES (PL 40861/0002, formerly PL 17871/0151).

2 It explains how the application for FULTIUM -D3 800 IU. CAPSULES was assessed and its authorisation recommended, as well as the conditions of use. It is not intended to provide practical advice on how to use FULTIUM -D3 800 IU CAPSULES . For practical information about using FULTIUM -D3 800 IU CAPSULES , patients should read the package leaflet or contact their doctor or pharmacist. FULTIUM -D3 800 IU CAPSULES may be referred to as FULTIUM -D3 or FULTIUM -D3 800 IU in this report. What is FULTIUM -D3 and what is it used for? FULTIUM -D3 is a medicine with well-established use'. This means that the medicinal use of the active substance of FULTIUM -D3 is well established in the European Union for at least ten years, with recognised efficacy and an acceptable level of safety.

3 FULTIUM -D3 contains the active ingredient colecalciferol (800 IU colecalciferol is equivalent to 20 micrograms of vitamin D3). vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. FULTIUM -D3 is recommended for use when the patient has a normal intake of dietary calcium. FULTIUM -D3 800 IU CAPSULES may be prescribed to treat or prevent vitamin D deficiency . deficiency of vitamin D may occur when diet or lifestyle does not provide the patient with enough vitamin D or when the body requires more vitamin D (for instance when a woman is pregnant).

4 FULTIUM -D3 800 IU. CAPSULES may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis). when it will be given with other medicines. How does FULTIUM -D3 work? The active ingredient colecalciferol (equivalent to vitamin D3) acts to maintain normal concentrations of calcium and phosphate in plasma by facilitating their absorption from the small intestine, enhancing their mobilisation from bone and decreasing their excretion by the kidney. How is FULTIUM -D3 used? FULTIUM -D3 is available as CAPSULES , which are taken by mouth and must be swallowed whole with water. This medicine should always be taken exactly as described in the package leaflet or as instructed by the patient's doctor or pharmacist.

5 The patient should check with the doctor or pharmacist if he/she is not sure. Please read section 3 of the package leaflet (PL) for detailed information on dosing recommendations, the route of administration, and the duration of treatment. FULTIUM -D3 can be obtained with a prescription. 2. UKPAR FULTIUM D3 800 IU CAPSULES PL 40861/0002. What benefits of FULTIUM -D3 have been shown in studies? As colecalciferol is a well-known substance and its use in the treatment and prevention of vitamin D. deficiency and as an adjunct to therapy for certain bone conditions, such as thinning of the bone (osteoporosis) is well established, the applicant presented data from the scientific literature at the time of initial assessment.

6 The literature provided confirmed the efficacy and safety of colecalciferol in the treatment and prevention of vitamin D deficiency and as an adjunct to therapy for certain bone conditions, such as thinning of the bone (osteoporosis). What are the possible side effects from FULTIUM -D3? Like all medicines, FULTIUM -D3 can cause side effects, although not everybody gets them. Uncommon side effects (affecting less than 1 in 100 people) with FULTIUM -D3 may include too much calcium in the: blood (hypercalcaemia) The following may be experienced: feeling or being sick, loss of appetite, constipation, stomach ache, feeling very thirsty, muscle weakness, drowsiness or confusion urine (hypercalciuria).

7 For the full list of side effects reported with FULTIUM -D3 see section 4 of the package leaflet available on the MHRA website. Also, for the full list of restrictions, see the package leaflet. Why is FULTIUM -D3 approved? The MHRA concluded that, in accordance with EU requirements, the benefits of FULTIUM -D3 800 IU. CAPSULES outweigh the identified risks and recommended that the product be approved for use. What measures are being taken to ensure the safe and effective use of FULTIUM -D3? A risk management plan has been developed to ensure that FULTIUM -D3 is used as safely as possible. Based on this plan safety information has been included in the Summary of Product Characteristics and the package leaflet for FULTIUM -D3 800 IU CAPSULES , including the appropriate precautions to be followed by healthcare professionals and patients.

8 Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about FULTIUM -D3. A Marketing Authorisation ( FULTIUM -D3 800 IU CAPSULES , PL 17871/0151) was first granted in the UK. to Jenson Pharmaceutical Services Limited on 28 October 2011. Subsequent to a Change of Ownership procedure, the Marketing Authorisation ( FULTIUM -D3 800 IU. CAPSULES ; PL 40861/0002) was granted in the UK to Internis Pharmaceuticals Limited on 24 September 2014. The full PAR for FULTIUM -D3 800 IU CAPSULES follows this summary.

9 For more information about treatment with FULTIUM -D3, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in January 2015. 3. UKPAR FULTIUM D3 800 IU CAPSULES PL 40861/0002. FULTIUM -D3 800 IU CAPSULES . PL 40861/0002. SCIENTIFIC DISCUSSION. TABLE OF CONTENTS. Introduction Page 5. Pharmaceutical assessment Page 7. Non-clinical assessment Page 9. Clinical assessment Page 9. Overall conclusions and risk benefit assessment Page 40. 4. UKPAR FULTIUM D3 800 IU CAPSULES PL 40861/0002. INTRODUCTION. The UK granted a Marketing Authorisation for the medicinal product FULTIUM D3 800IU CAPSULES (PL 17871/0151) to Jenson Pharmaceutical Services Limited on 28th October 2011.

10 This product is a prescription-only medicine. This is an abridged, bibliographic application, submitted under Article 10a of Directive 2001/83/EC, as amended. FULTIUM D3 800IU CAPSULES are used to treat and prevent vitamin D deficiency , as well as vitamin D. insufficiency in adolescents, adults and in the elderly. FULTIUM D3 800IU CAPSULES are also used as an adjunct to specific therapy for osteoporosis. vitamin D is produced naturally when our skin is exposed to ultraviolet B (UVB) radiation from the sun. UVB converts 7-dehydrocholesterol precursors into previtamin D3, which spontaneously changes to vitamin D3.