Each 100,000 IU capsule contains 0.02 mg Allura Red AC (E129) and 0.12 mg Sunset Yellow FCF (E110)

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT {invented name} 25,000 IU soft capsules {invented name} 50,000 IU soft capsules {invented name} 100,000 IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains colecalciferol (vitamin D3) 25,000 IU (equivalent to mg vitamin D3). Each capsule contains colecalciferol (vitamin D3) 50,000 IU (equivalent to 1.25 mg vitamin D3). Each capsule contains colecalciferol (vitamin D3) 100,000 IU (equivalent to 2.50 mg vitamin D3). Excipients with known effect: Each 25,000 IU capsule contains mg Allura Red AC (E129) Each 50,000 IU capsule contains mg Allura Red AC (E129) Each 100,000 IU capsule contains 0.02 mg Allura Red AC (E129) and 0.12 mg Sunset Yellow FCF (E110) For a full list of excipients, see section PHARMACEUTICAL FORM Soft capsule {invented name} 25,000 IU Light red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has 25 printed in white ink. Capsule dimensions are 12.5mm x 8.5mm {invented name} 50,000 IU Red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has 50 printed in white ink. Capsule dimensions are 12.5mm x 8.5mm {invented name} 100,000 IU Orange, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has 100 printed in white ink. Capsule dimensions are 12.5mm x 8.5mm. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Prophylaxis and treatment of vitamin D deficiency in adults and adolescents (children 12 years).

2 Vitamin D deficiency is defined as serum levels of 25-hydroxycolecalciferol (25(OH)D) <25 nmol/l. In addition to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency, preferably in combination with calcium. 4.2 Posology and method of administration Posology Recommended dose: One capsule 25,000 IU/month Treatment of vitamin D deficiency: The dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient s response to treatment. Treatment of symptomatic vitamin D deficiency: 100,000 IU loading dose or equivalent (2 x 50,000 IU in 1 week). A maintenance dose of 25,000 IU/month should be considered one month after loading dose. Dosage in hepatic impairment No dose adjustment is required. Dosage in renal impairment {invented name} should not be used in patients with severe renal impairment (see section 4.3). Paediatric population {invented name} is not recommended for use in children under 12 years of age. Method of administration The capsules should be swallowed whole with water. Patients should be advised to take {invented name} preferably with a meal. 4.3 Contraindications Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria. Nephrolithiasis. Nephrocalcinosis Hypervitaminosis D. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

3 4.4 Special warnings and precautions for use Patients who are being treated with monthly doses of {invented name} should be advised not to use other vitamin D containing products concomitantly. {invented name} should be prescribed with caution to patients suffering from sarcoidosis due to risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine. During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued. {invented name} should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolised normally and other forms of vitamin D should be used. The content of vitamin D in {invented name} should be considered when prescribing other medicinal products containing vitamin D. Additional doses of vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. {invented name} is not recommended in children younger than 12 years. 4.5 Interaction with other medicinal products and other forms of interaction Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics. Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D since the metabolism increases. Excessive dosing of vitamin D can induce hypercalcaemia, which may increase the risk of digitalis toxicity and serious arrhythimias due to the additive inotropic effects. The electrocardiogram (ECG) and serum calcium levels of patients should be closely monitored. Glucocorticoid steroids may increase vitamin D metabolism and elimination. During concomitant use, it may be necessary to increase the dose of {invented name} tablets. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. Orlistat may potentially impair the absorption of cholecalciferol as it is fat-soluble. The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.

4 4.6 Fertility, pregnancy and lactation Pregnancy {invented name} should be used during pregnancy, only in the case of a vitamin D deficiency. {invented name} is not recommended during pregnancy in patients without a vitamin D deficiency as the daily intake should not exceed 600 IU vitamin D. Studies in animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Breast-feeding Vitamin-D can be used during breast-feeding. Vitamin D3 passes into breast milk. This should be considered when giving additional vitamin D to the child. Fertility There are no data on the effect of {invented name} on fertility. However, normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility. 4.7 Effects on ability to drive and use machines There are no data about the effect of this product on driving capacity. An effect is, however, unlikely. 4.8 Undesirable effects Adverse reactions frequencies as defined as: uncommon ( 1/1,00 < 1/100), rare ( 1/10,000, <1/1,000) or not known (cannot be estimated from the available data). Immune system disorders Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angiooedema or laryngeal oedema. Metabolism and nutrition disorders Uncommon: Hypercalcaemia and hypercalciuria. Skin and subcutaneous disorders Rare: Pruritus, rash and urticaria. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.

5 4.9 Overdose Overdose can lead to hyper-vitaminosis D. An excess of vitamin D causes abnormally high levels of calcium in the blood, which can eventually severely damage the soft tissues, and kidneys. Tolerable Upper Intake Level for vitamin D3 (cholecalciferol) is set at 4000 IU (100 µg) per day. Vitamin D3 should not be confused with its active metabolites. cholecalciferol Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification. Treatment of hypercalcaemia: The treatment with vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, and cardiac glycosides must also be discontinued. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Vitamin D and analogues, colecalciferol ATC Code: A11CC05 Vitamin D increases the intestinal absorption of calcium and phosphate. Administration of vitamin D3 counteracts development of rickets in children and osteomalacia in adults. It also counteracts the increase of parathyroid hormone (PTH) which is caused by calcium deficiency and which causes increased bone resorption. In addition to bone and intestinal mucosa many other tissues have vitamin D receptors, to which the active hormonal form of vitamin D, calcitriol, binds. 5.2 Pharmacokinetic properties Absorption Vitamin D is easily absorbed in the small intestine. Distribution and biotransformation Cholecalciferol and its metabolites circulate in the blood bound to a specific globulin. Cholecalciferol is converted in the liver by hydroxylation to 25-hydroxycholecalciferol. It is then further converted in the kidneys to 1,25- dihydroxycholecalciferol. 1,25-dihydroxycholecalciferol is the active metabolite responsible for increasing calcium absorption. Vitamin D, which is not metabolised, is stored in adipose and muscle tissues.

6 After a single oral dose of cholecalciferol, the maximum serum concentrations of the primary storage form are reached after approximately 7 days. 25(OH)D 3 is then slowly eliminated with an apparent half-life in serum of about 50 days. Cholecalciferol and its metabolites are excreted mainly in the bile and faeces. Elimination Vitamin D is excreted mainly in bile and faeces with a small percentage found in urine. 5.3 Preclinical safety data At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is further no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients all-rac-α-tocopherol (E307) Medium Chain Triglycerides Glycerol Gelatine Allura Red AC (E129) Sunset Yellow FCF (E110) (100,000 IU only) Opacode White imprinting ink Shellac (E904) Titanium dioxide (E171) Simethicone 6.2 Incompatibilities Not applicable. 6.3 Shelf life 18 months 6.4 Special precautions for storage Do not store above 25 C. Store in the original package in order to protect from light. 6.5 Nature and contents of container 3 capsules packed in PVDC/Aluminium foil blisters, inserted into a cardboard carton.

7 6.6 Special precautions for disposal No special requirements 7 MARKETING AUTHORISATION HOLDER Consilient Health Limited, 5 th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland 8 MARKETING AUTHORISATION NUMBER(S) <To be completed nationally> 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <To be completed nationally> 10 DATE OF REVISION OF THE TEXT <To be completed nationally>

8 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Folded Carton 1. NAME OF THE MEDICINAL PRODUCT {invented name} 25,000 IU soft capsules {invented name} 50,000 IU soft capsules {invented name} 100,000 IU soft capsules colecalciferol 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 25,000 IU colecalciferol equivalent to mg vitamin D3. Each capsule contains 50,000 IU colecalciferol equivalent to 1.25 mg vitamin D3. Each capsules contains 100,000 IU colecalciferol equivalent to 2.5 mg vitamin D3. 3. LIST OF EXCIPIENTS 25,000 IU: Contains Allura Red AC (E129). See leaflet for further information. 50,000 IU: Contains Allura Red AC (E129). See leaflet for further information. 100,000 IU: Contains Allura Red AC (E129) and Sunset Yellow FCF (E110). See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS 3 soft capsules 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Swallow whole with water. Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP 9. SPECIAL STORAGE CONDITIONS Do not store above 25 C. Store in the original packaging in order to protect from light. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Consilient Health Limited

9 5 th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland 12. MARKETING AUTHORISATION NUMBER(S) < To be completed nationally> 13. BATCH NUMBER LOT 14. GENERAL CLASSIFICATION FOR SUPPLY Prescription Only Medicine 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE {invented name} 25,000 UI soft capsules {invented name} 50,000 UI soft capsules {invented name} 100,000 UI soft capsules 17. OTHER

10 MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister 1. NAME OF THE MEDICINAL PRODUCT {invented name} 25,000 IU soft capsules {invented name} 50,000 IU soft capsules {invented name} 100,000 IU soft capsules 2. NAME OF THE MARKETING AUTHORISATION HOLDER Consilient Health Limited 3. EXPIRY DATE Exp.: 4. BATCH NUMBER Batch: 5. OTHER

11 PACKAGE LEAFLET: INFORMATION FOR THE USER {invented name} 25,000 IU soft capsules {invented name} 50,000 IU soft capsules {invented name} 100,000 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 {invented name} is and what it is used for 2. What you need to know before you take {invented name} 3. How to take {invented name} 4. Possible side effects 5. How to store {invented name} 6. Contents of the pack and other information 1. WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {invented name} contains vitamin D3 which regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue. {invented name} is used to prevent and treat vitamin D3 deficiency in adults and adolescents (children aged 12 years). Your doctor may prescribe {invented name} as an adjunct to specific bone loss medication. Ask your doctor, pharmacist or other health personal if you have further questions and always follow their instructions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {INVENTED NAME} Do not take {invented name}: if you are allergic to colecalciferol or any of the other ingredients of this medicine (listed in section 6). if you have hypercalcaemia (increased levels of calcium in the blood) or hypercalciuria (increased levels of calcium in the urine). if you have hypervitaminosis D (increased levels of vitamin D in the blood). if you have kidney stones.

12 If any of the above applies to you, talk to your doctor or pharmacist before taking {invented name}. Warnings and precautions Talk to your doctor or pharmacist before taking {invented name}: if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints). when using other drugs containing vitamin D. if you have kidney problems or have had kidney stones. Children This medicine is not suitable for use in children under 12 years of age. Other medicines and {invented name} Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular any of the following: - Cholestyramine (used to treat high cholesterol). - Phenytoin or barbiturates (used to treat epilepsy). - Laxatives which contain paraffin oil. - Thiazide diuretics (to treat high blood pressure). - Glucocorticoids (to treat inflammation). - Cardiac glycosides (to treat heart conditions), e.g. digoxin. - Actinomycin (chemotherapy) - Imidazole (antifungal) - Orlistat (weight loss aid) {invented name} with food and drink See section 3 How to take {invented name}. Pregnancy, breast-feeding and fertility During pregnancy the daily intake should not exceed 600 IU vitamin D. {invented name} should only be used during pregnancy, if vitamin D deficiency has been clinically established. {invented name} can be used during breastfeeding. Vitamin D3 passes over into breast milk. This should be considered when giving additional vitamin D to the breast-fed child. There is no data on the effect of vitamin D3 on fertility. However, normal levels of vitamin D are not expected to have any adverse effects on fertility.

13 Ask your doctor or pharmacist for advice before taking {invented name} during pregnancy, if you are breast feeding or if you are planning to have a baby. Driving and using machines {invented name} has no known effects on the ability to drive or use machines. {invented name} contains Allura Red AC (E129) and Sunset Yellow FCF (E110) {invented name} 25,000 IU, 50,000 IU and 100,000 IU soft capsules all contain Allura Red AC (E129) which may cause allergic reactions. Additionally {invented name} 100,000 IU soft capsules also contain Sunset Yellow FCF (E110) which may cause allergic reactions. If you are allergic to the above colouring agents, consult your doctor or pharmacist. 3. HOW TO TAKE {INVENTED NAME} Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The capsules should be swallowed whole with water. You should take this medicine preferably together with a large meal to help your body absorb the vitamin D3. Adults and adolescents The recommended dose is one capsule 25,000 IU/month For the treatment of vitamin D deficiency the dose will be adjusted according to the level of vitamin D in your blood (25(OH)D levels). For the treatment of symptomatic vitamin D deficiency the recommended dose is one capsule of 100,000 IU or 2 capsules of 50,000 IU taken in 1 week. A maintenance dose of one capsule of 25,000 IU/month may be considered. Use in children {invented name} 25,000, 50,000 and 100,000 IU capsules are not intended for use in children under 12 years of age. Other forms of this medicine maybe more suitable for children; ask your doctor or pharmacist. If you take more {invented name} than you should If you have taken more of this medicine than directed, or if a child accidentally has taken this medicine, please contact your doctor or emergency unit for judgement of the risk and advice.

14 The most common symptoms of overdose are: nausea, vomiting, excessive thirst, the production of large amounts of urine over 24 hours, constipation and dehydration., high levels of calcium in the blood (hypercalcaemia and hypercalciuria) shown by lab test. If you forget to take {invented name} Do not take a double dose to make up for a forgotten dose. If you stop taking {invented name} If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking {invented name} and seek immediate medical help if you experience symptoms of serious allergic reactions, such as: swollen face, lips, tongue or throat difficulty swallowing hives and difficulty breathing Uncommon (may affect up to 1 in 100 people): Hypercalcaemia (increased levels of serum calcium) and hypercalciuria (increased levels of urine calcium). Rare (may affect up to 1 in 1,000 people): Itching, rash (pruritus/urticaria). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE {INVENTED NAME} Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after Exp. The expiry date refers to the last day of the month. Do not store above 25 C. Store in the original packaging in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

15 6. CONTENTS OF THE PACK AND OTHER INFORMATION What {invented name} contains 25,000 IU - The active substance is colecalciferol (vitamin D3). Each soft capsule contains mg colecalciferol corresponding to 25,000 IU vitamin D3. 50,000 IU - The active substance is colecalciferol (vitamin D3). Each soft capsule contains 1.25 mg colecalciferol corresponding to 50,000 IU vitamin D3. 100,000 IU - The active substance is colecalciferol (vitamin D3). Each soft capsule contains 2.5 mg colecalciferol corresponding to 100,000 IU vitamin D3. The other ingredients are: all-rac-α-tocopherol (E307), medium chain triglycerides, glycerol, gelatine, Opacode White imprinting ink (consisting of: shellac (E904), titanium dioxide (E171) and simethicone), Allura Red AC (E129) and Sunset Yellow FCF (E110) (100,000 IU only). What {invented name} looks like and contents of the pack 25,000 IU {invented name} 25,000 IU is a light red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has 25 printed in white ink. Capsule dimensions are 12.5mm x 8.5mm. 50,000 IU {invented name} 50,000 IU is a red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has 50 printed in white ink. Capsule dimensions are 12.5mm x 8.5mm. 100,000 IU {invented name} 100,000 IU is an orange, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has 100 printed in white ink. Capsule dimensions are 12.5mm x 8.5mm. Each carton contains 3 capsules packed in blister strips. Marketing Authorisation Holder Consilient Health Limited. 5 th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2 Ireland

16 Manufacturer McGregor Cory Limited Middleton Close, Banbury, Oxfordshire, OX16 4RS. United Kingdom This medicinal product is authorised in the following member states of the EEA under the following names: Denmark: Benferol D3 25,000 IU soft capsules, Benferol D3 50,000 IU soft capsules and Benferol D3 100,000 IU soft capsules Finland: Benferol D3 25,000 IU soft capsules, Benferol D3 50,000 IU soft capsules and Benferol D3 100,000 IU soft capsules Norway: Benferol VitaminD3 25,000 IU soft capsules, Benferol VitaminD3 50,000 IU soft capsules and Benferol VitaminD3 100,000 IU soft capsules Spain: Benferol D3 25,000 IU soft capsules, Benferol D3 50,000 IU soft capsules and Benferol D3 100,000 IU soft capsules Sweden: Benferol 25,000 IU soft capsules, Benferol 50,000 IU soft capsules and Benferol 100,000 IU soft capsules This leaflet was last revised in January 2016.