D-Seul 50000 I.U 20 Soft Gelatin Capsules Vitamin D3 (Cholecalciferol) 1. What D-Seul® is and what it is used for Pharmacotherapeutic group: D-Seul® contains cholecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps the kidneys and intestine absorb calcium and it helps build bones. Therapeutic indications: D-Seul® is used: To prevent vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D. With other medicine to treat certain bone conditions, such as thinning of the bone (osteoporosis). To treat vitamin D deficiency that has been confirmed by laboratory tests. 2. How to take D-Seul®: Always take this medicine exactly as your doctor or pharmacist 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 D-Seul® preferably together with a large meal to help your body absorb the vitamin D. Prevention (Prophylaxis) vitamin D deficiency in children (018-): 4001000- IU/DAY (up to 4000IU/DAY) (duration varies according to cases) 25000 IU/ every 6 to 8 weeks Prevention (Prophylaxis) vitamin D deficiency in adults: Up to 2000IU/day Up to 25000IU/month Treatment of vitamin D deficiency in children: Up to 2000IU/day for 6 weeks followed by maintenance dose. Treatment of vitamin D deficiency in adults: Up to 50000IU/week for up to 8 weeks followed by maintenance dose. Follow-up measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved. Use in children: D-Seul® S.G Capsules are not recommended for children under 12 years for all strengths except D-Seul® 50,000IU not recommended for use in under 18 years a. If you take more D-Seul® than you should If you or your child take more medicine than prescribed, stop using this medicine and contact your doctor. If it is not possible to talk to a doctor, go to the nearest hospital emergency department and take the medicine package with you. 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. b. If you forget to take D-Seul® Take the forgotten dose as soon as possible. Then take the next dose at the correct time. However, if it is almost time to take the next dose, do not take the dose you have missed; just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. After that, take the next capsule in accordance with the instructions given to you by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. c. If you stop taking D-Seul® If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 3. What you need to know before you take D-Seul®: a. Do not take D-Seul® if If you are allergic to vitamin D3 or any of the other ingredients of this medicine. If you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) If you have kidney stones (renal calculi) If you have serious renal impairment If you have high levels of vitamin D3 in your blood (hypervitaminosis D) If you have pseudohypoparathyroidism (disturbed parathyroid hormone metabolism) If you are pregnant for highest strength D-Seul® 50000IU S.G. Capsules. If you are under 18 years of age for highest strength D-Seul® 50000IU S.G. Capsules If any of the above applies to you, talk to your doctor or pharmacist before taking D-Seul®. b. Take special care with D-Seul® Talk to your doctor or pharmacist before taking D-Seul®: Are undergoing treatment with certain medicines used to treat heart disorders (e.g., cardiac glycosides, such as digoxin); Have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D3 in the body). Are taking medicines containing vitamin D3, or eating foods or milk enriched with vitamin D3. Are likely to be exposed to a lot of sunshine whilst using D-Seul®. Take additional supplements containing calcium. Your doctor will monitor your blood levels of calcium to make sure they are not too high whilst you are using D-Seul®. Have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine. Children This medicine is not suitable for use in children under 12 years for all strengths except D-Seul® 50,000IU not suitable for use in under 18 years c. Taking other medicines, herbal or dietary supplements Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking: Medicines that act on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethazide). When used at the same time as vitamin D3 these medicines may cause a large increase in the level of calcium in the blood and urine. Medicines containing vitamin D3 or eating food rich in vitamin D3, such as, some types of vitamin D3-enriched milk. Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal disease). These medicines may interfere with the way your body process vitamin D3. The following medicines because they can interfere with the effect or the absorption of vitamin D3: Antiepileptic medicines (anticonvulsants), barbiturates, Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D3. Medicines that lower the level of cholesterol in the blood (such as cholestyramine, or colestipol) Certain medicines for weight loss that reduce the amount of fat your body absorbs (e.g. orlistat) Certain laxatives (such as liquid paraffin). Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D since the metabolism increases. Glucocorticoid steroids may increase vitamin D metabolism and elimination. During concomitant use, it may be necessary to increase the dose of vitamin D. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. d. Taking D-Seul® with food and drink D-Seul® Soft Gelatin Capsules should be swallowed whole with water, preferably together with a large meal to help your body absorb the vitamin D. e. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. These formulations can be used during pregnancy but only if you have been diagnosed with vitamin D deficiency and following the advice of your doctor. The high strength formulation D-Seul® 50,000 is not recommended for use in pregnant and breastfeeding women. f. Driving and using machines D-Seul® should not affect your ability to drive or operate machinery. There is limited information on the possible effects of this medicine on your ability to drive. However, it is not expected that it would affect your ability to drive or operate machinery. 4. Possible side effects: Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking D-Seul® S.G Capsules and seek immediate medical help if you experience symptoms of serious allergic reactions, such as: Swollen face, lips, tongue or throat Difficult to swallow Hives and difficulty breathing. Side effects with D-Seul® S.G Capsules may include: Uncommon (may affect up to 1 in 100 people): Too much calcium in your blood (hypercalcaemia). Symptoms include: nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion, too much calcium in your urine (hypercalciuria). Rare (may affect up to 1 in 1,000 people): Skin rash (pruritus, urticaria) Itching. Hives 5. How to store D-Seul® Keep out of the reach and sight of children. Do not store above 30oC, protect from light. Do not use D-Seul® after the expiry date (Exp. Date) which is stated on the outer pack. The expiry date refers to the last day of that month. Do not use D-Seul® if you notice description of the visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information a. What D-Seul® Capsules contains: The active substance is: Vitamin D3 (Cholecalciferol). D-Seul® 2,000IU S.G. Capsules: Each soft gelatin capsule contains 2000 IU equivalent to 50 μg Vitamin D3 (Cholecalciferol). D-Seul® 5,000IU S.G. Capsules: Each soft gelatin capsule contains 5000 IU equivalent to 0.125 mg Vitamin D3 (Cholecalciferol). D-Seul® 10,000IU S.G. Capsules: Each soft gelatin capsule contains 10000 IU equivalent to 0.250 mg Vitamin D3 (Cholecalciferol). D-Seul® 50,000IU S.G. Capsules: Each soft gelatin capsule contains 50000 IU equivalent to 1.25 mg Vitamin D3 (Cholecalciferol). The other ingredients are: D-Seul® 2,000IU S.G. Capsules: Arachis oil, Butylhydroxyanisole, Gelatin, FD & Blue No 1, Glycerin & purified water. D-Seul® 5,000IU S.G. Capsules: Arachis oil, Butylhydroxyanisole, Gelatin, Ariavit quinoline yellow, Glycerin & purified water. D-Seul® 10,000IU S.G. Capsules: Arachis oil, Butylhydroxyanisole, Gelatin, Red No 33, Glycerin & purified water. D-Seul® 50,000IU S.G. Capsules: Arachis oil, Butylhydroxyanisole, Gelatin, Blue No 1, Glycerin & purified water. b. What D-Seul® looks like and contents of the pack Soft Gelatin Capsules Physical Description: D-Seul® 2,000 IU S.G Capsules: Greenish blue oval soft gelatin capsules. Contains pale yellowish oily liquid. D-Seul® 5,000 IU S.G Capsules: Yellow oval soft gelatin capsules contains pale yellowish oily liquid. D-Seul® 10,000 IU S.G Capsules: Pinkish red oval soft gelatin capsules contains pale yellowish oily liquid. D-Seul® 50,000 IU S.G Capsules: Blue oval soft gelatin capsules contains pale yellowish oily liquid. D-Seul® S.G. Capsules packed in HDPE jars with PP screw cap with induction sealing foil. With desiccant bag (silica gel granules) labeled with adhesive label in a carton box with a multi folded leaflet. Pack size: D-Seul® is available in the pack size of 30 S.G. Capsules for all strengths except D-Seul® 50,000IU S.G. Capsules the pack sizes 8, 12 & 20 S.G. capsules are available.