NATECAL D3 600 MG + 400 I.U. CHEWABLE TABLETS
Active substance: CHOLECALCIFEROL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
600 mg + 400 I.U. chewable tablet
NATECAL D3
(calcium + cholecalciferol)
Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor This medicine is for use in Adults only This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor In this leaflet: 1. What Natecal D3 is and what it is used for 2. Before you take Natecal D3 3. How to take Natecal D3 4. Possible side effects 5. How to store Natecal D3 6. Further information 1. WHAT NATECAL D3 IS AND WHAT IT IS USED FOR Natecal D3 chewable tablets contain two active substances, calcium carbonate and cholecalciferol (vitamin D3). Both calcium and vitamin D3 are found in the diet and vitamin D is also produced in the skin after exposure to the sun. Natecal D3 chewable tablets may be prescribed by doctors to treat and prevent vitamin D/calcium deficiency. Natecal D3 is used: - In the correction of calcium and vitamin D deficiencies in the elderly, - In combination with osteoporosis treatments where calcium and vitamin D levels are too low or where there is a high risk of them being too low. 2. BEFORE YOU TAKE NATECAL D3 Do not take Natecal D3 If you are hypersensitive to calcium, vitamin D3 or to any of the other ingredients of Natecal D3 (in particular soya bean oil) If you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) If you are suffering from kidney failure; If you have kidney stones If you have high levels of vitamin D in your blood (hypervitaminosis D) Take special care with Natecal D3 If you have had kidney stones or other kidney problems (your doctor will need to monitor your treatment carefully if your kidneys are not working properly to make sure you do not build up too much calcium in your blood) If you stay in bed for a long period (months) and if you have osteoporosis (brittle bones) because you may have high levels of calcium in your blood If you are taking any other medicines containing calcium or vitamin D (your doctor or your pharmacist will be able to tell you if you do) If you have sarcoidosis (your doctor will be able to tell you if you do) Taking other medicines Do not take the product without talking to your doctor or pharmacist if you are taking: Any other medicine containing vitamin D The following heart medicines: digoxin or other cardiac glycosides Tetracycline and fluoroquinolone antibiotics; it is recommended that you wait at least 3 hours after taking these medicines before taking Natecal D3 chewable tablets Thiazide diuretics If you take other drugs used to treat bone disorders, such as biphosphonates or sodium fluoride, it is recommended that a period of at least 3 hours has to pass before taking Natecal D3 chewable tablets Phenytoin (a medicine for epilepsy) and barbiturates (medicines which are used for epilepsy or which help you sleep), as they may make the vitamin D3 less effective. Orlistat (a medicine used to treat obesity), cholestyramine, laxatives such as paraffin oil, as they may reduce the amount of vitamin D3 you absorb. Estramustin (a medicine used in chemotherapy), thyroid hormones or medicines containing iron, zinc or strontium, as the amount absorbed may be reduced. They should be taken at least 2 hours before or after Natecal D3. Taking Natecal D3 with food and drinks This product is likely to interact with some foods, for example those containing oxalic acid (like spinach, rhubarb, sorrel, cocoa, tea), phosphate (e.g. ham, sausages, cheese spread) or phytic acid (e.g. pulses, whole cereals, chocolate).
Therefore it is recommended to take Natecal D3 two hours before or after meals containing this kind of food. Pregnancy and breast-feeding Natecal D3 chewable tablets should only be used in pregnancy and breast-feeding when it has been recommended by a doctor. Important information about some of the ingredients of Natecal D3 The product contains: sorbitol (E420), aspartame (E951), lactose, hydrogenated soya bean oil, sucrose. The product contains aspartame, which is a source of phenylalanine. Phenylalanine may be harmful for people with phenylketonuria. The product contains lactose, sucrose and sorbitol therefore if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The product contains soya oil, therefore if you are allergic to peanut or soya, do not use this medicinal product. 3. HOW TO TAKE NATECAL D3 Always take Natecal D3 exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults and elderly is one tablet twice a day (e.g. one in the morning and one in the evening) preferably after meals. The tablets may be chewed or sucked, they must not be swallowed whole. If you take more Natecal D3 than you should Contact your doctor. If you cannot do this, go to your nearest hospital accident and emergency (casualty) department, taking any remaining tablets and the packaging with you. If you forget to take Natecal D3 Take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Never take two doses at the same time. 4. POSSIBLE SIDE EFFECTS Like all medicines, Natecal D3 can cause side effects, although not everybody gets them. The following effects are uncommon: (occur in between 1 and 10 out of every 1,000 patients) hypercalcaemia (too much calcium in your blood) - the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, needing to pass urine more often, muscle weakness, drowsiness and confusion hypercalciuria (too much calcium in your urine) The following effects are rare: (occur in between 1 and 10 out of every 10,000 patients) nausea stomach ache constipation diarrhoea flatulence itching rash hives The frequency of the following effects is not known (cannot be estimated from the available data): Serious allergic (hypersensitivity) reactions such as swelling of the face, lips or tongue. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE NATECAL D3 Keep out of the reach and sight of children. Do not store above 30C. Store in the original package in order to protect from moisture. Do not take Natecal D3 after the expiry date which is stated on the box after exp. The expiry date refers to the last day of that month. 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 What Natecal D3 contains Each tablet contains the active substances: calcium carbonate (1500 mg equivalent to 600 mg calcium) and cholecalciferol (vitamin D3) (400 I.U equivalent to 0.01 mg). The other ingredients are: sorbitol (E 420), maltodextrin, croscarmellose sodium (E 468), aspartame (E 951), saccharin sodium (E 954), lactose monohydrate, aniseed flavour, peppermint flavour, molasses flavour, magnesium stearate, DL--tocopherol (E 307), hydrogenated soya bean oil, gelatine, sucrose, maize starch. What Natecal D3 looks like and contents of pack This medicinal product is a chewable tablet The tablet has a round, bevelled edge shape and is white to almost white with the inscription D on one side. Tablet container containing 12 or 60 tablets. Marketing Authorisation Holder Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK. Manufacturer ITALFARMACO S.p.A. Viale F. Testi, 330 20126 Milano. Tel. + 39 02 64431 - Fax. + 39 02644346 e-mail: info@italfarmaco.com Hard to Read? Date of preparation: 11/2010
Phone 0161 488 5555 for help
PK8800/2 - CP0020/3
600 mg + 400 I.U. chewable tablet
NATECAL D3
(calcium + cholecalciferol)
Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor This medicine is for use in Adults only This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor In this leaflet: 1. What Natecal D3 is and what it is used for 2. Before you take Natecal D3 3. How to take Natecal D3 4. Possible side effects 5. How to store Natecal D3 6. Further information 1. WHAT NATECAL D3 IS AND WHAT IT IS USED FOR Natecal D3 chewable tablets contain two active substances, calcium carbonate and cholecalciferol (vitamin D3). Both calcium and vitamin D3 are found in the diet and vitamin D is also produced in the skin after exposure to the sun. Natecal D3 chewable tablets may be prescribed by doctors to treat and prevent vitamin D/calcium deficiency. Natecal D3 is used: - In the correction of calcium and vitamin D deficiencies in the elderly, - In combination with osteoporosis treatments where calcium and vitamin D levels are too low or where there is a high risk of them being too low. 2. BEFORE YOU TAKE NATECAL D3 Do not take Natecal D3 If you are hypersensitive to calcium, vitamin D3 or to any of the other ingredients of Natecal D3 (in particular soya bean oil) If you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) If you are suffering from kidney failure; If you have kidney stones If you have high levels of vitamin D in your blood (hypervitaminosis D) Take special care with Natecal D3 If you have had kidney stones or other kidney problems (your doctor will need to monitor your treatment carefully if your kidneys are not working properly to make sure you do not build up too much calcium in your blood) If you stay in bed for a long period (months) and if you have osteoporosis (brittle bones) because you may have high levels of calcium in your blood If you are taking any other medicines containing calcium or vitamin D (your doctor or your pharmacist will be able to tell you if you do) If you have sarcoidosis (your doctor will be able to tell you if you do) Taking other medicines Do not take the product without talking to your doctor or pharmacist if you are taking: Any other medicine containing vitamin D The following heart medicines: digoxin or other cardiac glycosides Tetracycline and fluoroquinolone antibiotics; it is recommended that you wait at least 3 hours after taking these medicines before taking Natecal D3 chewable tablets Thiazide diuretics If you take other drugs used to treat bone disorders, such as biphosphonates or sodium fluoride, it is recommended that a period of at least 3 hours has to pass before taking Natecal D3 chewable tablets Phenytoin (a medicine for epilepsy) and barbiturates (medicines which are used for epilepsy or which help you sleep), as they may make the vitamin D3 less effective. Orlistat (a medicine used to treat obesity), cholestyramine, laxatives such as paraffin oil, as they may reduce the amount of vitamin D3 you absorb. Estramustin (a medicine used in chemotherapy), thyroid hormones or medicines containing iron, zinc or strontium, as the amount absorbed may be reduced. They should be taken at least 2 hours before or after Natecal D3. Taking Natecal D3 with food and drinks This product is likely to interact with some foods, for example those containing oxalic acid (like spinach, rhubarb, sorrel, cocoa, tea), phosphate (e.g. ham, sausages, cheese spread) or phytic acid (e.g. pulses, whole cereals, chocolate).
Therefore it is recommended to take Natecal D3 two hours before or after meals containing this kind of food. Pregnancy and breast-feeding Natecal D3 chewable tablets should only be used in pregnancy and breast-feeding when it has been recommended by a doctor. Important information about some of the ingredients of Natecal D3 The product contains: sorbitol (E420), aspartame (E951), lactose, hydrogenated soya bean oil, sucrose. The product contains aspartame, which is a source of phenylalanine. Phenylalanine may be harmful for people with phenylketonuria. The product contains lactose, sucrose and sorbitol therefore if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The product contains soya oil, therefore if you are allergic to peanut or soya, do not use this medicinal product. 3. HOW TO TAKE NATECAL D3 Always take Natecal D3 exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults and elderly is one tablet twice a day (e.g. one in the morning and one in the evening) preferably after meals. The tablets may be chewed or sucked, they must not be swallowed whole. If you take more Natecal D3 than you should Contact your doctor. If you cannot do this, go to your nearest hospital accident and emergency (casualty) department, taking any remaining tablets and the packaging with you. If you forget to take Natecal D3 Take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Never take two doses at the same time. 4. POSSIBLE SIDE EFFECTS Like all medicines, Natecal D3 can cause side effects, although not everybody gets them. The following effects are uncommon: (occur in between 1 and 10 out of every 1,000 patients) hypercalcaemia (too much calcium in your blood) - the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, needing to pass urine more often, muscle weakness, drowsiness and confusion hypercalciuria (too much calcium in your urine) The following effects are rare: (occur in between 1 and 10 out of every 10,000 patients) nausea stomach ache constipation diarrhoea flatulence itching rash hives The frequency of the following effects is not known (cannot be estimated from the available data): Serious allergic (hypersensitivity) reactions such as swelling of the face, lips or tongue. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE NATECAL D3 Keep out of the reach and sight of children. Do not store above 30C. Store in the original package in order to protect from moisture. Do not take Natecal D3 after the expiry date which is stated on the box after exp. The expiry date refers to the last day of that month. 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 What Natecal D3 contains Each tablet contains the active substances: calcium carbonate (1500 mg equivalent to 600 mg calcium) and cholecalciferol (vitamin D3) (400 I.U equivalent to 0.01 mg). The other ingredients are: sorbitol (E 420), maltodextrin, croscarmellose sodium (E 468), aspartame (E 951), saccharin sodium (E 954), lactose monohydrate, aniseed flavour, peppermint flavour, molasses flavour, magnesium stearate, DL--tocopherol (E 307), hydrogenated soya bean oil, gelatine, sucrose, maize starch. What Natecal D3 looks like and contents of pack This medicinal product is a chewable tablet The tablet has a round, bevelled edge shape and is white to almost white with the inscription D on one side. Tablet container containing 12 or 60 tablets. Marketing Authorisation Holder Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK. Manufacturer ITALFARMACO S.p.A. Viale F. Testi, 330 20126 Milano. Tel. + 39 02 64431 - Fax. + 39 02644346 e-mail: info@italfarmaco.com Hard to Read? Date of preparation: 11/2010
Phone 0161 488 5555 for help
PK8800/2 - CP0020/3
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
