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ALFAD- 0.25 MICROGRAMS

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AlfaD 0.25, 0.5 OR 1 microgram CAPSULES ALFACALCIDOL
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Please read Section 4 POSSIBLE SIDE EFFECTS to enable you to spot any of the signs that this may be happening to you. You should notify your doctor, who may need to change your dose. While you are taking AlfaD your doctor will take regular blood tests. This is very important in children, patients with kidney problems and patients on a high dose of AlfaD . This is to check the level of calcium and phosphate in your blood while you take your medicine. Your doctor may prescribe another medicine called a phosphate binding agent to take as well as AlfaD . This will help to keep the right amount of phosphate in your blood. Taking other medicines Talk to your doctor if you are taking any of the following: cardiac glycosides (for heart problems) e.g. digoxin barbiturates (to treat anxiety and insomnia) e.g. phenobarbital anticonvulsants (to control epilepsy or fits) e.g. phenytoin, carbamazepine, primidone mineral oil (to relieve constipation) colestyramine, colestipol (to lower cholesterol levels) sucralfate (to treat and prevent ulcers) large amounts of aluminium-containing antacids (to relieve heartburn and indigestion) e.g. aluminium hydroxide magnesium-containing antacids (to relieve heartburn or indigestion) or laxatives (to treat constipation) e.g. magnesium hydroxide preparations containing calcium (for calcium deficiency) e.g. calcium gluconate thiazide diuretics, often called water tablets , (for increasing the amount of urine you produce) e.g. bendroflumethiazide any other preparations containing vitamin D (to treat bone disease), e.g. ergocalciferol. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Important information about some of the ingredients of AlfaD AlfaD capsules contain arachis oil (peanut oil). If you are allergic to peanut or soya, DO NOT take AlfaD . This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per microgram. AlfaD capsules contain a small amount of sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicinal product contains mannitol, which may have a mild laxative effect. Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine. Driving and using machines AlfaD is not expected to affect your ability to drive or operate machinery.

IN THIS LEAFLET:
1. What AlfaD is and what it is used for 2. Before you take AlfaD 3. How to take AlfaD 4. Possible side effects 5. How to store AlfaD 6. Further information

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WHAT AlfaD IS AND WHAT IT IS USED FOR

AlfaD is the brand name of your medicine. The name of the active ingredient is alfacalcidol. This medicine will be referred to as AlfaD throughout this leaflet. Alfacalcidol is a vitamin D product which helps the body to use calcium and phosphate for healthy bones. Your medicine is used to: treat post menopausal osteoporosis and osteoporosis caused by treatment with glucocorticoids (used to treat inflammation, and problems with the immune system), in patients who are unable to take medicines known as bisphosphonates e.g. etidronate disodium treat bone disease related to kidney problems treat rickets/osteomalacia (which is a disease causing the bones to soften and weaken) treat patients with low or high activity of the parathyroid gland (with bone disease) maintain normal calcium levels within the body.

If you forget to take AlfaD If you forget to take a capsule, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. If you stop taking AlfaD DO NOT stop taking your medicine without talking to your doctor first even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.

These symptoms are signs that problems with your kidneys may be developing, such as kidney stones forming. Kidney stones may Bone disease related to kidney problems, rickets, osteomalacia, and parathyroid problems cause a sharp spasm in one side of your lower back. Adults and children over 20 kg If any of the side effects get serious, or if you 1.0 microgram a day notice any side effects not listed in this leaflet, The elderly please tell your doctor or pharmacist. 0.5 microgram a day Children under 20 kg HOW TO STORE AlfaD AlfaD is not recommended for use in children under 20 kg. Keep out of the reach and sight of children. Osteoporosis Do not store above 25 C. Do not transfer AlfaD Adults (including the elderly) to another container. 1.0 microgram a day. Do not use after the expiry date that is stated on the outer packaging. The expiry date refers to If you take more AlfaD than you should the last day of that month. If you (or someone else) swallow a lot of the Medicines should not be disposed of via capsules all together, or if you think a child has wastewater or household waste. Ask your swallowed any of the capsules, contact your pharmacist how to dispose of medicines no nearest hospital casualty department or your longer required. These measures will help to doctor immediately. protect the environment. An overdose is likely to cause loss of appetite, general weakness, feeling sick, being sick, FURTHER INFORMATION weakness, sweating, diarrhoea, headache, weight loss, vertigo, thirst, and excessive What AlfaD capsules contain: urination. The active ingredient is alfacalcidol Please take this leaflet, any remaining capsules, (1 -hydroxyvitamin D3) 0.25, 0.5 or and the container with you to the hospital or 1 microgram. doctor so that they know which capsules were The other ingredients are citric acid consumed. anhydrous (E330), propyl gallate (E310), The capsules should be swallowed preferably with a drink of water. The usual dose is:

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POSSIBLE SIDE EFFECTS

-tocopherol (vitamin E) (E307), ethanol anhydrous and arachis oil (peanut oil). The capsule shell contains gelatin, glycerol 85% (E422) and anidrisorb 85/70 (sorbitol, sorbitans, superior polyols and mannitol). The printing ink contains shellac 54% (E904) and black iron oxide (E172). The capsules contain the following colours: 0.25 microgram capsules: red iron oxide (E172) 0.5 microgram capsules: titanium dioxide (E171) and red iron oxide (E172) 1.0 microgram capsules: titanium dioxide (E171) and yellow iron oxide (E172).

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BEFORE YOU TAKE AlfaD

DO NOT take AlfaD if you: are allergic (hypersensitive) to alfacalcidol, any other vitamin D products or any of the other ingredients of this medicine have a peanut or soya allergy. These capsules contain small amounts of peanut oil (arachis oil) which can cause a severe allergic reaction in sensitive people have a condition called hypercalcaemia, which means you have high levels of calcium in your blood have a condition called calcification, which means you have high levels of calcium in your body tissues. Take special care with AlfaD Talk to your doctor before you start to take this medicine if you: have kidney problems (including kidney stones) have a diet deficient in calcium, as AlfaD may not work as well. You may get too much calcium or phosphate in your blood when you take this medicine.

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HOW TO TAKE AlfaD

Always take AlfaD exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. During your treatment with AlfaD , the calcium and phosphate levels in your blood will be monitored regularly (especially if you suffer from kidney problems) and your dosage adjusted to achieve the correct response.

Like all medicines, AlfaD can cause side effects, although not everybody gets them. Side effects are generally caused by having too much calcium in the blood. If the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital: an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if you notice any of the following: feeling sick, being sick or diarrhoea general weakness and lack of energy, loss of appetite, thirst, weight loss sweating vertigo headache excessive urination a dry mouth or a metallic taste in your mouth experiencing pain in your muscles or bones constipation. Other possible side effects include: Skin problems, such as: itching skin rash hives (urticaria). Kidney problems, with symptoms such as: needing to pass water (urine) less often swelling of any parts of your body fever with a pain in your side.

What AlfaD capsules look like and contents of the pack: The 0.25 microgram capsules are oval, opaque, reddish-brown, elastic soft gelatin capsules containing clear, pale yellow, oily solution. They are printed 0.25 on one side in black ink. The 0.5 microgram capsules are oval, opaque, pale pink, elastic soft gelatin capsules containing clear, pale yellow, oily solution. They are printed 0.5 on one side in black ink. The 1 microgram capsules are oval, opaque, cream to ivory, elastic soft gelatin capsules containing clear, pale yellow, oily solution. They are printed 1.0 on one side in black ink. The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, or 168 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder: TEVA UK Limited, Eastbourne BN22 9AG England. Company responsible for manufacture: Pharmachemie B.V., 2003 RN Haarlem, The Netherlands. AlfaD is a registered trademark of Teva Pharmaceutical Industries Ltd. This leaflet was last revised: April 2010 PL 00289/0459-0461 67933-T

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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