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1 Package leaflet : Information forthe userFultium-D3 800 IU Capsules(Colecalciferol)Read all of this leaflet carefullybefore you start taking this this leaflet . You may need to read you have any further questions, askyour doctor or medicine has been prescribed not pass it on to others. It mayharm them, even if their symptoms arethe same as any of the side effects gets serious, or ifyou notice any side effects not listed inthis leaflet , please tell your doctor this leaflet :1. What Fultium-D3 is and what it istaken for2. before you take Fultium-D33. How to take Fultium-D34. Possible side effects5. How to store Fultium-D36. Further information1. What Fultium-D3 is and what itis taken forFultium-D3 are capsules. They contain theactive ingredient:Vitamin D3 (800 IU colecalciferolequivalent to 20 micrograms Vitamin D3).

2 Vitamin D is found in the diet and is alsoproduced in the skin after exposure to thesun. Often vitamin D is given in combinationwith calcium. Fultium-D3 is recommendedfor use when you have a normal intake ofdietary be prescribed by your doctorto treat or prevent vitamin D of vitamin D may occur whenyour diet or lifestyle does not provideyou enough vitamin D or when your bodyrequires more vitamin D (for instance whenyou are pregnant). Fultium-D3 may also beprescribed for certain bone conditions, suchas thinning of the bone (osteoporosis) whenit will be given to you with other before you take Fultium-D3Do not take Fultium-D3 if youareallergic (hypersensitive) to vitaminD or any of the other ingredients in thecapsules (these are listed in section 6,Further information)have high levels of vitamin D in yourblood(hyper vitaminosis D)have high blood levels of calcium(hypercalcaemia) or high urine levels ofcalcium(hypercalciuria)havekidney stones or serious with your doctor before takingFultium-D3 ifyou havekidney damage doctor may want to measure thelevels of calcium in your blood or urineyou are being treated forheart diseaseyou havesarcoidosis (an immunesystem disorder which may affect yourliver, lungs, skin or lymph nodes)

3 You are already takingadditional dosesof calciumor vitamin youare taking Fultium-D3 your doctor willmonitor your blood levels of calcium tomake sure they are not too other medicinesPlease tell your doctor or pharmacist if youare taking or have recently taken any othermedicines, including medicines obtainedwithout a particular the following medicines mayinteract with Fultium-D3:Heart medicines (cardiac glycosidessuch as digoxin).Your doctormay monitor your heart with anelectrocardiogram (ECG) and measurethe levels of calcium in your bloodMedicines to treat epilepsy (such asphenytoin) or medicines to makeyou sleep (barbiturates such asphenobarbitone) as these medicines candecrease the effect of vitamin DGlucocorticoids (steroid hormones suchas hydrocortisone or prednisolone). Thesecan decrease the effect of vitamin (such as paraffin oil) ora cholesterol lowering drug calledcolestyramine may reduce theabsorption of vitamin DActinomycin (a medicine used to treatsome forms of cancer) andimidazoleantifungals (medicines such asclotrimazole and ketoconazole used totreat fungal diseases)

4 As they may interferewith the metabolism of vitamin Fultium-D3 with food anddrinkYou can take Fultium-D3 with or without foodand and breast-feedingIf you are pregnant or think you may bepregnant or you are breast-feeding youshould talk to your doctor or pharmacistbefore you take should be used duringpregnancy and breast-feeding only ifrecommended by your and using machinesFultium-D3 should not affect your ability todrive or operate How to take Fultium-D3 Always take Fultium-D3 exactly as yourdoctor has told severe vitamin D deficiency (for adultsand the elderly)Your doctor will usually prescribe you a doseof 1-4 capsules daily for up to 12 amount will depend on how low yourvitamin D levels are and how you respondto doctor will then tell youto take 1-2 capsules daily to maintain yourvitamin D moderate vitamin D deficiency (foradults and the elderly) or to preventvitamin D deficiencyYour doctor will usually prescribe1-2 capsules vitamin D deficiency in children over12 yearsYour doctor will usually prescribe you1 capsule osteoporosis (you will also be takingother medicines for this)Your doctor will usually prescribe 1 in pregnancy and breast-feedingTo treat vitamin D deficiency:Your doctorwill usually prescribe 1 - 5 capsules dailyfor up to 12 weeks, followed by a long termmaintenance term maintenance and to preventvitamin D deficiency.

5 Your doctor willusually prescribe 1 - 2 capsules should check with your doctor orpharmacist if you are capsules should beswallowed whole(not chewed) with isnot suitable for childrenunder 12 you take more Fultium-D3 than youshouldIf you accidentally take one capsule toomany, nothing is likely to happen. If youaccidentally take several capsules too manytell your doctor or get other medical adviceimmediately. If possible, take the capsules,the box and this leaflet with you to show thedoctor. If you take too many capsules youmay feel or be sick, become constipatedor have stomach pains, weak muscles,tiredness, lack of appetite, kidney problemsand in severe cases irregular heartbeats.(continued overleaf)927957419051505215052 DatamatrixPCP Header BoxProduct TitleComponentPack SizeIG CodeDimensionsProof UsedFonts UsedOperatorArtwork ChangeSuffixApproved by DateIssued byDatePoint Sizes UsedMin MaxPharmacodeBarcodeVeri cationReference Pro le NumberBODY TEXT ONLYL ocal AuthoritysubmissionrequiredLeaflet30s/90 sGKE310/06/2019 Fultium D3 800 IU Capsules92795741905168mm x 420mm10pt12ptRockwellBlackKeyline (Non-Printing)Technical Info (Non-Printing)Cirrus_Info_Box92795741905 16073 Change dimensions at request of you forget to take Fultium-D3If you forget to take your capsules, takethem as soon as you not take adouble dose to make up for a forgottendose.

6 After that, take the next capsule inaccordance with the instructions given toyou by your you have any further questions on theuse of this product, ask your doctor Possible side effectsLike all medicines, Fultium-D3 can causeside effects, although not everybody effects with Fultium-D3 may include:Uncommon side effects(affecting less than 1 in 100 people)too much calcium in your blood(hypercalcaemia).You may feelor be sick, lose your appetite, haveconstipation, stomach ache, feelvery thirsty, have muscle weakness,drowsiness or confusiontoo much calcium in your urine(hypercalciuria).Rare side effects(affecting less than 1 in 1000 people)skin of side effectsIf you get any side effects, talk to yourdoctor or pharmacist. This includes anypossible side effects not listed in can also report side effectsdirectly via the Yellow Card Scheme or search forMHRA Yellow Card in the Google Play orApple App reporting side effects you can helpprovide more information on the safety ofthis How to store Fultium-D3 Keep out of the sight and reach of below 25 blister foil in the original container inorder to protect from not use Fultium-D3 after the expiry datewhich is stated on the carton as "EXP".

7 Theexpiry date refers to the last day of should not be disposed of viawastewater or household waste. Ask yourpharmacist how to dispose of medicines nolonger required. These measures will help toprotect the Further informationWhat Fultium-D3 containsThe active ingredient (which makes themedicine work) is colecalciferol. Eachcapsule contains 800 IU colecalciferol(equivalent to 20 micrograms Vitamin D3).The other ingredients are:Capsule contentMaize oil, refinedButylated hydroxytoluene (BHT) (E321)Capsule ShellGelatinGlycerolBrilliant Blue WS (E133)Purified Fultium-D3 looks like andcontents of the packFultium-D3 800 IU Capsule is a bluecoloured translucent soft gelatin is available in blister packs containing28, 30, 56, 60 or 90 all pack sizes may be Authorisation Holder andManufacturerThe Marketing Authorisation Holder is:Internis Pharmaceuticals LaboratoriesLinthwaiteHuddersfieldWest YorkshireHD7 5 QHUnited KingdomThe Manufacturer is.

8 Swiss Caps GmbHGrassingerstrasse 9 Bad AiblingD - 83043 GermanyThis leaflet was last revised in 05/20199279574190511023765 DatamatrixPCP Header BoxProduct TitleComponentPack SizeIG CodeDimensionsProof UsedFonts UsedOperatorArtwork ChangeSuffixApproved by DateIssued byDatePoint Sizes UsedMin MaxPharmacodeBarcodeVeri cationReference Pro le NumberBODY TEXT ONLYL ocal AuthoritysubmissionrequiredLeaflet30s/90 sGKE310/06/2019 Fultium D3 800 IU Capsules92795741905168mm x 420mm10pt12ptRockwellBlackKeyline (Non-Printing)Technical Info (Non-Printing)Cirrus_Info_Box92795741905 16073 Change dimensions at request of