2. Before you take Fultium-D - Electronic Medicines …

1 Package Leaflet: Information forthe userFultium-D3 20,000 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.

2 Further information1. What Fultium-D3 is and what itis taken forFultium-D3 are capsules. They contain theactive ingredient:Vitamin D3(20,000 IU colecalciferolequivalent to 500 micrograms Vitamin D3).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).

3 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(hypervitaminosis 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 will need 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)

4 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).

5 Thesecan decrease the effect of vitamin DLaxatives (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) 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 to their high strength, Fultium-D320,000 IU capsules are not recommendedduring pregnancy and 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 in children and adolescentsThe recommended dose for:Prevention of vitamin D deficiency12-18 years.

6 20,000 IU (1 capsule)every 6 weeksTreatment of vitamin D deficiency12-18 years: 20,000 IU (1 capsule)once every 2 weeks for 6 20,000 IU Capsules are notsuitable for children under 12 in pregnancy and breast-feedingFultium-D3 20,000 IU capsules are in adultsThe recommended dose for:Prevention of vitamin D deficiency:20,000 IU/month (1 capsule), higherdoses may be required in certainsituationsTreatment of vitamin D deficiency:40,000 IU/week (2 capsules) for 7 weeks,followed by maintenance therapy,(equivalent to 1,400-2,000 IU/day, suchas 2-3 capsules per month), based on theadvice of your should check with your doctor orpharmacist if you are capsule should beswallowed wholewith water, preferably with the main mealof the you take more Fultium-D3 than youshouldIf you accidentally take too many capsulestell your doctor or get other medical adviceimmediately.

7 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 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. 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 orpharmacist.(continued overleaf)1505415054 DatamatrixPCP Header BoxProduct TitleComponentPack SizeIG CodeDimensionsProof UsedFonts UsedOperatorArtwork ChangeSuffixApproved by DateIssued byDatePoint Sizes UsedMin MaxPharmacodeBarcodeVeri cationReference Pro le NumberBODY TEXT ONLYL ocal AuthoritysubmissionrequiredLeaflet15s/30 sGKE314/06/2019 Fultium D3 20000 IU Capsules92795831905168mm x 420mm10pt12 ptRockwellBlackKeyline (Non-Printing)Technical Info (Non-Printing)

8 Cirrus_Info_Box9279583190516073 Change dimensions at request of 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 this can also report side effects directlyvia the Yellow Card Scheme or searchfor MHRA Yellow Card in the Google Playor Apple 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".

9 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 20,000 IU colecalciferol(equivalent to 500 micrograms Vitamin D3).The other ingredients are:Capsule ContentMaize oil, refinedButylated hydroxytoluene (BHT) (E321)Capsule ShellGelatinGlycerolQuinoline Yellow (E104)Purified Fultium-D3 looks like andcontents of the packFultium-D3 20,000 IU Capsule is a yellowcoloured translucent soft gelatin is available in blister packs containing7, 10, 14, 15, 20, 28, or 30 all pack sizes may be Authorisation Holder andManufacturerThe Marketing Authorisation Holder is:Internis Pharmaceuticals LaboratoriesLinthwaiteHuddersfieldWest YorkshireHD7 5 QHUnited KingdomThe Manufacturer is.

10 Swiss Caps GmbHGrassingerstrasse 9 Bad AiblingD - 83043 GermanyThis leaflet was last revised in 05/20199279583190511023772 DatamatrixPCP Header BoxProduct TitleComponentPack SizeIG CodeDimensionsProof UsedFonts UsedOperatorArtwork ChangeSuffixApproved by DateIssued byDatePoint Sizes UsedMin MaxPharmacodeBarcodeVeri cationReference Pro le NumberBODY TEXT ONLYL ocal AuthoritysubmissionrequiredLeaflet15s/30 sGKE314/06/2019 Fultium D3 20000 IU Capsules92795831905168mm x 420mm10pt12 ptRockwellBlackKeyline (Non-Printing)Technical Info (Non-Printing)Cirrus_Info_Box92795831905 16073 Change dimensions at request of