D-CURE 25,000IU ORAL

D-CURE 25,000IU ORAL

D-CURE 25,000IU Oral Solution

Cholecalciferol

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

Bạn đang đọc: D-CURE 25,000IU ORAL

What D-cure is used forHow D-cure worksBefore you use D-cureHow to use D-cureWhile you are using D-cureSide effectsStorage and disposal of D-cureProduct descriptionManufacturer and productregistration holderDate of revision

What D-cure is used for

D-cure 25,000 IU Oral Solution is avitaminproductcontainingcholecalciferol( equivalentvitaminVitaminfoundsomefoodsalsoproduced by the body toàn thân when skin isexposedsunlight .Vitaminhelpskidneysintestineabsorb calcium and ithelps buildbones ( refer to section Before youtake D-cure ) .D-cure 25,000 IU Oral Solution isused :preventionvitamindeficiency when there is significantrisk of deficiency or / and increaseddemand for vitamin DWith other medicines to treat certainbone conditions, such as thinning ofthe bone ( osteoporosis )To treat vitamin D deficiency thatbeenconfirmedlaboratorytests

How D-cure works

biologicallyactiveformVitaminstimulatesintestinalcalcium absorption, incorporation ofcalcium into the bone, and release ofcalciumfrombonetissue .small intestine it promotes rapid anddelayed calcium uptake. The passiveand active transport of phosphate isalsostimulated .kidney ,inhibits the excretion of calcium andphosphate .productionparathyroid hormone ( PTH ) in theparathyroids is inhibited directly bybiologicallyactiveformvitaminsecretioninhibitedadditionallyincreasedcalciumuptakesmall intestine under the influenceof biologically active vitamin D.

Before you use D-cure

When you must not use it

Do not take D-cure ifYou are allergic to vitamin D orany other ingredients of D-Cure( refersectionProductdescription : Ingredients )You have hypercalcaemia ( highlevels of calcium in the blood )You have hypercalciuria ( highlevels of calcium in the urine )havepseudohypoparathyroidism( disturbed parathyroid hormonemetabolism )You have renal calculi ( kidneystones )havehypervitaminosis( high levels of vitamin D in theblood ) .Do not take D-cure if any of theabove applies to you. If you are notsure ,talkyourdoctorpharmacist before taking D-cure .

Before you start to use it

Before you take D-cure you shouldtell your doctor if you :Are undergoing treatment withcertain medicines used to treatheartdisorders( e. g .cardiacglycosides, such as digoxin )Have sarcoidosis ( an immunesystemdisorderwhichcauseincreasedlevelsvitamin D in the body toàn thân )takingmedicinescontaining vitamin D, or eatingfoodsmilkenrichedwithvitamin DAre likely to be exposed to alot of sunshine whilst using D -cureTaking additional supplementscontainingcalcium .Yourdoctor will monitor your bloodlevels of calcium to make surethey are not too high whilst youare using D-cureHavekidneydamagedisease .Your doctor may want to measurethe levels of calcium in your bloodor urine

Pregnancy and breast-feeding

pregnantbreast -feeding ,thinkpregnant or are planning to havebaby ,yourdoctorpharmacistadvicebeforetaking this medicine .This high strength formulation is notrecommendedpregnantand breastfeeding women .

Driving and using machines

There is limited information on thepossible effects of this medicine onyour ability to drive. However, it isexpectedthatwouldaffectyour ability to drive or to operatemachinery .

Taking other medicines

Pleasetellyourdoctorpharmacist if you are taking or haverecently taken any other medicines ,includingmedicinesobtainedwithoutprescription .importantthatinformyourdoctoralreadybeingtreated with any of the following :Medicinesthatheartkidneys ,suchcardiacglycosides( e. g .digoxin )diuretics( e. g .bendroflumethazide ) .Whenusedsametimevitaminthesemedicinesmay cause a large increase inlevelcalciumblood and urineMedicines containing vitaminD or eating food enrich withvitaminsuchsometypes of vitamin D-enrichedmilkActinomycinmedicineused to treat some forms ofcancer )imidazoleantifungals ( e. g. clotrimazoleand ketoconazole, medicinesused to treat fungal disease ) .Thes emedicinesinterfere with the way your

D-CURE 25,000IU Oral Solution

Cholecalciferol

Consumer Medication Information Leaflet (RiMUP)

body toàn thân process vitamin Dfollowingmedicinesbecausetheyinterferewitheffectabsorption of vitamin D :antiepileptic medicines( anticonvulsants ) ,barbituratesglucocorticoids ( steroidhormonessuchhydrocortisoneprednisolone ) .Thes edecreaseeffectvitamin Dmedicinesthatlowerthe level of cholesterolin the blood ( such ascholestyramine ,colestipol )certainmedicinesweight loss that reducethe amount of fat yourbody toàn thânabsorbs( e. g .orlistat )certain laxatives ( suchas liquid paraffin )

Taking D-cure with food and drink

shouldtakethismedicinepreferably together with a large mealto help your body toàn thân absorb the vitaminD. You can also mix the solutionwith cold or lukewarm food, to helpyou take this medicine. For detailedinformation, see section How to useD-cure .

How to use D-cure

How much and when to use it

Always take D-cure exactly as yourdoctortoldyou .shouldcheck with your doctor or pharmacistif you are not sure .You should take D-cure preferablytogetherwithlargemeal .Thismedicine has a delicate taste of oliveoil. The contents of the ampoule isto be emptied directly into the mouthswallowedorallydiagram below .To help you take this medicine ,the full contents of the ampoule

may be emptied onto a spoon and

taken orally. You may also mixthe contents of the ampoule with asmall amount of cold orlukewarmfoodimmediatelybeforeuse .Makesureentiredosetaken .

Use in children and adolescents

The recommended dose for :

Prevention of vitamin D deficiency

in 0-1 years:

1 ampoule of D-cure 25,000 IUevery 8 weeks

Prevention of vitamin D deficiency

in 1-18 years:

1 ampoule of D-cure 25,000 IUevery 6 weeks

Treatment of vitamin D deficiency

in 0-18 years:

1 ampoule of D-cure 25,000 IUonce every 2 weeks for 6 weeks( followedmaintenancetherapy of 400 – 1000 IU / day ) .children ,D-curemixed with a small amount ofchildren’s foods, yogurt, milk ,cheese or other dairy products .Do not mix this medicine into abottle of milk or container ofsoftfood ,caseyourchilddoesconsumewholeportion, and does not receivethe full dose. You should makesurethatentiredosetaken. For children who are nolongerbreast-feedingshould give the prescribed dosewith a substantial meal .Do not store any product orfood mixture that contains D -cure for use at a later time or anext meal .

Use in pregnancy and breast-

feeding

This high strength formulationis not recommended .

Use in adults

The recommended dose for :

Prevention

of

vitamin

D

deficiency:

1 ampoule of D-cure 25,000IU once monthly. Higher dosesmay be required based on theadvice of your doctor .

Addition

to

specific

therapy

for

osteoporosis:

ampoule of D-cure 25,000 IUonce monthly .

Treatment of vitamin D deficiency:

ampoulesD-cure25,000 IU once weekly forweeks ,followedmaintenancetherapy( 1400 – 2000 IU once dailymay be required ), based onthe advice of your doctor .

How long to use it

Do not stop taking D-cure withoutfirst discussing it with your doctor .If you have any further questionson the use of this medicine, askyour doctor or pharmacist .

If you forget to use it

If you forget to take a dose of D -cure, take the forgotten dose assoon as possible. Then, take thenextdosecorrecttime .However, if it is almost time totake the next dose, do not takethe dose you have missed ; justtake the next dose as normal .Do not take a double dose to makeup for a forgotten dose .

If you use too much (overdose)

If you or your child takes moremedicinethanprescribed ,stopusing this medicine and contactyour doctor. If it is not possibletalkdoctor ,nearesthospitalemergencydepartment and take the medicine

D-CURE 25,000IU Oral Solution

Cholecalciferol

Consumer Medication Information Leaflet (RiMUP)

package with you .The most common symptoms ofoverdose are : nausea, vomiting ,excessive thirst, the productionof large amounts of urine overhours ,constipationdehydration ,highlevelscalciumblood( hypercalcaemiahypercalciuria )showntest .

While you are using D-cure

Things you must and must not do

Contact your doctor if any of thefollowing applies to you :undergoingtreatmentwithcertain medicines used to treatheartdisorders( e. g .cardiacglycosides, such as digoxin )havesarcoidosisimmunesystemdisorderwhichcauseincreasedlevelsvitamin D in the body toàn thân )takingmedicinescontainingvitamin D, or eating foods ormilk enriched with vitamin Dlikely to be exposed to a lot ofsunshine whilst using D-curetakeadditionalsupplementscontaining calciumhave kidney damage or disease

Things to be careful of

Whilethismedicine ,your doctor may want to monitorthe levels of calcium in blood orurine to make sure they are not toohigh whilst you are using D-cure .

Side effects

Likemedicines ,D-curecausesideeffects ,althougheverybody gets them. If the side -effects don’t go away after a fewdays ,feelunwellotherway ,talkyourdoctorbefore you take your next dose .Possible side effects may include :

Uncommon

( affects less than 1 in100 people ) :Too much calcium in your blood( hypercalcaemia )Too much calcium in your urine( hypercalciuria )

Rare

( affects less than 1 in 1,000people ) :Skin rashItchingHivessideeffectsgetsserious, or if you notice any sideeffectslistedthisleaflet ,pleasetellyourdoctorpharmacist .You may report any side effects oradverse drug reactions directly toNationalCentreAdverseDrugReactionMonitoringvisitingwebsiteww.npra.gov.my[ ConsumersReporting Side Effects to Medicines( ConSERF ) or Vaccines ( AEFI ) ] ”

Storage and disposal of D-cure

Keep out of the reach and sight ofchildren .Do not use D-cure after the expirydate which is stated on the cartonand labels after “ Exp ”. The expirydatereferslastmonth shown .Store below 30 °C in the originalcartonorderprotectcontents from light .Do not freeze or refrigerate .Medicines should not be disposed ofvia wastewater or household waste .Ask your pharmacist how to disposepackagingsmedicineslonger required. This way you willhelp to protect the environment .

Product description

What it looks like

D-cureclear ,slightlyyellow ,oily liquid .suppliedtransparentPVC / PVDC / PE ampoules .availablepackPVC / PVDC / PE ampoules .

Ingredients

activesubstancescholecalciferol ( Vitamin D3 )

otheringredientstocopherolacetate ,polyglyceryloleate ( E475 ) ,oliveoil ,refined ,sweetorange peel oil .

MAL 18086102AZ

Manufacturer

SMB Technology S.A.Rue du Parc Industriel 39B-6900 Marche en FamenneBelgium

Product registration holder

Hyphens Pharma Sdn BhdL1-10 và L1-11, PJ Midtown ,Jalan Kemajuan, Seksyen 13 ,46200, Petaling Jaya ,Selangor, Malaysia

Date of revision

Sept 2020

Serial number

NPRA ( R2 / 1 ) 200617 / 461

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