High dose vitamin D3 (cholecalciferol) capsules,

consumer medicines information.

Brand Name for capsules: D-3-50 (There are also vitamin D3 tablets made called Cal D forte
tablets).

Generic Name: cholecalciferol (vitamin D3) (KOE le kal SIF e role).

IMPORTANT NOTICE - PLEASE READ.

Currently 50,000 IU vitamin D3 tablets and capsules have not been assessed for approval by the
Australian Therapeutic Goods Administration (TGA) for use in Australia. This includes D-3-50
capsules and Cal D forte tablets. This means that these products have not been considered by an
Australian regulator with regard to quality, safety and efficacy.

Overseas, D-3-50 capsules are manufactured by Biotech Pharmacal of Fayetteville, Arkansas, USA.
This manufacturer holds a US federal government manufacturing license and is registered with the
US Food and Drug Administration. Cal D forte tablets are manufactured by PSM Healthcare of
Auckland, New Zealand and have Medsafe NZ registration.

What is cholecalciferol?
Cholecalciferol is another name for vitamin D3. This is important for the absorption of calcium from
the stomach and for the functioning of calcium in the body. Cholecalciferol is made in the body by the
action of UV light (from sunlight) on cholesterol in the skin or it may be obtained from diet. Few
Australians obtain enough vitamin D from their diet and many do not or cannot get an adequate sun
exposure to make enough vitamin D.

Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D, especially
conditions of the skin or bones.

Cholecalciferol may also be used for other purposes not listed in this medication guide.

Why high dose cholecalciferol?

High dose cholecalciferol capsules and tablets are used to treat medically diagnosed vitamin D
deficiency. This very often requires long term treatment for which these preparations may offer
greater convenience and lesser cost.

What should I know about cholecalciferol?

Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high
levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your
body to absorb nutrients from food (malabsorption).

Before starting cholecalciferol, tell your doctor if you are allergic to any drugs, or if you have heart
disease, kidney disease, or an electrolyte imbalance.

Before starting cholecalciferol tell your doctor about all your prescription and over-the-counter
medications (including antacids), vitamins, minerals (including calcium supplements), herbal
products, and drugs prescribed by other doctors. When taking cholecalciferol do not start a new
medication without telling your doctor.

Calcium supplements are commonly taken together with cholecalciferol, discuss whether or not you
need a calcium supplement with your doctor. Do not start a calcium supplement without discussing
the necessity with your doctor.

What should I discuss with my doctor or pharmacist before taking

cholecalciferol?
Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

high levels of calcium in your blood (hypercalcemia);

high levels of vitamin D in your body (hypervitaminosis D); or
any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Before taking cholecalciferol, tell your doctor if you are allergic to any drugs, or if you have:

heart or kidney disease or

an electrolyte imbalance.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take
this medication.

Your cholecalciferol dose needs may change if you are pregnant or breast-feeding. Tell your doctor if
you are pregnant or plan to become pregnant during treatment, or if you are breast-feeding a baby.

How should I take cholecalciferol?

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not take it
in larger amounts or for longer than recommended.

Your doctor may occasionally change your dose to make sure you get the best results from this
medication.

Cholecalciferol is only part of a complete program of treatment that may also include a special diet. It
is very important to follow the diet plan created for you by your doctor or nutrition counselor. You
should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store this medication at room temperature away from moisture, light, and heat.

What happens if I miss a dose?

If only one dose is missed just take the missed dose as soon as you remember and your next dose
when it is due. If a number of doses have been missed you may need a blood test so check with your
doctor.

What happens if I overdose?

Seek medical attention if you think you have used too much of this medicine. An overdose of vitamin
D can cause serious or life-threatening side effects.
Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting,
constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in
heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper
stomach spreading to your back, or fainting.

What should I avoid while taking cholecalciferol?

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice (note, calcium
supplements are commonly given with cholecalciferol). Use only the specific type of supplement or
antacid your doctor recommends.

Cholecalciferol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives;
difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking cholecalciferol and call
your doctor at once if you have a serious side effect such as:

thinking problems, changes in behavior, feeling irritable;

urinating more than usual;
chest pain, feeling short of breath; or
early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle
or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or
bothersome side effect. You may report side effects to the consumers adverse events medicines line
at 1300 134 237.

What other drugs will affect cholecalciferol?

Before taking cholecalciferol, tell your doctor if you are taking any of the following medicines:

seizure medication;
cholestyramine (Questran);
colestipol (Colestid);
steroids (prednisone and others);
digoxin (Lanoxin); or
a diuretic such as hydrochlorothiazide (Dithiazide), chlorthalidone (Hygroton), indapamide
(Dapa, Insig, Natrilix, Napamide, Indahexal ), and others,.
medications for blood pressure which may also contain a diuretic.

This list is not complete and there may be other drugs that can interact with cholecalciferol. Tell your
doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start a new medication without telling your
doctor.

Where can I get more information?

Your pharmacist or doctor can provide more information about cholecalciferol.
Remember, keep this and all other medicines out of the reach of children, never share your
medicines with others, and use this medication only for the indication prescribed