Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about KOSTEO capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking KOSTEO capsules against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What KOSTEO is used for
KOSTEO contains the active ingredient calcitriol, one of the naturally occurring and biologically active forms of Vitamin D. Calcitriol acts in the body in a similar manner to Vitamin D.
KOSTEO is used to treat people with osteoporosis, a disease where the bones of the body weaken, and in the prevention of osteoporosis in people taking oral corticosteroids.
KOSTEO capsules are also prescribed for patients who have low blood calcium levels due to osteodystrophy (a type of bone disease), hypoparathyroidism (a condition where the parathyroid glands have decreased function) and rickets.
KOSTEO increases calcium absorption in the intestine and stimulates healthy bone growth.
There are many different types of medicines used to treat bone conditions. KOSTEO belongs to a group of medicines known as vitamin D compounds.
Your doctor may have prescribed this medicine for another purpose.
Ask your doctor if you have any questions why KOSTEO has been prescribed for you.
This medicine is available only with a doctor's prescription.
KOSTEO is not addictive.
Before you take KOSTEO
When you must not take it
Do not take KOSTEO if:
- you have had an allergic reaction to KOSTEO, calcitriol or any ingredients listed in the Ingredients section of this leaflet
- you have high blood calcium levels (hypercalcaemia)
- you have vitamin D toxicity
- you are breastfeeding or wish to breastfeed.
KOSTEO may pass into the breastmilk and have unwanted effects in the baby.
Do not take KOSTEO if the package shows signs of tampering or if the capsules do not look quite right.
Do not take it if the expiry date (EXP) printed on the bottle has passed. If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking KOSTEO, talk to your doctor.
Before you start to take it
You must tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives
You must tell your doctor if you have any other health problems including:
- kidney problems.
- you are bedridden or in a wheelchair
- Vitamin D resistant rickets
- an abnormal heartbeat
You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking KOSTEO when pregnant.
If you have not told your doctor about any of the above, tell them before you take any KOSTEO.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop.
Some medicines and KOSTEO may interfere with each other. These include:
- medicines, vitamin tablets or health supplements containing vitamin D or calcium
- antacids containing magnesium
- thiazide diuretics
These medicines may be affected by KOSTEO, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor and pharmacist have a complete list of medicines to be careful with or avoid while taking KOSTEO.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
Use in children
When children are taking KOSTEO for a long time, the dose should be well controlled and blood levels of calcium should be monitored so that kidney stones don’t develop.
How to take KOSTEO
How much to take
Your doctor will tell you how many KOSTEO capsules to take each day. This will vary depending on the nature of your illness, the level of calcium in your blood and your individual response to KOSTEO. Your doctor will need to make regular measurements of the calcium level in your blood while you are taking KOSTEO.
Capsules should be swallowed whole with a glass of water.
Do not open the capsules and do not take any capsules that are damaged.
When to take it
KOSTEO can be taken at any time of day with or without food.
How long to take it for
KOSTEO is usually taken continuously for long term treatment.
Always tell your doctor if you want to stop taking KOSTEO, as stopping suddenly can lead to a rapid fall in calcium levels.
If you forget to take it
Do not take an extra dose. Wait until the next dose and take your normal dose then. Do not try to make up for the dose that you missed by taking more than one dose at a time.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much KOSTEO, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Signs of overdosage include loss of appetite, headache, excessive thirst, feeling sick, vomiting and constipation.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking it
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking KOSTEO.
Do not take any other medicines whether they require a prescription or not without first telling your doctor.
Tell your doctor if you become pregnant while taking KOSTEO.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the capsules are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can be checked.
Always discuss with your doctor any problems or difficulties during or after taking KOSTEO capsules.
KOSTEO and diet
You should discuss your diet with your doctor and adhere strictly to your dietary recommendations. Sudden changes in diet, particularly the amount of dairy products, may lead to increased calcium in your blood. If this happens, you may feel sick, vomit, be confused, experience weakness, be constipated and experience increased urination.
KOSTEO and laboratory tests
Make sure that you keep all blood test appointments with your doctor. These are to check your blood calcium levels while you are taking KOSTEO. Your doctor will discuss your specific needs with you.
Things you must not do
Do not suddenly stop taking KOSTEO or change the dose without first checking with your doctor. Your doctor will tell you the best way to slowly reduce the amount of KOSTEO you are taking before stopping completely.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give your medicine to anyone else even
if their symptoms seem similar to yours.
Do not use KOSTEO to treat other complaints unless your doctor says to.
Things to be careful of
Your ability to drive a car or operate machinery may be affected by medicines.
Normally, your ability to drive a car or operate machinery will not be affected by KOSTEO.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking KOSTEO.
KOSTEO helps most people but it may have unwanted side effects in a few. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Tell your doctor if you notice any of the following and they worry you:
- not feeling hungry (loss of appetite)
- feeling sick
- vomiting or stomach ache
- weakness or muscle weakness
- dry mouth or thirst
- irregular and/or rapid heart beat
- urinary tract infection
These are all symptoms of high levels of calcium in your blood. If you experience any of these, tell your doctor immediately.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Other side effects not listed above may also occur in some patients.
Tell your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you do not understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using it
Keep your capsules in the bottle until it is time to take them. If you take the capsules out of the bottle they may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep KOSTEO where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking KOSTEO, or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.
What it looks like
KOSTEO 0.25 microgram capsules are oval and red in colour.
KOSTEO does not contain sucrose, gluten, tartrazine or any other azo dyes.
Active ingredient – calcitriol
Each KOSTEO capsule contains 0.25 micrograms of calcitriol.
Inactive ingredients –
The capsules also contain:
- butylated hydroxyanisole (320)
- butylated hydroxytoluene (321)
- fractionated coconut oil
- sorbitol and the colours titanium dioxide (C177891), iron oxide red (C177491) and iron oxide yellow (C177492).
KOSTEO is available in blister packs of 100 capsules.
Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
Australian registration numbers:
AUST R 234863 (blister pack)
Date of revision: March 2017
Published by MIMS August 2017