Calcitriol Sandoz Capsules

Calcitriol Sandoz Capsules is a brand of medicine containing the active ingredient calcitriol.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Calcitriol Sandoz®

calcitriol capsules


Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Calcitriol Sandoz.

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 this medicine 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.

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WHAT CALCITRIOL SANDOZ IS USED FOR

This medicine is used to treat:

  • patients with osteoporosis (where the bones of the body weaken) and to prevent osteoporosis in patients taking oral corticosteroids
  • low blood calcium levels due to osteodystrophy (a type of bone disease)
  • hypoparathyroidism (a condition where the parathyroid glands have decreased function)
  • rickets.

It contains the active ingredient calcitriol, one of the naturally occurring and biologically active forms of vitamin D. Calcitriol belongs to a group of medicines known as vitamin D compounds. It works by increasing calcium absorption in the intestine and stimulating healthy bone growth, by acting in a similar manner to vitamin D in the body.

There are many different types of medicines used to treat bone conditions.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

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BEFORE YOU TAKE CALCITRIOL SANDOZ

When you must not take it

Do not take this medicine if you have had an allergy to:

  • calcitriol, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
  • any other similar medicines (vitamin D compounds).

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take this medicine if you have or have had any of the following medical conditions:

  • high blood calcium levels (called hypercalcaemia)
  • vitamin D toxicity.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney problems
  • vitamin D resistant rickets
  • you are bedridden or in a wheelchair.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking Calcitriol Sandoz.

Use in children

Careful control of dosing and blood levels of calcium is necessary in children on long term therapy to avoid the development of kidney stones.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Calcitriol Sandoz may interfere with each other. These include:

  • medicines, vitamin tablets or health supplements containing vitamin D or calcium
  • cholestyramine, a medicine used to lower cholesterol
  • antacids containing magnesium
  • digoxin, a medicine used to treat heart failure or control heart rhythm
  • thiazide diuretics, medicines used to remove excess fluid
  • phenytoin, a medicine used to control epilepsy
  • phenobarbital, a medicine used to control epilepsy
  • corticosteroids such as prednisolone, hydrocortisone, dexamethasone.

These medicines may be affected by Calcitriol Sandoz, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

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HOW TO TAKE CALCITRIOL SANDOZ

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how many 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 this medicine.

Your doctor will need to take regular measurements of the calcium level in your blood while you are taking this medicine.

Osteoporosis patients
Generally the daily dose for adults is 0.25 micrograms (one capsule) taken twice daily.

Osteodystrophy, hypoparathyroidism and rickets
Generally the initial daily dose for adults is 0.25 micrograms (one capsule) given in the morning. If calcium levels have not improved significantly after 2 to 4 weeks treatment, your doctor may gradually increase the dose in 0.25 microgram steps until a satisfactory calcium level in your blood is achieved.

For infants and small children with hypoparathyroidism
As for adults, the correct dose of this medicine must be determined by your doctor. For children between 1 and 5 years of age the recommended daily dose is 0.25 to 0.75 micrograms (one to three capsules).

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you. If you take the wrong dose, Calcitriol Sandoz may not work as well and your problem may not improve.

How to take it

Swallow the capsules whole with a full glass of water.

Do not open the capsules and do not take any capsules that are damaged.

When to take Calcitriol Sandoz

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take Calcitriol Sandoz

Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

Calcitriol Sandoz is usually taken continuously for long term treatment. Always tell your doctor if you want to stop taking your medicine as stopping suddenly can lead to a rapid fall in calcium levels.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Calcitriol Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Signs of an overdose may include loss of appetite, headache, excessive thirst, feeling sick, vomiting and constipation.

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WHILE YOU ARE TAKING CALCITRIOL SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Calcitriol Sandoz.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it is not effective and change your treatment unnecessarily.

Tell your doctor if you feel the capsules are not helping your condition.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests (such as checking your blood calcium levels) from time to time to make sure the medicine is working and to prevent unwanted side effects.

Always discuss with your doctor any problems or difficulties during or after taking this medicine.

Calcitriol Sandoz 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 experience weakness, feeling sick, vomiting, constipation, confusion and increased urination.

Things you must not do

Do not take Calcitriol Sandoz to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Do not let yourself run out of medicine over the weekend or on holidays.

Things to be careful of

Your ability to drive a car or operate machinery may be affected by some medicines. Normally, your ability to drive a car or operate machinery will not be affected by Calcitriol Sandoz.

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SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Calcitriol Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • not feeling hungry (loss of appetite)
  • feeling sick (nausea)
  • headache
  • fever
  • vomiting or stomach ache
  • constipation
  • 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.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

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AFTER TAKING CALCITRIOL SANDOZ

Storage

Keep your medicine in the original container. If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25oC.

Do not store Calcitriol Sandoz, or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

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PRODUCT DESCRIPTION

What it looks like

Calcitriol Sandoz 0.25 microgram - red coloured, oval, soft gelatin capsules containing a clear oily liquid.

Available in bottles of 100 capsules.

Ingredients

Active ingredient:

  • Calcitriol Sandoz 0.25 microgram – 0.25 microgram calcitriol.

Inactive ingredients:

  • butylated hydroxyanisole
  • butylated hydroxytoluene
  • fractionated coconut oil
  • gelatin
  • glycerol
  • sorbitol solution (70%) (non-crystallising)
  • iron oxide red
  • iron oxide yellow.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Calcitriol Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500

This leaflet was prepared in October 2011.

Australian Register Number
0.25 microgram capsules: AUST R 149506

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CMI provided by MIMS Australia, June 2014  

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