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Sitriol

contains the active ingredient calcitriol
CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about Sitriol.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Sitriol against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Sitriol is used for

Sitriol is used to:

• treat osteoporosis, a disease which causes bones to become weak and brittle
• prevent osteoporosis or bone loss in people taking oral corticosteroids such as prednisone.

Sitriol is also used to treat low calcium levels in people with:

• osteodystrophy, a bone growth disorder
• hypoparathyroidism – reduced function of the parathyroid glands
• rickets.

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.

The active ingredient in Sitriol is calcitriol. Calcitriol occurs naturally in humans and is the active form of vitamin D.

Sitriol works by improving the absorption of calcium from the intestine (gut) and by stimulating growth of healthy bones.

Sitriol is available only with a doctor`s prescription.

Sitriol is not addictive.

Before you take Sitriol

When you must not take it

Do not take Sitriol if you have had an allergic reaction to:

• medicines containing calcitriol (Rocaltrol, Citrihexal)
• vitamin D compounds such as ergocalciferol (Ostelin)
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take Sitriol if you have:

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

Some of the symptoms of hypercalcaemia and vitamin D toxicity may include weakness, headache, drowsiness, nausea, vomiting, dry mouth or thirst, loss of appetite, constipation and muscle or bone pain.

Do not take this medicine if you are breastfeeding or wish to breastfeed.

Sitriol may pass into breast milk and have unwanted effects in the baby.

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 are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.

Your doctor will discuss the risks and benefits of taking Sitriol during pregnancy.

Tell your doctor if you have or have had any other medical condition including:

• kidney problems
• heart problems.

Your doctor may want to take special care if you have any of these conditions.

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

Taking other medicines

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

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

• medicines or vitamin supplements containing vitamin D (e.g. Ostelin) or calcium (e.g. Caltrate)
• antacids containing magnesium (e.g. Mylanta, Gastrogel) for heartburn and indigestion
• digoxin (Lanoxin), a medicine used to treat some heart problems
• oral corticosteroids such as prednisone (Panafcort, Sone) and cortisone (Cortate)
• medicines containing thiazide diuretics (also called fluid tablets), used to treat high blood pressure, such as Moduretic, Amizide and Avapro HCT
• cholestyramine (Questran Lite), a medicine used to treat high cholesterol
• phenytoin (Dilantin), a medicine used to treat epilepsy
• phenobarbitone, a medicine used in the treatment of epilepsy and sleep problems.

These medicines may be affected by Sitriol 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.

How to take Sitriol

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 on the bottle, ask your doctor or pharmacist for help.

How much to take

Take Sitriol exactly as directed by your doctor.

Your doctor will tell you how many capsules you need to take each day and when to take them. This will vary depending on the nature of your illness, the calcium level in your blood, your response to Sitriol and whether or not you are taking any other medicines.

Osteoporosis

The usual dose for adults is one capsule (0.25 microgram) twice a day.

Osteodystrophy, Hypoparathyroidism and Rickets

The usual starting dose is one capsule (0.25 microgram) daily. Your doctor may increase the dose of Sitriol after two to four weeks if there is no response or improvement in your condition.

Infants and Small Children with Hypoparathyroidism

The correct dose of Sitriol will be determined by the child`s doctor.

For children between 1 and 5 years of age, the usual dose is one to three capsules (0.25 microgram to 0.75 microgram) each day.

Children on long-term treatment with Sitriol will require careful control of dosing and monitoring of blood calcium levels by their doctor. This will help prevent the formation of kidney stones.

How to take it

Swallow the capsules whole with a glass of water.

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

When to take it

Take your medicine at about the same time each day.

This will allow Sitriol to have the best effect and also help you remember when to take it.

Sitriol can be taken with or without food.

How long to take it for

Keep taking Sitriol for as long as your doctor recommends.

Sitriol is usually taken every day for long-term treatment.

If you forget to take it

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

Otherwise, take the missed dose as soon as you remember, and then go back to taking your capsules as you would normally.

Do not take a double dose to make up for the dose you missed.

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

If you have any questions about this, check with your doctor or pharmacist.

If you take too much (overdose)

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

You may need urgent medical attention.

If you take too much Sitriol, you may feel extremely thirsty, weak, lose your appetite, have a headache, vomit or be constipated.

While you are taking Sitriol

Things you must do

Discuss the calcium intake from your diet with your doctor and carefully follow your recommended diet while you are taking Sitriol.

Sudden increases in the amount of calcium from your diet while you are on Sitriol, particularly in the amount of dairy products, may lead to increased calcium in your blood, followed by other unwanted effects.

Tell your doctor immediately if you experience any of the signs of high calcium levels in the blood.

Some of the signs of increased blood calcium levels include weakness, drowsiness, feeling sick, vomiting.

Keep all of your doctor`s appointments so that your progress can be checked.

Your will need to have regular blood tests to check your calcium levels. This is to prevent unwanted side effects.

People with normal kidney function are recommended to drink plenty of fluids to prevent possible dehydration, while taking Sitriol.

Before starting any new medicine, tell your doctor or pharmacist that you are taking Sitriol.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Sitriol.

If you become pregnant while taking Sitriol, tell your doctor.

If you plan to have surgery, tell your doctor that you are taking Sitriol so your blood calcium levels can be checked more often.

People immobilised or confined to bed after surgery are sometimes likely to have increased calcium levels.

Things you must not do

Do not use Sitriol to treat any other complaints unless your doctor tells you to.

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

Things to be careful of

Your ability to drive a car or operate machinery can be affected by medicines. However, Sitriol will not normally affect your ability to do these things.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sitriol.

Like all other medicines, Sitriol may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

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

Tell your doctor as soon as possible if you notice any of the following and they worry you:

• fever, increased thirst, dry mouth, metallic taste
• loss of appetite, nausea (feeling sick), vomiting
• constipation, stomach (abdominal) pain
• headache, drowsiness, confusion
• weakness
• muscle or bone pain
• urinary tract infection which you may notice as a painful, burning sensation when urinating (passing water); or a frequent urge to urinate
• irregular and/or rapid heart beat.

These are all symptoms of high levels of calcium in your blood. You may need medical attention for the above side effects.

If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:

• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.
• sudden or severe itching, skin rash or hives.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some patients. Some of these side effects (such as high cholesterol levels) can only be found when your doctor does tests from time to time to check your progress.

After taking Sitriol

Storage

Keep Sitriol 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.

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 capsules in a cool dry place where the temperature stays below 30 degrees C.

Keep the capsules away from light.

Do not store Sitriol or any other medicine in the bathroom or near a sink. Do not leave Sitriol in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

Sitriol capsules are oval-shaped, with one half red-orange in colour and the other half off-white.

Each bottle contains 100 capsules.

Ingredients

The active ingredient in Sitriol is calcitriol. Each Sitriol capsule contains 0.25 microgram of calcitriol.

The capsules also contain the following inactive ingredients:

• butylated hydroxyanisole (320)
• butylated hydroxytoluene (321)
• medium chain triglycerides
• gelatin
• glycerol
• hydrogenated products of partially hydrolysed starch
• titanium dioxide (171)
• Canthaxanthin 10% CWS/N (contains colour 161g).

Sitriol capsules do not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

• Sitriol is supplied by:
• Alphapharm Pty Limited
• (ABN 93 002 359 739)
• Chase Building 2
• Wentworth Park Road
• Glebe NSW 2037
• Phone: (02) 9298 3999
• Medical Information
• Phone: 1800 028 365
• www.alphapharm.com.au
• Australian registration number:
• Sitriol – AUST R 93229
• This leaflet was prepared on
• 15 January 2007.

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