Paricalcitol
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Zemplar is used for
Zemplar contains a synthetic form of activated vitamin D and belongs to the Vitamin D group of medicines.
Zemplar is used to treat secondary hyperparathyroidism associated with chronic kidney disease.
Secondary hyperparathyroidism
Kidney disease can cause a condition called secondary hyperparathyroidism. Normally your body makes a hormone called parathyroid hormone (PTH). PTH makes sure you have just enough calcium and phosphorus in your blood to keep your bones, heart, muscles, nerves and blood vessels working well. When your kidneys are working, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosphorus in and out of your bones.
When your kidneys are not working properly, the calcium and phosphorus balance in your body is upset, and your parathyroid glands send out high levels of PTH. This condition is called secondary hyperparathyroidism, and it can cause bone disease and also may be a risk factor for heart disease and abnormal calcium deposits in blood vessels and other parts of the body. Zemplar lowers PTH.
Your doctor, may have prescribed Zemplar for another reason. Ask your doctor if you have any questions why Zemplar has been prescribed for you.
Before you take Zemplar
It is important to limit the amount of phosphorus in your diet.
Phosphate-binding agents may be needed to control phosphorus levels. If you are taking calcium-based phosphate binders, the doctor may need to adjust your dose.
Your doctor will need to do blood tests to monitor your treatment.
When you must not take Zemplar
Do not take Zemplar if:
1. you have had an allergic reaction to paricalcitol, vitamin D or any of the ingredients in Zemplar listed at the end of this leaflet
2. you have high levels of calcium in your blood (called hypercalcaemia)
3. you have vitamin D toxicity
Do not take Zemplar if the package is torn or shows signs of tampering.
Do not take Zemplar if the expiry date (EXP) printed on the pack 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 Zemplar, talk to your doctor, nurse or pharmacist.
Before you start to take Zemplar
You must tell your doctor if:
1. you are allergic to any other medicines, foods, dyes or preservatives
2. you have any other health problems
3. you are pregnant or intend to become pregnant
4. you are breast-feeding or intend to breast-feed
Zemplar may pass into breast milk and have unwanted effects in the baby.
Your doctor will discuss the risks and benefits of taking Zemplar during pregnancy or breast-feeding.
If you have not told your doctor about any of the above, tell them before you take any Zemplar.
Taking other medicines
Several medicines can cause unwanted reactions if used with Zemplar.
Ask your doctor or pharmacist for advice before taking this medicine.
In particular tell your doctor if you are taking any of the following medicines:
ketoconazole, a medicine used to treat fungal infections
Cholestyramine
digitalis compounds such as digoxin - used for certain heart conditions.
medicines which contain aluminium e.g. antacids or phosphate binders.
These medicines may be affected by Zemplar, 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.
This is not a complete list of medicines which may interfere with Zemplar.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal remedies, including those obtained without a prescription from a pharmacy, supermarket or health food shop.
How to take Zemplar CAPSULES
How much to take
Always take Zemplar capsules exactly as your doctor, nurse or pharmacist has instructed you. You should check with your doctor, nurse or pharmacist if you are unsure. If you feel that the effect of Zemplar capsules is too strong or too weak, talk to your doctor, nurse or pharmacist.
The proper dose of Zemplar capsules must be determined for each patient. The doctor will use the results of some laboratory tests to help determine the proper dose for you. Once Zemplar is started, the dose is likely to need adjusting, depending on how you respond to treatment.
For chronic kidney disease Stage 3 and 4 (pre-dialysis patients) your doctor may direct you to take your Zemplar capsules every day or every other day (not more than three times in one week). A typical dose is one capsule every day or every other day.
If you are undergoing dialysis, your doctor may direct you to take your Zemplar capsules three times a week and no more frequently than every other day.
Once your condition is under control, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your parathyroid hormone, calcium and phosphorus levels.
Follow all directions given to you by your doctor carefully.
If you do not understand the instructions on the pharmacist's label fixed on the box, ask your doctor or pharmacist for help.
How to take it
Swallow capsules whole with a glass of water.
When to take it
Zemplar capsules may be taken with or without food.
How long to take Zemplar
Zemplar is usually taken continuously for long-term treatment. Always tell your doctor if you want to stop taking Zemplar as stopping suddenly can lead to a rapid rise in PTH levels.
If you forget to take Zemplar
If you forget to take a capsule, take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed. Thereafter, continue to use Zemplar capsules as your doctor, nurse or pharmacist has directed.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
How Zemplar Injection is given
Your doctor or nurse will usually administer Zemplar Injection during haemodialysis.
Dosing will be individualised and based on the results of some laboratory tests.
For children with secondary hyperparathyroidism
The doctor will determine the dose for children and will be based on the results of some laboratory tests.
Careful control of dosing and blood levels of PTH, calcium and phosphorus is necessary in children on long-term therapy.
In case of an overdose
Immediately telephone your doctor, or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Zemplar. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor, nurse or pharmacist.
While you are taking Zemplar
Things you must do
Always follow your doctor's, instruction carefully.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Zemplar.
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 or being given Zemplar.
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 or injections 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 or being given Zemplar.
Zemplar 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 and/or phosphorus in your blood. If this happens, you may experience weakness, feeling sick, vomiting, constipation, confusion and increased urination.
Zemplar and Laboratory Tests
Make sure that you keep all blood test appointments with your doctor. These are to check your blood PTH, calcium and phosphorus levels while you are taking Zemplar. Your doctor will discuss your specific needs with you.
Things you must not do
Do not suddenly stop taking Zemplar or change the dose without first checking with your doctor. Your doctor will tell you the best way to slowly reduce the amount of Zemplar you are taking before stopping completely.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give Zemplar to anyone else even if their symptoms seem similar to yours.
Do not use Zemplar 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 Zemplar.
Side Effects
Like all medicines, Zemplar can have side effects.
Tell your doctor immediately if you notice any of the following:
severe rash, hives or other signs of allergic reaction
swollen face, hands or feet
trouble breathing or swallowing
shortness of breath with exertion or upon lying down
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking Zemplar.
Zemplar 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:
confusion
feeling sleepy
dizziness
weakness
muscle pain
bone pain
constipation
nausea
vomiting
stomach pains or upset stomach
itchy skin
increased thirst
increased urination
Other side effects not listed above may also occur in some patients.
Ask your doctor or pharmacist for more information about side effects, as they have a more complete list of side effects. Inform your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor if you notice anything else that is making you feel unwell.
After taking Zemplar
Storage
Keep your capsules in the pack until it is time to take them.
If you take the capsules out of the pack they may not keep well.
Keep Zemplar in a cool dry place where the temperature stays below 30 degrees 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 windowsills.
Heat and dampness can destroy some medicines.
Keep Zemplar where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground are a good place to store medicines.
Disposal
Medicines should not be disposed of via wastewater or household waste.
If your doctor tells you to stop taking Zemplar, or the capsule has passed its expiry date, ask your pharmacist what to do with any capsules that are left over.
Product Description
What Zemplar looks like:
Zemplar 1 microgram capsules are oval, grey, soft gelatin capsules imprinted with the Abbott logo and ZA and are available in bottles of 30 and blister packs of 28.
Zemplar 2 microgram capsules are oval, orange-brown, soft gelatin capsules imprinted with the Abbott logo and ZF and are available in bottles of 30 and blister packs of 28.
Zemplar 4 microgram capsules are oval, gold, soft gelatin capsules imprinted with the Abbott logo and ZK and are available in bottles of 30 and blister packs of 28.
Zemplar 2 microgram/mL Injection is available in single-dose ampoules in packs of 5.
Zemplar 5microgram/mL Injection is available in single-dose ampoules in packs of 5.
Zemplar 10 microgram/2mL Injection is available in single-dose ampoules in packs of 5.
Ingredients
Zemplar Capsules:
Active ingredient - paricalcitol
Each Zemplar capsule contains either, 1 microgram, 2 micrograms or 4 micrograms of paricalcitol.
Inactive ingredients -
medium chain triglycerides
ethanol
butylated hydroxytoluene
gelatin
glycerol
titanium dioxide
iron oxide red (2 mcg capsules only)
iron oxide yellow (2 mcg and 4mcg capsules)
iron oxide black (1 mcg capsules only)
water
Zemplar Injection:
Active ingredient - paricalcitol
Zemplar ampoules contain either, 2 micrograms/mL, 5 micrograms/mL or 10 micrograms/2 mL of paricalcitol.
Inactive ingredients -
propylene glycol
ethanol
water
Zemplar does not contain sucrose, gluten, tartrazine or any other azo dyes.
Zemplar Capsules 1 microgram blister pack - AUST R 121760
Zemplar Capsules 1 microgram bottle pack - AUST R 121761 *
Zemplar Capsules 2 microgram blister pack - AUST R 121762
Zemplar Capsules 2 microgram bottle pack - AUST R 121763 *
Zemplar Capsules 4 microgram blister pack - AUST R 121764*
Zemplar Capsules 4 microgram bottle pack - AUST R 121765 *
Zemplar Injection 2 microgram/mL - AUST R 147422 *
Zemplar Injection 5 microgram/mL - AUST R 121759 *
Zemplar Injection 10 microgram/2mL -AUST R 131743 *
* Products not currently marketed
Distributor
Zemplar is distributed by:
Abbott Australasia Pty Ltd
32-34 Lord Street
Botany NSW 2019
This leaflet was prepared on: 24 February 2010
Version 04
