Active ingredient
- paricalcitol
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL41042/0011 .
Zemplar 1 microgram capsule, soft
Package leaflet: Information for the patient
Zemplar 1 microgram capsules, soft
Zemplar 2 micrograms capsules, soft
paricalcitol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Zemplar is and what it is used for
2. What you need to know before you take Zemplar
3. How to take Zemplar
4. Possible side effects
5. How to store Zemplar
6. Contents of the pack and other information
1. What Zemplar is and what it is used for
Zemplar contains the active substance paricalcitol, which is a synthetic form of active vitamin D.
Active vitamin D is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In people who have normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in kidney failure the production of active vitamin D is markedly reduced. Zemplar therefore provides a source of active vitamin D, when the body cannot produce enough and helps to prevent the consequences of low levels of active vitamin D, namely high levels of parathyroid hormone which can cause bone problems. Zemplar is used in adult patients with kidney disease Stages 3, 4 and 5 and children aged 10 to 16 years with kidney disease Stages 3 and 4.
2. What you need to know before you take Zemplar
Do not take Zemplar
Your doctor will be able to tell you if these conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zemplar.
Other medicines and Zemplar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the action of this medicine or may increase the likelihood of side-effects. It is particularly important to tell your doctor if you are taking any of the following medicines:
Zemplar with food and drink
Zemplar may be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is no adequate data on the use of paricalcitol in pregnant women. Potential risk in human use is not known, therefore paricalcitol should not be used unless clearly necessary.
It is not known if paricalcitol passes into human breast milk. Tell your doctor before breast-feeding while taking Zemplar.
Driving and using machines
Zemplar should not affect your ability to drive or use machines.
Zemplar contains ethanol (alcohol)
This medicine contains a small amount of ethanol (an alcohol), less than 100mg per capsule, which may modify or increase the effect of other medicines. This could be harmful to people who suffer from liver disease, alcoholism, epilepsy, brain injury, or disease as well as in pregnant or breast-feeding women and children.
3. How to take Zemplar
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Chronic Kidney Disease Stages 3 and 4
In adult patients the usual initial dose is one capsule every day, or every other day, up to three times a week. Your doctor will use the results of your laboratory tests to decide the correct dose for you. Once Zemplar is started, the dose is likely to need adjusting, depending on how you respond to treatment. Your doctor will help determine the correct dose of Zemplar for you.
Chronic Kidney Disease Stage 5
In adult patients the usual initial dose is one capsule every other day, up to three times a week. Your doctor will use the results of your laboratory tests to decide the correct dose for you. Once Zemplar is started, the dose is likely to need adjusting, depending on how you respond to treatment. Your doctor will help determine the correct dose of Zemplar for you.
Liver disease
If you have mild to moderate liver disease, your dose will not need to be adjusted. However, there is no experience in patients with severe liver disease.
Renal transplant
The usual dose is one capsule every day, or every other day, up to three times a week. Your doctor will use the results of your laboratory tests to decide the correct dose for you. Once Zemplar is started, the dose is likely to need adjusting, depending on how you respond to treatment. Your doctor will help determine the correct dose of Zemplar for you.
Use in children and adolescents
In children ages 10 to 16 years of age with chronic kidney disease Stages 3 or 4 the usual initial dose is one capsule every other day, up to three times a week. Your doctor will use the results of your laboratory tests to decide the correct dose for you. Once Zemplar is started, the dose is likely to need adjusting, depending on how you respond to treatment. Your doctor will help determine the correct dose of Zemplar for you.
The efficacy of Zemplar in children with CKD Stage 5 has not been established.
There is no information on the use of Zemplar capsules in children under the age of 10 years.
Use in elderly
There is a limited amount of experience of using Zemplar in patients aged 65 years or older. In general no overall differences in effectiveness or safety were seen between patients aged 65 years or older and younger patients.
If you take more Zemplar than you should
Too much Zemplar can cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms which can appear soon after taking too much Zemplar may include a feeling of weakness and/or drowsiness, headache, nausea (feeling sick) or vomiting (being sick), a dry mouth, constipation, pains in muscles or bones and a metallic taste in the mouth.
Symptoms which can develop over a longer period of taking too much Zemplar include loss of appetite, drowsiness, weight loss, sore eyes, a runny nose, itchy skin, feeling hot and feverish, loss of sex drive and severe abdominal pain (due to an inflamed pancreas) and kidney stones. Your blood pressure may be affected and heart beat irregularities (palpitations) can occur. The results of blood and urine tests may show high cholesterol, urea, nitrogen and raised levels of liver enzymes. Zemplar may rarely cause mental changes including confusion, drowsiness, insomnia or nervousness.
If you take too much Zemplar, or experience any of the above, seek medical advice immediately.
If you forget to take Zemplar
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the dose that you have missed, simply continue to take Zemplar as previously directed (dose and time) by your doctor.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zemplar
Unless your doctor tells you to stop your treatment, it is important to keep taking Zemplar as your doctor has directed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important: Tell your doctor immediately if you notice any of the following side effects:
Tell your doctor or nurse if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
If you experience an allergic reaction, please contact your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects (see details below).
By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
5. How to store Zemplar
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Zemplar contains
Zemplar 1 micrograms capsules
Zemplar 2 micrograms capsules
What Zemplar looks like and contents of the pack
Zemplar 1 micrograms capsules
Zemplar 1 microgram capsules, is an oval, grey soft capsule imprinted with ZA.
Each carton contains either 1 or 4 foil blister packs. Each pack contains 7 capsules.
Zemplar 2 micrograms capsules
Zemplar 2 micrograms capsules, is an oval, orange-brown soft capsule imprinted with ZF.
Each carton contains either 1 or 4 foil blister packs. Each pack contains 7 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UK:
Manufacturer:
Manufacturer:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic: Zemplar
Estonia: Zemplar, 1 mikrogramm pehmekapslid, Zemplar, 2 mikrogrammi pehmekapslid
Germany: Zemplar 1 Mikrogramm Weichkapseln, Zemplar 2 Mikrogramm Weichkapseln
Greece: Zemplar 1 μικρογραμμάριο καψάκια, μαλακά, Zemplar 2 μικρογραμμάρια καψάκια, μαλακά
Hungary: Zemplar 1 mikrogramm lágy kapszula, Zemplar 2 mikrogramm lágy kapszula
Ireland: Zemplar 1 microgram capsules, soft, Zemplar 2 micrograms capsules, soft
Italy: Zemplar 1 microgrammo capsule molli, Zemplar 2 microgrammi capsule molli
Latvia: Zemplar 1 mikrograma mīkstās kapsulas, Zemplar 2 mikrogramu mīkstās kapsulas
Lithuania: Zemplar 1 mikrogramas minkštosios kapsulės, Zemplar 2 mikrogramai minkštosios kapsulės
Netherlands: Zemplar 1 microgram capsules, zacht
Portugal: Zemplar 1 micrograma cápsulas moles, Zemplar 2 microgramas cápsulas moles
Romania: Zemplar 1 microgram, capsule moi, Zemplar 2 micrograme, capsule moi
Slovakia: Zemplar 1 mikrogram mäkké kapsuly, Zemplar 2 mikrogramy mäkké kapsuly
Slovenia: Zemplar 1 mikrogram mehke kapsule, Zemplar 2 mikrograma mehke kapsule
Spain: Zemplar 1 microgramo cápsulas blandas, Zemplar 2 microgramos cápsulas blandas
Sweden: Zemplar 1 mikrogram kapsel, mjuk, Zemplar 2 mikrogram kapsel, mjuk
United Kingdom: Zemplar 1 microgram capsules, soft, Zemplar 2 micrograms capsules, soft
This leaflet was last revised in September 2020.
For information in large print, tape, CD or Braille, phone 01628 561090 (UK) or 01 428 7900 (Ireland).
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
+44 (0)1628 561 092
+44 (0)1628 561 092