What is a Patient Information Leaflet and why is it useful?

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: PL41042/0010.


Zemplar 5 microgram/ml Solution for Injection

Package leaflet: Information for the patient

Zemplar 5 micrograms/ml solution for injection

paricalcitol

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Zemplar is and what it is used for
2. What you need to know before you are given Zemplar
3. How Zemplar is used
4. Possible side effects
5. How to store Zemplar
6. Contents of the pack and other information

1. What Zemplar is and what is it 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, in patients with chronic kidney disease namely high levels of parathyroid hormone which can cause bone problems. Zemplar is used in adult patients with kidney disease Stages 5.

2. What you need to know before you are given Zemplar

You should not be given Zemplar

  • if you are allergic to paricalcitol or any of the other ingredients of this medicine (listed in section 6).
  • if you have very high levels of calcium or vitamin D in your blood.

Your doctor will be able to tell you if these conditions apply to you.

Warnings and precautions

Talk to your doctor or nurse before being given Zemplar.

  • before the treatment begins, it is important to limit the amount of phosphorus in your diet. Examples of foods high in phosphorous include tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and grains.
  • phosphate-binding medicines, which keep phosphate from being absorbed from your food, 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.

Other medicines and Zemplar

Tell your doctor, nurse 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:

  • to treat fungal infections such as candida or thrush, (for example ketoconazole)
  • to treat heart problems or high blood pressure (for example digoxin, diuretics or water pills).
  • that contain a source of phosphate (for example, medicines to lower calcium levels in the blood)
  • that contain calcium or vitamin D, including supplements and multivitamins that can be bought without a prescription
  • that contain magnesium or aluminium, for example some types of indigestion medicines (antacids) and phosphate-binders
  • to treat elevated cholesterol levels (for example cholestyramine)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine.

It is not known if it is safe for pregnant women to use this medicine, therefore its use is not recommended during pregnancy or if you may become pregnant.

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 may make you feel dizzy, which can affect your ability to drive safely or use heavy machines.

Do not drive or use machines if you feel dizzy.

Zemplar contains ethanol

This medicinal product contains 20% v/v of ethanol (alcohol). Each dose may contain up to 1.3g ethanol which may be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy.

3. How Zemplar is used

Your doctor will use the results of your laboratory tests to decide the correct starting dose for you. Once treatment with Zemplar has started, the dose may be adjusted, based upon the results of routine laboratory tests. Using your lab results, your doctor will help determine the correct dose of Zemplar for you.

Zemplar will be given by a doctor or nurse while you are having your treatment on the kidney machine. It will be given through the tube (bloodline) that is used to connect you to the machine. You will not need to have an injection because Zemplar can be put directly into the tube that is being used for your treatment. You will not be given Zemplar more frequently than every other day and not more than three times a week.

If you are given too much Zemplar

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.

If you experience high level of calcium in your blood after taking Zemplar, your doctor will ensure you receive the appropriate treatment to return your calcium to normal limits. Once your calcium levels return to normal limits, you may be given Zemplar at a lower dose.

Your doctor will be checking your blood levels. If you experience any of the above, seek medical advice immediately.

Symptoms which can develop over a longer period of receiving 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.

Zemplar contains 30% by volume of Propylene glycol as an ingredient. Cases of poisonous effects related to the high doses of Propylene glycol have only rarely been reported and would not be expected when being given to kidney patients on a kidney machine because Propylene glycol is removed from the blood during dialysis.

If you receive too much Zemplar, or experience any of the above, seek medical advice immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Various allergic reactions have been seen with Zemplar. Important: Tell your doctor or nurse immediately if you notice any of the following side effects:

  • Shortness of breath
  • Difficulty breathing or swallowing
  • Wheezing
  • Rash, itchy skin, or including hives
  • Swelling of the face, lips, mouth, tongue or throat.

Tell your doctor or nurse if you notice any of the following side effects:

Common (may affect up to 1 in 10 people) are:

  • low levels of parathyroid hormone
  • high levels of calcium (feeling sick or being sick, constipated or confused); phosphorous in the blood (probably no symptoms but it can make bones more likely to break)
  • headache
  • unusual taste in the mouth
  • itchy skin

Uncommon (may affect up to 1 in 100 people) are:

  • blood infection, pneumonia (lung infection), sore throat, infections in the vagina, influenza
  • breast cancer
  • decreased number of red cells (anaemia – feeling weak, shortness of breath, looking pale); decreased number of white cells (more likely to get infections); swollen glands in the neck, armpit and/or groin
  • high levels of parathyroid hormones
  • high levels of potassium in the blood, low levels of calcium in the blood, loss of appetite
  • confusion, which is sometimes severe (delirium), personality disorders (not feeling like yourself), agitation (feeling jittery, anxious), problems sleeping, nervousness
  • coma (a deep state of unconsciousness during which the person cannot respond to the environment), stroke, fainting, muscular spasms in arms and legs, even during sleep, decreased touch sensation, tingling or numbness, dizziness
  • increased pressure in the eye, pink eye (itchy/crusty eyelids)
  • earache
  • heart attack, irregular/fast heartbeat
  • low blood pressure, high blood pressure
  • fluid on the lungs, asthma, wheezing, difficulty breathing, nose bleeds, cough
  • bleeding from the rectum, inflammation of the colon, diarrhoea, stomach ache, difficulty swallowing, constipation, nausea, vomiting, dry mouth
  • Skin rash with itchy blisters, hair loss, excessive hair growth, excessive and unpredictable sweats
  • joint pain, joint stiffness, back pain, muscle twitching, muscle pain
  • breast pain, difficulty having an erection
  • abnormal way of walking, general swelling or localised swelling of the ankles, feet and legs, injection site pain, fever, chest pain, unusual tiredness or weakness, a general feeling of discomfort, thirst
  • increased bleeding time (blood will not clot so quickly), increase of a liver enzyme, change in laboratory test results, weight loss

Not known Frequency (frequency cannot be estimated from the available data):

  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing; itchy skin (hives); stomach bleeding.

You may not be able to tell if you have some of the side effects listed above unless you are told so by your doctor.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist 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 directly (see details below).

Ireland:

Healthcare professionals are asked to report any suspected adverse reactions via

HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

United Kingdom:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellow

card or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

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.

Zemplar should be used immediately after opening.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last date of that month.

Do not use this medicine if you notice particles or discolouration.

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

  • The active substance is paricalcitol. Each ml of solution contains 5 micrograms of paricalcitol.
  • The other ingredients are: ethanol (alcohol), propylene glycol, and water for injection.

What Zemplar looks like and contents of the pack

Zemplar solution for injection is a watery, clear and colourless solution, free from visible particles.

It is supplied in containers with 5 glass ampoules of 1 ml or 2 ml or 5 glass vials of 1 ml or 2 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

In Ireland:

AbbVie Limited
Citywest Business Campus
Dublin 24
Ireland

In the UK:

AbbVie Ltd
Maidenhead
SL6 4UB
UK

Vial Manufacturer:

AbbVie S.r.l. S.R.
148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Zemplar 5 Mikrogramm/ml - Injektionslösung

Cyprus: Zemplar 5 mcg/ml ενέσιμο διάλυμα

Czech Republic: Zemplar

Finland: Zemplar 5 mikrog/ml injektioneste, liuos

Germany: Zemplar 5 Mikrogramm/ml Injektionslösung

Greece: Zemplar 5 mcg/ml ενέσιμο διάλυμα

Hungary: Zemplar 5 mikrogramm/ml oldatos injekció

Ireland: Zemplar 5 micrograms/ml solution for injection

Italy: Zemplar 5 microgrammi/ml soluzione iniettabile

Netherlands: Zemplar, oplossing voor injectie 5 microgram/ml

Portugal: Zemplar 5 microgramas/ml solução Injetável

Slovakia: Zemplar 5 mikrogramov/ml injekčný roztok

Spain: Zemplar 5 microgramos/ml solución inyectable

Sweden: Zemplar 5 mikrogram/ml injektionsvätska, lösning

United Kingdom: Zemplar 5 micrograms/ml solution for injection

This leaflet was last revised in March 2019.

For information in large print, tape, CD or Braille, phone 01628 561092 (UK) or 01 428 7900 (Ireland).