ZEMPLAR 1 microgram SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Zemplar 1 microgram soft capsules

Zemplar 2 micrograms soft capsules

Paricalcitol

Contents of the pack and other information

1. What is Zemplar and what is it used for
2. What you need to know before you take Zemplar
3. How to take Zemplar
4. Possible side effects
5. Storage of Zemplar

1. Contents of the pack and other information

1. What is Zemplar 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 necessary for the normal functioning of many body tissues, including the parathyroid gland and bones. In people with normal kidney function, this active form of vitamin D is produced naturally by the kidneys, but in kidney failure, the production of active vitamin D is markedly reduced. Therefore, Zemplar provides a source of active vitamin D when the body cannot produce enough and helps prevent the consequences of low levels of active vitamin D, specifically high levels of parathyroid hormone that can cause bone problems. Zemplar is used in adult patients with chronic kidney disease stages 3, 4, and 5 and in children aged 10 to 16 years with chronic kidney disease stages 3 and 4.

2. What you need to know before you take Zemplar

Do not take 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 tell you if these conditions apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting Zemplar.

• before starting treatment, it is important that you limit the amount of phosphorus in your diet.
• you may need to use phosphorus binders to control phosphorus levels. If you are taking phosphorus binders with calcium content, your doctor may adjust the dose.

• your doctor will perform blood tests to monitor your treatment.
• in some patients with chronic kidney disease stages 3 and 4, an increase in blood levels of a substance called creatinine has been observed. However, this increase does not reflect a decrease in kidney function.

Taking Zemplar with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines may affect the action of this medicine or increase the risk 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 oral thrush (e.g., ketoconazole)
• to treat heart problems or high blood pressure (e.g., digoxin, diuretics, or fluid-removing medicines)
• that contain a phosphate source (e.g., medicines to reduce calcium levels in the blood)
• that contain calcium or vitamin D, including supplements or multivitamins that can be purchased without a prescription
• that contain magnesium or aluminum (e.g., some antacids and phosphate binders)
• to treat high cholesterol (e.g., colestyramine)

Taking Zemplar with food and drinks

Zemplar can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. There is not enough data on the use of paricalcitol in pregnant women. The risk in humans is unknown; therefore, paricalcitol should not be used during pregnancy unless clearly necessary.

It is not known whether paricalcitol passes into breast milk. If you are taking Zemplar, inform your doctor before breastfeeding your child.

Driving and using machines

Zemplar should not affect your ability to drive or use machines.

Zemplar contains ethanol (alcohol)

This medicine contains 0.71 mg of alcohol (ethanol) in each 1 microgram capsule and 1.42 mg of alcohol (ethanol) in each 2 microgram capsule. The amount per capsule of this medicine is equivalent to less than 1 ml of beer or wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Zemplar

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Chronic Kidney Disease, Stages 3 and 4

In adult patients, the usual starting dose is one capsule daily, or one capsule every other day, up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to decide the correct dose for you. Once you start treatment with Zemplar, you may need a dose adjustment based on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

Chronic Kidney Disease, Stage 5

In adult patients, the usual starting dose is one capsule every other day, up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to determine the correct dose for you. Once you start treatment with Zemplar, you may need a dose adjustment based on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

Liver Disease

If you have mild to moderate liver disease, you do not need to adjust the dose. However, there is no experience in patients with severe liver disease.

Kidney Transplant

The usual dose is one capsule daily, or one capsule every other day, up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to decide the correct dose for you. Once you start treatment with Zemplar, you may need a dose adjustment based on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

Use in Children and Adolescents

In children aged 10 to 16 years with chronic kidney disease stages 3 or 4, the usual starting 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. Once you start Zemplar, you may need a dose adjustment based on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

Zemplar has not been shown to be effective in children with chronic kidney disease stage 5.

There is no information on the use of Zemplar capsules in children under 10 years of age.

Use in Elderly

There is limited experience with the use of Zemplar in patients aged 65 and over. In general, no overall differences in efficacy or safety have been observed between patients over 65 years and younger patients.

If you take more Zemplar than you should

Taking too much Zemplar can cause abnormally high calcium levels in the blood, which can be harmful. Symptoms that may appear after taking too much Zemplar may include: feeling weak and/or sleepy, headache, nausea (feeling sick) or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and metallic taste.

Long-term symptoms that may occur after taking too much Zemplar may include: loss of appetite, sleepiness, weight loss, eye pain, runny nose, itching, feeling hot, and fever, loss of sexual appetite, severe abdominal pain (due to pancreatitis), and kidney stones. Your blood pressure may be affected, and you may experience irregular heartbeats (palpitations). Blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzymes. Rarely, Zemplar can cause mental changes such as confusion, sleepiness, insomnia, or nervousness.

If you take too much Zemplar or experience any of the symptoms described above, consult your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Zemplar

If you forget to take a dose, take it as soon as you remember. However, if it is close to the time of your next dose, do not take the missed dose. Continue with your treatment as your doctor told you.

Do not take a double dose to make up for forgotten doses.

If you stop taking Zemplar

Do not stop taking Zemplar unless your doctor tells you to.

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:

• Allergic reactions (such as shortness of breath, wheezing, rash, itching, or swelling of the face and lips)

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

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

• increased levels of calcium in the blood, in addition to increased calcium time, an increase in another substance called phosphate may occur (in patients with significant chronic kidney disease).
• phosphate levels in the blood may also increase.

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

• pneumonia (lung infection)
• decreased levels of parathyroid hormone
• decreased appetite
• decreased levels of calcium
• dizziness
• unusual taste in the mouth
• headache
• irregular heartbeat
• stomach discomfort or pain
• constipation
• diarrhea
• dry mouth
• heartburn (reflux or indigestion)
• nausea
• vomiting
• acne
• itching
• rash
• hives
• muscle cramps
• muscle pain
• breast pain on palpation
• weakness
• feeling tired, unwell
• swelling in the legs
• pain
• increased levels of creatinine
• abnormal liver function tests

If you experience an allergic reaction, please contact your doctor immediately.

Reporting of side effects

If you experience 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 via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zemplar

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Zemplar

Zemplar 1 microgram capsules

• The active substance is paricalcitol. Each soft capsule contains 1 microgram of paricalcitol.
• The other ingredients are: medium-chain triglycerides, ethanol, butylhydroxytoluene.
• The capsule shell contains: gelatin, glycerol, water, titanium dioxide (E 171), iron oxide black (E 172).
• The printing ink contains: propylene glycol, iron oxide black (E 172), polyvinyl acetate phthalate, macrogol 400, ammonium hydroxide.

Zemplar 2 micrograms capsules

• The active substance is paricalcitol. Each soft capsule contains 2 micrograms of paricalcitol.
• The other ingredients are: medium-chain triglycerides, ethanol, butylhydroxytoluene.
• The capsule shell contains: gelatin, glycerol, water, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172).
• The printing ink contains: propylene glycol, iron oxide black (E 172), polyvinyl acetate phthalate, macrogol 400, ammonium hydroxide.

Appearance and packaging

Zemplar 1 microgram capsules

Zemplar 1 microgram capsules are soft, oval-shaped capsules, gray in color, with the inscription ZA.

Each carton contains 4 aluminum blisters with 7 capsules each (28 capsules).

Zemplar 2 micrograms capsules

Zemplar 2 micrograms capsules are soft, oval-shaped capsules, orange-brown in color, with the inscription ZF.

Each carton contains 4 aluminum blisters with 7 capsules each (28 capsules).

Marketing authorization holder and manufacturer

Marketing authorization holder:AbbVie Spain S.L.U. Avda. de Burgos, 91, 28050 Madrid, Spain.

Manufacturer:Tjoapack Netherlands, B.V, Nieuwe Donk 9, ETTEN-LEUR, 4879AC, Netherlands

Or

ABBVIE DEUTSCHLAND GMBH & CO. KG Knollstrasse 67061 Ludwigshafen, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Czech Republic:Zemplar

Germany:Zemplar 1 Mikrogramm Weichkapseln, Zemplar 2 Mikrogramm Weichkapseln

Greece:Zemplar 1 μικρογραμμ?ριο καψ?κια, μαλακ?, Zemplar 2 μικρογραμμ?ρια καψ?κια, μαλακ?

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

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

United Kingdom (Northern Ireland):Zemplar 1 microgram capsules, soft, Zemplar 2 micrograms capsules, soft

Date of last revision of this leaflet:October 2022

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

To listen to or request a copy of this leaflet in large print, please contact the local representative of the marketing authorization holder.