Zemplar 1 microgram soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zemplar 1 microgram capsule

Zemplar 2 microgram capsules

Paricalcitol

Package leaflet:

1. What Zemplar is and what it is used for

2. What you need to know before taking 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 necessary for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In people with normal kidney function, this active form of vitamin D is naturally produced by the kidneys; however, in renal 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, which 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 taking Zemplar

Do not take Zemplar

• if you are allergic to paricalcitol or to 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 advise you if any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Zemplar.

• before starting treatment, it is important that you limit the amount of phosphorus in your diet.

• you may need to use phosphate-binding agents to control phosphorus levels. If you are taking calcium-containing phosphate binders, your doctor may adjust your dose.

• your doctor will carry out blood tests to monitor your treatment.

• in some patients with stage 3 and 4 chronic kidney disease, 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 taking, have recently taken, or might need to 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 inform your doctor if you are taking any of the following medicines:

• for treating fungal infections such as candidiasis or oral thrush (e.g. ketoconazole)
• for treating heart problems or high blood pressure (e.g. digoxin, diuretics or medications that remove fluid)
• containing a source of phosphate (e.g. medications to lower calcium levels in the blood)
• containing calcium or vitamin D, including supplements or multivitamins available without a prescription
• containing magnesium or aluminium (e.g. some medicines for indigestion (antacids) and phosphate-binding medicines)
• for treating high cholesterol levels (e.g. cholestyramine)

Taking 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 become pregnant, consult your doctor or pharmacist before using this medicine. There are insufficient 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 unknown whether paricalcitol passes into breast milk. If you are taking Zemplar, inform your doctor before breastfeeding your baby.

Driving and using machines

Zemplar should not affect your ability to drive or operate machinery.

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 contained in this medicine does not produce any noticeable effect.

3. How to take Zemplar

Always follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Chronic Kidney Disease, Stages 3 and 4

In adult patients, the usual initial dose is one capsule daily, or one capsule on alternate days up to a maximum of three times a week. Your doctor will use the results of certain laboratory tests to determine the correct dose for you. Once treatment with Zemplar has been started, a dose adjustment is likely depending 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 initial dose is one capsule on alternate days, up to a maximum of three times a week. Your doctor will use the results of certain laboratory tests to determine the correct dose for you. Once treatment with Zemplar has been started, a dose adjustment is likely depending on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

Hepatic impairment

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

Renal transplant

The usual dose is one capsule daily, or one capsule on alternate days up to a maximum of three times a week. Your doctor will use the results of certain laboratory tests to determine the correct dose for you. Once treatment with Zemplar has been started, a dose adjustment is likely depending 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 initial dose is one capsule on alternate days, up to three times per week. Your doctor will use the results of your laboratory tests to determine the correct dose. Once Zemplar is started, the dose may need to be adjusted depending on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

The efficacy of Zemplar has not been established in children with CKD stage 5.

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

Use in elderly patients

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

If you take more Zemplar than you should

An overdose of Zemplar may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur after taking an excessive dose of Zemplar may include: feeling weak and/or drowsy, headache, nausea (feeling sick) or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and metallic taste.

Symptoms that may occur in the long term after excessive intake of Zemplar may include: loss of appetite, drowsiness, weight loss, eye pain, runny nose, skin itching, sensation of warmth and fever, loss of sexual appetite, severe abdominal pain (due to inflammation of the pancreas), and kidney stones. Your blood pressure may be affected and irregular heartbeats (palpitations) may occur. Blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels. Rarely, Zemplar may cause mental changes such as confusion, drowsiness, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 almost time for your next capsule, do not take the missed dose and continue your treatment as normally directed by your doctor.

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

If you stop taking Zemplar

Do not stop treatment with Zemplar unless your doctor tells you to.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Important: Tell your doctor immediately if you notice any of the following adverse effects:

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

Inform your doctor or nurse if you experience any of the following adverse effects:

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

• increased blood levels of a substance called calcium; in addition to prolonged calcium exposure, increased levels of another substance called phosphate may occur (in patients with significant chronic kidney disease).
• blood phosphate levels may also increase.

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

• pneumonia (lung infection)
• decreased levels of parathyroid hormone
• decreased appetite
• decreased calcium levels
• 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 of the skin
• rash
• hives
• muscle cramps
• muscle pain
• breast tenderness on palpation
• weakness
• feeling of tiredness, malaise
• swelling in the legs
• pain
• increased creatinine levels
• changes in liver function tests

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 components are: medium-chain triglycerides, ethanol, butylhydroxytoluene.
• The capsule shell contains: gelatin, glycerol, water, titanium dioxide (E 171), black iron oxide (E 172).
• The printing ink contains: propylene glycol, black iron oxide (E 172), polyvinyl acetate phthalate, macrogol 400, ammonium hydroxide.

Zemplar 2 microgram capsules

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

Appearance of the product and contents of the pack

Zemplar 1 microgram capsules

Zemplar 1 microgram capsules are grey, oval-shaped soft capsules with the imprint "ZA".

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

Zemplar 2 microgram capsules

Zemplar 2 microgram capsules are orange-brown, oval-shaped soft capsules with the imprint "ZF".

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: AbbVie Spain S.L.U. Avda. de Burgos, 91, 28050 Madrid, Spain.

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

This medicinal product is authorised 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 the most recent revision of this leaflet: October 2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of 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 Authorisation Holder.