Label: Information for the Patient

Zemplar 1 microgram Soft Capsules

Zemplar 2 micrograms Soft Capsules

Paricalcitol

6. Contents of the pack and additional information

Zemplar contains the active ingredient paricalcitol, which is a synthetic form of the 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 renal function, this active form of vitamin D is produced naturally by the kidneys, but in renal insufficiency, 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 to 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 stage 3, 4, and 5 renal disease and in children aged 10 to 16 years with stage 3 and 4 renal disease.

Do not take Zemplar

• if you are allergic to paricalcitol or any of the other components of this medication (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 affect you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zemplar.

• before starting treatment, it is essential to limit the amount of phosphorus in your diet.
• you may need to use phosphate-binding agents to control your phosphorus levels. If you are taking phosphate-binding agents containing calcium, your doctor may adjust your dose.

• your doctor will perform blood tests to monitor your treatment.
• in some patients with chronic kidney disease in 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 renal function.

Taking Zemplar with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect the action of this medication or increase the likelihood of adverse effects. It is particularly important to inform your doctor if you are taking any of the following medications:

• to treat fungal infections such as candida or mouth ulcers (e.g. ketoconazole)
• to treat heart problems or high blood pressure (e.g. digoxin, diuretics, or medications that remove fluids)
• containing a source of phosphate (e.g. medications to lower calcium levels in the blood)
• containing calcium or vitamin D, including supplements or multivitamins that can be purchased without a prescription
• containing magnesium or aluminum (e.g. some medications for indigestion (antacids) and medications that bind to phosphorus)
• to treat high cholesterol (e.g. cholestyramine)

Taking Zemplar with food and drinks

Zemplar can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. There are insufficient data on the use of paricalcitol in pregnant women. The risk in humans is unknown, so paricalcitol should not be used during pregnancy unless clearly necessary.

The passage of paricalcitol into breast milk is unknown. If you are taking Zemplar, inform your doctor before breastfeeding your child.

Driving and operating machinery

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

Zemplar contains ethanol (alcohol)

This medication 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 medication is equivalent to less than 1 ml of beer or wine.

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

Always follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 every other day up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to decide on the correct dose for you. Once treatment with Zemplar is started, it is likely that the dose will need to be adjusted 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 initial 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 treatment with Zemplar is started, it is likely that the dose will need to be adjusted 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 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 every other day up to a maximum of three times a week.Your doctor will use the results of some laboratory tests to decide on the correct dose for you. Once treatment with Zemplar is started, it is likely that the dose will need to be adjusted 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 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 on the correct dose. Once Zemplar is started, it is likely that the dose will need to be adjusted based on your response to treatment. Your doctor will help you determine the correct dose of Zemplar.

The efficacy of Zemplar in children with chronic kidney disease stage 5 has not been established.

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

Use in the elderly

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

If you take more Zemplar than you should

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

Long-term symptoms that may occur after excessive intake of Zemplar may include: loss of appetite, drowsiness, weight loss, eye pain, nasal discharge, skin 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 irregular heartbeats (palpitations) may occur. Laboratory tests may show high cholesterol, urea, nitrogen, and elevated liver enzymes. 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication 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 the next capsule, do not take the forgotten capsule and continue with the treatment as indicated by your doctor.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Zemplar

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important: Inform 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)

Inform 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 a substance called calcium in the blood, in addition to increased calcium time, may also occur increased levels of another substance called phosphate (in patients with significant chronic kidney disease).
• The levels of phosphate 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 calcium levels
• Dizziness
• Rare taste in the mouth
• Headache
• Irregular heartbeat
• Abdominal discomfort or pain
• Constipation
• Diarrea
• Dry mouth
• Heartburn (reflux or indigestion)
• Nausea
• Vomiting
• Acne
• Itching skin
• Rash
• Hives
• Muscle cramps
• Muscle pain
• Palpable breast pain
• Weakness
• Sensation of fatigue, discomfort
• Swelling in the legs
• Pain
• Increased levels of creatinine
• Abnormalities in liver function tests

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Zemplar

Zemplar 1 microgram capsules

• The active ingredient is paricalcitol. Each soft capsule contains 1 microgram of paricalcitol.
• The other components are: medium-chain triglycerides, ethanol, butylhydroxytoluene.
• The capsule coating 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 microgram capsules

• The active ingredient is paricalcitol. Each soft capsule contains 2 micrograms of paricalcitol.
• The other components are: medium-chain triglycerides, ethanol, butylhydroxytoluene.
• The capsule coating 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 of the product and contents of the package

Zemplar 1 microgram capsules

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

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

Zemplar 2 microgram capsules

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

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

Holder of the marketing authorization and responsible for manufacturing

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

Responsible for manufacturing: 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) with the following names:

Republic of Czechia: 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 m ä kk é 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

Last review date of this leaflet: October 2022

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

For listening or requesting a copy of this leaflet in large print, please contact the local representative of the holder of the marketing authorization.