PLEOPAR 1 MICROGRAM CAPSULES

Introduction

Package Leaflet: Information for the User

Pleopar 1 microgram soft capsules EFG

paricalcitol

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pleopar and what is it used for
2. What you need to know before you take Pleopar
3. How to take Pleopar
4. Possible side effects
5. Storing Pleopar
6. Contents of the pack and further information

1. What is Pleopar and what is it used for

Pleopar contains the active substance paricalcitol, which is a synthetic form of active vitamin D.

Active vitamin D is necessary for the proper 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 in the kidneys, but in cases of kidney failure, the production of active vitamin D is markedly reduced. Therefore, Paricalcitol 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 in patients with kidney disease (stages 3, 4, and 5), specifically high levels of parathyroid hormone, which can cause bone problems.

2. What you need to know before you take Pleopar

Do not take Pleopar

• 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 you are affected by these conditions. Warnings and precautions

Consult your doctor or pharmacist before starting paricalcitol

• Before starting treatment, it is essential to 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 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 kidney function.

Taking Pleopar with other medicines

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

Some medicines may change the effect of this medicine or increase the risk of side effects. It is particularly important that you tell your doctor if you are taking any of the following medicines:

• For treating fungal infections such as thrush or oral thrush (e.g., ketoconazole)
• For treating 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);
• For treating high cholesterol (e.g., colestyramine).

Pleopar with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

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 potential risk to humans is unknown, so paricalcitol should not be used during pregnancy unless clearly necessary.

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

Driving and using machines

Paricalcitol does not affect the ability to drive or use machines.

Pleopar contains ethanol

This medicine contains 0.55% ethanol (alcohol), which corresponds to 1.42 mg per capsule.

3. How to take Pleopar

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Chronic kidney disease, stages 3 and 4

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 paricalcitol, you may need a dose adjustment based on your response to treatment. Your doctor will calculate the correct dose of paricalcitol for you.

Chronic kidney disease, stage 5

The usual dose is one capsule every other day, or one capsule up to a maximum of three times a week. Once you start treatment with paricalcitol, you may need a dose adjustment based on your response to treatment. Your doctor will calculate the correct dose of paricalcitol.

Liver disease

If you have mild or moderate liver disease, you will 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 paricalcitol, you may need a dose adjustment based on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

Use in children and adolescents

There is no information on the use of paricalcitol in children.

Use in elderly

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

If you take more Pleopar than you should

Taking too much paricalcitol can cause abnormally high calcium levels in the blood, which can be harmful. Symptoms that may appear soon after taking too much paricalcitol 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.

Symptoms that may occur after long-term excessive intake of this medicine may include: loss of appetite, feeling weak, weight loss, dry eyes, runny nose, itching skin, 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. Blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzymes. Rarely, this medicine can cause mental changes such as confusion, sleepiness, insomnia, or nervousness.

If you take too much paricalcitol 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 Pleopar

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 capsule, do not take the missed capsule and continue with your treatment as your doctor instructed.

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

If you stop taking Pleopar

Do not stop taking paricalcitol 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 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:

Common side effects (may affect up to 1 in 10 people) observed in patients during the use of paricalcitol capsules include increased blood levels of a substance called calcium, in addition to increased calcium time, an increase in another substance called phosphate (in patients with significant chronic kidney disease) may occur.

Uncommon side effects (may affect up to 1 in 100 people) observed in patients during the use of paricalcitol capsules include allergic reactions (such as difficulty breathing, skin rash, itching, or swelling of the face and lips), decreased parathyroid hormone levels, diarrhea, muscle cramps, nausea, dizziness, discomfort or stomach pain, vomiting, weakness, fatigue, skin rash, pneumonia, decreased appetite, increased phosphorus levels, decreased calcium levels, unusual taste in the mouth, irregular heartbeat, constipation, dry mouth, heartburn (reflux or indigestion), acne, itching skin, hives, muscle pain, breast tenderness, feeling unwell, swelling in the legs, pain, increased creatinine levels, and changes in 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, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Pleopar

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pleopar

• The active substance is paricalcitol

Each soft capsule contains 1 microgram of paricalcitol

• The other ingredients (excipients) in the capsules are: medium-chain triglycerides, anhydrous ethanol, butylhydroxytoluene (BHT) (E321).
• The capsule shell contains: gelatin, anhydrous glycerol, purified water, titanium dioxide (E171), iron oxide black (E172).

Appearance and pack contents

Pleopar 1 microgram soft capsules are oval, gray, size 2.

Pleopar is available in boxes, containing PVC/PE/PVDC-aluminum blisters with 28 soft capsules.

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II.

1. Alcorcón (Madrid)

Spain

Manufacturer:

GAP S.A. Agissilaou 46

17341 Athens

You can request more information about this medicine from the local representative of the marketing authorization holder:

SPA Farma Ibérica S.L.U.

Carrer de Roc Boronat, 147

08018 Barcelona

Spain

This leaflet was last revised in September 2019

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