Prospect: information for the user

Pleopar 1 microgram soft capsules EFG

paricalcitol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Pleopar contains the active ingredient 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 individuals with normal renal function, this active form of vitamin D is produced naturally in the kidneys, but in cases of renal insufficiency, 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 to prevent the consequences of low levels of active vitamin D in patients with kidney disease (stages 3, 4, and 5), specifically elevated parathyroid hormone levels, which can cause bone problems.

Do not take Pleopar

• 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 paricalcitol.

• 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 with calcium content, 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 Pleopar 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 modify the effect 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:

• For fungal infections such as candida or mouth ulcers (for example, ketoconazole)
• For heart problems or high blood pressure (for example, digoxin, diuretics, or medications that remove liquids)
• That contain a source of phosphate (for example, medications to lower 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 (for example, some medications for indigestion (antacids) and medications that bind to phosphorus);
• For high cholesterol levels (for example, cholestyramine).

Pleopar with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

Paricalcitol does not affect your ability to drive or operate machinery.

Pleopar contains ethanol

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

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

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 paricalcitol is initiated, it is likely that you will 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 treatment with paricalcitol is initiated, it is likely that you will need a dose adjustment based on your response to treatment. Your doctor will calculate the correct dose of paricalcitol.

Liver Disease

If you have any mild or 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 paricalcitol is initiated, it is likely that you will 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 the Elderly

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

If You Take More Pleopar Than You Should

A high dose of paricalcitol can produce abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may appear shortly after taking too much paricalcitol may include: weakness and/or drowsiness, headache, nausea (feeling unwell) or vomiting (being unwell), dry mouth, constipation, muscle or bone pain, and metallic taste.

Long-term symptoms that may occur after excessive intake of this medication may include: loss of appetite, weakness, weight loss, dry eyes, nasal discharge, skin itching, feeling hot and fever, loss of sexual appetite, severe abdominal pain (due to pancreatitis inflammation), 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, this medication may cause mental changes such as confusion, drowsiness, 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 medication 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 the next capsule, do not take the forgotten capsule and continue with the treatment as your doctor instructed.

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

If You Interrupt Treatment with Pleopar

Do not stop treatment with paricalcitol 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 medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Rare adverse 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 levels of parathyroid hormone, diarrhea, muscle cramps, nausea, dizziness, stomach discomfort or pain, vomiting, weakness, fatigue, skin rash, pneumonia, decreased appetite, increased levels of phosphorus, decreased levels of calcium, unusual taste in the mouth, irregular heartbeat, constipation, dry mouth, stomach burning (reflux or indigestion), acne, skin itching, urticaria, muscle pain, breast tenderness, feeling of discomfort, swelling in the legs, pain, increased levels of creatinine, and liver function test abnormalities.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and bottle 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 the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pleopar

• The active principle is paricalcitol

Each soft capsule contains 1 microgram of paricalcitol

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

Appearance of the product and contents of the packaging

Pleopar 1 microgram soft capsules are oval, gray in color, 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. Industrial Park Urtinsa II.

28923. Alcorcón (Madrid)

Spain

Responsible for manufacturing:

GAP S.A. Agissilaou 46

17341 Athens

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

SPA Farma Ibérica S.L.U.

Carrer de Roc Boronat, 147

08018 Barcelona

Spain

This leaflet has been reviewed in September 2019

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