Pleopar 1 microgram soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pleopar 1 microgram capsule 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Pleopar is and what it is 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 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 in the kidneys; however, 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 sufficient amounts, and helps prevent the consequences of low levels of active vitamin D in patients with kidney disease (stages 3, 4, and 5), specifically elevated levels of parathyroid hormone, which can cause bone problems.

2. What you need to know before starting to take Pleopar

Do not take Pleopar

• If you are allergic to paricalitol or to any of the other components 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

Consult your doctor or pharmacist before starting to take paricalcitol.

• Before starting treatment, it is important to limit the amount of phosphorus in your diet.
• It may be necessary to use phosphate binders to control phosphorus levels. If you are taking phosphate binders containing calcium, your doctor may adjust your dosage.
• 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 reduction in renal function.

Taking Pleopar with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may alter the effect of this medicine or may increase the likelihood of adverse effects. It is especially important that you inform your doctor if you are taking any of the following medicines:

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

Pleopar with food and drinks

This medicine may be taken with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, 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 potential risk for human use 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 paricalcitol, inform your doctor before breastfeeding your child.

Driving and use of machinery

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

Pleopar contains ethanol

This medicine contains 0.55% ethanol (alcohol); this small amount corresponds to 1.42 mg per capsule.

3. How to take Pleopar

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Chronic kidney disease, stages 3 and 4

The usual dose is one capsule daily or one capsule on alternate days, up to a maximum of three times per week. Your doctor will use the results of certain laboratory tests to determine the correct dose for you. Once paricalcitol treatment has been started, a dose adjustment based on your response to treatment will likely be needed. Your doctor will calculate the correct dose of paricalcitol for you.

Chronic kidney disease, stage 5

The usual dose is one capsule on alternate days, or one capsule up to a maximum of three times per week. Once treatment with paricalcitol has been started, a dose adjustment may be necessary depending on your response to treatment. Your doctor will determine the correct dose of paricalcitol for you.

Hepatic impairment

If you have mild or moderate liver disease, no dose adjustment is necessary. However, there is no experience with paricalcitol 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 per week. Your doctor will use the results of certain laboratory tests to decide the correct dose for you. Once treatment with paricalcitol has been started, a dose adjustment may be necessary depending on your response to treatment. Your doctor will help determine the correct dose of paricalcitol.

Use in children and adolescents

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

Use in the elderly

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

If you take more Pleopar than you should

An excessive dose of paricalcitol may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur shortly after taking too much paricalcitol 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 following excessive intake of this medicine may include: loss of appetite, feeling weak, weight loss, dry eyes, runny nose, skin itching, feeling hot 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, this medicine 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, 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 Pleopar

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 capsule and continue your treatment as normally directed by your physician.

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

If treatment with Pleopar is interrupted

Do not stop treatment with paricalcitol unless your doctor instructs you to do so.

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 can cause adverse effects, although not everyone will experience them.

Important: Tell 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 increased blood levels of a substance called calcium, and prolonged elevation of calcium; an increase in another substance called phosphate may also occur (in patients with significant chronic kidney disease).

Uncommon 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, 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, rash, pneumonia, loss of appetite, increased phosphorus levels, decreased calcium levels, unusual taste in the mouth, irregular heartbeat, constipation, dry mouth, heartburn (reflux or indigestion), acne, skin itching, hives, muscle pain, breast tenderness, feeling unwell, swelling in the legs, pain, increased creatinine levels, and abnormalities 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 Pleopar

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the outer packaging and bottle after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Pleopar

• The active substance is paricalcitol.

Each soft capsule contains 1 microgram of paricalcitol.

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

Appearance of the product and contents of the pack

Pleopar 1 microgram capsules are oval-shaped, grey 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. Polígono Industrial Urtinsa II.

Alcorcón (Madrid)

Spain

Manufacturer:

GAP S.A. Agissilaou 46

17341 Athens

You can request further information about this medicinal product 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 was reviewed in September 2019

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/