PARICALCITOL AUROVITAS SPAIN 1 MICROGRAM SOFT GEL CAPSULES

2. What you need to know before you take Paricalcitol Aurovitas Spain

Do not take Paricalcitol Aurovitas Spain

• 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

Talk to your doctor or pharmacist before you start taking Paricalcitol Aurovitas Spain.

• Before starting treatment, it is important that you limit the amount of phosphorus in your diet.
• You may need to use phosphorus-binding agents to control phosphorus levels. If you are taking phosphorus-binding agents with calcium content, your doctor may modify the dose.
• Your doctor will perform blood tests to monitor your treatment.
• In some patients with chronic kidney disease stages 3 and 4, an increase in creatinine levels has been observed. However, this increase does not reflect a decrease in kidney function.

Other medicines and Paricalcitol Aurovitas Spain

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

Some medicines may affect the action of this medicine or increase the risk of side effects.

It is particularly important to inform your doctor if you are taking:

• medicines to treat fungal infections such as candida and oral thrush (e.g., ketoconazole)

• medicines for the heart or blood pressure (e.g., digoxin and diuretics or fluid-removing medicines)
• medicines that bind to phosphorus (e.g., medicines to reduce calcium levels in the blood)
• medicines that contain calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription
• medicines that contain magnesium or aluminum, e.g., some medicines for indigestion (antacids)
• cholestyramine (medicines used to lower cholesterol levels, e.g., cholestyramine).

Taking Paricalcitol Aurovitas Spain with food and drinks

Paricalcitol Aurovitas Spain can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 are not enough data on the use of paricalcitol in pregnant women. The risk in humans is unknown, so it should not be used during pregnancy unless clearly necessary.

It is unknown whether paricalcitol passes into breast milk. If you are taking Paricalcitol Aurovitas Spain, inform your doctor before breastfeeding your child.

Driving and using machines

Paricalcitol Aurovitas Spain should not affect your ability to drive or use machines.

Paricalcitol Aurovitas Spain contains ethanol

This medicine contains 1.420 mg of alcohol (ethanol) per soft capsule, which is equivalent to 1.420 mg/capsule. The amount of one capsule of this medicine is equivalent to less than 0.035 ml of beer or 0.014 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to take Paricalcitol Aurovitas Spain

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 the correct dose for you.

Once treatment with Paricalcitol Aurovitas Spain is started, 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 Aurovitas Spain.

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 Paricalcitol Aurovitas Spain is started, 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 Aurovitas Spain.

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.

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 treatment with Paricalcitol Aurovitas Spain is started, 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 Aurovitas Spain.

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 the correct dose. Once Paricalcitol Aurovitas Spain is started, it is likely that the dose will need to be adjusted, depending on how you respond to treatment. Your doctor will help you determine the correct dose of Paricalcitol Aurovitas Spain.

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

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

Elderly patients

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 Paricalcitol Aurovitas Spain than you should

An overdose of Paricalcitol Aurovitas Spain can cause abnormally high blood calcium levels, which can be harmful. The symptoms that may appear after taking an overdose of Paricalcitol Aurovitas Spain may include: feeling of weakness and/or drowsiness, headache, nausea (feeling sick) or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and metallic taste.

The symptoms that may occur after long-term overdose of Paricalcitol Aurovitas Spain may include: loss of appetite, feeling of weakness, weight loss, dry eyes, runny nose, itching of the skin, feeling of heat, and fever, loss of sexual appetite, severe abdominal pain (due to pancreatitis), and kidney stones. Your blood pressure may be affected, and you may experience irregular heartbeats (palpitations). Blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels.

Rarely, Paricalcitol Aurovitas Spain may cause mental changes such as confusion, drowsiness, insomnia, or nervousness.

If you take too much Paricalcitol Aurovitas Spain 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 taken.

If you forget to take Paricalcitol Aurovitas Spain

If you forget to take a dose, take it as soon as you remember. However, if it is near the time of the next capsule, do not take the missed capsule and continue with the treatment as your doctor indicated.

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

If you stop taking Paricalcitol Aurovitas Spain

Unless your doctor tells you to stop treatment, it is important to continue taking Paricalcitol Aurovitas Spain as your doctor has indicated.

If you have any other 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:

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

Tell your doctor or nurse if you experience any of the following side effects:

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

• increase in blood levels of a substance called calcium, in addition to the increase in calcium time, an increase in another substance called phosphate (in patients with significant chronic kidney disease)
• phosphate levels in the blood may also increase.

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

• pneumonia (lung infection)
• decrease in parathyroid hormone levels
• decrease in appetite
• decrease in 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 pain on palpation
• weakness
• feeling of tiredness, discomfort
• swelling in the legs
• pain
• increase in creatinine levels
• 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 they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the www.notificaRAM.es website.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paricalcitol Aurovitas Spain

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 after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Paricalcitol Aurovitas Spain

• The active ingredient is paricalcitol. Each soft capsule contains 1 microgram of paricalcitol.
• The other ingredients (excipients) are: medium-chain triglycerides, ethanol, butylhydroxytoluene.

The capsule shell contains: gelatin, anhydrous glycerol, titanium dioxide (E171), and black iron oxide (E172).

Appearance and packaging

Paricalcitol Aurovitas Spain 1 microgram are oval, gray, soft capsules.

They are available in cardboard boxes containing 7, 28, or 30 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

G.A.P. SA

46, Agissilaou str.

Agios Dimitrios

Attiki,

Greece

or

Rafarm S.A.

Thesi Poussi Hantzi, AgiouLouka, Paiania,

19002 Attiki

Greece

or

Viminco A/S

Lodshusvej 11, Skælskør

DK-4230,

Denmark

Date of last revision of this leaflet: March 2024

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