Prospect: information for the user

Paricalcitol Aurovitas Spain 1 microgram 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 only for you, and you must not give it to other people even if they have the same symptoms as you, 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.

1.What is Paricalcitol Aurovitas Spain and what is it used for

2.What you need to knowbefore starting to takeParicalcitol Aurovitas Spain

3.How to take Paricalcitol Aurovitas Spain

4.Possible adverse effects

1. Storage ofParicalcitol Aurovitas Spain

6.Contents of the package and additional information

ParicalcitolAurovitas Spaincontains the active substance paricalcitol, whichis a synthetic form of 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 the case of kidney failure, the production of active vitamin D is markedly reduced. Therefore, Paricalcitol Aurovitas Spain 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 with high levels of parathyroid hormone that can cause bone problems.Paricalcitol Aurovitas Spain 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 Paricalcitol Aurovitas Spain

-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 Aurovitas Spain.

• Before starting treatment, it is essential to limit the amount of phosphorus in your diet.
• You may need to use phosphorus chelating agents to control phosphorus levels. If you are taking phosphorus chelating 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 creatinine levels has been observed. However, this increase does not reflect a decrease in renal function.

Other medications and Paricalcitol Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take 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:

• medications to treat fungal infections such as candida and mouth ulcers (e.g., ketoconazole)

• heart medications or blood pressure medications (e.g., digoxin and diuretics or medications that remove fluids)
• medications that bind to phosphorus(e.g., medications to reduce calcium levels in the blood)
• medications containing calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription
• medications containing magnesium or aluminum, for example, some medications for indigestion (antacids)
• colestiramine (medications used to reduce cholesterol levels (e.g., colestiramine).

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 medication.

There are insufficient 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.

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

Driving and operating machinery

Paricalcitol Aurovitas Spain should not affect your ability to drive or operate machinery.

Paricalcitol Aurovitas Spain containsethanol

This medicationcontains 1,420 mg of alcohol (ethanol) in each soft capsule, which is equivalent to 1,420 mg/capsule. The amount of alcohol in this medication is less than 0.035 ml of beer or 0.014 ml of wine. The small amount of alcohol in this medication will not have noticeable effects.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 per day, 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 Aurovitas Spain 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 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 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 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.

Renal transplant

The usual dose is one capsule per day, 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 Aurovitas Spain 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 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 on the correct dose. Once Paricalcitol Aurovitas Spain is initiated, 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 Paricalcitol Aurovitas Spain.

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

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

Older patients

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

If you take moreParicalcitol Aurovitas Spainthan you should

A high dose of Paricalcitol Aurovitas Spain can cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may appear after taking a high dose of Paricalcitol Aurovitas Spain may include: feeling weak and/or drowsy, 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 Paricalcitol Aurovitas Spain may include: loss of appetite, feeling weak, 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 test results may show high cholesterol, urea, nitrogen, and elevated liver enzymes.

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 medication and the amount ingested.

If you forget to takeParicalcitol Aurovitas Spain

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 withParicalcitol Aurovitas Spain

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

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

Like all medicines, this medicine may 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, as well as increased calcium time, may also occur increased levels of another substance called phosphate (in patients with significant chronic kidney disease)
• 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
• Breast tenderness
• Weakness
• Feeling 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.

This medication does not require special storage conditions.

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 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Paricalcitol Aurovitas Spain

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

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

Appearance of the product and content of the container

Paricalcitol Aurovitas Spain 1 microgram are soft, oval-shaped capsules of gray color.

They are presented in cardboard containers that contain 7, 28 or 30 capsules.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: March 2024

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