Package Leaflet: Information for the User

Paricalcitol cinfa1 microgram EFG Soft Capsules

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Paricalcitol cinfa contains the active ingredient paricalcitol, which is a synthetic form of the 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 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, specifically high levels of parathyroid hormone that can cause bone problems. Paricalcitol 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 cinfa

• if you are allergic to paricalcitol or any of the other ingredients in 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 cinfa.

• 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 levels of a substance called creatinine has been observed.However, this increase does not reflect a decrease in renal function.

Other medications and paricalcitol cinfa

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

Some medications may affect the action of this medication or increase the likelihood of adverse effects.

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

Paricalcitol cinfa with food and beverages

Paricalcitol 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 before using this medication.

There is insufficient data on the use of paricalcitol in pregnant women. The risk in humans is unknown, so paricalcitol should not be used during pregnancy unless 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 should not affect your ability to drive or operate machinery.

Paricalcitol cinfa contains ethanol (alcohol)

This medication contains 0.71 mg of alcohol (ethanol) in each capsule. The amount in the capsule of this medication is equivalent to less than 0.0177 ml of beer or 0.0071 ml of wine.The small amount of alcohol in this medication has no perceptible effect.

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

In adult patients, the initial recommended 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 the dose will need to be adjusted based on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

Chronic kidney disease, stage 5

In adult patients, the initial recommended 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 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.

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 recommended 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 withparicalcitol,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.

Use in children and adolescents

In children aged 10 to 16 years with chronic kidney disease stages 3 or 4, the initial recommended 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 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.

The efficacy of paricalcitol in children with CKD stage 5 has not been established.

There is no information on the use of paricalcitol in children under 10 years of age.

Use in elderly patients

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

If you take more paricalcitol cinfa 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 after taking a high dose of 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 paricalcitol 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, paricalcitol 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 paricalcitol cinfa

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 with paricalcitol cinfa

Do not interrupt 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 medicines, this medicine can 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 patients):

• 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).
• Blood phosphate levels may also increase.

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

• Pneumonia (lung infection)
• Decreased levels of parathyroid hormone
• Decreased appetite
• Decreased calcium levels
• Dizziness
• Rare taste in the mouth
• Headache
• Irregular heartbeat
• Discomfort or stomach pain
• Constipation
• Dyspepsia
• Dry mouth
• Heartburn (reflux or indigestion)
• Nausea
• Vomiting
• Acne
• Itching skin
• Rash
• Hives
• Muscle cramps
• Muscle pain
• Palpable breast pain
• Weakness
• Sensation 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:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at thePuntoSIGREpharmacy drop-off point. 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 cinfa

• The active ingredient is paricalcitol. Each soft capsule contains 1 microgram of paricalcitol.
• The other components are:

• Capule content: medium-chain triglycerides, anhydrous ethanol, and butylhydroxytoluene (E-321).
• Components of the empty capsule: gelatin (E-441), glycerol (E-422), purified water, titanium dioxide (E-171), and iron oxide black (E-172).

Appearance of the product and contents of the packaging

Paricalcitol cinfa are soft, oval-shaped, gray capsules containing a colorless or yellowish solution.

Paricalcitol cinfa is presented in PVC/PVDC-Aluminum blisters of 7 capsules.

Each package contains 7 (1 blister) or 28 (4 blisters) soft capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: paricalcitol cinfa 1 microgram soft capsules EFG

Portugal: paricalcitol cinfa 1 microgram soft capsule

Last review date of this leaflet:November 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78812/P_78812.html

QR code to:https://cima.aemps.es/cima/dochtml/p/78812/P_78812.html