PARICALCITOL CINFA 1 MICROGRAM SOFT CAPSULES

2. What you need to know before you take Paricalcitol Cinfa

Do not take Paricalcitol Cinfa

• 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 Cinfa.

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

Other medicines and Paricalcitol Cinfa

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 likelihood of side effects. It is particularly important to inform your doctor if you are taking any of the following medicines:

• to treat fungal infections such as thrush or oral candidiasis (e.g., ketoconazole)
• to treat heart problems or high blood pressure (e.g., digoxin, diuretics, or fluid-eliminating medicines)
• that contain a phosphate source (e.g., medicines to reduce 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 antacids and phosphate-binding medicines)
• to treat high cholesterol (e.g., cholestyramine)

Taking Paricalcitol Cinfa with food and drinks

Paricalcitol can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

There is not enough data on the use of paricalcitol in pregnant women. The risk in humans 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 using machines

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

Paricalcitol Cinfa contains ethanol (alcohol)

This medicine contains 0.71 mg of alcohol (ethanol) per capsule. The amount in one capsule of this medicine is equivalent to less than 0.0177 ml of beer or 0.0071 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Paricalcitol Cinfa

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

Chronic kidney disease, stages 3 and 4

In adult patients, the recommended 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 the correct dose for you. Once treatment with paricalcitol 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.

Chronic kidney disease, stage 5

In adult patients, the recommended 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 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.

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 recommended 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 the correct dose for you. Once treatment with paricalcitol 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.

Use in children and adolescents

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

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

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

Use in older people

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

If you take more Paricalcitol Cinfa than you should

Taking too much paricalcitol can cause abnormally high calcium levels in the blood, which can be harmful. The symptoms that may appear after taking too much paricalcitol may include: feeling weak and/or sleepy, 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 excessive intake of paricalcitol may include: loss of appetite, feeling weak, weight loss, dry eyes, runny nose, itching of the skin, feeling hot, 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 test results may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels. Rarely, paricalcitol can cause mental changes such as confusion, sleepiness, 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 medicine 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 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 forgotten doses.

If you stop taking Paricalcitol Cinfa

Do not stop taking paricalcitol unless your doctor tells you to.

If you have any further questions on the use of this product, 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 may occur (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 tenderness
• weakness
• feeling tired, unwell
• swelling in the legs
• pain
• increase in creatinine levels
• abnormal 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Paricalcitol Cinfa

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from light and moisture.

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 Cinfa

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

• Capsule content: medium-chain triglycerides, anhydrous ethanol, and butylhydroxytoluene (E-321).
• Empty capsule components: gelatin (E-441), glycerol (E-422), purified water, titanium dioxide (E-171), and black iron oxide (E-172).

Appearance and packaging

Paricalcitol Cinfa are soft, oval capsules, gray in color, containing a colorless or yellowish solution.

Paricalcitol Cinfa is available in PVC/PVDC-Aluminum blisters of 7 capsules.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Paricalcitol Cinfa 1 microgram soft capsules EFG

Portugal: Paricalcitol Cinfa 1 microgram soft capsule

Date of the last revision of this leaflet:November 2020

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

You can access detailed and updated information on 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