Paricalcitol Cinfa 1 microgram capsule EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paricalcitol cinfa 1 microgram soft capsules EFG

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 you should not give it to others, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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

1. What paricalcitol cinfa is and what it is used for

Paricalcitol cinfa contains the active substance paricalcitol, which is a synthetic form of active vitamin D. Active vitamin D is necessary for the normal function 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 by the kidneys; however, in renal failure, 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 prevent the consequences of low levels of active vitamin D, specifically high levels of parathyroid hormone, which can cause bone problems. Paricalcitol is used in adult patients with stages 3, 4, and 5 chronic kidney disease and in children aged 10 to 16 years with stages 3 and 4 chronic kidney disease.

2. What you need to know before starting paricalcitol cinfa

Do not take paricalcitol cinfa

• if you are allergic to paricalcitol or to 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 advise you if any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take paricalcitol cinfa.

• Before starting treatment, it is important that you limit the amount of phosphorus in your diet.
• Phosphate-binding agents may be needed to control phosphorus levels. If you are taking phosphate-binding agents containing calcium, your doctor may adjust your dose.
• Your doctor will perform blood tests to monitor your treatment.
• In some patients with stage 3 and 4 chronic kidney disease, an increase in levels of a substance called creatinine has been observed. However, this increase does not reflect a decline in kidney function.

Other medicines and paricalcitol cinfa

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

Some medicines may affect the action of this medicine or may increase the likelihood of side effects. It is particularly important to inform your doctor if you are taking any of the following medicines:

• for treating fungal infections such as candidiasis or oral thrush (e.g., ketoconazole)
• for treating heart problems or high blood pressure (e.g., digoxin, diuretics, or medications that eliminate fluids)
• containing a source of phosphate (e.g., medications to reduce calcium levels in the blood)
• containing calcium or vitamin D, including supplements or multivitamins available without a prescription
• containing magnesium or aluminum (e.g., some medicines for indigestion (antacids) and phosphate-binding medicines)
• for treating high cholesterol levels (e.g., cholestyramine)

Taking paricalcitol cinfa with food and drink

Paricalcitol may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

There are insufficient 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.

Driving and using machines

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

Paricalcitol cinfa contains ethanol (alcohol)

This medicine contains 0.71 mg of alcohol (ethanol) per capsule. The amount of alcohol 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 contained in this medicine does not produce any noticeable effect.

3. How to take paricalcitol cinfa

Follow exactly the administration instructions for this medicine as indicated by your doctor. If 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 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 treatment with paricalcitol has been started, dose adjustments may be necessary depending 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 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 treatment with paricalcitol has been started, dose adjustments may be necessary depending 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, no dose adjustment is required. However, there is no experience in patients with severe liver disease.

Renal transplant

The recommended 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 treatment with paricalcitol has been started, dose adjustments may be necessary depending 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 on alternate days, up to three times per week. Your doctor will use the results of your laboratory tests to determine the correct dose. Once paricalcitol treatment is started, the dose may need to be adjusted depending on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

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

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

Use in elderly patients

Experience with paricalcitol in patients aged 65 years and older is limited. In general, no overall differences in effectiveness or safety have been observed between patients over 65 years and younger patients.

If you take more paricalcitol cinfa 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 after taking an excessive dose of paricalcitol may include: feeling weak and/or drowsy, headache, nausea (feeling unwell) or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and metallic taste.

Symptoms that may occur long-term after excessive intake of paricalcitol 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, 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, contact 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 paricalcitol cinfa

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 dose and continue your treatment as prescribed by your doctor.

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

If you stop taking paricalcitol cinfa

Do not stop treatment with paricalcitol unless your doctor tells you to.

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 experiences them.

Important: Immediately tell your doctor if you notice any of the following adverse 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 adverse effects:

Frequent (may affect up to 1 in 10 patients):

• Increased blood levels of a substance called calcium; in addition to increased calcium time, increased levels of another substance called phosphate may occur (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
• Unusual taste in the mouth
• Headache
• Irregular heartbeat
• Stomach discomfort or pain
• Constipation
• Diarrhea
• Dry mouth
• Heartburn (reflux or indigestion)
• Nausea
• Vomiting
• Acne
• Itchy skin
• Rash
• Hives
• Muscle cramps
• Muscle pain
• Breast tenderness
• Weakness
• Feeling tired, unwell
• Swelling in the legs
• Pain
• Increased creatinine levels
• Changes 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of paricalcitol cinfa

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, 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 paricalcitol cinfa

• The active substance is paricalcitol. Each soft capsule contains 1 microgram of paricalcitol.

• The other components are:

• Capsule contents: 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 black iron oxide (E-172).

Appearance of the product and contents of the container

Paricalcitol cinfa are soft, oval, grey-colored capsules containing a colorless or slightly yellowish solution.

Paricalcitol cinfa is available in PVC/PVDC-aluminum blisters of 7 capsules.

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

Only certain package 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 medicinal product 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 most recent review of this leaflet: November 2020

Detailed 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/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78812/P_78812.html

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