PARICALCITOL STADA 1 MICROGRAM CAPSULE SOFT EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paricalcitol Stada 1 microgram capsule soft EFG

Read the entire leaflet carefully before you start taking 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, 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 side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Paricalcitol Stada is and what it is used for

Paricalcitol Stada contains the active substance paricalcitol, which is a synthetic form of active vitamin D.

Active vitamin D is necessary for the normal functioning 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 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 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 chronic kidney disease stages 3, 4, and 5, and in children aged 10 to 16 years with chronic kidney disease stages 3 and 4.

2. What you need to know before starting to take Paricalcitol Stada

Do not take Paricalcitol Stada:

• 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 Stada.

• before starting treatment, it is important that you limit the amount of phosphorus in your diet.

• you may need to use phosphate-binding agents to control phosphorus levels.

• if you are taking phosphate-binding agents containing calcium, your doctor may adjust your dose.

• your doctor will carry out 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.

Taking Paricalcitol Stada with other medicines

Tell 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 paricalcitol or may increase the likelihood of side effects. It is especially important to inform your doctor if you are taking any of the following medicines:

• medicines used to treat fungal infections such as candida or oral thrush (e.g. ketoconazole);
• medicines used to treat heart problems or high blood pressure (e.g. digoxin, diuretics or medicines that remove fluid);
• medicines containing high amounts of calcium or vitamin D, including supplements or multivitamins available without a prescription;
• medicines containing magnesium or aluminum (e.g. some medicines for indigestion (antacids) and medicines that bind phosphorus);
• medicines used to treat high cholesterol levels (e.g. cholestyramine).

Taking Paricalcitol Stada with food and drink

Paricalcitol Stada may be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist 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 not known whether paricalcitol passes into breast milk. If you are taking paricalcitol, inform your doctor before breastfeeding your child.

Driving and using machines

Paricalcitol Stada is not expected to affect your ability to drive or operate machinery.

Paricalcitol Stada contains ethanol

This medicine contains small amounts of ethanol (an alcohol), less than 100 mg per capsule, which may alter or increase the effect of other medicines. This may be harmful for people with liver disease, alcoholism, epilepsy, brain injury or brain disease, as well as for pregnant or breast-feeding women and children.

3. How to take Paricalcitol Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Chronic kidney disease, stages 3 and 4

For adult patients, the usual 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 started, a dose adjustment may be needed depending on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

Chronic kidney disease, stage 5

For adult patients, the usual 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 started, a dose adjustment may be needed depending on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

Hepatic impairment

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 patients

The usual 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 started, a dose adjustment may be needed depending on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

Use in children and adolescents

For 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 per week. Your doctor will use the results of certain laboratory tests to determine the correct dose for you. Once paricalcitol treatment is started, a dose adjustment may be needed depending on your response to treatment. Your doctor will help you determine the correct dose of paricalcitol.

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

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

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 Stada than you should

An overdose 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 sick) or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and metallic taste.

Symptoms that may occur in the 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, consult your doctor immediately. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Paricalcitol Stada

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 forgotten doses.

If you stop taking Paricalcitol Stada

Do not stop treatment with paricalcitol unless instructed by your doctor.

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 may cause adverse effects, although not everyone gets them.

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

Frequent adverse effects (may affect up to 1 in 10 people) observed in patients during the use of paricalcitol capsules include increased blood levels of a substance called calcium, as well as increased calcium time; an increase in another substance called phosphate may also occur (in patients with significant chronic kidney disease). Blood phosphate levels may also rise.

Uncommon adverse effects (may affect up to 1 in 100 people) observed in patients during the use of paricalcitol capsules include allergic reactions (such as difficulty breathing, skin rash, itching, or swelling of the face and lips), decreased levels of parathyroid hormone, diarrhea, muscle cramps, nausea, dizziness, stomach discomfort or pain, vomiting, weakness, fatigue, skin rash, pneumonia, loss of appetite, decreased calcium levels, unusual taste in the mouth, irregular heartbeat, constipation, dry mouth, heartburn (reflux or indigestion), acne, skin itching, hives, muscle pain, breast tenderness, feeling unwell, swelling in the legs, pain, increased creatinine levels, liver function test abnormalities, and headache.

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 nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paricalcitol Stada

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paricalcitol Stada

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

• The other components are:

• capsule contents: medium-chain triglycerides, 96% ethanol, and butylhydroxytoluene (E321).

• capsule shell: gelatin (E441), water, glycerol (E422), titanium dioxide (E 171).

Appearance of the product and contents of the pack

Paricalcitol Stada 1 microgram are soft, oval, white or slightly white capsules containing a clear oily liquid.

They are available in blister packs containing 7, 28 or 30 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Date of the most recent review of this leaflet: December 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/