Label: Information for the User

Paricalcitol Stada1 microgram EFG Soft Capsules

Read this label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others 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 label. See section 4.

ParicalcitolStadacontains the active ingredient paricalcitol, which is 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 individuals 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 children aged 10 to 16 years with stage 3 and 4 renal disease.

Do not take Paricalcitol Stada

• 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 these conditions affect you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paricalcitol Stada.

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

Taking Paricalcitol Stada with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

• to treat fungal infections such as candida, mouth ulcers (for example, ketoconazole)
• to treat heart problems or high blood pressure (for example, digoxin, diuretics, or medicines that remove liquids);
• that contain high levels of calcium or vitamin D, including supplements or multivitamins that can be purchased without a prescription;
• that contain magnesium or aluminium (for example, some antacids and medicines that bind to phosphorus)
• to treat high cholesterol levels (for example, cholestyramine)

Taking Paricalcitol Stada with food and drinks

Paricalcitol Stada can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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, 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 Stada should not 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 modify or increase the effect of other medicines. This may be harmful to people with liver disease, alcoholism, epilepsy, brain damage, or disease, as well as pregnant women or breastfeeding women and children.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in 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 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 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 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.

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 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 usual initial dose is one capsule every two days, up to three times a week. Your doctor will use the results of some laboratory tests to decide on the correct dose for you. Once 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.

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

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

Older adults

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 Stada than you should

A high dose of paricalcitol may cause 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), 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. It is recommended to bring the packaging and the medication 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 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 Stada

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 medications, this medication may produce adverse effects, although not everyone will experience them.

Important: Inform your doctor immediately 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 an increase in blood levels of a substance called calcium, as well as an increase in the time of calcium, which may also occur an increase in another substance called phosphate (in patients with significant chronic kidney disease). Blood phosphate levels may also increase.

Rare 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, decreased appetite, decreased calcium levels, unusual taste in the mouth, irregular heartbeat, constipation, dry mouth, stomach burning (reflux or indigestion), acne, skin itching, urticaria, muscle pain, breast tenderness, feeling unwell, swelling in the legs, pain, increased creatinine levels, and liver function test abnormalities, and headache.

If you experience an allergic reaction, please contact your doctor immediately.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 30°C.

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 in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paricalcitol Stada

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

• The other components are:

• capsule content: medium-chain triglycerides, 96% ethanol, and butylhydroxytoluene (E321).
• capsule: gelatin (E441), water, glycerol (E422), and titanium dioxide (E 171).

Appearance of the product and contents of the packaging

Paricalcitol Stada 1 microgram are soft, oval-shaped, white or off-white capsules containing a transparent oily liquid.

It is available in blister packs of 7, 28, or 30 capsules.

Only some sizes of packaging may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Last review date of this leaflet: December 2018

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