PARICALCITOL STADA 1 MICROGRAM SOFT CAPSULES

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

Do nottake ParicalcitolStada:

• if you are allergicto paricalcitol or any of the other ingredients of this medicine (listed in section 6).
• if you have very high levels of calciumor vitamin Din your blood.

Your doctor will tell you if these conditions affect you.

Warnings and precautions

Talk to your doctor or pharmacist before starting Paricalcitol Stada.

• before starting treatment, it is important that you limit the amount of phosphorus in your diet.
• you may need to use phosphorus binders to control phosphorus levels.
• if you are taking phosphorus binders 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 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.

Taking ParicalcitolStadawith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines may affect the action of paricalcitol 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, oral thrush (e.g., ketoconazole)
• to treat heart problems or high blood pressure (e.g., digoxin, diuretics, or fluid-removing medicines)
• that contain high levels of calciumor vitamin D, including supplements or multivitamins that can be purchased without a prescription
• that contain magnesiumor aluminum(e.g., some medicines for indigestion (antacids) and phosphate binders)
• to treat high cholesterol levels (e.g., colestyramine)

Taking ParicalcitolStadawith food and drinks

Paricalcitol Stada can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

There are 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 Stada should not affect your ability to drive or use machines.

ParicalcitolStadacontains ethanol

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per capsule, which may modify or increase the effect of other medicines. This can be harmful to people who suffer from liver disease, alcoholism, epilepsy, brain damage or disease, as well as pregnant or breastfeeding women and children.

3. How to take Paricalcitol Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 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.

Kidney 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 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 childrenand 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 the correct dose for you. Once paricalcitol is started, it is likelythat 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 CKD stage 5 has not been established.

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

Elderly patients

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 ParicalcitolStadathan you should

Taking too much paricalcitol can cause abnormally high blood calcium levels, which can be harmful. 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.

Long-term symptoms that may occur after taking too much paricalcitol may include: loss of appetite, feeling weak, weight loss, dry eyes, runny nose, itchy 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 tests may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels. Rarely, paricalcitol may 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 taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take ParicalcitolStada

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 missed doses.

If you stop taking ParicalcitolStada

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

If you have any further questions on the use of this medicine, 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:

Common side 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, in addition to increased calcium time, an increase in another substance called phosphate (in patients with significant chronic kidney disease) may occur. Phosphate levels in the blood may also increase.

Uncommon side 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 parathyroid hormone levels, diarrhea, muscle cramps, nausea, dizziness, discomfort or stomach pain, vomiting, weakness, fatigue, skin rash, pneumonia, decreased appetite, decreased calcium levels, unusual taste in the mouth, irregular heartbeat, constipation, dry mouth, heartburn (reflux or indigestion), acne, itchy skin, hives, muscle pain, breast tenderness, feeling unwell, swelling in the legs, pain, increased creatinine levels, and changes in liver function tests and headache.

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 nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Paricalcitol Stada

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

Do not store above 30°C.

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

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 further information

Composition of ParicalcitolStada

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

• The other ingredients are:

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

Appearance and packaging

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratory 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 last revision of this leaflet: December 2018

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