PARICALCITOL NORMON 1 MICROGRAM SOFT CAPSULES

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

Do not take Paricalcitol NORMON

• 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 Paricalcitol NORMON

• Before starting treatment, it is essential to 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.

Taking Paricalcitol NORMON with other medicines

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 Paricalcitol NORMON or produce side effects more frequently.

It is particularly important to inform your doctor if you are taking:

• Ketoconazole (used to treat fungal infections such as thrush, oral thrush)
• Cholestyramine (used to lower cholesterol levels)
• Medicines for the heart or blood pressure (e.g., digoxin and diuretics or medicines that eliminate fluids) or
• Medicines that contain high calcium content.

It is also important to inform your doctor if you are taking medicines that contain magnesium or aluminum, such as some medicines for indigestion (antacids) and medicines that bind to phosphorus (phosphate binders).

Taking Paricalcitol NORMON with food and drinks

Paricalcitol NORMON can be taken with or without food.

Pregnancy and breastfeeding

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 is not enough data on the use of paricalcitol in pregnant women. The risk in humans is unknown; Paricalcitol NORMON should not be used during pregnancy unless clearly necessary.

It is unknown whether paricalcitol passes into breast milk. If you are taking Paricalcitol NORMON, inform your doctor before breastfeeding your child.

Driving and using machines

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

Paricalcitol NORMON contains ethanol

This medicine contains "0.31%" ethanol (alcohol), which corresponds to 0.7 mg per dose.

3. How to take Paricalcitol NORMON

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

Chronic kidney disease, stages 3 and 4

The usual dose is one capsule daily, 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 NORMON 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 NORMON.

Chronic kidney disease, stage 5

The usual 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 NORMON 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 NORMON.

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.

Use in children

There is no information on the use of Paricalcitol NORMON in children under 5 years, and experience is limited in children over 5 years.

Elderly patients

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

If you take more Paricalcitol NORMON than you should

Taking too much Paricalcitol NORMON can cause abnormally high calcium levels in the blood, which can be harmful. The symptoms that may appear after taking too much Paricalcitol NORMON 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 NORMON may include: loss of appetite, feeling weak, weight loss, dry eyes, runny nose, itching skin, feeling hot, and fever. 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 NORMON can cause mental changes such as confusion, sleepiness, insomnia, or nervousness.

If you take too much Paricalcitol NORMON 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 NORMON

If you forget to take a dose, take it as soon as you remember. However, if it is close to the time of taking 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 Paricalcitol NORMON

Do not stop taking Paricalcitol NORMON unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following side effects:

In patients with chronic kidney disease in stage 3 and 4

Frequent side effects (may affect up to 1 in 10 people) include: rash (skin eruption) and stomach upset.

Uncommon side effects (may affect up to 1 in 100 people) include: allergic reactions (such as difficulty breathing, wheezing, rash, itching, or swelling of the face and lips), itching, hives, constipation, dry mouth, muscle cramps, dizziness, and unusual taste in the mouth. There may also be changes in liver function test results. Increase in blood levels of a substance called creatinine (in pre-dialysis patients). See also the section "Warnings and precautions".

In patients with chronic kidney disease in stage 5

Frequent side effects (may affect up to 1 in 10 people) that may occur are: diarrhea, heartburn (reflux or indigestion), decreased appetite, dizziness, chest pain, and acne. Abnormal calcium levels in the blood may also appear.

Frequent side effects (may affect up to 1 in 10 people) observed during treatment with injectable paricalcitol that may occur are: headache, unusual taste in the mouth, itching, decreased parathyroid hormone levels, increased calcium and phosphorus levels.

Uncommon side effects (may affect up to 1 in 100 people) during treatment with injectable paricalcitol that may occur are: irregular heart rhythms, prolonged bleeding time, changes in liver test results, weight loss, cardiac arrest, rapid heartbeat, decreased red blood cell count, decreased white blood cell count, lymph node inflammation, lack of blood flow to the brain (stroke and cerebral vascular accident), loss of consciousness, sensitivity, and voluntary motor ability (coma), fainting, dizziness, tremors, feeling of pins and needles in the body, numbness, high eye pressure, red eyes, ear pain, fluid retention in the lungs (pulmonary edema), nosebleeds, difficulty breathing, wheezing, coughing, low blood flow to the intestine (ischemia), anal bleeding, stomach pain, difficulty swallowing, irritable bowel syndrome (irritable bowel syndrome), diarrhea, constipation, heartburn, vomiting, nausea, dry mouth, indigestion, skin rash with itching, generalized rash, blisters, hair loss, hair growth, night sweats, pain at the injection site, burning sensation on the skin, joint pain, muscle pain, back pain, joint stiffness, muscle spasms, high parathyroid hormone levels, loss of appetite (anorexia), decreased appetite, blood infection, pneumonia, flu, cold, sore throat, vaginal infections, breast cancer, low blood pressure, high blood pressure, chest pain (chest pain), gait disturbances, swelling in the legs, generalized swelling, chest discomfort, fever, weakness, pain, fatigue, general malaise, thirst, abnormal sensitivity, breast pain, allergy, difficulty having an erection (impotence), delirium, confusion, anxiety, insomnia, nervousness, agitation.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paricalcitol NORMON

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

Store below 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to 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 Paricalcitol NORMON

• The active ingredient of Paricalcitol NORMON is paricalcitol. Each soft capsule contains 1 microgram of paricalcitol.
• The other ingredients (excipients) in the capsules are: medium-chain triglycerides, ethanol, butylhydroxytoluene.
• The capsule shell contains: gelatin, glycerol, purified water, and titanium dioxide (E-171).

Appearance of the product and pack contents

The Paricalcitol NORMON soft capsules are white or almost white, oval, filled with a clear solution.

This medicine is available in boxes containing 28 soft capsules, available in blisters.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of last revision of the leaflet: October 2014

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.