Prospecto:Information for the Patient

Paricalcitol NORMON 1 microgram capsules

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.See section 4.

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

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

3. How to take Paricalcitol NORMON

4. Possible adverse effects

5. Storage of Paricalcitol NORMON

6. Contents of the package and additional information

Paricalcitol NORMONis a synthetic form of the active vitamin D.

The active vitamin D is necessary for the normal functioning of many body tissues, including the parathyroid gland and bones. In people with normal renal function, this active form of vitamin D is produced naturally by the kidneys, but in the case of kidney failure, the production of active vitamin D is markedly reduced. Therefore,Paricalcitol NORMONprovides 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 in patients with kidney disease (stages 3, 4, and 5), specifically with high levels of parathyroid hormone that can cause bone problems.

Do not take Paricalcitol NORMON

• If you are allergic to paricalcitol or any of the other components of this medication (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 NORMON

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

Taking Paricalcitol NORMON with other medications

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

Some medications may affect the action of Paricalcitol NORMON or produce adverse effects more frequently.

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

• Ketoconazole (used to treat fungal infections such as candida, mouth ulcers)
• Colestiramine (used to lower cholesterol levels)
• Medications for the heart or blood pressure (e.g. digoxin and diuretics or medications that remove fluids) or
• Medications containing high calcium content.

You should also inform your doctor if you are taking medications containing magnesium or aluminum, such as some medications for indigestion (antacids) and medications that bind to phosphorus (phosphate-binding agents).

Taking Paricalcitol NORMON with food and beverages

Paricalcitol NORMON can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.. There is insufficient 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.

The passage of paricalcitol into breast milk is unknown. If you are taking Paricalcitol NORMON, inform your doctor before breastfeeding your child.

Driving and operating machinery

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

Paricalcitol NORMON contains ethanol

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of 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 on the correct dose for you.

Once treatment with Paricalcitol NORMON has begun, it is likely that you will need to adjust the dose 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 has begun, it is likely that you will need to adjust the dose 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.

Older patients

There is limited experience in the use of paricalcitol in patients 65 years or 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 NORMON than you should

A high dose of Paricalcitol NORMON can produce abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may appear after taking a high dose of Paricalcitol NORMON may include: feeling weak and/or drowsy, 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 NORMON may include: loss of appetite, feeling weak, weight loss, dry eyes, nasal discharge, skin itching, feeling hot and fever, loss of sexual appetite, severe abdominal pain (due to pancreatitis inflammation), 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 NORMON may cause mental changes such as confusion, drowsiness, 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 medication 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 the next capsule, do not take the forgotten capsule and continue with the treatment as your doctor instructed.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Paricalcitol NORMON

Do not interrupt treatment with Paricalcitol NORMON unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

In patients with chronic kidney disease stage 3 and 4

The frequent (can affect up to 1 in 10 people) include: hives (skin rash) and stomach discomfort.

The infrequent (can affect up to 1 in 100 people) include: allergic reactions (such as difficulty breathing, wheezing, hives, skin itching or swelling of the face and lips), skin itching, urticaria, constipation, dry mouth, muscle cramps, dizziness, and unusual taste in the mouth. Abnormalities in liver function test results may also occur. An increase in blood levels of a substance called creatinine (in pre-dialysis patients). See also the "Warnings and precautions" section.

In patients with chronic kidney disease stage 5

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

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

The infrequent side effects (can affect up to 1 in 100 people) during treatment with paricacitol injectable that may occur are: irregular heart rhythm, increased bleeding time, liver function test abnormalities, weight loss, cardiac arrest, rapid heart rate, decreased red blood cell count, decreased white blood cell count, lymph node inflammation, lack of cerebral perfusion (stroke and cerebral vascular accident), loss of consciousness, abnormal sensitivity and voluntary motor ability (coma), fainting, dizziness, tremors, feeling of needles and pins in the body, numbness, high blood pressure in the eye, pink eyes, red eyes, ear pain, pulmonary edema, nasal bleeding, difficulty breathing, wheezing, cough, low intestinal blood flow (ischemia), anal bleeding, stomach pain, difficulty swallowing, irritable bowel syndrome (irritable bowel syndrome), diarrhea, constipation, stomach acid, vomiting, nausea, dry mouth, heavy digestion, hives (skin rash) with itching, generalized rash, blisters, hair loss, hair growth, night sweats, pain at the injection site, skin burning sensation, 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, leg swelling, generalized swelling, chest discomfort, fever, weakness, pain, fatigue, general discomfort, thirst, abnormal sensitivity, breast pain, allergy, erectile dysfunction, delirium, confusion, anxiety, insomnia, nervousness, agitation.

Reporting of side effects

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

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

Store below 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 point of 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 NORMON

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

Appearance of the product and contents of the packaging

The soft capsules of Paricalcitol NORMON are white or almost white, oval-shaped, and filled with a transparent solution.

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon S.A.

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

Last review date of the leaflet: October 2014

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