Paricalcitol Normon 1 microgram soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Paricalcitol NORMON 1 microgram soft capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Paricalcitol NORMON 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 cases of kidney failure, the production of active vitamin D is markedly reduced. Therefore, Paricalcitol NORMON 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 in patients with kidney disease (stages 3, 4, and 5), specifically those with high levels of parathyroid hormone that may cause bone problems.

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

Do not take Paricalcitol NORMON

• 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 NORMON

• Before starting treatment, it is important that you limit the amount of phosphorus in your diet.
• Phosphate-binding agents may be needed to control phosphorus levels. If you are taking phosphate-binding agents containing calcium, your doctor may adjust your dose.
• Your doctor will perform 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 NORMON 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 NORMON or increase the risk of adverse effects.

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

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

It is also important to inform your doctor if you are taking medicines containing magnesium or aluminium, for example, some medicines for indigestion (antacids) and medicines that bind to phosphate (phosphate binders).

Taking Paricalcitol NORMON with food and drink

Paricalcitol NORMON may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. 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 baby.

Driving and using machines

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

Paricalcitol NORMON contains ethanol

This medicine contains “0.31”% ethanol (alcohol), a small amount corresponding to 0.7 mg per dose.

3. How to take Paricalcitol NORMON

Follow exactly the instructions for administration of this medicine as given 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 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 NORMON has been started, a dose adjustment may be required depending on your response to treatment.

Your doctor will help determine the correct dose of Paricalcitol NORMON.

Chronic kidney disease, stage 5

The usual 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 NORMON has been started, a dose adjustment may be required depending on your response to treatment.

Your doctor will help determine the correct dose of Paricalcitol NORMON.

Liver disease

If you have mild to moderate liver disease, no dose adjustment is necessary. 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 of age, and experience is limited in children over 5 years of age.

Elderly patients

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

An overdose of Paricalcitol NORMON 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 NORMON may include: feeling weak and/or drowsy, headache, nausea (feeling unwell) or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and metallic taste.

Symptoms that may occur over the long term after excessive intake of Paricalcitol NORMON 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 almost time for your next dose, do not take the missed capsule and continue your treatment as directed by your doctor.

Do not take a double dose to make up for a missed dose.

If you stop taking Paricalcitol NORMON

Do not stop treatment with Paricalcitol NORMON unless instructed by your doctor.

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

4. Possible adverse effects

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

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

In patients with chronic kidney disease stage 3 and 4

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

Uncommon (may affect up to 1 in 100 people) include: allergic reactions (such as difficulty breathing, breathing noises (wheezing), rash (skin eruption), itching or swelling of face and lips), skin itching, urticaria, constipation, dry mouth, muscle cramps, dizziness and unusual taste in mouth. Changes in liver function test results may also occur. Increase in blood levels of a substance called creatinine (in pre-dialysis patients). See also section “Warnings and precautions”.

In patients with chronic kidney disease stage 5

Frequent adverse effects (may 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 levels of calcium in the blood may also occur.

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

Uncommon adverse effects (may affect up to 1 in 100 people) during treatment with injectable paricalcitol that may occur are: irregular heartbeat, prolonged bleeding time, liver function test abnormalities, weight loss, cardiac arrest, very rapid heartbeat, decreased number of red blood cells, decreased number of white blood cells, lymph node swelling, lack of blood supply to the brain (stroke and cerebrovascular accident), loss of consciousness, sensation and voluntary motor function (coma), fainting, dizziness, tremors, pins and needles sensation in the body, numbness, high eye pressure, pink eyes, red eyes, ear pain, fluid retention in the lungs (pulmonary edema), nosebleeds, difficulty breathing, breathing noises, cough, poor intestinal blood supply (ischemia), anal bleeding, stomach pain, difficulty swallowing, irritable bowel (irritable bowel syndrome), diarrhea, constipation, stomach acidity, vomiting, nausea, dry mouth, indigestion, itchy rash (skin eruption), generalized rash, blisters, hair loss, hair growth, night sweats, injection site pain, burning sensation on skin, joint pain, muscle pain, back pain, joint stiffness, muscle twitching, high levels of parathyroid hormone, loss of appetite (anorexia), decreased appetite, blood infection, pneumonia, flu, cold, dry throat, vaginal infections, breast cancer, low blood pressure, high blood pressure, chest pain (thoracic pain), walking disturbances, swelling in legs, generalized swelling, chest discomfort, fever, weakness, pain, fatigue, general malaise, thirst, abnormal sensation, breast pain, allergy, difficulty achieving an erection (impotence), delirium, confusion, anxiety, insomnia, nervousness, agitation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist 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 Medicines: https://notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paricalcitol NORMON

• The active substance in 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 shell contains: gelatin, glycerol, purified water, and titanium dioxide (E-171).

Appearance of the product and contents of the pack

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

This medicine is supplied 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 the most recent review of the leaflet: October 2014

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