Patient Information Leaflet: Package Insert

Paricalcitol Normon 2 micrograms/mL injectable solution EFG

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using Paricalcitol Normon

3. How to use Paricalcitol Normon

4. Possible side effects

5. Storage of Paricalcitol Normon

6. Contents of the pack and additional information

Paricalcitol Normon is a synthetic analog of activated vitamin D used to prevent and treat high levels of parathyroid hormone in the blood in patients with kidney failure undergoing dialysis treatment. Elevated parathyroid hormone levels may be due to low levels of activated vitamin D in patients with kidney failure.

Activated vitamin D is required for the proper functioning of many bodily tissues, including kidneys and bones.

No use Paricalcitol Normon:

• If you are allergic to paricalcitol or any of the other components of this medication (see section 6).
• If you have very high levels of calcium or vitamin D in your blood. Your doctor will monitor your blood levels and may tell you if these conditions apply to you.

Warnings and precautions:

• Before starting treatment, it is essential to limit the amount of phosphorus ingested in your diet. Examples of foods that contain high levels of phosphorus are: tea, soda, beer, cheese, milk, cream, fish, liver of chicken or beef, beans, peas, cereals, nuts, and whole foods.
• To control phosphorus levels, it may be necessary to use phosphorus chelating agents that prevent the absorption of phosphorus from the diet.
• If you are taking phosphorus chelating agents with calcium content, your doctor may need to adjust the dose.
• Your doctor will need to perform blood tests to monitor your treatment.

Use of Paricalcitol Normon with other medications

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

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

• To treat fungal infections such as candida or aphthous ulcers (for example, ketoconazole)
• To treat the heart or blood pressure (for example, digoxin and diuretics)
• That contain magnesium (for example, some types of antacids called anti-acids, such as magnesium trisilicate).
• That contain aluminum (for example, phosphorus chelating agents, such as aluminum hydroxide).

Consult your doctor, nurse, or pharmacist before taking any medication.

Use of Paricalcitol Normon with food and beverages

Paricalcitol may be administered with or without food.

Pregnancy and breastfeeding

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

The safety of this medication for pregnant women or breastfeeding women is unknown. Therefore, it should only be used after consulting with your doctor who will help you make the decision that best suits you.

The alcohol content should be taken into account in the case of pregnant women or breastfeeding women (see Paricalcitol Normon contains ethanol and propylene glycol).

Consult your doctor, nurse, or pharmacist before using any medication.

Driving and operating machinery

No studies have been conducted on the effects of paricalcitol on the ability to drive or operate machinery. During treatment with paricalcitol, your ability to drive safely or operate heavy machinery may be affected. Paricalcitol may make you feel dizzy, weak, and/or drowsy.

Do not drive or operate machinery if you have these symptoms.

Paricalcitol Normon contains ethanol and propylene glycol

This medication contains 12.7% ethanol, equivalent to 100 mg per ampoule. The amount in the ampoule of this medication is equivalent to less than 2.5 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medication does not produce any noticeable effect.

This medication contains 400 mg of propylene glycol in each ampoule, equivalent to 400 mg/ml.

Dosage

Your doctor will use the results of laboratory tests to determine the initial appropriate dose for you. Once you have started treatment with Paricalcitol Normon, the dose must be adjusted based on the results of routine laboratory tests. Using the results of your tests, your doctor will help you determine the appropriate dose of Paricalcitol Normon for you.

Paricalcitol Normon will be administered by the doctor or nurse while you are being treated with the kidney machine. It will be administered through the tube that connects you to the machine. You will not need to receive an injection as Paricalcitol Normon can be introduced directly into the tube that is being used for your treatment. You will not be receiving Paricalcitol Normon more frequently than every other day and no more than 3 times a week.

If you use more Paricalcitol Normon than you should

Too much Paricalcitol Normon can cause high levels of calcium (in the blood and urine), phosphate, and parathyroid hormone (in the blood) that may require treatment.

The symptoms that may appear after receiving an overdose of Paricalcitol Normon are:

• Feeling weak and/or drowsy
• Headache
• Feeling sick
• Dry mouth, constipation
• Muscle and bone pain
• Strange taste in the mouth

The symptoms that may appear after a long period of receiving too much Paricalcitol Normon are:

• Loss of appetite
• Drowsiness
• Weight loss
• Irritation in the eyes
• Nasal discharge
• Itching skin
• Feeling feverish
• Loss of sexual appetite
• Severe abdominal pain
• Kidney stones
• Your blood pressure may be affected and you may be aware of your own heartbeats (palpitations).

Paricalcitol Normon contains 38.6% v/v of propylene glycol as an excipient. Isolated cases of toxic effects related to the administration of high doses of propylene glycol have been described, although they are not expected when administered to patients undergoing dialysis treatment because propylene glycol is eliminated from the blood during dialysis.

If you experience high levels of calcium in the blood after using Paricalcitol Normon, your doctor will prescribe the necessary treatment to return your calcium levels to normal. Once your calcium levels return to normal, it is likely that you will be administered low doses of Paricalcitol Normon.

However, your doctor will monitor your blood levels and if you experience any of the mentioned symptoms, seek medical advice immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, paricalcitol may have adverse effects, although not everyone will experience them.

Several allergic reactions have been reported with paricalcitol.Important: If you notice any of the following adverse effects, inform your doctor or nurse immediately:

• Lack of air
• Difficulty breathing and swallowing
• Whistling
• Hives, skin itching or urticaria
• Swelling of the face, lips, mouth, tongue, or throat.

Inform your doctor or nurse if you notice any of the following adverse effects:

The most common adverse effects (at least 1 in 100 patients) are:

• Headache;
• Unusual taste in the mouth;
• Skin itching;
• Decreased parathyroid hormone levels;
• Increased levels of calcium (feeling sick, constipated, or confused) and phosphorus in the blood (probably asymptomatic but may make bones susceptible to fractures).

Rare (at least 1 in 1000 patients):

• Allergic reactions (such as difficulty breathing, whistling, hives, itching, or swelling of the face and lips); blisters with itching;
• Blood infection, decreased red blood cell count (anemia – feeling weak, difficulty breathing, paleness); decreased white blood cell count (increased susceptibility to infections), swelling of lymph nodes in the neck, armpits, and/or groin; prolonged bleeding time (blood will not clot quickly);
• Myocardial infarction, stroke, chest pain, irregular or rapid heartbeat, decreased blood pressure, increased blood pressure;
• Coma (a deep state of unconsciousness during which a person cannot interact with their environment);
• Unusual fatigue, weakness, dizziness, syncope;
• Pain at the injection site;
• Pneumonia (lung infection), fluid in the lungs, asthma, wheezing, cough, difficulty breathing;
• Throat irritation, cold, fever, feverish symptoms, pink eye (itching and crusts on eyelids), increased eye pressure, ear pain, nasal bleeding;
• Nervous tics; confusion, which in some cases is severe (delirium), agitation (feeling nervous, anxious), nervousness, personality disorders (not feeling like oneself);
• Tickling or numbness, decreased touch, sleep problems, nocturnal sweating, muscle spasms in arms and legs, even during sleep;
• Dry mouth, thirst, nausea, difficulty swallowing, vomiting, loss of appetite, weight loss, heartburn, diarrhea, and abdominal pain, rectal bleeding;
• Difficulty achieving an erection, breast cancer, vaginal infection;
• Chest pain, back pain, muscle or joint pain, feeling of heaviness caused by general or localized inflammation in ankles, feet, and legs (edema); abnormal gait;
• Hair loss; excessive hair growth;
• Increased liver enzymes; increased parathyroid hormone levels, increased potassium levels in the blood, decreased calcium levels in the blood.

Unknown frequency:

• Swelling of the face, lips, mouth, tongue, and throat that may cause difficulty swallowing or breathing; skin itching (urticaria), gastrointestinal bleeding. Seek medical help immediately.

You may not identify these adverse effects unless your doctor has previously informed you.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist. Even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Paricalcitol Normon should be used immediately after opening.

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.

Do not use this medication if you observe particles or discoloration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Paricalcitol Normon

• The active principle is paricalcitol. Each ml of solution contains 2 micrograms of paricalcitol.
• The other components are: ethanol (alcohol), propylene glycol (E-1520) and water forparenteral preparations.

Aspect of the product and size of the packaging

Paricalcitol Normon is a clear and colorless aqueous solution, free of visible particles. It is presented in containers with 5 ampoules of 1 ml.

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 this leaflet:july2014

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

Instructions for the healthcare professional

Paricalcitol Normon 2 micrograms/ml injectable solution

Preparation for injectable solution

Paricalcitol Normon 2 micrograms/ml injectable solution is for single use. As with other parenteral medications, observe the solution for visible particles and color before administration.

Compatibility

Propylene glycol interacts with heparin and neutralizes its effects. Paricalcitol NORMON injectable solution contains propylene glycol as an excipient and should be administered through a different administration site from heparin.

This medication should not be mixed with other medications.

Storage and expiration

Parenteral products should be inspected before administration for the presence of visible particles and color. The solution is clear and colorless.

This medication does not require special storage conditions.

This medication has an expiration date of 2 years.

Dosage and administration

Paricalcitol Normon injectable solution is administered through the hemodialysis access.

Adults

1) Initial dose calculation:

The initial dose of paricalcitol is based on the following formula:

Dose (micrograms) = 8 x basal PTH level (pmol/l)

or

Dose (micrograms) = 80 x basal PTH level (pg/ml)

and administered as a bolus intravenous dose, with a maximum frequency of alternate days and at any time during dialysis.

The maximum safe dose administered in clinical studies was 40 micrograms.

2) Dose titration:

Accepted levels for PTH in patients with terminal renal failure undergoing dialysis are not more than 1.5 to 3 times the upper limit of normal non-uremic, 15.9 to 31.8 pmol/l (150-300 pg/ml) for intact PTH. Individualized dose titration is necessary to achieve optimal physiological variables.

If hypercalcemia or a corrected Ca x P product, elevated persistently, greater than 5.2 mmol2/l2(65 mg2/dl2), is observed, reduce or discontinue the dose until these parameters normalize.

Then, restart paricalcitol administration at lower doses. It may be necessary to reduce the dose when PTH levels decrease in response to therapy.

A suggested dosage adjustment table is provided below: