Paricalcitol Normon 5 micrograms/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Paricalcitol Normon 5 micrograms/ml injection solution EFG

Read the entire leaflet carefully before you start using 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 others, even if they have the same symptoms as you, because 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 using Paricalcitol Normon
3. How to use 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 analogue of activated vitamin D used to prevent and treat high levels of parathyroid hormone in the blood of patients with renal failure who are undergoing kidney machine treatment (haemodialysis). Elevated parathyroid hormone levels may be due to low levels of activated vitamin D in patients with renal failure.

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

2. What you need to know before starting to use Paricalcitol Normon

Do not use Paricalcitol Normon:

• If you are allergic to paricalcitol or to any of the other ingredients of this medicine (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 can tell you whether these conditions apply to you.

Warnings and precautions:

• Before starting treatment, it is important that you limit the amount of phosphorus you consume in your diet. Examples of foods high in phosphorus include: tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and whole grain foods.
• It may be necessary to use phosphate-binding agents to control phosphorus levels, which prevent the absorption of dietary phosphorus.
• If you are taking phosphate-binding agents containing calcium, 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 medicines

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

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

• For treating fungal infections such as candidiasis or thrush (e.g., ketoconazole)
• For treating heart conditions or high blood pressure (e.g., digoxin and diuretics)
• Containing magnesium (e.g., certain types of antacids used for dyspepsia, such as magnesium trisilicate)
• Containing aluminum (e.g., phosphate binders such as aluminum hydroxide)

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

Use of Paricalcitol Normon with food and drinks

Paricalcitol may be administered 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.

It is unknown whether this medicine is safe for pregnant or breastfeeding women. Therefore, it should only be used after consulting with your doctor, who will help you make the most appropriate decision.

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

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

Driving and using machines

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 experience these symptoms.

Paricalcitol Normon contains ethanol and propylene glycol

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

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

This medicine contains 400 mg of propylene glycol per vial, equivalent to 400 mg/ml.

3. How to use Paricalcitol Normon

Dosage

Your doctor will use the results of laboratory tests to determine the appropriate initial dose for you. Once you have started treatment with Paricalcitol Normon, the dose should 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 a physician or nurse while you are being treated with the kidney machine. It will be given 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 being used for your treatment. You will not receive Paricalcitol Normon more frequently than on alternate days and no more than 3 times per week.

If you use more Paricalcitol Normon than you should

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

Symptoms that may occur after receiving an overdose of Paricalcitol Normon include:

• Feeling weak and/or drowsy
• Headache
• Feeling unwell
• Dry mouth, constipation
• Pain in muscles and bones
• A strange taste in the mouth

Symptoms that may occur after a prolonged period of receiving too much Paricalcitol Normon include:

• Loss of appetite
• Drowsiness
• Weight loss
• Eye irritation
• Runny nose
• Itching of the skin
• Feeling feverish
• Loss of sexual appetite
• Severe abdominal pain
• Kidney stones
• Your blood pressure may be affected and awareness of your own heartbeat (palpitations).

Paricalcitol Normon contains 38.6% v/v propylene glycol as excipient. Isolated cases of toxic effects related to the administration of high doses of propylene glycol have been reported, although these are not expected when administered to patients undergoing treatment with a kidney machine, as propylene glycol is removed from the blood during dialysis.

If you experience high levels of calcium in your blood after using Paricalcitol Normon, your doctor will prescribe appropriate treatment to return calcium levels to normal. Once your calcium levels return to normal, you will likely be given lower doses of Paricalcitol Normon.

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

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

4. Possible adverse effects

Like all medicines, Paricalcitol Normon may have adverse effects, although not everyone will experience them.

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

• Shortness of breath
• Difficulty breathing and swallowing
• Wheezing
• Rash, skin itching, or hives
• 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 (affecting at least 1 in 100 patients) are:

• Headache
• Unusual taste in the mouth
• Skin itching
• Decrease in parathyroid hormone levels
• Increase in blood calcium (feeling unwell, constipation, or confusion) and phosphorus levels (likely asymptomatic but may make bones susceptible to fracture)

Uncommon (affecting at least 1 in 1,000 patients):

• Allergic reactions (such as difficulty breathing, wheezing, rash, pruritus, or swelling of face and lips); itchy blisters
• Blood infection, decreased number of red blood cells (anemia – feeling weak, shortness of breath, paleness); decreased number of white blood cells (increased susceptibility to infections), swelling of neck, armpit, and/or groin lymph nodes; prolonged bleeding time (blood does not clot as quickly)
• Myocardial infarction, stroke, chest pain, irregular or rapid heartbeat, decreased blood pressure, increased blood pressure
• Coma (deep state of unconsciousness during which a person cannot interact with their environment)
• Unusual tiredness, weakness, dizziness, fainting
• Pain at the injection site
• Pneumonia (lung infection), fluid in the lungs, asthma, wheezing, cough, difficulty breathing
• Throat irritation, cold, fever, flu-like symptoms, pink eye (itching and crusting of eyelids), increased eye pressure, ear pain, nosebleeds
• Nervous tics; confusion, sometimes severe (delirium), agitation (feeling nervous, anxious), restlessness, personality disorders (feeling unlike oneself)
• Tingling or numbness, reduced sense of touch, sleep disturbances, night sweats, muscle spasms in arms and legs, even during sleep
• Dry mouth, thirst, nausea, difficulty swallowing, vomiting, loss of appetite, weight loss, heartburn, diarrhea, stomach pain, constipation, rectal bleeding
• Difficulty achieving an erection, breast cancer, vaginal infection
• Chest pain, back pain, muscle/joint pain, sensation of heaviness due to general or localized swelling in ankles, feet, and legs (edema); abnormal walking pattern
• Hair loss; excessive hair growth
• Increased liver enzymes; increased parathyroid hormone levels, increased blood potassium levels, decreased blood calcium levels

Frequency not known:

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

You may not recognize these adverse effects unless your doctor has previously informed you about them.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist. This includes any possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.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.

No special storage conditions are required.

Paricalcitol Normon must be used immediately after opening.

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.

Do not use this medicine if particles or discoloration are observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paricalcitol Normon

• The active substance is paricalcitol. Each ml of solution contains 5 micrograms of paricalcitol.
• The other components are: ethanol (alcohol), propylene glycol (E-1520) and water for injections.

Nature of the product and pack size

Paricalcitol Normon is a clear, colourless aqueous solution, free from visible particles. It is supplied in packs containing 5 ampoules of 1 ml each.

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 this leaflet: July 2014

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

Instructions for healthcare professionals

Paricalcitol Normon 5 micrograms/ml injectable solution

Preparation for injectable solution

Paricalcitol Normon 5 micrograms/ml injectable solution is for single use only. As with other parenteral medications, the solution should be visually inspected for particulate matter and discoloration prior to administration.

Compatibility

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

This medicine must not be mixed with other medicinal products.

Storage and expiry

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. The solution is clear and colourless.

This medicine does not require special storage conditions.

The shelf life of this medicine is 2 years.

Dosage and administration

Paricalcitol Normon injectable solution is administered via the haemodialysis access.

Adults

1. The initial dose should be calculated based on baseline parathyroid hormone (PTH) levels.

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

Initial dose (micrograms) = baseline level of intact PTH in pmol/l
8

or

= baseline level of intact PTH in pg/ml
80

and administered as an intravenous bolus dose, with a maximum frequency of every other day, at any time during dialysis.

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

2. Dose titration:

The currently accepted target range for PTH levels in subjects with end-stage renal disease on dialysis is no more than 1.5 to 3 times the upper normal non-uraemic limit, i.e., 15.9 to 31.8 pmol/l (150–300 pg/ml) for intact PTH. To achieve appropriate physiological levels, individualized monitoring and dose titration are required.

If hypercalcaemia or a persistently elevated corrected Ca × P product greater than 5.2 mmol²/l² (65 mg²/dl²) occurs, the dose should be reduced or interrupted until these parameters return to normal.

Paricalcitol administration should then be restarted at a lower dose. Dose reduction may also be necessary when PTH levels decrease in response to therapy.

The following table is suggested as a guide for dose titration: