Prospecto:information for the user

Paricalcitol SUN 2micrograms/mL injectable solution EFG

Paricalcitol SUN 5micrograms/mL injectable solution EFG

Read this prospectus carefully before starting to use 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 or nurse.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.See section 4.

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

2.What you need to know before Paricalcitol SUN is administered

3.How to use Paricalcitol SUN

4.Possible adverse effects

5.Storage of Paricalcitol SUN

6.Contents of the package and additional information

Paricalcitol SUN contains the active ingredient paricalcitol, which is a synthetic form of active vitamin D.

Active vitamin D is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In individuals with normal renal function, this active form of vitamin D is produced naturally by the kidneys, but in renal insufficiency, the production of active vitamin D is significantly reduced. Paricalcitol SUN, therefore, provides 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 chronic kidney disease, namely high levels of parathyroid hormone that can cause bone problems. Paricalcitol SUN is used in adult patients with stage 5 chronic kidney disease..

No useParicalcitol SUN

-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 monitor your blood levels and can tell you if these conditions apply to you.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before they administerParicalcitolSUN:

-Before starting treatment, it is essential to limit the amount of phosphorus ingested in your diet. Some examples of high-phosphorus foods are tea, soft drinks, beer, cheese, milk, cream, fish, chicken liver or beef liver, beans, peas, cereals, nuts, and whole foods.

-To control phosphorus levels, it may be necessary to use phosphate-binding medications, which prevent the absorption of phosphorus from the diet.

-If you are taking calcium-containing phosphate binders, your doctor may need to adjust your dose.

-Your doctor will need to perform blood tests to monitor your treatment.

Children and adolescents

Paricalcitol SUN is not recommended for use in adolescents and children under 18 years old.

Use of Paricalcitol SUN with other medications

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

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

-For treating fungal infections such as candida or thrush, (for example, ketoconazole)

-For treating the heart or high blood pressure (for example, digoxin and diuretics)

-Containing a source of phosphate (for example, medications to reduce blood calcium levels)

--Containing calcium or vitamin D, including over-the-counter supplements and multivitamins.

-Containing magnesium or aluminum (for example, some types of antacids)and phosphate binders.

-For treating high cholesterol (for example, cholestyramine.)

Use of Paricalcitol SUN with food and beverages

Paricalcitol SUN 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, pharmacist, or nurse before using this medication.

The safety of this medication for pregnant women is unknown, so its use is not recommended during pregnancy or if you may become pregnant.

The effects of paricalcitol on human breast milk are unknown. Inform your doctor before breastfeeding while using Paricalcitol SUN..

Driving and operating machinery

Paricalcitol SUN may cause dizziness. Do not drive or operate machinery if you feel dizzy.

Paricalcitol SUN contains ethanol

This medication contains 20% v/v of ethanol (alcohol). Each dose may contain up to 1.3g of ethanol. This medication may be harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

Dosage

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

Paricalcitol SUN will be administered by a doctor or nurse while you are receiving treatment with the kidney machine. It will be administered through the tube (route) used to connect you to the machine. You will not need to receive an injection because Paricalcitol SUN can be administered directly into the tube used for treatment. Paricalcitol SUN will be administered at a maximum frequency of alternate days and no more than three times a week.

If you are given more Paricalcitol SUN than you should

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

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

-weakness or drowsiness

-headache

-unpleasantness or feeling sick

-dry mouth, constipation

-muscle and bone pain

-strange taste in the mouth.

The symptoms that may develop after a long period of receiving too much Paricalcitol SUN are:

-loss of appetite

-drowsiness

-weight loss

-eye irritation

-nasal discharge

-itching on the skin

-sensation of heat and fever

-loss of sexual appetite

-severe abdominal pain

-kidney stones

-your blood pressure may be affected and you may become aware of your own heartbeat (palpitations).

If you experience any of the above symptoms, seek medical attention immediately.

However, your doctor will monitor your blood levels and if you have high levels of calcium in your blood after administration of Paricalcitol SUN, your doctor will ensure that you receive the appropriate treatment to bring your calcium levels back to normal. Once your calcium levels return to normal, you may be able to receive Paricalcitol SUN at a lower dose.

Paricalcitol SUN contains 15% by volume of propylene glycol as an excipient. Rare cases of toxic effects related to the administration of high doses of propylene glycol have been reported, but these effects are not expected when administered to patients with renal insufficiency undergoing treatment with a kidney machine because propylene glycol is eliminated from the blood during dialysis.

In case of overdose or accidental ingestion, seek immediate medical attention or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Important:

Various allergic reactions have been observed with Paricalcitol SUN.Inform your doctor or nurseimmediatelyif you notice any of the following side effects

-shortness of breath

-difficulty breathing or swallowing

-whistling

-skin rash, itching, or urticaria

-swelling of the face, lips, mouth, tongue, or throat.

These side effects are infrequent or their frequency is unknown.

Inform your doctor or nurseimmediatelyif you have stomach bleeding.This may manifest as black stools.

The frequency of this side effect is unknown.

Inform your doctor as soon as possible if you experience any of the following side effects:

Frequent: may affect up to 1 in 10 people

-headache

-strange taste in the mouth

-itching skin

-low parathyroid hormone levels

-high calcium levels (nausea, constipation, or confusion); low phosphorus levels in the blood (may not cause symptoms but may make bones more prone to breaking).

Rare (may affect up to 1 in 100 people)

-blood infection; decrease in red blood cells (anemia: feeling weak, difficulty breathing, paleness); decrease in white blood cells (increased susceptibility to infections); inflammation of the neck, armpit, and/or groin lymph nodes; prolonged bleeding time (blood does not clot as quickly)

-heart attack; stroke; chest pain; irregular or rapid heartbeats; low blood pressure; high blood pressure.

-coma (deep state of unconsciousness during which a person cannot interact with their environment)

-unusual fatigue, weakness; dizziness; fainting

-pain at the injection site

-pneumonia (lung infection); fluid in the lungs; asthma (whistling, coughing, difficulty breathing)

-throat pain; cold; fever; flu symptoms; conjunctivitis (itching/formation of discharge on the eyelids); increased eye pressure; ear pain; nasal bleeding

-muscle spasms; confusion, sometimes severe (delirium); agitation (feeling nervous, anxious); nervousness; personality disorders (not feeling like oneself)

-tingling or numbness; decreased sensation; sleep problems; 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 and stomach pain; constipation; rectal bleeding

-difficulty achieving an erection; breast cancer; vaginal infections

-chest pain; back pain; muscle pain/joint pain; generalized or localized swelling causing a feeling of heaviness in the legs, feet, and ankles (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.

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

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 leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano : https:// www.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 the vials in the outer packaging to protect them from light. This medication does not require special storage conditions.

Paricalcitol SUN should be used immediately after opening.

Do not use Paricalcitol SUN after the expiration date that appears on the vial and on the packaging after CAD:. The expiration date is the last day of the month indicated.

Do not use Paricalcitol SUN if you observe particles or discoloration.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. This way, you will help protect the environment.

Composition of Paricalcitol SUN

-The active ingredient is paricalcitol.

Paricalcitol SUN 2micrograms/ml: 1ml of solution contains 2micrograms of paricalcitol.

Paricalcitol SUN 5micrograms/ml:1ml of solution contains 5micrograms of paricalcitol.

-The other components are ethanol (alcohol), propylene glycol, and water for injection preparations.

Appearance of Paricalcitol SUN and packaging contents

Paricalcitol SUN injectable solution EFG is a transparent, colorless, and particle-free aqueous solution.

Paricalcitol SUN 2micrograms/ml is packaged in boxes with 5glass vials of 1ml of injectable solution.

Paricalcitol SUN 5micrograms/ml is packaged in boxes with 5glass vials of 1ml or 2ml of injectable solution.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Phone:+34 93 342 78 90

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:ParicalcitolSUN 2Micrograms/ml Injectable Solution

Paricalcitol SUN 5 Micrograms/ml Injectable Solution

Italy:Paracalcitolo SUN2micrograms/ml injectable solution

Paracalcitolo SUN 5 micrograms/ml injectable solution

Spain:Paricalcitol SUN 2micrograms/ml injectable solutionEFG

Paricalcitol SUN 5 micrograms/ml injectable solution EFG

Last review date of this leaflet: February 2019

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

This information is intended solely for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

See the Summary of Product Characteristics for more information

How to prepare and administer Paricalcitol SUN

Preparation of the injectable solution

Paricalcitol SUN is for single use. Like other parenteral medications, the solution should be visually inspected for particles and discoloration before administration.

Incompatibilities

Propylene glycol interacts with heparin and neutralizes its effects. Paricalcitol SUN contains propylene glycol as an excipient and should be administered through a different injection port from heparin.

This medication should not be mixed with other medications.

Storage

Parenteral medications should be visually inspected for particles and discoloration before administration.The solution is transparent and colorless.

Store in the original packaging. This medication does not require special storage conditions.

Dosage and administration

Paricalcitol SUN is administered through the hemodialysis access.

Adults

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

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

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

8

Ó

=baseline PTH intact level in pg/ml

80

and administered intravenously (IV) as a bolus, with a maximum frequency of every other day, at any time during dialysis.

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

2) Dose adjustment:

The accepted levels currently for the range of PTH in patients with end-stage renal disease undergoing dialysis are not more than 1.5 to 3 times the upper normal non-uremic limit, 15.9 to 31.8 pmol/l (150-300 pg/ml), for PTH intact.To achieve the desired levels of physiological variables, individualized dose adjustment and monitoring are necessary. If hypercalcemia or a corrected Ca x P product, elevated persistently, greater than 5.2 mmol2/l2(65 mg2/dl2), is observed, the dose should be reduced or discontinued until these parameters normalize. Then, the administration of paricalcitol should be restarted at lower doses. It may be necessary to reduce the dose when PTH levels decrease in response to therapy.

The following table is suggested as an approximation for dose adjustment: