Label: information for the user

Paricalcitol Accordpharma 5 micrograms/mL injectable solutionEFG

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

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

Paricalcitol Accordpharma is a synthetic analog of activated vitamin D, which is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In people with normal renal function, this active form of vitamin D is naturally produced by the kidneys, but in renal insufficiency, the production of active vitamin D is significantly reduced. Therefore, paricalcitol 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, specifically with high levels of parathyroid hormone that can cause bone problems. Paricalcitol is indicated in adult patients with stage 5 chronic kidney disease.

Do not use Paricalcitol Accordpharma:

• 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 may tell you if these conditions apply to you.

Warnings and precautions

Consult your doctor or nurse before starting to use Paricalcitol Accordpharma.

• 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 phosphate-binding agents that prevent the absorption of phosphorus from the diet.
• If you are taking phosphate-binding 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 Accordpharma with other medications

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

Some medications may affect the action of paricalcitol or increase the risk 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 thrush (for example, ketoconazole).
• To treat heart problems or high blood pressure (for example, digoxin and diuretics).
• That contain a source of phosphate (for example, medications that lower calcium levels in the blood)
• That contain calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription
• That contain magnesium or aluminum (for example, some types of antacids and phosphate-binding agents).

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

Use of Paricalcitol Accordpharma with food and drinks

Paricalcitol can be administered with or without food.

Pregnancy and lactation

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

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

It is not known if paricalcitol passes into human breast milk. Inform your doctor before breastfeeding while using Paricalcitol Accordpharma.

Driving and operating 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.

Important information about some of the components of Paricalcitol Accordpharma

This medication contains 157.8 mg of alcohol (ethanol) in each ml (which is equivalent to 20% in V/V).

At maximum dose of 40 mg:

• Paricalcitol Accordpharma 5 mg/ml. The amount of alcohol in this medication is equivalent to less than 32 ml of beer or 13 ml of wine.
• Paricalcitol Accordpharma 2 mg/ml: The amount of alcohol in this medication is equivalent to less than 79 ml of beer or 32 ml of wine.

It is unlikely that the amount of alcohol contained in this medication will have any noticeable effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

The amount of alcohol contained in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before being administered this medication. This medication is harmful to people with alcoholism.

If you have an addiction to alcohol, consult your doctor or pharmacist before being administered this medication.

Your doctor will use the results of laboratory tests to determine the initial appropriate dose for you. Once you have started treatment with paricalcitol, 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 this medication for you.

Paricalcitol 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 this medication can be introduced directly into the tube that is being used for your treatment. You will not be receiving paricalcitol more frequently than every other day and no more than 3 times a week.

Ifyou use more Paricalcitol Accordpharma than you should

A high dose of paricalcitol can produce abnormally high levels of calcium in the blood, which can be harmful.The symptoms that may appear shortly after taking too much paricalcitol may include:

• Weakness and/or drowsiness
• Headache
• Nausea (feeling sick) or vomiting (being sick)
• Dry mouth, constipation
• Constipation
• Muscle and bone pain
• Metalllic taste in the mouth

If you experience high levels of calcium in the blood after using paricalcitol, your doctor will prescribe the appropriate 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 this medication.

Your doctor will monitor your blood levels. If you experience any of the symptoms mentioned above, seek medical advice immediately.

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

• Loss of appetite
• Drowsiness
• Weight loss
• Dryness in the eyes
• Runny nose
• Itching skin
• Feeling hot and fever
• Loss of sexual appetite
• Severe abdominal pain (due to pancreatitis inflammation)
• Kidney stones
• Your blood pressure may be affected and irregular heartbeats (palpitations) may occur.
• The results of blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels.
• Rarely, paricalcitol may cause mental changes such as confusion, drowsiness, insomnia, or nervousness.

If you experience high levels of calcium in the blood after using paricalcitol, your doctor will prescribe the appropriate 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 this medication.

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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

Frequent (may affect up to 1 in 10 people) are:

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

Rare(may affect up to 1 in 100 people) are:

• Blood infection, decreased red blood cell count (anemia – feeling weak, difficulty breathing, paleness); decreased white blood cell count (increased susceptibility to infections), lymph node inflammation in the neck, armpits, and/or groin; prolonged bleeding time (blood will not clot quickly);
• Myocardial infarction, chest pain, irregular or rapid heartbeat, low blood pressure, high blood pressure;
• Coma (deep state of unconsciousness during which a person cannot interact with the environment); stroke, fainting;
• Unusual fatigue or weakness, a general feeling of discomfort, dizziness, syncope;
• Pain at the injection site;
• Pneumonia (lung infection), fluid in the lungs, asthma, wheezing, cough, difficulty breathing, nasal bleeding;
• Throat pain, flu, fever, pink eye (itching and crusts on eyelids), increased eye pressure, ear pain;
• Confusion, which in some cases is severe (delirium), agitation (feeling nervous, anxious), sleep problems, nervousness, personality disorders (not feeling like oneself);
• Tickling or numbness, decreased tactile sensation, muscle spasms in arms and legs, even during sleep;
• Dry mouth, thirst, nausea, difficulty swallowing, vomiting, loss of appetite, weight loss, diarrhea, and stomach pain, constipation, colon inflammation, rectal bleeding;
• Difficulty achieving an erection, breast pain, breast cancer, vaginal infection;
• Back pain, joint pain, general or localized inflammation in ankles, feet, and legs (edema); abnormal gait;
• Rash on the skin with blisters and itching, hair loss; excessive hair growth; excessive and unpredictable sweating;

• Increased liver enzymes; high levels of parathyroid hormones, high levels of potassium in the blood, low levels of calcium in the blood, changes in laboratory test results.

Unknown frequency(cannot be estimated from available data):

• Swelling of face, lips, mouth, tongue, and throat that may cause difficulty swallowing or breathing; skin itching (urticaria), stomach bleeding.

If you notice these symptoms, seek medical help immediately.

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor, nurse, or pharmacist immediately.

Reporting side effects

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

Keepthis medicationout of the sight and reach of children.

Store the ampoules in the outer packaging to protect from light.

Paricalcitol Accordpharma must be used immediately after opening.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe particles or discoloration.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacisthow to dispose ofthepackaging and themedicines that you no longerneed.This will help to protect the environment.

Composition of Paricalcitol Accordpharma

• The active ingredient is paricalcitol. Each ml of solution contains 5 micrograms of paricalcitol.
• The other components are ethanol, macrogol-15 hydroxystearate, and water forpreparationsinjectables.

Aspect of the product and content of the packaging

Paricalcitol Accordpharma 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

Holder of the marketing authorization

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n, Edifici Est, 6th floor.

08039, Barcelona (Spain)

Responsible for manufacturing

Pharmaten, S.A

Dervenakion 6

15351 Pallini Attiki

GREECE

Last review date of thisleaflet:June 2023

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

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This information is intended solely for healthcare professionals:

Instructions for the healthcare professional

Paricalcitol Accordpharma 5 micrograms/ml injectable solution

Preparation for injectable solution

Paricalcitol Accordpharma 5 micrograms/ml injectable solution is for single use. As with other parenteral medications, observe the solution for visible particles and color before administration.

Compatibility

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.

Store the ampoules in the outer packaging to protect from light.

Thismedicine has an expiration date of 2 years.

Dosage and administration

Paricalcitol Accordpharma injectable solution is administered through the dialysis access.

Adults

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

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

or