Paricalcitol AccordPharma 2 micrograms/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paricalcitol Accordpharma 2 micrograms/ml injection solution EFG

Read the entire 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, ask your doctor or pharmacist.
• 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before using Paricalcitol Accordpharma

3. How to use Paricalcitol Accordpharma

4. Possible side effects

5. How to store Paricalcitol Accordpharma

6. Contents of the pack and other information

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

Paricalcitol Accordpharma is a synthetic analogue of activated vitamin D, which is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In individuals with normal kidney function, this active form of vitamin D is naturally produced by the kidneys; however, in renal insufficiency, the production of active vitamin D is markedly reduced. Therefore, paricalcitol provides a source of active vitamin D when the body cannot produce sufficient amounts, and helps prevent the consequences of low levels of active vitamin D in patients with chronic kidney disease, specifically high levels of parathyroid hormone that may cause bone problems. Paricalcitol is indicated in adult patients with chronic kidney disease stage 5.

2. What you need to know before using Paricalcitol Accordpharma

Do not use Paricalcitol Accordpharma:

• 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 monitor your blood levels and can determine whether these conditions apply to you.

Warnings and precautions

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

• 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 calf liver, beans, peas, cereals, nuts, and whole grain foods.
• To control phosphorus levels, it may be necessary to use phosphate-binding agents that 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.

Using Paricalcitol Accordpharmawith other medicines

Tell your doctor, nurse, 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 or increase the likelihood of side effects. It is especially 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 problems or high blood pressure (e.g., digoxin and diuretics).
• That contain a source of phosphate (e.g., medicines that reduce calcium levels in the blood).
• That contain calcium or vitamin D, including supplements and multivitamins available without a prescription.
• That contain magnesium or aluminium (e.g., certain types of medicines for indigestion (antacids) and phosphate binders).

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

Using Paricalcitol Accordpharmawith food and drinks

Paricalcitol 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.

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

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

Driving and using machines

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.

Important information about some of the ingredients of Paricalcitol Accordpharma

This medicine contains 157.8 mg of alcohol (ethanol) per ml (equivalent to 20% v/v).

At the maximum dose of 40 mg:

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

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. However, it could have some effects in young children, such as drowsiness.

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

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

If you are addicted to alcohol, consult your doctor or pharmacist before this medicine is administered to you.

3. How to use Paricalcitol Accordpharma

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

Paricalcitol will be administered by a doctor 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 this medicine can be introduced directly into the tube being used for your treatment. You will not receive paricalcitol more frequently than every other day and no more than 3 times per week.

If you use more Paricalcitol Accordpharma than you should

An excessive dose of paricalcitol may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may appear shortly after taking too much paricalcitol include:

• Feeling weak and/or drowsy
• Headache
• Nausea (feeling sick) or vomiting (being sick)
• Dry mouth, constipation
• Constipation
• Muscle and bone pain
• Metallic taste in the mouth

If you develop high levels of calcium in the blood after using paricalcitol, 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 this medicine.

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

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

• Loss of appetite
• Drowsiness
• Weight loss
• Dry eyes
• Runny nose
• Itchy skin
• Feeling hot and feverish
• Loss of sexual appetite
• Severe abdominal pain (due to inflammation of the pancreas)
• Kidney stones
• Your blood pressure may be affected and you may experience irregular heartbeats (palpitations).
• 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 develop high levels of calcium in the blood after using paricalcitol, 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 this medicine.

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 medicine and the amount ingested.

4. Possible adverse effects

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

Several allergic reactions have been reported with Paricalcitol Accordpharma. 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:

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

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

Uncommon (may affect up to 1 in 100 people):

• Blood infection, decreased number of red blood cells (anemia – feeling of weakness, 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, chest pain, irregular or rapid heartbeat, low blood pressure, high blood pressure
• Coma (deep state of unconsciousness during which a person cannot interact with their surroundings); stroke, fainting
• Unusual tiredness or weakness, general feeling of discomfort, dizziness, syncope
• Pain at the injection site
• Pneumonia (lung infection), fluid in the lungs, asthma, wheezing, cough, difficulty breathing, nosebleeds
• Sore throat, flu, fever, pink eye (itching and crusting of eyelids), increased eye pressure, ear pain
• Confusion, sometimes severe (delirium), agitation (feeling restless, anxious), trouble sleeping, nervousness, personality changes (feeling unlike oneself)
• Tingling or numbness, decreased sense of touch, muscle spasms in arms and legs, even during sleep
• Dry mouth, thirst, nausea, difficulty swallowing, vomiting, loss of appetite, weight loss, diarrhea, stomach pain, constipation, inflammation of the colon, rectal bleeding
• Difficulty achieving an erection, breast pain, breast cancer, vaginal infection
• Back pain, joint pain, general swelling or localized swelling in ankles, feet, and legs (edema); abnormal walking pattern
• Skin rash with itchy blisters, hair loss; excessive hair growth; excessive and unpredictable sweating
• Increased liver enzymes; elevated parathyroid hormone levels; high blood potassium levels; low blood calcium levels; changes in laboratory test results

Frequency not known (cannot be estimated from available data):

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

If you experience these symptoms, seek medical help immediately.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor, nurse, or pharmacist immediately.

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paricalcitol Accordpharma

Keep this medicine out of 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 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 you notice particles or discoloration.

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

6. Contents of the pack and other information

Composition of Paricalcitol Accordpharma

• The active substance is paricalcitol. Each ml of solution contains 2 micrograms of paricalcitol.
• The other components are ethanol, macrogol-15 hydroxystearate and water for injections.

Nature of the product and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare S.L.U.

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

08039, Barcelona (Spain)

Manufacturer

Pharmaten, S.A

Dervenakion 6

15351 Pallini Attiki

GREECE

Date of the most recent review of this leaflet: June 2023

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/

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This information is intended for healthcare professionals only:

Instructions for the healthcare professional

Paricalcitol Accordpharma 2 micrograms/ml injectable solution

Preparation for injectable solution

Paricalcitol Accordpharma 2 micrograms/ml injectable solution is for single use only. As with other parenteral medicines, the solution should be inspected visually for particulate matter and discoloration prior to administration.

Compatibility

This medicine must not be mixed with other medicinal products.

Storage and expiry

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

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

The shelf life of this medicine is 2 years.

Dosage and method of administration

Paricalcitol Accordpharma 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:

o