PARICALCITOL ACCORDPHARMA 5 micrograms/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Paricalcitol Accordpharma 5 micrograms/ml solution for injectionEFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Paricalcitol Accordpharma and what is it used for
2. What you need to know before you use Paricalcitol Accordpharma
3. How to use Paricalcitol Accordpharma
4. Possible side effects
5. Storing Paricalcitol Accordpharma
6. Contents of the pack and other information

1. What is Paricalcitol Accordpharma and what is it 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 people with normal kidney function, this active form of vitamin D is produced naturally by the kidneys, but in renal failure, 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 chronic kidney disease stage 5.

2. What you need to know before you use Paricalcitol Accordpharma

Do not use Paricalcitol Accordpharma:

• If you are allergic to paricalcitol or any of the other ingredients of this medicine (listed in section 6).
• If you have very high levels of calcium or vitamin D in the blood.

Your doctor will monitor your blood levels and will be able to tell you if these conditions apply to you.

Warnings and precautions

Talk to your doctor or nurse before you start using Paricalcitol Accordpharma.

• Before starting treatment, it is important that you 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, chicken or beef liver, beans, peas, cereals, nuts, and whole foods.
• To control phosphorus levels, it may be necessary to use phosphorus-binding agents that prevent the absorption of phosphorus from the diet.
• If you are taking phosphorus-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.

Using Paricalcitol Accordpharma with other medicines

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

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

• For treating fungal infections such as 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 decrease 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 (e.g., some types of medicines for indigestion (antacids) and phosphorus binders).

Talk to your doctor, nurse, or pharmacist before taking any medicine.

Using Paricalcitol Accordpharma with food and drinks

Paricalcitol can be administered with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is not known if this medicine is safe for pregnant or breast-feeding women. Therefore, it should only be used after consulting with your doctor, who will help you make the best decision for you.

It is not known if paricalcitol passes into human breast milk. Tell your doctor before breast-feeding while using Paricalcitol Accordpharma.

Driving and using machines

During treatment with paricalcitol, your ability to drive safely or use heavy machinery may be affected.

Paricalcitol may make you feel dizzy, weak, and/or sleepy.

Do not drive or use machines if you have these symptoms.

Important information about some of the ingredients of Paricalcitol Accordpharma

This medicine contains 157.8 mg of alcohol (ethanol) in each ml (which is 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 on adults or adolescents. It may have some effects on small children, such as drowsiness.

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

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before you are given this medicine. This medicine is harmful to people with alcoholism.

If you have alcohol dependence, talk to your doctor or pharmacist before you are given this medicine.

3. How to use Paricalcitol Accordpharma

Your doctor will use the results of laboratory tests to decide the initial dose suitable 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 dose of this medicine suitable for you.

Paricalcitol will be administered by your 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 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 a week.

If you use more Paricalcitol Accordpharma than you should

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

• Feeling of weakness and/or sleepiness
• Headache
• Nausea (feeling sick) or vomiting (being sick)
• Dry mouth, constipation
• Constipation
• Pain in muscles and bones
• Metallic 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 to normal calcium levels. Once your calcium levels return to normal, it is likely that you will be given low doses of this medicine.

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:

• Lack of appetite
• Sleepiness
• Weight loss
• Dry eyes
• Runny nose
• Itching of the skin
• Feeling of heat and fever
• Lack of sexual appetite
• Severe abdominal pain (due to pancreatitis)
• Kidney stones
• Your blood pressure may be affected, and irregular heartbeats (palpitations) may occur.
• Blood and urine test results may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels.
• Rarely, paricalcitol may cause mental changes such as confusion, sleepiness, 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 to normal calcium levels. Once your calcium levels return to normal, it is likely that you will be given low doses of this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Shortness of breath
• Difficulty breathing and swallowing
• Wheezing
• Rash, itching of the skin, or hives
• Swelling of the face, lips, mouth, tongue, or throat.

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

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

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

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

• Blood infection, decrease in red blood cell count (anemia - feeling of weakness, difficulty breathing, paleness); decrease in white blood cell count (increased susceptibility to infections), inflammation of neck, armpit, and/or groin lymph nodes; increase in bleeding time (blood will not clot quickly);
• Heart attack, chest pain, irregular/fast heartbeat, low blood pressure, high blood pressure;
• Coma (deep state of unconsciousness during which a person cannot interact with the environment); stroke, fainting,
• Unusual tiredness or weakness, general feeling of illness, dizziness, fainting;
• Pain at the injection site;
• Pneumonia (lung infection), fluid in the lungs, asthma, wheezing, cough, difficulty breathing, nosebleeds;
• Sore throat, flu, fever, conjunctivitis (itching and crusts on eyelids), increased pressure in the eye, ear pain;
• Confusion, which can be severe (delirium), agitation (feeling of nervousness, anxiety), sleep disorders, nervousness, personality disorders (not feeling like oneself);
• Numbness or tingling, 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, and stomach pain, constipation, colon inflammation, rectal bleeding;
• Difficulty having an erection, breast pain, breast cancer, vaginal infection;
• Back pain, joint pain, general or localized swelling in ankles, feet, and legs (edema); abnormal gait;
• Skin rash with blisters and itching, hair loss; excessive hair growth; excessive and unpredictable sweating;

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

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

• Swelling of the face, lips, mouth, tongue, and throat that can cause difficulty swallowing or breathing; itching of the skin (hives), 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 think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor, nurse, or pharmacist immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Paricalcitol Accordpharma

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

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

Paricalcitol Accordpharma should be used immediately after opening.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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 no longer required. This will help protect the environment.

6. Container contents and additional information

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 for injectable preparations.

Appearance of the product and container contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n, Edifici Est, 6ª planta.

08039, Barcelona (Spain)

Manufacturer

Pharmaten, S.A

Dervenakion 6

15351 Pallini Attiki

GRECIA

Date of the last revision of thisleaflet:June 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Instructions for the healthcare professional

Paricalcitol Accordpharma 5 micrograms/ml solution for injection

Preparation for solution for injection

Paricalcitol Accordpharma 5 micrograms/ml solution for injection is for single use. As with other parenteral medicines, the solution should be inspected for particles and discoloration before administration.

Compatibility

This medicinal product must not be mixed with other medicinal products.

Storage and shelf-life

Parenteral products should be inspected for visible particles and discoloration before administration. The solution is clear and colorless.

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

This medicinal product has a shelf-life of 2 years.

Posology and method of administration

Paricalcitol Accordpharma solution for injection is administered through the hemodialysis access.

Adults

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

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

or