Prospect: Information for the User

Paricalcitol Accord 2 micrograms/ml injectable solution EFG

Paricalcitol Accord 5 micrograms/ml injectable solution EFG

Paricalcitol

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

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

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

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

3. How to use Paricalcitol Accord

4. Possible adverse effects.

5. Storage of Paricalcitol Accord.

6. Contents of the package and additional information.

Paricalcitol Accord 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 naturally produced by the kidneys, but in renal insufficiency, the production of active vitamin D is significantly reduced. Therefore,Paricalcitolprovides 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.Paricalcitolis indicated in adult patients with stage 5 chronic kidney disease.

No use Paricalcitol Accord:

• If you are allergic to the active ingredient 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 may tell you if these conditions apply to you.

Warnings and precautions

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

• 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 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.

Use of Paricalcitol Accord with other medications

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

Some medications may affect the action of this medication or increase the likelihood 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 (e.g., Ketoconazol)
• To treat heart problems or high blood pressure (e.g., digoxin and diuretics)
• That contain a source of phosphate (e.g., 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 (e.g., some types of antacids and phosphorus-binding agents)

Pregnancy and breastfeeding

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

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

The passage of Paricalcitol Accord into breast milk is unknown. Contact your doctor before breastfeeding while using Paricalcitol Accord.

Driving and operating machinery

Paricalcitol Accord may make you feel dizzy, which can affect your ability to drive safely or operate heavy machinery.

Do not drive or operate machinery if you feel dizzy.

Paricalcitol Accord contains anhydrous ethanol

5 mcg/mL:

This medication contains up to 2.21 g of anhydrous ethanol (alcohol) per dose, equivalent to approximately 32 mg/kg. The amount in each dose of this medication is equivalent to about 55 ml of beer or 22 ml of wine.

It is unlikely that the amount of alcohol in this medication will have an effect on adults and adolescents, and it is likely that its effects on children will not be noticeable. It may have some effects on younger children, for example, drowsiness.

The alcohol in this medication may alter the effects of other medications. Talk to your doctor or pharmacist if you are taking other medications.

2 mcg/mL:

This medication contains up to 5.52 g of anhydrous ethanol (alcohol) per dose, equivalent to approximately 79 mg/kg. The amount in each dose of this medication is equivalent to about 138 ml of beer or 55 ml of wine.

It is likely that the alcohol in this preparation will affect children. These effects may include drowsiness and changes in behavior. It may also affect your ability to concentrate and participate in physical activities.

The amount of alcohol in this medication may affect your ability to drive or operate machinery. This is because it may affect your judgment and reaction time.

The amount of alcohol in this medication may alter the effects of other medications. Talk to your doctor or pharmacist if you are taking other medications.

This medication is 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.

Your doctor will use the results of laboratory tests to determine the initial appropriate dose for you.

Once you have started treatment with Paricalcitol Accord, 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 Paricalcitol Accord for you.

Paricalcitol Accord 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 Paricalcitol Accord can be introduced directly into the tube that is being used for your treatment.

You will not be receiving Paricalcitol Accord more frequently thanevery other dayand no more than 3 times a week.

If you take more Paricalcitol Accord than you should

Too much Paricalcitol Accord can cause high levels of calcium in the blood. The symptoms that may appear after receiving an overdose of Paricalcitol Accord are:

• Weakness and/or drowsiness
• Headache
• Nausea or vomiting (feeling unwell)
• Dry mouth, constipation
• Muscle or 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 Paricalcitol.

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 Accord are:

• Loss of appetite
• Drowsiness
• Weight loss
• Irritation in the eyes
• Nasal discharge
• Itching skin
• Febrile sensation
• Loss of sexual appetite
• Severe abdominal pain (due to pancreatitis inflammation)
• Kidney stones
• Your blood pressure may be affected and you may experience awareness of your own heartbeats (palpitations).

Your blood pressure may be affected and palpitations may occur. Blood and urine test results may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels. Rarely, Zemplar may cause mental changes such as confusion, drowsiness, insomnia, or nervousness.

Paricalcitol Accord contains 30% by volume of propylene glycol as an excipient. Isolated cases of toxic effects related to the administration of high doses of propylene glycol have been described, although they are not expected when administered to patients undergoing dialysis treatment because propylene glycol is eliminated from the blood during dialysis.

If you use too much Paricalcitol Accord or experience any of the above, seek medical advice immediately.

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 can cause side effects, although not everyone will experience them.

Several allergic reactions have been reported with Paricalcitol Accord. 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):

• Headache;
• Strange 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):

• Blood infection, pneumonia (lung infection), sore throat, vaginal infections, flu
• breast cancer
• 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
• High levels of parathyroid hormone
• High levels of potassium in the blood, low levels of calcium in the blood, loss of appetite
• Confusion, which in some cases is severe (delirium), personality disorders (not feeling like oneself), agitation (feeling nervous, anxious), sleep problems, nervousness
• Coma (deep state of unconsciousness during which a person cannot interact with their environment), stroke, fainting, muscle spasms in arms and legs, even during sleep, decreased tactile sensation, tingling or numbness, dizziness
• Increased eye pressure, red conjunctiva (itchy/bleary eyes)
• Ear pain
• Myocardial infarction, irregular or rapid heart rhythm
• Low blood pressure, high blood pressure
• Pulmonary edema, asthma, wheezing, difficulty breathing, nasal bleeding, cough
• Rectal bleeding, colon inflammation, diarrhea, stomach pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth
• Rash with blisters and itching, hair loss, excessive hair growth, excessive and unpredictable sweating
• Joint pain, joint stiffness, back pain, muscle spasms, muscle pain
• Breast pain, difficulty achieving an erection
• Abnormal gait, general or localized swelling of ankles, feet, and legs, pain at the injection site, fever, chest pain, unusual fatigue or weakness, general feeling of discomfort, thirst
• Prolonged bleeding time (blood does not clot as quickly), increased liver enzyme, change in laboratory test results, weight loss

Frequency unknown (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.

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 effects not mentioned in this prospectus, inform your doctor, nurse, or pharmacist immediately.

Reporting side effects

If you experience side effects, consult your doctor, hospital pharmacist, or nurse, even if they are possible side effects not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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.

No special temperature conditions for conservation are required. Keep the ampule/vial in the outer packaging to protect it from light.

Paricalcitol Accord must be used immediately after opening.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe particles or discoloration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Paricalcitol Accord

• The active ingredient is paricalcitol. Each milliliter of solution contains 2 micrograms or 5 micrograms of paricalcitol.
• The other components (excipients) are: anhydrous ethanol (alcohol), propylene glycol, and water for injectable preparations.

Appearance of the product and contents of the package

Paricalcitol Accord is a clear, colorless, and particle-free aqueous solution.

It is presented in containers with 1 vial or 5 vials of 1 ml or 2 ml.

It is presented in containers with 5 ampoules of 1 ml or 2 ml.

Only some package sizes may be commercially available.

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, Schimatari, 32009

Greece

This medicinal product is authorized in the Member States of the EEA under the following names:

Last review date of this leaflet: June 2021

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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Instructions for healthcare professionals

Paricalcitol Accord 2 microgramos/ml solution for injection

Paricalcitol Accord 5 microgramos/ml solution for injection

Preparation for injectable solution

Paricalcitol Accord 2 microgramos/ml or 5 microgramos/ml solution for injection is for single use. As with other parenteral medications, observe the solution for the presence of particles and color before administration.

Compatibility

Propylene glycol interacts with heparin and neutralizes its effects. Paricalcitol Accord solution for injection contains propylene glycol as an excipient and should be administered through a different administration site from heparin.

This medication should not be mixed with other medications,since compatibility studies have not been performed.

Storage and shelf life

The solution should be visually inspected before administration for the presence of particles and discoloration.

This medication does not require special temperature conditions for storage.

Keep the ampoule/vial in the outer packaging to protect it from light.

This medication has a shelf life of 2 years.

Use immediately after opening

Dosage and administration

Paricalcitol Accord is administered by hemodialysis.

Dosage

Adults

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

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

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

8

or

=baseline PTH intact level in pg/ml

80

and administered as an intravenous bolus, with a maximum frequency of alternate days and at any time during dialysis.

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

2) Dose titration:

Accepted levels currently for the PTH range in patients with terminal renal failure undergoing dialysis are not more than 1.5 to 3 times the upper normal limit for non-uremic subjects, 15.9 to 31.8 pmol/l (150-300 pg/ml) for PTH intact. To achieve the desired levels of physiological variables, individualized dose titration is necessary. If hypercalcemia or a corrected Ca x P product, persistently elevated, 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.

A suggested table is provided as an approximation for dose titration: