Paricalcitol Altan 5 micrograms/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paricalcitol Altan 5 micrograms/ml solution for injection EFG

Paricalcitol Altan 2 micrograms/ml solution for injection EFG

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.

If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Paricalcitol Altan contains the active substance 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 kidney function, this active form of vitamin D is naturally produced by the kidneys; however, in renal failure, the production of active vitamin D is markedly reduced. Therefore, Paricalcitol provides a source of active vitamin D when the body cannot produce enough, helping to prevent the consequences of low levels of active vitamin D in patients with chronic kidney disease, specifically those with elevated levels of parathyroid hormone that may cause bone problems. Paricalcitol is indicated in adult patients with Stage 5 chronic kidney disease.

2. What you need to know before using Paricalcitol Altan

Do not use Paricalcitol Altan:

• 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 can determine whether any of these conditions apply to you.

Warnings and precautions

• Consult your doctor or nurse before starting Paricalcitol Altan. Before starting treatment, it is important that you limit the amount of phosphorus ingested 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 your dose.
• Your doctor will need to perform blood tests to monitor your treatment.

Use of Paricalcitol Altan with other medicines

Inform 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 may increase the likelihood of adverse effects. It is particularly important that you inform your doctor if you are taking any of the following medicines:

• Medicines to treat fungal infections such as candidiasis or thrush (e.g., ketoconazole).
• Medicines to treat heart conditions or high blood pressure (e.g., digoxin and diuretics).
• Medicines containing a source of phosphate (e.g., medicines that reduce calcium levels in the blood).
• Medicines containing magnesium or aluminum (e.g., certain types of antacids for dyspepsia and phosphate binders).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is unknown whether this medicine is safe for pregnant women; therefore, its use is not recommended during pregnancy or if you may become pregnant.

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

Driving and using machines

Paricalcitol may cause dizziness, which could affect your ability to drive safely or operate heavy machinery.

Do not drive or operate machinery if you feel dizzy.

Paricalcitol Altan contains ethanol and propylene glycol.

Ethanol

This medicine contains 87 mg of ethanol (alcohol) per ml, equivalent to 1.74 g of EtOH per 40 microgram dose for a 70 kg adult (= 25 mg EtOH/kg). The amount in 20 ml of this medicine is equivalent to approximately 44 ml of beer or 18 ml of wine.

The amount of alcohol in this medicine is unlikely to have effects in adults and adolescents, and its effects are unlikely to be noticeable in children. However, it may have some effects in younger children, for example, drowsiness.

The alcohol in this medicine may alter the effects of other medicines. Speak with your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before being administered this medicine.

If you are alcohol-dependent, consult your doctor or pharmacist before being administered this medicine.

Propylene glycol

This medicine contains 0.4 mg of propylene glycol per ml, equivalent to (39% v/v).

If your child is under 5 years of age, consult your doctor or pharmacist before administering this medicine, especially if they are taking other medicines containing propylene glycol or alcohol.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional monitoring while you are taking this medicine.

If you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional monitoring while you are taking this medicine.

3. How to use Paricalcitol Altan

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

Paricalcitol will be administered by your 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 paricalcitol can be directly introduced into the tube being used for your treatment. You will not receive paricalcitol more frequently than on alternate days and no more than 3 times per week.

If you use more Paricalcitol Altan than you should

An overdose of paricalcitol may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur shortly after taking too much paricalcitol may include a feeling of weakness and/or drowsiness, headache, nausea (feeling sick), or vomiting (being sick), dry mouth, constipation, muscle or bone pain, and a 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 paricalcitol.

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

Symptoms that may develop over a prolonged period of excessive paricalcitol intake include loss of appetite, drowsiness, weight loss, eye pain, nasal discharge, skin itching, sensation of heat and fever, loss of sexual desire, and severe abdominal pain (due to inflammation of the pancreas), and kidney stones. Blood pressure may be affected, and irregularities in heartbeats (palpitations) may occur. Blood and urine tests may show high levels of cholesterol, urea, nitrogen, and elevated liver enzymes. Rarely, paricalcitol may cause mental disturbances such as confusion, drowsiness, insomnia, or nervousness.

Paricalcitol Altan contains 39% by volume of propylene glycol as an ingredient. Toxic effects related to high doses of propylene glycol have been reported only rarely and would not be expected in renal patients undergoing treatment with a kidney machine, since propylene glycol is removed from the blood during dialysis.

If you receive too much paricalcitol or experience any of the above symptoms, contact your doctor immediately.

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. Important: if you notice any of the following adverse effects, inform your doctor or nurse immediately:

• shortness of breath
• difficulty breathing or 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:

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

• low levels of parathyroid hormone
• high levels of calcium in the blood (feeling sick or being sick, constipation, or confusion); phosphorus in the blood (likely asymptomatic but may make bones susceptible to fracture)
• headache
• metallic or unusual taste in the mouth
• skin itching

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

• blood infection, pneumonia (lung infection), sore throat, vaginal infections, flu
• breast cancer
• decreased number of red blood cells (anemia – feeling weak, shortness of breath, paleness)
• decreased number of white blood cells (increased susceptibility to infections), swelling of lymph nodes in the neck, armpit, 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, sometimes severe (delirium), personality disorders (not feeling like oneself), agitation (feeling restless, anxious), trouble sleeping, nervousness
• coma (a deep state of unconsciousness during which a person cannot interact with their surroundings), stroke, fainting, muscle spasms in arms and legs, even during sleep, decreased sense of touch, tingling or numbness, dizziness
• increased pressure in the eye, red conjunctiva (itching/sticky eyelids)
• ear pain
• heart attack, irregular or rapid heartbeat
• low blood pressure, high blood pressure
• fluid in the lungs, asthma, wheezing, difficulty breathing, nosebleeds, cough
• rectal bleeding, inflammation of the colon, diarrhea, stomach pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth
• skin rash with itchy blisters, 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 walking pattern, general swelling or localized swelling of ankles, feet, and legs, pain at injection site, fever, chest pain, unusual tiredness or weakness, general feeling of being unwell, thirst
• prolonged bleeding time (blood does not clot as quickly), increased liver enzyme, changes in laboratory test results, weight loss

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

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

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 effects not listed in this leaflet, inform your doctor, nurse, or pharmacist immediately.

5. Storage of Paricalcitol Altan

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Paricalcitol Altan should be a clear, colourless solution. Do not use if the solution is discoloured or contains particles.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Paricalcitol Altan

• The active substance is paricalcitol.

Each ml of solution contains 5 micrograms of paricalcitol

Each ml of solution contains 2 micrograms of paricalcitol

• The other components are: ethanol (alcohol), propylene glycol, and water for injections.

Nature of the product and contents of the container

Paricalcitol Altan is a clear, colourless aqueous solution, free from visible particles.

Paricalcitol Altan 5 micrograms/ml injectable solution

Available in:

1 ml vials containing 5 micrograms/ml

2 ml vials containing a total of 10 micrograms

or

1 ml ampoules containing 5 micrograms/ml

2 ml ampoules containing a total of 10 micrograms

Paricalcitol Altan 2 micrograms/ml injectable solution

Available in 1 ml ampoules containing 2 micrograms/ml

or

Available in 1 ml vial containing 2 micrograms/ml

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma, Las Rozas,

28230 Madrid

Spain

Manufacturer

RAFARM S.A.

Tesis Pousi-Hatzi, Agiou Louka

Peania, Attiki, 19002, P.O.BOX 37

This medicinal product is authorized in EU member states under the following names:

PT/H/451/01-02/DC

• Portugal REXTOL
• Czech REXTOL
• Spain Paricalcitol Altan
• Greece REXTOL

Date of the most recent review of this leaflet: August 2025

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

This information is intended for healthcare professionals only:

Paricalcitol Altan 5 micrograms/ml injectable solution EFG

Paricalcitol Altan 2 micrograms/ml injectable solution EFG

Concentrate for injectable solution

Paricalcitol Altan 2 and 5 micrograms/ml injectable solution is for single use. As with other parenteral medicines, the solution should be inspected visually for particulate matter and discoloration prior to administration.

Compatibility

Propylene glycol interacts with heparin and neutralizes its effects. Paricalcitol Altan injectable solution contains propylene glycol as an excipient and must be administered through a different administration site than heparin.

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

Storage and expiry

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

This medicinal product does not require any special storage conditions.

The shelf life of this medicinal product is 2 years.

Dosage and administration

Paricalcitol Altan 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:

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