Label: information for the user

Paricalcitol ALTAN5 micrograms/ml injectable solution EFG

Paricalcitol ALTAN2 micrograms/ml injectable solution EFG

Read this label carefully before starting to use the medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

1. Contents of the package and additional information.

The active ingredient ofParicalcitolALTANis paricalcitol. Paricalcitol is a synthetic (man-made) analog of vitamin D. In healthy individuals, the active form of vitamin D is naturally produced by the kidneys, but when the kidneys fail, active vitamin D production decreases, leading to low calcium levels and high parathyroid hormone levels in the blood. Paricalcitol is used to replace the active form of vitamin D produced naturally by the body.

Paricalcitol ALTANis used for the prevention and treatment of secondary hyperparathyroidism (high parathyroid hormone levels can cause bone problems) in patients undergoing hemodialysis due to renal failure.

If you have secondary hyperparathyroidism, you may notice that:

• You feel weak or tired.
• Your appetite decreases.
• You experience nausea or vomiting.
• You have bone or muscle pain.

• You need to urinate frequently.

Do not useParicalcitolALTAN:

• 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 can tell you if these conditions apply to you.

Be especially careful withParicalcitolALTAN

• 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 chelating agents that prevent the absorption of phosphorus from the diet.
• If you are taking phosphorus chelating 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 other medications

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

Some medications may affect the action of ParicalcitolALTANor increase the likelihood of adverse effects. It is particularly important to inform your doctor if you are using any of the following medications:

• Parallel to treat fungal infections such as candida or thrush (for example, Ketoconazol).
• To treat the heart or blood pressure (for example, digoxin and diuretics).
• That contain magnesium (for example, some types of medications for indigestion called antacids, such as magnesium trisilicate).
• That contain aluminum (for example, phosphorus chelating agents, such as aluminum hydroxide).

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

Use ofParicalcitolALTANwith food and drinks

ParicalcitolALTANcan be administered before, after, or during meals. It is very important to follow the diet recommended by your doctor to obtain the maximum benefits of treatment and to prevent side effects. Do not take other vitamins/supplements (such as calcium, vitamin D) unless your doctor tells you to.

Pregnancy and breastfeeding

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

There is not enough data on the use of paricalcitol in pregnant women. The potential risk of its use in humans is unknown, so paricalcitol should not be administered unless it is clearly necessary.

It is unknown whether paricalcitol passes into breast milk. Inform your doctor if you are breastfeeding. Your doctor will decide if this treatment is necessary for you.

Driving and operating machinery

Paricalcitol may make you feel dizzy or confused; your ability to drive or operate machinery may be affected. Do not drive or operate machinery until you know how this medication affects you.

Important information about some of the components ofParicalcitolALTAN

ParicalcitolALTANcontains 11% v/v of ethanol (alcohol), which corresponds to 1.3 g per dose, equivalent to 2 ml of beer, or 1 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

The dose to be administered is calculated by your doctor. The paricalcitol dose varies for each patient. Your doctor will use laboratory test results to decide on the appropriate dose for you.

Once you have started treatment withParicalcitolALTAN, the dose may need to be adjusted, depending on how you respond to treatment.

Administration form

ParicalcitolALTANwill be administered by your doctor intravenously (through a vein using a needle) while undergoing hemodialysis.

ParicalcitolALTANwill not be administered more than every other day.

Use ofParicalcitolALTANin children

There is no information on the use of paricalcitol in children under 5 years old, and experience is limited in children over 5 years old.

Your doctor will decide if this treatment is necessary.

If you take moreParicalcitolALTANthan you should

Too muchParicalcitolALTANmay cause high levels of calcium in the blood that may require treatment.

The symptoms that may appear quickly after receiving an overdose ofParicalcitolALTANinclude:

• Weakness and/or drowsiness.
• Headache.
• Feeling of nausea.
• Dry mouth, constipation.
• Muscle and bone pain.
• Unusual taste in the mouth.

The symptoms that may appear after a long period of receiving too muchParicalcitol ALTANinclude:

• Loss of appetite.
• Drowsiness.
• Weight loss.
• Irritation in the eyes.
• Nasal discharge.
• Itching skin.
• Feeling hot and fever.
• Loss of sexual desire.
• Severe abdominal pain.
• Kidney stones.
• Your blood pressure may be affected and you may be aware of your own heartbeats (palpitations).

Paricalcitol ALTANcontains propylene glycol as a component. 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 because propylene glycol is removed from the blood during dialysis.

However, your doctor will monitor your blood levels and if you experience any of the mentioned symptoms, 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 medications,ParicalcitolALTANmay cause side effects, although not everyone will experience them.

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

• Lack of breath.
• Difficulty breathing and swallowing.
• Wheezing.
• Hives, skin itching, or urticaria.
• Swelling of the 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 100 people):

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

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

• Allergic reactions (such as difficulty breathing, wheezing, hives, itching, or swelling of the face and lips); blistering with itching.
• Blood infection, decreased red blood cell count (anemia – feeling weak, difficulty breathing, paleness); decreased white blood cell count (increased susceptibility to infections), swelling of lymph nodes in the neck, armpits, and/or groin; prolonged bleeding time (blood will not clot quickly).
• Myocardial infarction, stroke, chest pain, irregular or rapid heartbeat, decreased blood pressure, increased blood pressure.
• Coma (deep state of unconsciousness during which a person cannot interact with their environment).
• Unusual fatigue, weakness, dizziness, syncope.
• Pain at the injection site.
• Pneumonia (lung infection), fluid in the lungs, asthma (wheezing, coughing, difficulty breathing).
• Throat irritation, cold, fever, feverish symptoms, pink eye (itching and crusts on eyelids), increased eye pressure, ear pain, nasal bleeding.
• Nervous tics; confusion, which in some cases can be severe (delirium), agitation (feeling nervous, anxious), nervousness, personality disorders (not feeling like oneself).
• Tingling or numbness, decreased sensation, sleep problems, nocturnal sweating, muscle spasms in arms and legs, even during sleep.
• Dry mouth, thirst, nausea, difficulty swallowing, vomiting, loss of appetite, weight loss, heartburn, diarrhea, and abdominal pain, constipation: rectal bleeding.
• Difficulty achieving an erection, breast cancer, vaginal infection.
• Chest pain, back pain, muscle/joint pain, feeling of heaviness caused by general or localized inflammation in ankles, feet, and legs (edema); abnormal gait.
• Hair loss; excessive hair growth.
• Increased liver enzymes; increased parathyroid hormone levels, increased potassium levels in the blood, decreased calcium levels in the blood.

Unknown frequency:

• Swelling of the face, lips, mouth, tongue, and throat that may cause difficulty swallowing or breathing; skin itching (urticaria), gastric hemorrhage. 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 effects not mentioned in this prospectus, inform your doctor.

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

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.

Paricalcitol ALTAN should be a clear and colorless solution. Do not use if the solution is discolored or contains particles.

This medication does not require special storage conditions.

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

Composition of Paricalcitol ALTAN

• The active principle is paricalcitol.

Paricalcitol ALTAN 5 micrograms/ml injectable solution

Each ml of solution contains 5 micrograms of paricalcitol. Each vial or ampoule of 1 ml contains 5 micrograms of paricalcitol. Each vial or ampoule of 2 ml contains 10 micrograms of paricalcitol.

Paricalcitol ALTAN 2 micrograms/ml injectable solution

Each ml of solution contains 2 micrograms of paricalcitol. Each vial or ampoule of 1 ml contains 2 micrograms of paricalcitol.

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

Appearance of the product and contents of the package

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

Paricalcitol ALTAN 5 micrograms/ml injectable solution

Available in:

Ampoules of 1ml containing 5 micrograms/ml

Ampoules of 2ml containing a total of 10 micrograms

or

Vials of 1ml containing 5 micrograms/ml

Vials of 2ml containing a total of 10 micrograms

Paricalcitol ALTAN 2 micrograms/ml injectable solution

Available in ampoules of 1ml containing 2 micrograms/ml

or

Available in vial of 1ml containing 2 micrograms/ml

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma, Las Rozas,

28230 Madrid

Spain

Manufacturer Responsible

RAFARM S.A.

Tesis Pousi-Hatzi, Agiou Louka

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

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

PT/H/451/01-02/DC

• Portugal REXTOL
• Czech REXTOL
• Denmark Paricalcitol Alternova
• Spain Paricalcitol ALTAN
• Finland Paricalcitol Alternova
• Greece REXTOL
• Slovakia REXTOL

This leaflet was approved in: February 2017

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es

This information is intended solely for healthcare professionals:

Paricalcitol ALTAN 5 micrograms/ml injectable solution EFG

Paricalcitol ALTAN 2 micrograms/ml injectable solution EFG

Preparation for injectable solution

Paricalcitol ALTAN 2 and 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

Propylene glycol interacts with heparin and neutralizes its effects. Paricalcitol ALTAN injectable solution 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.

Storage and Expiration

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

This medication does not require special storage conditions.

This medication has an expiration date of 2 years.

Dosage and Administration

Paricalcitol ALTAN injectable solution is administered through the hemodialysis access.

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 initial (micrograms) = basal level of PTH intact in pmol/l

8

Ó

= basal level of PTH intact in pg/ml

80

And administered as an intravenous (IV) 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.

1. Dose titration:

Accepted levels currently for the PTH range in patients with terminal renal failure undergoing dialysis is not more than 1.5 to 3 times the upper limit of normal non-uremic, 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 required.

If hypercalcemia or a corrected Ca x P product, elevated persistently, greater than 5.2 mmol2/l2 (65 mg 2 /dl 2 ) , reduce or discontinue the dose until these parameters normalize. Then, restart paricalcitol administration at lower doses. It may be necessary to reduce the dose when PTH levels decrease in response to therapy.

The following table is suggested as an approximation for dose titration: