PARICALCITOL ALTAN 5 micrograms/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Paricalcitol ALTAN5 micrograms/ml solution for injection EFG

Paricalcitol ALTAN2 micrograms/ml solution for injection EFG

Read all of this leaflet carefully before you start using this medicine.

• 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 symptoms 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.

Contents of the pack:

1. What Paricalcitol ALTAN is and what it is used for.
2. What you need to know before you use Paricalcitol ALTAN
3. How to use Paricalcitol ALTAN
4. Possible side effects.
5. Storing Paricalcitol ALTAN

1. Contents of the pack and further information.

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

The active substance of Paricalcitol ALTAN is paricalcitol. Paricalcitol is a synthetic (man-made) analogue of vitamin D. In healthy people, the active form of vitamin D is produced naturally by the kidneys, but when the kidney fails, the production of active vitamin D is reduced, which can cause 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 ALTAN is used for the prevention and treatment of secondary hyperparathyroidism (high levels of parathyroid hormone can cause bone problems) in patients undergoing haemodialysis due to kidney failure.

If you have secondary hyperparathyroidism, you may notice that:

• You feel weak or tired.
• Your appetite decreases.
• You feel nauseous or vomit.
• You have bone or muscle pain.

• You need to urinate frequently.

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

Do not useParicalcitolALTAN:

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

Take special care withParicalcitolALTAN

• Before starting treatment, it is important that you limit the amount of phosphorus you ingest 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 binders that prevent phosphorus absorption from the diet.
• If you are taking phosphorus binders with calcium content, your doctor may need to adjust the dose.
• Your doctor will need to perform blood tests to monitor your treatment.

Using other medicines

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

Some medicines may affect the action of Paricalcitol ALTAN or increase the risk of side effects. It is particularly important that you inform your doctor if you are using any of the following medicines:

• For treating fungal infections such as thrush (e.g., ketoconazole).
• For treating heart or blood pressure problems (e.g., digoxin and diuretics).
• That contain magnesium (e.g., some types of antacids, such as magnesium trisilicate).
• That contain aluminium (e.g., phosphorus binders, such as aluminium hydroxide).

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

UsingParicalcitolALTANwith food and drinks

Paricalcitol ALTAN can be administered before, after, or during meals. It is very important to follow the diet recommended by your doctor to get 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is not known if 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 using machines

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

Important information about some of the ingredients ofParicalcitolALTAN

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

This medicine is harmful to people with alcoholism.

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

3. How to use Paricalcitol ALTAN

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

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

Method of administration

Paricalcitol ALTAN will be administered by your doctor intravenously (into a vein via a needle) while you are undergoing haemodialysis.

Paricalcitol ALTAN will not be administered more than every other day.

UsingParicalcitolALTANin children

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

Your doctor will decide if this treatment is necessary.

If you take moreParicalcitolALTANthan you should

Too much Paricalcitol ALTAN can cause high levels of calcium in the blood, which may require treatment.

The symptoms that may appear quickly after receiving an overdose of Paricalcitol ALTAN include:

• Feeling of weakness and/or drowsiness
• Headache.
• Feeling sick.
• Dry mouth, constipation.
• Pain in muscles and bones.
• Unusual taste in the mouth.

The symptoms that may appear after a long period of receiving too much Paricalcitol ALTAN include:

• Lack of appetite.
• Drowsiness.
• Weight loss.
• Irritation in the eyes.
• Runny nose.
• Itching of the skin.
• Feeling of heat and fever.
• Lack of sexual appetite.
• Severe abdominal pain.
• Kidney stones.
• Your blood pressure may be affected, and you may be aware of your own heartbeat (palpitations).

Paricalcitol ALTAN contains 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 treatment with a kidney machine because propylene glycol is eliminated from the blood during dialysis.

However, your doctor will monitor your blood levels, and if you experience any of the symptoms mentioned, seek medical advice immediately.

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

4. Possible side effects

Like all medicines, Paricalcitol ALTAN can cause side effects, although not everybody gets them.

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

• Shortness of breath.
• Difficulty breathing and swallowing.
• Wheezing.
• Rash, itching, 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 100 people):

• 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):

• Allergic reactions (such as difficulty breathing, wheezing, rash, itching, or swelling of the face and lips); blistering.
• Blood infection, decrease in red blood cell count (anaemia – feeling weak, 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, stroke, chest pain, irregular/rapid heartbeat, decrease in blood pressure, increase in blood pressure.
• Coma (deep state of unconsciousness during which a person cannot interact with their environment).
• Unusual tiredness, weakness, dizziness, fainting.
• Pain at the injection site.
• Pneumonia (lung infection), fluid in the lungs, asthma (wheezing, coughing, difficulty breathing).
• Throat irritation, cold, fever, flu-like symptoms, conjunctivitis (itching and crusts on the eyelids), increase in eye pressure, ear pain, nosebleed.
• Nervous tics; confusion, which can be severe (delirium), agitation (feeling nervous, anxious), nervousness, personality disorders (not feeling like oneself).
• Numbness or tingling, decreased touch, sleep problems, night sweats, muscle spasms in arms and legs, even during sleep.
• Dry mouth, thirst, nausea, difficulty swallowing, vomiting, loss of appetite, weight loss, heartburn, diarrhoea, and stomach pain, constipation: rectal bleeding.
• Difficulty having an erection, breast cancer, vaginal infection.
• Chest pain, back pain, muscle/joint pain, feeling of heaviness caused by general or localized swelling in the ankles, feet, and legs (oedema); abnormal gait.
• Hair loss; excessive hair growth.
• Increase in liver enzymes; increase in parathyroid hormone, increase in potassium levels in the blood, decrease in calcium levels in the blood.

Frequency not known:

• Swelling of the face, lips, mouth, tongue, and throat that can cause difficulty swallowing or breathing; itching of the skin (hives), stomach bleeding. 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, inform your doctor.

5. Storing Paricalcitol ALTAN

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

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition ofParicalcitolALTAN

• The active ingredient is paricalcitol.

Paricalcitol ALTAN 5 micrograms/ml injectable solution

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

Paricalcitol ALTAN 2 micrograms/ml injectable solution

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

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

Appearance of the Product and Container Content

Paricalcitol ALTAN is a clear and colorless aqueous solution, free of visible particles.

ParicalcitolALTAN5 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

ParicalcitolALTAN2 micrograms/ml injectable solution

Available in ampoules of 1ml containing 2 micrograms/ml

or

Available in vials 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

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

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

This information is intended only for healthcare professionals:

ParicalcitolALTAN5 micrograms/ml injectable solution EFG

ParicalcitolALTAN2 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 medicines, the solution should be inspected for particles and discoloration 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 than heparin.

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

Storage and Shelf-Life

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

This medicinal product does not require special storage conditions.

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

Posology and Method of Administration

Paricalcitol ALTAN injectable solution 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:

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

8

or

= basal level of intact PTH in pg/ml

80

And administered as an intravenous (IV) bolus, with a maximum frequency of every other day and at any time during dialysis.

The maximum dose administered safely in clinical trials was 40 micrograms.

1. Dose titration:

The currently accepted levels for the range of PTH in subjects with terminal renal insufficiency undergoing dialysis are not more than 1.5 to 3 times the upper normal limit in non-uremic patients, 15.9 to 31.8 pmol/l (150-300 pg/ml) for intact PTH. To achieve adequate levels of physiological variables, individual monitoring and dose titration are necessary.

If hypercalcemia or an elevated corrected Ca x P product is observed, the dose should be reduced or interrupted until these parameters normalize. Then, the administration of paricalcitol should be restarted at a lower dose. It may be necessary to reduce the dose when PTH levels decrease in response to therapy.

The following table is suggested as a guide for dose titration: