Label: information for the user

Etalpha 2 micrograms injectable solution

alfacalcidol

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

-This medication will be administered by a healthcare professional.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Etalpha is and for what it is used

2.What you need to know before Etalpha is administered

3.How to use Etalpha

4.Possible adverse effects

5.Storage of Etalpha

6.Contents of the package and additional information

Etalpha belongs to a group of medications called vitamin D analogs that regulate calcium and phosphorus levels in your body.

The active ingredient of Etalpha is alfacalcidol. Alfacalcidol exerts its action by being converted into calcitriol (the active form of vitamin D) in the liver.

This medication is indicated in situations where there is an alteration of calcium and phosphorus metabolism due to reduced production of 1,25-dihydroxyvitamin D in patients undergoing long-term hemodialysis.

No use Etalpha

-if you are allergic to alfacalcidol or any of the other components of this medication (listed in section 6).

-if you have high levels of calcium in your blood (hypercalcemia).

As Etalpha treatment may cause high levels of calcium in your blood (hypercalcemia), you should be aware of the following signs and symptoms of hypercalcemia:

-loss of appetite (anorexia)

-fatigue

-nausea

-vomiting

-constipation or diarrhea

-increased urine production

-sweating

-headache

-thirst

-high blood pressure

-drowsiness

-dizziness

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Etalpha.

You should be especially careful with Etalpha if:

-you have arteriosclerosis, heart valve sclerosis, or kidney stones (nephrolithiasis). These conditions may worsen if you have high levels of calcium in your blood (hypercalcemia).

-you suffer from pulmonary tissue calcification.

-you have kidney disease or any kidney impairment. To maintain an acceptable serum phosphate level, phosphate binders may be used.

-you have inflammatory diseases such as sarcoidosis. These conditions have the potential to increase your sensitivity to Etalpha.

-you are being treated with heart medications (cardiac glycosides). If your blood calcium level increases too much (hypercalcemia), the use of these medications may cause changes in your heart rhythm.

Your doctor will perform blood tests during treatment to monitor your calcium and phosphate levels.

Use of Etalpha with Other Medications

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

It is essential to inform your doctor if:

• you are being treated with diuretics, preparations containing calcium, or other preparations containing vitamin D, as these may increase the risk of elevated calcium levels in your blood (hypercalcemia).
• you are being treated with antiepileptic medications (barbiturates, phenytoin, carbamazepine, or primidone). You may require a higher dose of Etalpha.
• you are taking antacids containing magnesium, as these may increase the risk of elevated magnesium levels in your blood (hypermagnesemia).
• you are being treated with preparations containing aluminum (such as aluminum hydroxide or sucralfate), as this may increase aluminum absorption.

Pregnancy and Lactation

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

Etalpha may be used during pregnancy and lactation only when your doctor considers it essential.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

The influence of Etalpha on your ability to drive and operate machines is negligible or insignificant.

However, dizziness may occur during treatment, which you should be aware of if you drive or operate machines.

Etalpha Contains Ethanol, Propylene Glycol, and Sodium

This medication contains up to 160 mg of ethanol per dose (equivalent to 4 micrograms of alfacalcidol), which is 10% ethanol (alcohol). The amount in each dose of this medication is equivalent to 4 ml of beer or 1.7 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

This medication contains 415 mg of propylene glycol per milliliter, equivalent to 20.75 mg/kg/day (which corresponds to 0.1 micrograms/kg/day of alfacalcidol).

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

This medication contains less than 23 mg (1 mmol) of sodium per ml of solution, making it essentially "sodium-free".

Etalpha will be administered intravenously by a healthcare professional.

Adults and children over 20 kg of weight:

The initial dose is 1 microgram (0.5 ml) per day.

Children under 20 kg of weight:

The initial dose is 0.05 micrograms (0.025 ml) per kg of weight per day.

The maintenance dose is generally between 0.25 and 2 micrograms (0.125 to 1 ml) per day.

The vials must be shaken well before use.

Your doctor may adjust these doses according to your needs. For this, your doctor will perform blood tests or may request other diagnostic tests.

When administered to patients undergoing dialysis, the initial dose for adults is 1 microgram (0.5 ml) per dialysis. The maximum recommended dose is 6 micrograms (3 ml) per dialysis and no more than 12 micrograms (6 ml) per week.

If you receive more Etalpha than you should

If you receive more Etalpha than you should, it may cause an increase in the level of calcium in your blood, which is controlled by discontinuing treatment.

If your calcium levels in the blood are very high, you may need to be administered a diuretic and intravenous fluids or you may be given corticosteroids.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount used.

If you forgot your Etalpha treatment

Consult your doctor as soon as possible so that they can tell you what to do in these cases.

If you interrupt your Etalpha treatment

Your doctor will indicate the duration of your Etalpha treatment. Do not suspend treatment before, as it may be harmful to your health.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (may affect up to 1 in 10 patients):

-High levels of calcium in the blood

-Excessive levels of phosphorus in the blood

-Abdominal pain and discomfort

-Dermatological eruption

-Itching

-Excessive calcium in urine

Less Frequent Adverse Effects (may affect up to 1 in 100 patients):

-Confusion

-Headache

-Diarrhea

-Vomiting

-Constipation

-Nausea

-Muscle pain

-Worsening of renal function (including acute renal insufficiency)

-Kidney stones

-Calcium deposits in the kidneys

-Fatigue

-Weakness

-Discomfort

-Calcium deposits in non-osseous tissues

Rare Adverse Effects (may affect up to 1 in 1000 patients):

-Dizziness

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in refrigerator (between 2°C and 8°C).

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Etalpha

• The active principle is alfacalcidol.

One milliliter of injectable solution contains 2 micrograms of alfacalcidol. Each vial contains 2 micrograms of alfacalcidol in 1 milliliter of injectable solution.

-The other components areethanol, citric acid monohydrate, sodium citrate, propylene glycol, and water for injectable preparations.

Appearance of the product and content of the container

Etalpha 2 micrograms is presented as a colorless and transparent injectable solution, for intravenous administration, in amber glass vials. Each container contains 10 vials.

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

CENEXI SAS

Rue Marcel et Jacques Gaucher,

94120 Fontenay-sous-Bois (France)

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet: January 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.