ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

Etalpha2 micrograms/ml oral drops in solution

alfacalcidol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness 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. See section 4.

Contents of the pack

1. What Etalpha is and what it is used for
2. What you need to know before you take Etalpha
3. How to take Etalpha
4. Possible side effects
5. Storage of Etalpha
6. Contents of the pack and further information

1. What Etalpha is and what it is used for

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

The active substance of Etalpha is alfacalcidol, a form of vitamin D.

Alfacalcidol works by being converted into calcitriol (the active form of vitamin D) in the liver.

The medicine is indicated in situations where there is an alteration of calcium and phosphorus metabolism due to reduced production of 1,25-dihydroxyvitamin D.

2. What you need to know before you take Etalpha

Do not take Etalpha

• if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcaemia).

As during treatment with Etalpha, high levels of calcium in your blood (hypercalcaemia) may appear, you should know the following signs and symptoms of hypercalcaemia:

• loss of appetite (anorexia)
• fatigue
• nausea
• vomiting
• constipation or diarrhoea
• increased urine production
• sweating
• headache
• thirst
• high blood pressure
• drowsiness
• dizziness

Warnings and precautions

Consult your doctor or pharmacist before taking Etalpha.

Be particularly careful with Etalpha if:

• you have arteriosclerosis, cardiac valve sclerosis, or kidney stones (nephrolithiasis). These conditions may worsen if you have high levels of calcium in your blood (hypercalcaemia).
• you suffer from lung tissue calcification.
• you have renal bone disease or any kidney disorder. To maintain acceptable serum phosphorus levels, phosphorus binders may be used.
• you have inflammatory diseases such as sarcoidosis. These conditions have the potential to increase sensitivity to Etalpha.
• you are being treated with heart medications (cardiac glycosides). If the level of calcium in your blood increases too much (hypercalcaemia), the use of these medications can cause changes in your heart rhythm.

During treatment, your doctor will perform blood tests to monitor calcium and phosphorus levels.

Using Etalpha with other medicines

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

It is important that you inform your doctor if:

• you are being treated with diuretics, calcium-containing preparations, or other vitamin D-containing preparations, as these may increase the risk of elevated calcium levels in your blood (hypercalcaemia).
• you are being treated with anti-epileptic 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 high magnesium levels in your blood (hypermagnesaemia).
• you are being treated with aluminium-containing preparations (such as aluminium hydroxide or sucralfate), as this may increase aluminium absorption.

• you are taking bile acid sequestrants such as cholestyramine at the same time as Etalpha, as this may alter the intestinal absorption of Etalpha. To reduce the possibility of interference, alfacalcidol should be administered at least 1 hour before or 4-6 hours after ingestion of bile acid sequestrants.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The influence of Etalpha on the ability to drive and use machines is negligible.

However, dizziness may occur during treatment, which you should take into account if you drive or use machines.

Etalpha contains ethanol, sorbitol, macrogolglycerol hydroxystearate, and methyl parahydroxybenzoate

This medicine contains up to 113 mg of alcohol (ethanol) in each dose (corresponding to 2 micrograms of alfacalcidol), which is equivalent to 14% ethanol (alcohol). The amount in each dose of this medicine is equivalent to less than 3 ml of beer or 1.5 ml of wine.

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

This medicine contains 452 mg of sorbitol in each ml, equivalent to 6.5 mg sorbitol/kg/day for an adult (70 kg). Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains macrogolglycerol hydroxystearate.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

3. How to take Etalpha

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

1 ml or 20 drops of Etalpha oral drops in solution are equivalent to 2 micrograms of alfacalcidol (1 drop is equivalent to 0.1 micrograms of alfacalcidol).

Adults and children over 20 kg in weight:

The initial dose is 1 microgram (0.5 ml) per day, i.e., 10 drops per day.

Children under 20 kg in weight:

The initial dose is 0.05 micrograms per kg of body weight per day.

The maintenance dose is usually between 0.25 and 1 microgram per day.

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

If you take more Etalpha than you should

If you have taken too much Etalpha, contact your doctor or pharmacist.

An overdose can lead to high levels of calcium in your blood and urine. Therefore, your doctor may need to perform tests.

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

If you forget to take Etalpha

Do not take a double dose to make up for forgotten doses. Continue according to the prescribed dosage.

If you stop taking Etalpha

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• high levels of calcium in the blood
• excessive phosphorus in the blood
• abdominal pain and discomfort
• skin rash
• itching
• excess calcium in the urine

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

• confusion
• headache
• diarrhea
• vomiting
• constipation
• nausea
• muscle pain
• worsening of kidney function (including acute kidney failure)
• kidney stones
• calcium deposits in the kidneys
• fatigue
• tiredness
• malaise
• calcium deposits in non-osseous tissues

Rare side effects (may affect up to 1 in 1000 people):

• dizziness

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etalpha

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

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

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

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. Contents of the pack and further information

Composition of Etalpha

• The active substance is alfacalcidol.

1 ml of solution (20 drops) contains 2 micrograms of alfacalcidol.

• The other ingredients are sorbitol (E-420), ethanol, macrogolglycerol hydroxystearate, sodium citrate, methyl parahydroxybenzoate (E-218), citric acid monohydrate, all-rac-α-tocopherol, and purified water.

Appearance of the product and pack contents

Colourless, transparent or slightly opalescent solution.

Etalpha oral drops in solution are presented in a 10 ml amber glass bottle with a dosing dropper.

Marketing authorisation holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Date of last revision of this leaflet: January 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.