DELTIUS 50,000 IU/2.5 ML ORAL SOLUTION

Read the entire package leaflet carefully before starting to take this medicine because it contains important information for you

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Deltius and what is it used for
2. What you need to know before taking Deltius
3. How to take Deltius
4. Possible side effects
5. Storage of Deltius
6. Package contents and additional information

1. What is Deltius and what is it used for

Deltius contains the active substance colecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D helps the body absorb calcium in the kidneys and intestines, which helps form bones. A deficiency of vitamin D is the main cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Deltius is used for the initial treatment of clinically relevant vitamin D deficiency in adults.

2. What you need to know before taking Deltius

Do not take Deltius

• if you are allergic to vitamin D3 or any other component of this medicine (listed in section 6).
• if you have high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).
• if you have kidney stones (renal calculi) or severe kidney failure
• if you have high levels of vitamin D3 in the blood (hypervitaminosis D).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before taking Deltius if you:
• are being treated with certain medications for heart conditions (e.g., cardiac glycosides, such as digoxin).
• have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D3 in the body).
• are being treated with diuretics (e.g., benzothiadiazine).
• are immobilized
• have pseudo-hypoparathyroidism
• are being treated with medications that contain vitamin D3 or are taking foods or milk enriched with vitamin D3.
• are likely to be exposed to the sun while using Deltius.
• are taking other supplements that contain calcium. Your doctor should monitor your calcium levels to ensure they are not too high during treatment with Deltius.

• have kidney disease or tend to form kidney stones. Your doctor should monitor your blood and urine calcium levels.

• your doctor should monitor your blood calcium levels through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for an extended period.

Children and adolescents

Deltius is not recommended for use in children and adolescents under 18 years of age.

Using Deltius with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is especially important if you are taking:

• medicines used to treat heart or kidney diseases, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medicines are used at the same time as vitamin D, they can cause a significant increase in blood and urine calcium levels.
• medicines that contain vitamin D3 or foods rich in vitamin D3, such as some types of milk enriched with vitamin D3.
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medicines used to treat fungal diseases). These medicines can interfere with the processing of vitamin D3 in the body.
• the following medicines, as they may interfere with the effect or absorption of vitamin D3:

• anti-epileptic medicines (anticonvulsants), barbiturics.
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3.
• medicines that lower cholesterol levels in the blood (e.g., cholestyramine or colestipol).
• certain medicines used to lose weight by reducing fat absorption (e.g., orlistat);
• certain laxatives (e.g., liquid paraffin).

Taking Deltius with food, drinks, and alcohol

You should take this medicine preferably with one of the main meals to help with the absorption of vitamin D3. You can take it alone or mix the solution with cold or lukewarm food. For more information, see section 3 "How to take Deltius".

Pregnancy, breastfeeding, and fertility

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

This high-dose presentation is not recommended during pregnancy and breastfeeding due to its high dose of vitamin D3.

Driving and using machines

Information on the possible effects of this medicine on the ability to drive is limited. However, it is not expected that your ability to drive and use machines will be affected.

3. How to take Deltius

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

Shake before use.

Deltius should be taken preferably with the main meals.

This medicine has an olive oil flavor. Deltius can be taken alone or mixed with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the complete dose.

Use in adults

The recommended dose is 1 vial of 25,000 IU per week for the first month. After the first month, the dose may be reduced.

High doses may be required:

• 50,000 IU/week for 6-8 weeks;

This initial treatment may be followed by maintenance therapy, as indicated by your doctor.

Your doctor will adjust the dose for you.

Pediatric population

Deltius is not recommended for children and adolescents under 18 years of age.

Use during pregnancy and breastfeeding

Deltius is not recommended.

If you take more Deltius than you should

If you take more than the prescribed amount, stop taking the medicine and call your doctor. If you cannot contact your doctor, go to the emergency department of the nearest hospital and take the medicine package with you.

You can also contact the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, dehydration, and high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) determined by laboratory tests.

If you forget to take Deltius

If you forget to take a dose of Deltius, take the next dose as soon as possible. Then, take the next dose at the usual time. However, if it is close to the time of the next dose, do not take the missed dose and take the next dose at the usual time.

Do not take a double dose to make up for missed doses.

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

4. Possible side effects

Like all medicines, Deltius can cause side effects, although not everyone gets them.

The possible side effects associated with the use of Deltius may be:

Uncommon(affect 1 in 100 people):

• Excess calcium in the blood (hypercalcemia)
• Excess calcium in the urine (hypercalciuria)

Rare(affect 1 in 1,000 people):

• Skin rash (hives or skin eruption)
• Itching (pruritus)
• Urticaria

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Deltius

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

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not refrigerate or freeze.

Keep in the original package to protect from light.

Do not use this medicine if the solution appears cloudy.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

What Deltius contains

• The active substance is colecalciferol (vitamin D3).

1 single-dose vial contains 1.25 mg of colecalciferol (vitamin D3) equivalent to 50,000 IU.

• The other ingredients are: olive oil.

Appearance of Deltius and package contents

Deltius 50,000 IU is a clear, colorless to greenish-yellow oral solution. It is supplied in an amber glass bottle sealed with a tamper-evident plastic cap.

Each package contains 1, 2, or 4 single-dose vials containing 2.5 ml of solution.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid),

Spain

Tel.: 916572323

Manufacturer:

Abiogen Pharma S.p.A.

Via Meucci, 36 –

56121 Pisa

Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

England; DELTIUS 50,000 IU/2.5 ml oral solution

Greece: DELTIUS 50,000 IU/2.5 ml π?σιμο δι?λυμα

France: DELTIUS 50,000 IU/2.5 ml solution buvable

Portugal: DELTIUS 50,000 IU/2.5 ml solução oral

Cyprus: DELTIUS 50,000 IU/2.5 ml π?σιμο δι?λυμα

Date of the last revision of this package leaflet: March 2019

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