Product Information for the User

Deltius 50,000 IU/2.5 mlOral Solution

colecalciferol (vitamin D3)

Read this entire product information carefully before starting to take this medication, as it contains important information for you

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

Product Information Contents:

1. What is Deltius and what it is used for

2. What you need to know before starting to take Deltius

3. How to take Deltius

4. Possible adverse effects

5. Storage of Deltius

6. Contents of the package and additional information

Deltius contains the active ingredient colecalciferol (vitamin D3). Vitamin D3can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes the absorption of calcium in the kidneys and intestines, aiding in bone formation. Deficiency of vitamin D is the primary cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

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

Do not take Deltius

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

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Deltius if you:
• are being treated with certain medications for heart disease (e.g., cardiac glycosides, such as digoxin).
• have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D3 levels in the body).
• are being treated with diuretics (e.g., benzothiadiazine).
• are immobile.
• have pseudohypoparathyroidism.
• are being treated with medications containing vitamin D3 or taking foods or milk enriched with vitamin D3.
• are likely to be exposed to sunlight while using Deltius.
• are taking other supplements containing calcium. Your doctor should monitor your calcium levels to ensure they are not too high while you are taking Deltius.

• have kidney disease or kidney damage and are prone to forming kidney stones. Your doctor should monitor your calcium levels in your blood and urine.

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

Children and adolescents

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

Use of Deltius with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is especially important if you are taking:

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

• antiepileptic medications (anticonvulsants), barbiturates.
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3.
• medications that lower cholesterol levels in the blood (e.g., cholestyramine or colestipol).
• some weight loss medications that reduce fat absorption (e.g., orlistat);
• some laxatives (e.g., liquid paraffin).

Taking Deltius with food, drinks, and alcohol

You should take this medication preferably with one of your 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, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

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

Driving and operating machinery

The information on possible effects of this medication on driving ability is limited. However, it is not expected to affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Shake before use.

Deltius should be taken preferably with main meals.

This medication has a taste of olive oil. Deltius can be taken alone or by mixing the solution with a small amount of cold or lukewarm food immediately before ingestion. Make sure to take the complete dose.

Use in adults

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

Higher doses may be required:

-50,000 UI/week for 6 – 8 weeks;

This initial treatment may be followed by a 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 lactation

Deltius is not recommended.

If you take more Deltius than you should

If you take more than the prescribed amount, stop taking the medication and call your doctor. If you cannot contact your doctor, go to the nearest hospital emergency service and bring the packaging with the medication.

You can also contact the Toxicological Information Service, phone 915620420, indicating the medication and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for up to 24 hours, constipation, dehydration, and elevated levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) determined by clinical 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 you are close to the time of the next dose, do not take the missed dose and instead take the next dose at the usual time.

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

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

Like any other medication, Deltius may produce adverse effects, although not all people will experience them.

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

Rarely Occurring(affect 1 in 100 people):

- Hypercalcemia (excess calcium in the blood)

- Hypercalciuria (excess calcium in the urine)

Uncommon(affect 1 in 1000 people):

- Cutaneous rash (hives or skin eruption)

- Pruritus (itching)

- Urticaria

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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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.

Do not store above 25 °C.

Do not refrigerate or freeze.

Store in the original packaging to protect it from light.

Do not use this medication if the solution appears cloudy.

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

What Deltius contains

• The active ingredient is colecalciferol (vitamin D3).

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

• The other components are: olive oil.

Appearance of Deltius and contents of the packaging

Deltius 50,000 UI is a transparent, colorless to yellow-green oily oral solution. It is supplied in an amber glass bottle sealed with a plastic cap resistant to handling.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid),

Spain

Phone: 916572323

Manufacturer responsible:

Abiogen Pharma S.p.A.

Via Meucci, 36 –

56121 Pisa

Italy

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

England;DELTIUS 50 000 I.U. /2,5 ml oral solution

Greece:DELTIUS 50 000 I.U. /2,5 mlπ?σιμο δι?λυμα

France:DELTIUS 50 000 I.U. /2,5 ml solution buvable

Portugal:DELTIUS 50 000 I.U. /2,5 ml solução oral

Cyprus:DELTIUS 50 000I.U. /2,5 mlπ?σιμοδι?λυμα

Last review date of this leaflet: March 2019

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