DELTIUS 25,000 IU/2.5 mL ORAL SOLUTION

Introduction

P

Deltius 25,000 IU/2.5 ml oral solution

colecalciferol (vitamin D3)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication 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 side effects not listed in this leaflet. See section 4.

Contents of the 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 oral solution contains colecalciferol (vitamin D3) as the active ingredient. Vitamin D3 can be found in some foods and is produced by our body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestines, helping to form bone. Vitamin D deficiency is the main cause of rickets (mineralization deficiency of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Deltius oral solution 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 medication (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 renal insufficiency.
• if you have high levels of vitamin D in the blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Deltius if:

• you are being treated with certain medications for heart conditions (e.g., cardiac glycosides, such as digoxin).
• you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D in the body).
• you are being treated with medications that contain vitamin D or taking foods or milk enriched with vitamin D.
• you are likely to be exposed to the sun while using this medication.
• you are also taking calcium supplements. Your doctor should monitor your calcium levels to ensure they are not too high during your treatment with Deltius.

• you have kidney disease. 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 a prolonged period.

Children and adolescents

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

Other medications and Deltius

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

• medications for heart or kidney conditions, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in calcium levels in the blood and urine.

• medications that contain vitamin D or foods rich in vitamin D, such as some types of vitamin D-enriched milk.

• actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medications used to treat fungal diseases). These medications can interfere with how your body processes vitamin D3.
• the following medications, as they may interfere with the effect or absorption of vitamin D3:

• antiepileptic medications (anticonvulsants), barbiturics.
• 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 (such as cholestyramine or colestipol).
• certain medications used to lose weight by reducing fat absorption (e.g., orlistat);
• certain laxatives (such as liquid paraffin).

Taking Deltius with food, drinks, and alcohol

You should take Deltius 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 warm 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 or pharmacist before using this medication.

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

Driving and using machines

Information on the possible effects of this medication on the ability to drive is limited. However, it is not expected to affect your ability to drive and use machines.

3. How to take Deltius

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

Shake before use.

Deltius should be taken preferably with the main meals

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

Use in adults

The recommended dose is 1 vial (25,000 IU) per week for the first month, and your doctor will adjust the dose.

Pediatric population

Deltius 25,000 IU is not recommended in children and adolescents under 18 years of age.

Pregnancy and breastfeeding

Deltius 25,000 IU is not recommended during pregnancy and breastfeeding.

If you take more Deltius than you should

Stop taking the medication and consult your doctor or pharmacist immediately if you or your child take more of this medication than prescribed by your doctor. If it is not possible to speak with your doctor, go to the nearest hospital and take the medication packaging with you.

You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The most common symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, and dehydration, high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) in 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 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible side effects may include:

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

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

Rare(may affect up to 1 in 1,000 people):

• Skin rash (rash 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Deltius

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

Do not use this medication after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light.

Do not refrigerate or freeze.

Do not use this medication if the solution appears cloudy.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Deltius

• The active ingredient is colecalciferol (vitamin D3).

1 single-dose vial of 2.5 ml of oral solution contains 25,000 IU of colecalciferol (vitamin D3), equivalent to 0.625 mg.

1 ml of oral solution contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 0.25 mg.

• The other ingredients are: olive oil.

Appearance of Deltius and package contents

Deltius 25,000 IU/2.5 ml oral solution is a clear, colorless to greenish-yellow oily solution, without visible solid particles and/or precipitates. It is presented in amber glass vials sealed with a plastic cap.

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

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

ITALFARMACO, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa

Italy

This medication is authorized in the member states of the European Economic Area under the following names:

Spain: Deltius 25,000 IU/2.5 ml oral solution

UK: Deltius 25,000 IU/2.5 ml oral solution

Greece: Deltius 25,000 IU/2.5 ml π?σιμο δι?λυμα

France: Deltius 25,000 IU/2.5ml oral solution

Portugal: Deltius 25,000 IU/2.5 ml oral solution

Date of the last revision of this leaflet:October 2018

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