Patient Information Leaflet

Deltius 25.000 UI/2.5 ml oral solution

colecalciferol (vitamin D3)

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

• Keep this 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 for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Deltius is and what it is used for
2. What you need to know before you start taking Deltius
3. How to takeDeltius
4. Possible side effects
5. Storage ofDeltius
6. Contents of the pack and additional information

Deltius oral solution contains colecalciferol (vitamin D3) as its active ingredient.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 thekidneysand theintestine, aiding in bone formation.Vitamin D deficiency is the primary cause of rickets (inadequate mineralization 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.

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

• you have kidney disease or renal damage. 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 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

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 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 milk enriched with vitamin D.

• 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), 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 cholestipol).
• some medications used to aid weight loss by reducing fat absorption (e.g., orlistat);
• some laxatives (e.g., liquid paraffin).

Taking Deltius with food, drinks, and alcohol

You should take Deltius preferably with one of your main meals to help with the absorption of vitamin D3. You can take it on its own 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, 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 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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

Shake before use.

Deltius should be taken preferably with main meals.

This medication has a flavor 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.

Adult Use

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

Pediatric Population

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

Pregnancy and Lactation

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

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 than the prescribed amount of this medication. If it is not possible to speak with the doctor, go to the nearest hospital and bring the medication packaging with you.

You can also contact the Toxicological 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 up to 24 hours, constipation, and dehydration, elevated 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 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 all medications, this medication may produce adverse effects, although not all people may experience them.

The possible adverse effects may include:

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

• Hypercalcemia (elevated calcium in the blood)
• Hypercalciuria (elevated calcium in the urine)

Very Rare(may affect up to 1 in 1,000 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 86°F (30°C).

Store in the original packaging to protect it from light.

Do not refrigerate or freeze.

Do not use this medication if the solution appears cloudy.

Medications should not be disposed of through drains or 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 Deltius

• The active principle is colecalciferol (vitamin D3).

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

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

• The other components are: olive oil.

Appearance of Deltius and contents of the packaging

Deltius 25,000 UI/ 2.5 ml oral solutionis a transparent, colorless to yellow-green oily solution, without visible solid particles and/or precipitates. It is presented in topaz-colored glass vials sealed with a plastic stopper.

Each package contains1 or 4 single-dose vials containing 2.5 ml of solution.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ITALFARMACO, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa

Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Deltius 25,000 UI/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 solution buvable

Portugal:Deltius 25 000 UI/2.5 ml oral solution

Date of the last review of this leaflet:October 2018

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/.