Deltius 25,000 IU/2.5 ml oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Deltius 25,000 UI/2.5 ml oral solution

colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine as 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 medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Deltius is and what it is 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. Contents of the pack and other information

1. What Deltius is and what it is used for

Deltius oral solution contains as its active substance colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by our body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestines, thereby aiding bone formation. Vitamin D deficiency is the main cause of rickets (deficient bone mineralization in children) and osteomalacia (inadequate bone mineralization 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 starting to take Deltius

Do not take Deltius

• if you are allergic to vitamin D3 or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).
• if you have kidney stones (renal calculi) or severe renal 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 used for heart conditions (e.g., cardiac glycosides such as digoxin).

• you have sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D in the body).

• you are being treated with medications containing vitamin D or consume vitamin D–fortified foods or milk.

• you are likely to be exposed to sunlight while using this medicine.

• you are additionally taking supplements containing calcium. Your doctor should monitor your calcium levels to ensure they do not become too high during treatment with Deltius.

• you have kidney disease or kidney damage. 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

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

Other medicines and Deltius

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking:

• medicines used to treat heart or kidney diseases, such as cardiac glycosides (for example, digoxin) or diuretics (for example, bendroflumethiazide). When these medicines are used at the same time as vitamin D3, they may cause a significant increase in calcium levels in the blood and urine.

• medicines containing vitamin D or foods rich in vitamin D, such as certain types of vitamin D-fortified milk.

• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungals (for example, clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with how your body processes vitamin D3.

• the following medicines, as they may interfere with the effect or absorption of vitamin D3:

• anti-epileptic medicines (anticonvulsants), barbiturates.

• 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 (such as cholestyramine or colestipol).

• some medicines used for weight loss by reducing the absorption of dietary fat (for example, orlistat).

• some laxatives (such as liquid paraffin).

Taking Deltius with food, drinks, and alcohol

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

Pregnancy, lactation, and fertility

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

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

Driving and use of machinery

Information regarding possible effects of this medicine on the ability to drive is limited. However, it is not expected that your ability to drive or operate machinery will be affected.

3. How to take Deltius

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Shake before use.

Deltius should preferably be taken with main meals.

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

Use in adults

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

Paediatric population

Deltius is not recommended.

Pregnancy and breastfeeding

Deltius is not recommended.

If you take more Deltius than you should

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

You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

The most common symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation and dehydration, elevated levels of calcium in blood and urine (hypercalcaemia 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. Afterwards, take the following dose at the usual time. However, if it is almost time for 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 forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Possible adverse effects may include:

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

• High levels of calcium in the blood (hypercalcemia)
• High levels of calcium in the urine (hypercalciuria)

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

• Skin rash (rash or skin eruption)
• Pruritus (itching)
• Urticaria

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Deltius

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from light.

Do not refrigerate or freeze.

Do not use this medicine if the solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deltius

• The active substance is colecalciferol (vitamin D3).

1 single-dose vial of 2.5 ml 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 component is: olive oil.

Appearance of Deltius and contents of the pack

Deltius 25,000 IU/2.5 ml oral solution is an oily, clear solution, colourless to yellowish-green, without visible solid particles and/or precipitates. It is presented in amber glass vials sealed with a plastic stopper.

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

Only certain pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

UK: DELTIUS 25,000 I.U./2.5 ml oral solution

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

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

Greece: DELTIUS 25,000 I.U./2.5 ml πόσιμο διάλυμα

Cyprus: DELTIUS 25,000 I.U./2.5 ml πόσιμο διάλυμα

Date of the most recent review of this leaflet: October 2018

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