Deltius 50,000 IU/2.5 ml oral solution

Package leaflet: Information for the user

Introduction

Patient Information Leaflet

Deltius 50,000 UI/2.5 ml oral solution

colecalciferol (vitamin D3)

Read the entire leaflet carefully before starting to take 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, 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:

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. How to store Deltius
6. Contents of the pack and other information

1. What Deltius is and what it is used for

Deltius contains the active substance colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestine, thereby supporting bone formation. Vitamin D deficiency is the main cause of rickets (inadequate bone mineralization in children) and osteomalacia (inadequate bone mineralization 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 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 D3 in your blood (hypervitaminosis D).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting treatment with Deltius if you:

• are being treated with certain medications used for heart conditions (e.g., cardiac glycosides such as digoxin).

• have sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D3 in the body).

• are taking diuretics (e.g., benzothiadiazines).

• are immobilized.

• suffer from pseudohypoparathyroidism.

• are being treated with medications containing vitamin D3 or consume vitamin D3-enriched foods or milk.

• are likely to be exposed to sunlight while using Deltius.

• take other supplements containing calcium. Your doctor should monitor your calcium levels to ensure they do not become too high during treatment with Deltius.

• have kidney disease or kidney damage and are prone to developing 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 a prolonged period.

Children and adolescents

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

Use of Deltius with other medicines

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 D, they may cause a significant increase in calcium levels in the blood and urine.

• medicines containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3-fortified milk.

• actinomycin (a medicine used in the treatment of some types of cancer) and imidazole antifungals (for example, clotrimazole and ketoconazole, which are medicines used to treat fungal infections). These medicines may interfere with the body's processing of 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 this medicine 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 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 are planning to become pregnant, consult your doctor before using this medicine.

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

Driving and using machines

Information on the potential 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 given by your doctor. 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 of 25,000 IU weekly for the first month. After the first month, dose reduction may be considered.

Higher doses may be required:

• 50,000 IU/week for 6 – 8 weeks;

This initial treatment may be followed by a maintenance therapy, according to your doctor's instructions.

Your doctor will adjust the dose for you.

Paediatric population

Deltius is not recommended.

Use during pregnancy and breastfeeding

Deltius is not recommended.

If you take more Deltius than you should

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

You may also contact the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation, dehydration, and elevated levels of calcium in blood and urine (hypercalcaemia and hypercalciuria) detected 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 your 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 any other medicine, Deltius may cause adverse effects, although not everyone will experience them.

Possible adverse effects associated with the use of Deltius include:

Uncommon (affects 1 in 100 people):

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

Rare (affects 1 in 1000 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 Medicinal Products: 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 the sight and reach of children.

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

Do not store above 25 °C.

Do not refrigerate or freeze.

Keep in the original container to protect from light.

Do not use this medicine if the solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 contains 1.25 mg of colecalciferol (vitamin D3), equivalent to 50,000 IU.

• The other components are: olive oil.

Appearance of Deltius and contents of the pack

Deltius 50,000 IU is a clear, oily oral solution, colourless to yellowish-green. It is supplied in an amber glass bottle sealed with a tamper-proof plastic cap.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas, Madrid

Spain

Manufacturer:

Abiogen Pharma S.p.A.

Via Meucci, 36

56121 Pisa

Italy

This medicinal product is authorised in the European Economic Area Member States under the following names:

UK: DELTIUS 50 000 I.U. /2.5 ml oral solution

Greece: DELTIUS 50 000 I.U. /2.5 ml π?σιμο δι?λυμα

Portugal: DELTIUS 50 000 I.U. /2.5 ml solução oral

Spain: DELTIUS 50.000 UI/2.5 ml solución oral

Cyprus: DELTIUS 50 000 I.U. /2.5 ml π?σιμο δι?λυμα

Date of the most recent review of this leaflet: March 2019

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/