Deltius 10,000 IU/mL oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Deltius 10,000 IU/ml oral drops solution

colecalciferol (vitamin D3)

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this 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 oral drops solution contains colecalciferol (vitamina 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 aiding bone formation. Vitamin D deficiency is the main cause of rickets (inadequate bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Deltius oral drops solution is used to prevent and treat vitamin D3 deficiency in adults, adolescents, and children who are at an identified risk of vitamin D3 deficiency.

Deltius oral drops solution may also be used as an adjunct to specific medication for bone mass loss.

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 failure.
• 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 medicines 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 taking medicines containing vitamin D or consuming foods or milk fortified with vitamin D.
• you are likely to be exposed to sunlight while using this medicine.
• you are taking other 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 calcium levels in blood and urine.
• your doctor should monitor blood calcium levels by laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.

Other medicines and Deltius

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

• medicines used to treat heart or kidney diseases, such as cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in 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 to treat certain types of cancer) and imidazole antifungals (e.g. clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with the metabolism of vitamin D3 in the body.

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

• antiepileptic drugs (anticonvulsants), barbiturates.

• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), which may reduce the effect of vitamin D3.

• medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol).

• certain medicines used for weight loss by reducing fat absorption (e.g. orlistat).

• certain laxatives (such as liquid paraffin).

Use of Deltius with food, drinks and alcohol

You should preferably take Deltius during one of the main meals to help the absorption of vitamin D3. You may take it alone or by mixing the drops 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. Deltius should be taken during pregnancy and breastfeeding only on the advice of your doctor.

Vitamin D overdosage should be avoided during pregnancy, as prolonged hypercalcemia may cause delayed physical and mental development, supravalvular aortic stenosis, and retinopathy in the child.

Driving and use of machines

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

3. How to take Deltius

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

Shake well before use.

Deltius should preferably be taken with main meals.

This medicine has an olive oil flavour. Deltius may be taken alone or by mixing the prescribed number of drops with a spoonful or a small amount of cold or lukewarm food immediately before ingestion. Make sure you take the full dose.

Use in adults

The recommended dose for vitamin D deficiency and as a supplement to specific treatment for bone loss (osteoporosis) is 3-4 drops (600 IU - 800 IU) per day.

For the treatment of vitamin D deficiency, the usual dose is 4 drops (800 IU) per day. Higher doses should be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), the severity of the disease, and the patient's response to treatment.

The daily dose must not exceed 4,000 IU (20 drops per day).

Use in children and adolescents

For the prevention of vitamin D deficiency in children (0 to 11 years) at identified risk, the recommended dose is 2 drops (400 IU) per day. For prevention in adolescents (12 to 18 years) at identified risk, the recommended dose is 3-4 drops (600-800 IU) per day.

For the treatment of vitamin D deficiency in children (0 to 11 years) and adolescents (12 to 18 years), the dose should be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), the severity of the disease, and the patient's response to treatment. The daily dose must not exceed 1,000 IU for children under 1 year of age, 2,000 IU per day for children aged 1 to 10 years, and 4,000 IU per day for adolescents.

In children, Deltius may be mixed with a small amount of children's food, yoghurt, milk, cheese, or other dairy products. Do not add Deltius to bottles of milk or other food containers that the child may not fully consume, to avoid missing part of the dose. Ensure that the child takes the complete dose. For children who have passed the breastfeeding stage, the prescribed dose should be administered with a main meal.

Do not store any product or food containing Deltius for later use or for the next meal.

Use during pregnancy and breastfeeding

The recommended dose is 400 IU/day (2 drops). Higher doses may be required after confirmation of vitamin D deficiency, but you should not take more than your doctor recommends.

Instructions for use of the bottle with dropper applicator

The package contains a bottle and a dropper. The bottle is closed with a child-resistant plastic cap. The dropper is protected by a plastic tube. To use the medicine, shake the bottle before use and follow the instructions below:

1. To open the bottle, press the cap down and turn it at the same time (see Figure 1). Do not discard the plastic cap, as you will need it to close the bottle;
2. Before using the dropper, unscrew the plastic tube protecting it (see Figure 2). Do not discard the plastic tube, as you will need it to store the dropper after each use;
3. Insert the glass stem of the dropper into the bottle to draw up the liquid. Dispense the prescribed number of drops into a spoon;
4. Close the bottle with its original cap and store the dropper in the plastic tube. Make sure both are securely closed (see Figure 3);
5. Store the bottle and dropper in the original package.

Instructions for use of the dropper bottle

The pack contains a dropper bottle. The dropper bottle is closed with a child-resistant cap.

The following are instructions for opening and use:

• To open the dropper bottle, press down and turn the plastic cap at the same time;

• Turn the dropper bottle upside down in a vertical position and collect the prescribed number of drops into a spoon;

• After administering the drops, return the dropper bottle to an upright vertical position;

• To close the dropper bottle, screw the child-resistant plastic cap back on securely;

• Place the dropper bottle back into the original cardboard packaging.

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 you cannot speak to a doctor, go to the nearest hospital and take the medicine pack 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, and 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 missed dose as soon as possible. Then, take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose; instead, take the next dose at the usual time.

Do not take a double dose to make up for missed 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, this medicine may cause adverse effects, although not everyone will experience them. Possible adverse effects associated with the use of Deltius may include:

Uncommon (affect less than 1 in 1,000 people):

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

Rare (affect less than 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 via 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, following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original container to protect from light.

Do not refrigerate or freeze.

After first opening the container, the medicine may be used for a maximum period of 6 months.

Do not use this medicine if you notice that the solution is cloudy.

Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Deltius

The active substance is colecalciferol (vitamin D3).

1 ml of oral solution (50 drops) contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 0.25 mg.

1 drop contains 200 IU of colecalciferol (vitamin D3).

The other component is: olive oil.

Appearance of Deltius and contents of the container

Deltius 10,000 IU/ml oral drops in solution is an oily oral solution, transparent, ranging from colourless to yellowish-green, without visible solid particles and/or precipitates. It is presented in:

• Bottle with dropper applicator

20 ml amber glass bottle closed with a child-resistant plastic cap.

Each pack contains one amber glass bottle containing 10 ml of solution (corresponding to 500 drops) and a dropper applicator (with CE marking 0068).

• Dropper bottle

20 ml amber glass dropper bottle with a child-resistant plastic cap.

Each pack contains one amber glass dropper bottle containing 10 ml of solution (corresponding to 500 drops).

Not all presentations may be marketed.

Marketing Authorization Holder

ITALFARMACO, S.A.

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 European Economic Area member states under the following names:

Spain: Deltius 10,000 IU/ml oral drops in solution

UK: Deltius 10,000 I.U./ml oral drops, solution

Greece: Deltius Π?σιμες σταγ?νες δι?λυμα 10.000 IU/ML

France: Deltius 10,000 IU/ml, solution buvable en gouttes

Portugal: Deltius 10,000 IU/ml Gotas orais, solução

Date of the most recent revision of this leaflet: April 2021

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/.