Leaflet: Information for the user

Deltius 10.000 UI/ml oral drops in solution

colecalciferol (vitamin D3)

Read this leaflet carefully before starting to take 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 should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Deltius oral drops in solution contain colecalciferol (vitamin D3). 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 the kidneys and intestine, 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 drops in solution are used to prevent and treat vitamin D3deficiency in adults, adolescents, and children with identified risk of vitamin D3deficiency.

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

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 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 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 fortified foods or milk.
• you are likely to be exposed to sunlight while taking this medication.
• you are taking other supplements that contain calcium. Your doctor will need to monitor your calcium levels to ensure they are not too high while you are taking Deltius.
• you have kidney disease or damage. Your doctor will need to monitor your calcium levels in your blood and urine.
• your doctor will need to monitor your calcium levels in your blood through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for an extended period.

Other medications and Deltius

Inform 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 used to treat 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 fortified foods, 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, which are medications used to treat fungal diseases). These medications can interfere with the processing of vitamin D3 in the body.
• 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 promote weight loss by reducing fat absorption (e.g., orlistat).
• some laxatives (e.g., liquid paraffin).

Use of 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 alone or mix 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, or think you may be pregnant, consult your doctor before using this medication.Deltius should only be taken during pregnancy and breastfeeding under the recommendation of your doctor.

Vitamin D overdoses should be avoided during pregnancy, as prolonged hypercalcemia can cause physical and mental developmental delays, aortic stenosis, and retinopathy in the child.

Driving and operating machinery

The information on possible effects of this medication on driving ability is limited. However, it is not expected to affect driving ability and the use of machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Shake before use.

Deltius should be taken preferably with main meals.

This medication has a olive oil flavor. Deltius can 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 to take the complete dose.

Use in adults

The recommended dose forthevitamin D deficiencyand as a complement to specific medication for bone loss (osteoporosis) is 3-4 drops (600 UI - 800 UI) per day.

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

The daily dose should not exceed 4,000 UI (20 drops per day).

Use in children and adolescents

For the prevention of vitamin D deficiency in children (0 to 11 years) at risk, the recommended dose is 2 drops (400 UI) per day. For prevention in adolescents (12 to 18 years) at risk, the recommended dose is 3-4 drops (600-800 UI) 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 depending on the desired serum levels of 25-hydroxyvitamin D (25 (OH) D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1,000 UI per day for children under 1 year, 2,000 UI per day for children 1 to 10 years old, and 4,000 UI per day for adolescents.

In children, Deltius can be mixed with a small amount of child food, yogurt, milk, cheese, or other dairy products. Do not add Deltius to baby bottles or other containers with food that the child will not consume completely, in order to avoid the child not taking the complete dose. Make sure the child takes the complete dose. In children who have passed the lactation stage, the prescribed dose should be taken 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 lactation

The recommended dose is 400 UI/day (2 drops). Higher doses may be needed after confirming vitamin D deficiency, but do not take more than your doctor recommends.

Instructions for usefor the bottle withdropper

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 medication, 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 throw the plastic cap, you will use it to close it;
2. Before using the dropper, unscrew the plastic tube that protects it (see Figure 2). Do not throw the plastic tube, you will use it to store it after each use;
3. Insert the glass rod of the dropper into the bottle to extract the content. Put the prescribed number of drops in a spoon;
4. Close the bottle with its original cap and store the dropper in the plastic tube. Make sure both are well closed (see Figure 3);
5. Store the bottle and the dropper in the original package.

Instructions for use of the dropper bottle

The package contains a dropper bottle. The dropper bottle is closed by a child-resistant plastic cap.

Below are the instructions for opening and use:

a.To open the dropper bottle, press and turn the plastic cap at the same time;

b.Place the dropper bottle upside down in a vertical position and collect the prescribed number of drops in a spoon;

c.After finishing the administration of the drops, place the dropper bottle in a vertical position upwards;

d.To close the dropper bottle, screw the child-resistant plastic cap back on;

e.Place the dropper bottle in the cardboard box of the original package.

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 you cannot speak with your doctor, go to the nearest hospital and bring the package with the medication.

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 24 hours, constipation, dehydration, and elevated levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

If you forgot 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 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 compensate for the missed doses.

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

Like any other medication, this medication may produce adverse effects, although not everyone will experience them. The possible adverse effects associated with the use of Deltius may be:

Infrequent(affect less than 1 in 100 people):

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

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

• Cutaneous rash (skin rash 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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 at a temperature above 30°C.

Store in the original packaging to protect it from light.

Do not refrigerate or freeze.

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

Do not use this medication if you observe that the solution is cloudy.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you do not need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. By doing so, you will help protect the environment.

Composition ofDeltius

The active principle is colecalciferol (vitamin D3).

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

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

The other components are: olive oil.

Appearance of Deltius and packaging content

Deltius 10,000 UI/ml oral drops solutionis a transparent, colorless to yellow-green oily oral solution, without visible solid particles and/or precipitates. It is presented in:

• Bottlewith dropper

Bottleof topaz-colored glass of 20 ml closed with a child-resistant plastic cap.

Each package contains a topaz-colored glass bottle containing 10 ml of solution (corresponding to 500 drops) and a dropper (with CE marking 0068).

• Dropper bottle

Dropper bottle of topaz-colored glass of 20 ml with a child-resistant plastic cap.

Each package contains a topaz-colored glass dropper bottle containing 10 ml of solution (corresponding to 500 drops).

Not all presentations may be commercially available.

Marketing Authorization Holder

ITALFARMACO, S.A.

San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa

Italy

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Spain:Deltius10,000 UI/ml oral drops solution

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

Greece:Deltius Π?σιμες σταγ?νες δι?λυμα 10,000 IU/ML

France:Deltius 10 000 UI/ml, oral solution in drops

Portugal:Deltius10000 UI/ml Oral drops, solution

Last review date of this leaflet:April 2021

Thedetailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.