Leaflet: information for the user

Deltius 25 000 U.I. hard capsules

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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must 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, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Deltius contains the active ingredient 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 intestines, 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 is used to prevent and treat 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 failure;

-if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Deltius, if you:

-are being treated with certain medications for heart disease (e.g., cardiac glycosides, such as digoxin).

-have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D levels in the body).

-are being treated with diuretics (e.g., benzothiadiazine)

-are immobile

-have pseudohypoparathyroidism

-are being treated with medications containing vitamin D, or take foods or milk enriched with vitamin D.

-are likely to be exposed to a lot of sunlight while using Deltius

-take other supplements containing calcium. Your doctor should monitor your calcium levels in the blood to ensure they are not too high while you are taking Deltius.

-have kidney disease or kidney damage and are prone to forming kidney stones. Your doctor may want to monitor your calcium levels in the blood and urine.

-Your doctor should monitor your calcium levels in the blood through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 UI for a prolonged period.

Children and adolescents

The use is not recommended in children and adolescents under 18 years old.

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 disease or kidney disease, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in calcium levels in the blood and urine.

-medications containing 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, which are medications used to treat fungal diseases). These medications can interfere with the processing of vitamin D3 in the body.

-medications for tuberculosis, such as rifampicin and isoniazid

-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 (such as cholestyramine or colestipol).;
• some medications used to lose weight by reducing fat absorption (e.g., orlistat).;
• some laxatives (such as liquid paraffin).

Taking Deltius with food, drinks, and alcohol

You should take Deltius preferably with food to help absorb vitamin D3.

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 high concentration is not recommended for use in pregnant women and breastfeeding women.

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 use machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The capsule should be swallowed whole (for example, with water)

Deltius should be taken preferably with food.

Use in adults

The recommended dose is one 25,000 UI capsule per week for the first month. After the first month, the dose may be reduced.

Higher doses may be required:

-50,000 UI/week for 6 – 8 weeks;

This initial treatment may be followed by maintenance therapy, as indicated by your doctor.

Your doctor will adjust the dose for you.

Pediatric population

Deltius is not recommended for children and adolescents under 18 years.

Pregnancy and Lactation

Deltius is not recommended.

If you take more Deltius than you should

If you take more than the prescribed amount, stop taking the medication and call your doctor. If you are unable to contact your doctor, go to the nearest hospital emergency department and bring the packaging with the medication.

You can also contact the Toxicology Information Service, phone 915620420, indicating the medication and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for up to 24 hours, constipation, dehydration, and elevated levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) determined by 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 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.

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 associated with the use of Deltius may be:

Rarely Occurring(affect up to 1 in 100 people):

- Hypercalcemia (excess calcium in the blood)

- Hypercalciuria (excess calcium in the urine)

Uncommon(affect up to 1 in 1000 people):

- Cutaneous rash (skin rash or 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.

Store in the original packaging to protect it from light.

Do not refrigerate or freeze

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Deltius

• The active principle is colecalciferol (vitamin D 3 ).

A capsule contains: 0.625 mg of colecalciferol (vitamin D 3 ) equivalent to 25,000 IU.

• The other excipients are:

• A refined olive oil,
• Gelatin,
• Titanium dioxide (E-171),
• Yellow Iron oxide (E-172),
• Black Iron oxide (E-172).

Appearance of the product and contents of the packaging

Deltius 25,000 IU is a hard capsule with a transparent body and white cap, with a green band. The size of the capsule is 15.9 mm x 5.8 mm .

It contains an oily solution and is supplied in aluminum PVC / PVDC blisters in cardboard boxes.

Each box may contain 1, 3, 4, 8 or 12 capsules.

Only some packaging sizes may be marketed.

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

Last review date of this leaflet: March 2019

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