DELTIUS 25,000 IU HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Deltius 25,000 IU Hard Capsules

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Deltius and what is it used for
2. What you need to know before you take Deltius
3. How to take Deltius
4. Possible side effects
5. Storage of Deltius
6. Contents of the pack and further information

1. What is Deltius and what is it used for

Deltius contains the active substance colecalciferol (Vitamin D3). Vitamin D3 can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D helps the body absorb calcium in the kidneys and intestines, which helps form bones. A deficiency of Vitamin D is the main 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.

2. What you need to know before you take Deltius

Do not take Deltius:

• if you are allergic to Vitamin D3 or any of the other ingredients of this medicine (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 taking Deltius if you:

• are being treated with certain medicines for heart conditions (e.g., cardiac glycosides, such as digoxin).
• have sarcoidosis (an autoimmune disease that can cause increased levels of Vitamin D in the body).

• are being treated with diuretics (e.g., benzothiadiazine)
• are immobilized
• have pseudo-hypoparathyroidism
• are being treated with medicines that contain 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 that contain calcium. Your doctor should monitor your blood calcium levels to ensure they are not too high during your treatment with Deltius.
• have kidney disease or damage and if you have a tendency to form kidney stones. Your doctor may want to 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 at the same time as Vitamin D3, they can cause a significant increase in blood and urine calcium levels.
• medicines that contain Vitamin D or foods rich in Vitamin D, such as some types of milk enriched with Vitamin D.
• actinomycin (a medicine used to treat some types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medicines used to treat fungal diseases). These medicines can interfere with the processing of Vitamin D3 in the body.
• medicines used to treat tuberculosis, such as rifampicin and isoniazid
• the following medicines, as they may interfere with the effect or absorption of Vitamin D3:
  • antiepileptic medicines (anticonvulsants), barbiturics;
  • 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);
  • certain medicines used to lose weight by reducing fat absorption (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

Taking Deltius with Food, Drinks, and Alcohol

You should take Deltius preferably with food to help with the absorption of Vitamin D3.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This high concentration is not recommended for use in pregnant or breast-feeding women.

Driving and Using Machines

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

3. How to Take Deltius

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The capsule should be swallowed whole (e.g., with water)

Deltius should be taken preferably with food.

Use in Adults

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

High doses may be required:

• 50,000 IU/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 in children and adolescents under 18 years of age.

Pregnancy and Breast-feeding

Deltius is not recommended.

If You Take More Deltius Than You Should

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

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

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

If You Forget to Take Deltius

If you forget to take a dose of Deltius, take the next missed dose as soon as possible. Then, take the next dose at the usual time. However, if it is close to the time of the next dose, do not take the missed dose and take the next dose at the usual time.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects associated with the use of Deltius may be:

Uncommon(affect up to 1 in 100 people):

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

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

• Skin rash (hives or skin eruption)
• Itching (pruritus)
• Urticaria

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from light.

Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Deltius

• The active substance is colecalciferol (Vitamin D3).

One capsule contains: 0.625 mg of colecalciferol (Vitamin D3) equivalent to 25,000 IU.

• The other excipients are:

• 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 Pack

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.

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:March 2019

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