Deltius 25.000 UI hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deltius 25,000 IU hard capsules

colecalciferol (vitamin D3)

Read this entire 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may 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.

Contents of the 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 failure;
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Deltius if you:

• are being treated with certain medicines used for heart conditions (e.g., cardiac glycosides such as digoxin).
• have sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D in the body).
• are being treated with diuretics (e.g., benzothiadiazines).
• are immobilized.
• suffer from pseudohypoparathyroidism.
• are being treated with medicines containing vitamin D, or consume vitamin D–enriched foods or milk.
• are likely to be exposed to significant sunlight while using Deltius.
• take other supplements containing calcium. Your doctor should monitor your blood 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 may wish to monitor your blood and urine calcium levels.
• your doctor should monitor blood calcium levels via laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.

Children and adolescents

Use 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 need to take any other medicines. This is especially important if you are taking:

• medicines used to treat heart or kidney conditions, 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–enriched 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 body's processing of vitamin D3.
• medicines used to treat tuberculosis, for example, rifampicin, isoniazid.
• 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), as they may reduce the effect of vitamin D3;
  • medicines that reduce 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).

Taking Deltius with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

Information regarding possible effects of this medicine on the ability to drive is limited. However, driving and operating machinery are not expected to be affected.

3. How to take Deltius

Follow exactly the instructions for use provided in this leaflet or those given 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 preferably be taken with food.

Use in adults

The recommended dose is one 25,000 IU capsule once weekly for the first month. After the first month, a lower dose 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, as directed by your doctor.

Your doctor will adjust the dose according to your needs.

Paediatric population

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

Pregnancy and breastfeeding

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 reach your doctor, go immediately to the nearest hospital emergency department and take the medicine packaging with you.

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

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, increased 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 missed dose as soon as possible. Then, take the next dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the regular time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Possible adverse effects associated with the use of Deltius may include:

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 (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 30 °C.

Keep in the original packaging to protect from light.

Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and additional 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, featuring a green band. The capsule measures 15.9 mm x 5.8 mm.

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

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

Only certain 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 medicinal product is authorized in the European Economic Area Member States under the following names:

UK: DELTIUS 25 000 I.U. hard capsules
Greece: DELTIUS 25.000 I.U. σκληρά καψύλες
Spain: DELTIUS 25.000 UI cápsulas duras
Portugal: DELTIUS 25 000 U.I. cápsulas
Cyprus: Deltius 25.000 IU σκληρά καψύλες

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

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