DELCRIN 50,000 IU/2.5 ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Delcrin50,000 IU/2.5 ml Oral Solution

Colecalciferol (Vitamin D3)

For use in adults

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Delcrin and what is it used for

Delcrin contains the active substance colecalciferol (Vitamin D3). The main function of Vitamin D is to ensure good absorption of calcium in the intestines and to promote adequate bone mineralization.

Delcrin oral solution is used to prevent and treat Vitamin D deficiency in adults.

2. What you need to know before you take Delcrin

Do not take Delcrin

• 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 the blood (hypercalcemia) or in the urine (hypercalciuria).
• If you have kidney stones (renal calculi) or severe kidney failure.
• If you have high levels of Vitamin D3 in the blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• If you have a disorder of the parathyroid hormone (pseudohypoparathyroidism).

Tell your doctor if you are already taking other products that contain Vitamin D, foods or milk fortified with Vitamin D, as Vitamin D accumulates in the body and an overdose can cause toxic effects. That's why you should not exceed the recommended dose.

Your doctor will monitor you and perform blood and/or urine tests if:

• you have kidney stones (renal calculi);
• you have kidney problems;
• you are an elderly patient and are being treated with cardiac glycosides or diuretics;
• you suffer from sarcoidosis or other granulomatous diseases.

Children and adolescents

It is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Delcrin

Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.

The effect of Delcrin may be affected by other medicines. Tell your doctor if you are taking:

• medicines for treating epilepsy;
• barbiturates (used during anesthesia or as a sleeping medicine);
• rifampicin (an antibiotic);
• thiazide diuretics (medicines that promote urinary excretion, such as hydrochlorothiazide);
• glucocorticoids (used to treat inflammation);
• medicines that contain digitalis (for the treatment of heart conditions);
• antacids that contain aluminum;
• preparations that contain magnesium;
• medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol);
• certain medicines for weight loss that reduce the amount of fat absorbed by your body (e.g., orlistat);
• certain laxatives (such as liquid paraffin);
• actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazol, medicines used to treat fungal diseases). These medicines may interfere with the way your body processes Vitamin D3.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, adequate intake of Vitamin D is necessary. If you are pregnant or breastfeeding, 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 formulation is not recommended for pregnant and breastfeeding women, and a product with lower doses should be used.

Driving and using machines

There is no information on the possible effects of this medicine on the ability to drive.

3. How to take Delcrin

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

Shake before use.

You should take Delcrin preferably with a meal.

This medicine has an olive oil flavor. Delcrin can be taken alone or you can also mix the solution with a small amount of cold or lukewarm food. Make sure to take the complete dose.

Dose

Use in adults

Your doctor should consider lower doses for the initial treatment of clinically relevant Vitamin D deficiency. In this case, other available pharmaceutical products should be used.

In case higher doses are required, the following posology may be considered under medical supervision:

• 50,000 IU (one vial) once a week, (up to a maximum of 6 weeks).

Pediatric population

Delcrin is not recommended for children and adolescents under 18 years of age.

Pregnancy and breastfeeding

Delcrin is not recommended during pregnancy or breastfeeding.

If you take more Delcrin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, calcium levels in the blood and urine may increase, with symptoms such as nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.

An overdose during the first 6 months of pregnancy can cause toxic effects in the fetus; there is a correlation between overdose or extreme maternal sensitivity to Vitamin D during pregnancy and delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. The increase in calcium levels in the maternal blood can also cause suppression of parathyroid function in babies, resulting in reduced calcium levels in the blood, muscle cramps, and spasms (tetany) and convulsions.

If you forget to take Delcrin

Do not take a double dose to make up for forgotten doses. Omit the forgotten dose and continue treatment as usual.If you stop taking DelcrinDo not stop taking Delcrin on your own. 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.

Frequency not known: frequency cannot be estimated from the available data:

• allergic reactions (hypersensitivity);
• weakness, loss of appetite (anorexia), thirst;
• drowsiness, confusion;
• headache;
• constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth;
• skin rash, itching, urticaria;
• excessive calcium deposited in the kidneys (nephrocalcinosis), increased urine production, kidney failure
• high levels of calcium in the blood and urine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, 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 Delcrin

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 carton after “EXP”. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light. Do not 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 other information

Composition of Delcrin

• The active substance is colecalciferol (Vitamin D3). 1 ml contains: 0.25 mg of colecalciferol (equivalent to 10,000 IU). 1 drop contains: 200 IU of colecalciferol.
• The other ingredients are: refined olive oil.

Appearance and packaging

Transparent solution, slightly yellow, odorless.

Each pack contains a 10 ml amber glass bottle with a child-resistant polyethylene cap. The pack contains a bottle with a dropper inserted.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OP PHARMA SRL

Via Monte Rosa, 61

20149 - Milan

Italy

Manufacturer

Mipharm S.p.a.

Via Bernardo Quaranta 12

20141, Milan, Italy

Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino

S.S. 16 Zona Industriale

73010 Zollino - Lecce, Italy

Local Representative:

Laboratorios Rubió, S.A.

Industria 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of last revision of this leaflet:September 2021

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