Package Insert: Information for the User

Delcrin25,000 IU/2.5 ml Oral Solution

Colecalciferol (Vitamin D3)

For use in adults

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Delcrin contains the active ingredient colecalciferol (vitamin D3).The main function of vitamin D is to ensure proper absorption of calcium in the intestines and

promote adequate bone mineralization.

Delcrin oral solution is used toprevent and treat vitamin D deficiency in adults.

Do not take Delcrin

• If you are allergic to vitamin D3or to 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 insufficiency.
• If you have high levels of vitamin D3 in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Inform your doctor if you are already taking other products containing vitamin D, foods or milk enriched with vitamin D, as vitamin D accumulates in the body and an overdose can cause toxic effects.
That is why the recommended dose should not be exceeded.

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 have sarcoidosis or other granulomatous diseases.

Children and adolescents

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

Use of Delcrin with other medications

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

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

• Medications for treating epilepsy;
• Barbiturates (used during anesthesia or as a sleep medication);
• Rifampicin (an antibiotic);
• Thiazide diuretics (medications that promote urine excretion, such as hydrochlorothiazide);
• Glucocorticoids (used to treat inflammation);
• Medications containing digitalis (for the treatment of heart conditions);
• Antacids containing aluminum;
• Preparations containing magnesium;
• Medications that reduce cholesterol levels in the blood (such as cholestyramine or colestipol);
• Certain weight loss medications that reduce the amount of fat your body absorbs (e.g., orlistat);
• Certain laxatives (such as liquid paraffin);
• Actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medications used to treat fungal diseases). These medications may interfere with the way your body processes vitamin D3.

Pregnancy and breastfeeding

Adequate vitamin D intake is necessary during pregnancy and breastfeeding. If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

This high-concentration formulation is not recommended for pregnant women and breastfeeding women, and a product with lower doses should be used.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Shake before use.

Take Delcrin preferably with a meal.

This medication has a taste of olive oil.Delcrin can be taken alone or mixed with a small amount of cold or lukewarm food.Make sure to take the full dose.

Dose

Adult use

The recommended dose is 1 vial (25,000 IU) per week for the first month, your doctor will adjust the dose.

Pediatric population

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

Pregnancy and lactation

Delcrin is not recommended during pregnancy or lactation.

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 medication and the amount ingested.

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

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

If you forgot to take Delcrin

Do not take a double dose to compensate for the missed dose. Omit the missed dose and continue treatment as usual.

If you stop taking Delcrin
Do not stop taking Delcrin on your own.

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 will experience them.

Unknown frequency: the frequency cannot be estimated from the available data:

• Allergic reactions (hypersensitivity);
• Weakness, loss of appetite (anorexia), thirst;
• Drowsiness, state of confusion;
• Headache;
• Constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth;
• Skin rash, itching, urticaria;
• Excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal insufficiency
• High levels of calcium in the blood and urine.

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.

Store in the original packaging to protect it from light. Do not 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 your 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 Delcrin

- The active ingredient is colecalciferol (vitamin D3).1 ml contains: 0.25 mg of colecalciferol (equivalent to 10,000 UI). 1 drop contains: 200 UI of colecalciferol.

- The other components are: refined olive oil.

Appearance of the product and contents of the packaging

Transparent, slightly yellow, odorless solution.

Each package contains an amber-colored glass vial of 10 ml, with a closed polyethylene cap that is child-resistant. The package contains a vial with an inserted dropper.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

OP PHARMA SRL

Via Monte Rosa, 61

20149 - Milan

Italy

Responsible for manufacturing

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

Last review date of this leaflet:September 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/