Package Insert: Information for the User

Delcrin10.000 UI/mlOral drops in solution

Colecalciferol (Vitamin D3)

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 who may 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 good calcium absorption in the intestines and promote adequate bone mineralization.

Delcrin oral drops in solution are used to prevent vitamin D3deficiency in adults, adolescents, and children with identified risk of vitamin D deficiency and to treat vitamin D deficiency


Delcrin oral drops in solution can also be used as an adjunct to specific medication for bone mass loss.

Do not take Delcrin

• 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 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 Delcrin.

• If you have a hormonal parathyroid imbalance (pseudohypoparathyroidism).

Inform your doctor if you are already taking other products containing calcium or vitamin D (including metabolites or analogs of vitamin D), foods or milk enriched with vitamin D, as vitamin D accumulates in the body and an overdose can cause toxic effects.
This 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.

Use of Delcrin with other medications

Inform your doctor or pharmacist that you are using or have recently used 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 to treat epilepsy;
• Barbiturates (used during anesthesia or as a sleep medication);
• Rifampicin, isoniazid (antibiotics);
• Thiazide diuretics (medications that promote urine excretion, such as hydrochlorothiazide);
• Glucocorticoids (used to treat inflammation);
• Medications containing digitals (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
If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Vitamin D deficiency is harmful to the mother and child.

Delcrin should only be used during pregnancy and breastfeeding if recommended by your doctor.

Vitamin D overdoses should be avoided during pregnancy, as prolonged hypercalcemia can cause physical and mental developmental delays, aortic stenosis, and retinopathy in the child.

Driving and operating machinery

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

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

Shake before use.

Take Delcrin preferably with main meals.

This medication has a taste of olive oil. You can take it alone or also mix the prescribed amount of drops with a spoon or with a small amount of cold or lukewarm foods. Make sure to take the full dose.

Dose recommended is:

Use in adults

The recommended dose

• for the prevention of vitamin D deficiency is 3-4 drops (600 IU - 800 UI) per day.
• As a complement to specific medication for bone loss (osteoporosis) is 3-4 drops (600 UI - 800 UI) per day. According to national guidelines and medical evaluation, your doctor may increase the dose up to 5 drops (1000 UI) per day.

For the treatment of vitamin D deficiency, the dose is usually 4 drops (800 UI) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxyvitamin D (25 (OH) D), the severity of the disease, and the patient's response to treatment.

The daily dose should not exceed 4000 UI (20 drops per day).

Use in children and adolescents

For the prevention of vitamin D deficiency in children (0 to 11 years) with identified risk, the recommended dose is 2 drops (400 UI) per day.

From the second year of life, in case of multiple risk factors, according to clinical evaluation, the doctor may increase the dose up to 4 drops (800 UI) per day.

For prevention in adolescents (12 to 17 years) with identified risk, the recommended dose is 3-4 drops (600-800 UI) per day.

For the treatment of vitamin D deficiency in children (0 to 11 years) and adolescents (12 to 17 years), the dose should be adjusted depending on the desired serum levels of 25-hydroxyvitamin D (25 (OH) D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1000 UI per day for children under 1 year, 2000 UI per day for children 1 to 10 years old, and 4000 UI per day for adolescents.

Delcrin can be mixed with a small amount of food for children, yogurt, milk, cheese, or other dairy products. Do not add Delcrin to baby bottles with milk or other containers with food that the child will not consume completely uninterrupted, in order to avoid the child not taking the full dose. Make sure the child takes the full dose. In cases of children who have passed the breastfeeding stage, the prescribed dose should be administered with a main meal.

Do not store any product or food containing Delcrin for later use or for the next meal.

Use during pregnancy and lactation

The recommended dose is 400-600 UI / day (2-3 drops). Higher doses may be required after confirmation of vitamin D deficiency, but do not take more than recommended by your doctor.
Vitamin D and its metabolites pass into breast milk. This should be taken into account when administering additional vitamin D to the child.

Instructions for use

The container contains a bottle with a dropper inserted. The bottle is sealed with a child-resistant plastic cap. To use the medication, shake the bottle before use and follow the instructions below:

1. To open the bottle, press the cap down and turn at the same time (see Figure 1);
2. put the number of drops prescribed on a spoon;
3. re-tighten the cap to close the bottle;
4. place the bottle in the original cardboard box.

Figure 1

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, polyuria, constipation, dehydration.

The increase in maternal blood calcium levels can also cause suppression of parathyroid function in infants, resulting in low blood calcium levels, muscle cramps, and spasms (tetany) and convulsions (see Pregnancy and Lactation section).

If you forget to take Delcrin

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

If you interrupt treatment with Delcrin
Do not stop taking Delcrin on your own.

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

Like all medications, this medication may produce adverse effects, although not everyone 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 not listed in this prospectus. You can also report them directly through the National System for 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.

Five months after the first opening, the medication must be discarded, even if it has not been used in full.

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

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

Composition of Delcrin

- The active principle 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 a dropper inserted.

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. Chemical and Pharmaceutical Laboratory Salentino

S.S. 16 Industrial Zone

73010 Zollino - Lecce, Italy

Local Representative:

Laboratorios Rubió, S.A.

Industry 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/