Delcrin 10,000 IU/mL oral solution in drops

Patient Information Leaflet

Introduction

Patient Information Leaflet

Delcrin 10,000 IU/mL oral drops solution

Colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Delcrin is and what it is used for

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

Delcrin oral drops solution is used to prevent vitamin D3 deficiency in adults, adolescents, and children who are at an identified risk of vitamin D deficiency, and to treat vitamin D deficiency. Delcrin oral drops solution can also be used as an adjunct to specific medication for bone mass loss.

2. What you need to know before using Delcrin

Do not take Delcrin

• 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 D3 in your blood (hypervitaminosis D).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Delcrin.

• if you have a parathyroid hormone imbalance (pseudohypoparathyroidism).

Inform your doctor if you are already taking other products containing calcium or vitamin D (including vitamin D metabolites or analogues), vitamin D–enriched foods or milk, as vitamin D accumulates in the body and overdose may cause toxic effects. Therefore, the recommended dose must not be exceeded.

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

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

Use of Delcrin with other medicines

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

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

• medicines to treat epilepsy;
• barbiturates (used during anaesthesia or as sleeping medication);
• rifampicin, isoniazid (antibiotics);
• thiazide diuretics (medicines that promote urinary excretion, such as hydrochlorothiazide);
• glucocorticoids (used to treat inflammation);
• medicines containing digitoxics (for the treatment of heart conditions);
• antacids containing aluminium;
• magnesium-containing preparations;
• medicines that reduce cholesterol levels in the blood (such as cholestyramine or colestipol);
• certain weight-loss medicines 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 ketoconazole, medicines used to treat fungal diseases). These medicines may interfere with the way your body processes vitamin D3.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Vitamin D deficiency is harmful to both mother and child. Delcrin should be used during pregnancy and breast-feeding only if recommended by your doctor.

Vitamin D overdoses must be avoided during pregnancy, as prolonged hypercalcemia may cause delayed physical and mental development, supravalvular aortic stenosis, and retinopathy in the child.

Driving and use of machines

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

3. How to take Delcrin

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Shake well before use.

You should take Delcrin preferably during the main meals.

This medicine has an olive oil flavour. It may be taken alone or mixed with a spoonful or a small amount of cold or lukewarm food. Make sure you take the full dose.

The recommended dose is:

Use in adults

The recommended dose

• for prevention of vitamin D deficiency is 3–4 drops (600 IU – 800 IU) daily.
• as an adjunct to specific treatment for bone loss (osteoporosis) is 3–4 drops (600 IU – 800 IU) daily. According to national guidelines and medical assessment, your doctor may increase the dose up to 5 drops (1000 IU) daily.

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

The daily dose must not exceed 4,000 IU (20 drops daily).

Use in children and adolescents

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

From the second year of life, in case of multiple risk factors, according to clinical assessment, the doctor may increase the dose up to 4 drops (800 IU) daily.

For prevention in adolescents (12 to 17 years) with identified risk, the recommended dose is 3–4 drops (600–800 IU) daily.

For treatment of vitamin D deficiency in children (0 to 11 years) and adolescents (12 to 17 years), the dose should be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and the patient's response to treatment. The daily dose must not exceed 1000 IU in children under 1 year, 2000 IU daily in children aged 1 to 10 years, and 4000 IU daily in adolescents.

In children, Delcrin may be mixed with a small amount of infant food, yoghurt, milk, cheese or other dairy products. Do not add Delcrin to bottles of milk or other food containers that the child may not consume completely at once, to avoid the child not receiving the full dose. Ensure that the child takes the complete dose. In 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 breastfeeding

The recommended dose is 400–600 IU/day (2–3 drops). Higher doses may be required after confirmation of vitamin D deficiency, but you must not take more than your doctor recommends. Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Instructions for use

The container consists of a bottle with a dropper inserted. The bottle is sealed with a child-resistant plastic closure. To use the medicine, shake the bottle before use and follow the instructions below:

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

Figure 1

If you take more Delcrin than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.

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

Elevated calcium levels in maternal blood may also cause suppression of parathyroid function in infants, resulting in low blood calcium levels, muscle cramps and spasms (tetany), and seizures (see section Pregnancy and Breastfeeding).

If you forget to take Delcrin

Do not take a double dose to make up for a missed dose. Skip the missed dose and continue your treatment as usual.

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

If you have any further 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 will experience 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, diarrhoea, metallic taste, dry mouth;
• excessive calcium deposition in the kidneys (nephrocalcinosis), increased volume of urine excreted, renal failure;
• high levels of calcium in the blood and urine.

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 via the Spanish National Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

After first opening, the medicine must be discarded after 5 months, even if it has not been completely used.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 colecalciferol (equivalent to 10,000 IU). 1 drop contains: 200 IU colecalciferol.
• The other component is: refined olive oil.

Appearance of the medicinal product and contents of the pack

Clear, slightly yellow, odourless solution.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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:

OP PHARMA SRL

Via Monte Rosa, 61

20149 - Milan

Italy

Date of the most recent revision of this leaflet: September 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/