Delcrin 25,000 IU/2.5 ml oral solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Delcrin 25,000 UI/2.5 ml oral solution
Colecalciferol (vitamin D3)
For use in adults
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.
Leaflet contents:
- What Delcrin is and what it is used for
- What you need to know before taking Delcrin
- How to take Delcrin
- Possible side effects
- How to store Delcrin
- 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 solution is used for the prevention and treatment of vitamin D deficiency in adults.
2. What you need to know before taking Delcrin
Do not take Delcrin
- If you are allergic to vitamin D3 or to any of the other components 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 starting to take this medicine.
Inform your doctor if you are already taking other products containing vitamin D, or vitamin D–enriched foods or milk, since vitamin D accumulates in the body and an overdose may cause toxic effects. For this reason, the recommended dose should not be exceeded.
Your doctor will monitor you and may perform 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 suffer from sarcoidosis or other granulomatous diseases.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Taking Delcrin with other medicines
Tell your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.
The effect of Delcrin may be affected by other medicines. Inform your doctor if you are taking:
- medicines used to treat epilepsy;
- barbiturates (used during anesthesia or as sleeping medication);
- rifampicin (an antibiotic);
- thiazide diuretics (medicines that promote urinary excretion, such as hydrochlorothiazide);
- glucocorticoids (used to treat inflammation);
- medicines containing digitalis (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 how your body processes vitamin D3.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, an adequate intake of vitamin D is required. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This high–concentration formulation is not recommended for pregnant or breastfeeding women, and a product with lower doses should be used.
Driving and using 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. If in doubt, consult your doctor or pharmacist again.
Shake well before use.
You should take Delcrin preferably with a meal.
This medicine has an olive oil flavour. Delcrin can be taken alone or may also be mixed with a small amount of cold or lukewarm food. Make sure you take the full dose.
Dosage
Use in adults
The recommended dose is 1 vial (25,000 IU) per week for the first month; your doctor will then adjust the dose.
Paediatric 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
In case of overdose, calcium levels in 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 delayed physical and mental development in the child, supravalvular aortic stenosis, and retinopathy. Increased calcium levels in maternal blood may also cause suppression of parathyroid function in babies, resulting in reduced blood calcium levels, muscle cramps and spasms (tetany), and seizures.
If you forget to take Delcrin
Do not take a double dose to make up for missed doses. Skip 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 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 experiences them.
Frequency not known: frequency cannot be estimated from the available data:
- allergic reactions (hypersensitivity);
- weakness, loss of appetite (anorexia), thirst;
- somnolence, confusion;
- headache;
- constipation, flatulence, abdominal pain, nausea, vomiting, diarrhoea, metallic taste, dry mouth;
- skin rash, itching, urticaria;
- excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure;
- high levels of calcium in the blood and urine.
Reporting of adverse effects
If you experience any 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 Delcrin
Keep this medicine out of 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.
Store in the original packaging to protect from light. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 of colecalciferol (equivalent to 10,000 IU). 1 drop contains: 200 IU of colecalciferol.
- The other component is: refined olive oil.
Appearance of the 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 dropper bottle with dropper insert.
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/