UVEDIN 25,000 IU/2.5 ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Uvedin25,000 IU/2.5 ml Oral Solution

Colecalciferol (Vitamin D3)

For use in adults

Read this entire leaflet carefully before starting to take 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 to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Uvedin and what is it used for

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

This medicine is used to prevent and treat Vitamin D deficiency in adults.

2. What you need to know before taking Uvedin

Do not take Uvedin

• If you are allergic to Vitamin D3 or any of the other components 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 renal insufficiency.
• If you have high levels of Vitamin D3 in the blood (hypervitaminosis D).

Warnings and precautions

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

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. Therefore, do 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 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 Uvedin

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

The effect of Uvedin may be affected by other medicines. Inform 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 containing digitalis (for the treatment of heart conditions);
• antacids containing aluminum;
• preparations containing magnesium;
• 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 breastfeeding

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.

During pregnancy and breastfeeding, adequate intake of Vitamin D is necessary. This high-concentration formulation is not recommended in 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 Uvedin

Follow the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Shake before use.

You should take this medicine preferably with a meal.

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

Dose

Use in adults

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

Pediatric population

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

Pregnancy and breastfeeding

This medicine is not recommended during pregnancy or breastfeeding.

If you take more Uvedin 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 may 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 Uvedin

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 UvedinDo not stop taking this medicine on your own.

If you have any other questions about 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 deposits in the kidneys (nephrocalcinosis), increased urine production, renal insufficiency
• high levels of calcium in the blood and urine.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 Uvedin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the outer packaging to protect from light. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Uvedin

• 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 components are: refined olive oil.

Appearance and packaging of the product

Transparent, slightly yellow, odorless solution.

Each pack contains a 15 ml amber glass bottle filled with 10 ml of oral drops solution, with a child-resistant polyethylene cap. The pack contains a bottle with a dropper insert.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Lorien S.L.

Av. Josep Tarradellas 8, Ático 1ª

08029

Barcelona, SPAIN

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

Date of the last revision of this leaflet: December 2022

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/