UVEDIN 10,000 IU/mL ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

Uvedin10,000 IU/mloral drops in solution

Colecalciferol (Vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 you take Uvedin
3. How to take Uvedin
4. Possible side effects
5. Storage of Uvedin
6. Contents of the pack and other 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 absorption of calcium in the intestines and to promote adequate bone mineralization.

This medicine is used to prevent Vitamin D3 deficiency in adults, adolescents, and children with an identified risk of Vitamin D deficiency and to treat Vitamin D deficiency. This medicine can also be used as an adjunct to specific medication for bone loss (osteoporosis).

2. What you need to know before you take Uvedin

Do not take Uvedin

• If you are allergic to Vitamin D3 or any of the other ingredients 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 kidney failure.
• If you have high levels of Vitamin D3 in the blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before taking Uvedin.

• If you have a hormonal imbalance of the parathyroid gland (pseudo-hypoparathyroidism).

Tell your doctor if you are already taking other products that contain calcium or Vitamin D (including metabolites or analogs of Vitamin D), fortified foods or milk with Vitamin D, as Vitamin D accumulates in the body and an overdose can cause toxic effects. That's why you should 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 and are being treated with cardiac glycosides or diuretics;
• You suffer from sarcoidosis or other granulomatous diseases.

Other medicines and Uvedin

Tell your doctor or pharmacist that you are taking or have recently taken or might take any other medicines.

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

• Medicines for treating epilepsy;
• Barbiturates (used during anesthesia or as a sleeping pill);
• Rifampicin, isoniazid (antibiotics);
• 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 lower cholesterol levels in the blood (such as cholestyramine or colestipol);
• Certain weight loss medicines that reduce the amount of fat your body absorbs (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

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Vitamin D deficiency is harmful to the mother and child. This medicine should be used during pregnancy and breastfeeding only if your doctor has recommended it.

Vitamin D overdoses should be avoided during pregnancy, as prolonged hypercalcemia can cause physical and mental developmental delays, supravalvular aortic stenosis, and retinopathy in the child.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 exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Shake before use.

You should take this medicine preferably with the main meals.

This medicine has an olive oil flavor. It can be taken alone or you can also mix the prescribed amount of drops with a spoon or a small amount of cold or warm food. Make sure to take the complete dose.

The recommended dose is:

Use in adults

The recommended dose

• For the prevention of Vitamin D deficiency is 3-4 drops (600 IU - 800 IU) per day.
• As a supplement to specific treatment for bone loss (osteoporosis) is 5 drops (800 IU) per day. According to national guidelines and medical assessment, your doctor may increase the dose up to 5 drops (1,000 IU) per day.

For the treatment of Vitamin D deficiency, the dose is usually 4 drops (800 IU) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25 (OH) D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 4,000 IU (20 drops per day).

Use in children and adolescents

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

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

For the treatment of Vitamin D deficiency in children (from 0 to 11 years) and adolescents (from 12 to 17 years), the dose should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25 (OH) D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1,000 IU per day for children under 1 year, 2,000 IU per day for children from 1 to 10 years, and 4,000 IU per day for adolescents.

In children, this medicine can be mixed with a small amount of baby food, yogurt, milk, cheese, or other dairy products. Do not add Uvedin to baby bottles or other containers with food that the child will not consume completely and continuously, in order to avoid the child not taking the complete dose. You must ensure that the child takes the complete dose. In cases of children who have passed the breastfeeding stage, the prescribed dose should be administered with some main meal.

Do not store any product or food that contains this medicine to be used later or in 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 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 package contains a bottle with a dropper inserted. The bottle is sealed with a child-resistant plastic cap. 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. Put the prescribed number of drops in a spoon;
3. Replace the cap to close the bottle;
4. Place the bottle in the original carton box.

Figure 1

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, whose symptoms are: nausea, vomiting, thirst, polydipsia, polyuria, constipation, dehydration.

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. (See section Pregnancy and Breastfeeding).

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 further questions on 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;
• Somnolence, confusion;
• Headache;
• Constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth;
• Rash, itching, urticaria;
• Too much calcium deposited in the kidneys (nephrocalcinosis), increased urine production, kidney failure;
• High levels of calcium in the blood and urine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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 expiry date which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

5 months after the first opening, the medicine must be discarded, even if it is not fully used.

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

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

6. Contents of the pack and other 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 ingredients are: refined olive oil.

Appearance and packaging

Clear, slightly yellowish solution, odorless.

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

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 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/