Prospecto: information for the user

Vitamina D3 Fresenius Kabi 14.400 IU/ml oral drops in solution EFG

colecalciferol (vitamin D3)

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they 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 prospect. See section4.

1.What is Vitamina D3 Fresenius Kabi and how it is used

2.What you need to know before starting to take Vitamina D3 Fresenius Kabi

3.How to take Vitamina D3 Fresenius Kabi

4.Possible adverse effects

1. Storage of Vitamina D3 Fresenius Kabi

6.Contents of the package and additional information

This medication contains the active ingredient colecalciferol (vitamin D3).

This medicationis used for:

-Prevention and treatment of vitamin D deficiency

-Treatment of rickets (a disease affecting bone development in children)

-As an adjunct to treatment for osteoporosis in patients at risk of vitamin D deficiency

Do not take Vitamina D3 Fresenius Kabi:

-if you are allergic to the active ingredient or any of the other components of this medication (listed in section6).

-if you have a disease that causes high levels of calcium in the blood or an increase in the excretion of calcium in the urine (such as with treatment with certain medications, such as benzotiazine derivatives, or if you are bedridden)

-if you have, or are prone to developing, kidney stones that contain calcium

-if you have an excess of vitamin D

-if you have severe arteriosclerosis (hardening of the arteries)

-if you have severe renal dysfunction

Warnings and precautions

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

You should exercise special caution when taking this medication:

-if you are being treated with certain heart medications (cardiac glycosides) or thiazide diuretics

-if you have severe renal dysfunction. In this case, your doctor will monitor your calcium and phosphate levels in the blood. You should be aware of the risk of soft tissue calcification.

-in the case of severe renal dysfunction, the use of colecalciferol is not recommended. Your doctor may prescribe another vitamin D supplement.

-if you have sarcoidosis (Boeck's disease), there is a risk of increased formation of the active form of vitamin D.

-in the case of decreased bone mass due to inactivity (e.g., bed rest), there is a higher risk of elevated calcium levels in the blood.

Your doctor will check your calcium levels in the blood and urine periodically and monitor your renal function during long-term use. If necessary, your doctor will instruct you to reduce the dose or discontinue treatment.

Increased levels of parathyroid hormone can increase vitamin D metabolism and thus increase the requirements for vitamin D.

Additional doses of vitamin D should only be taken under close medical supervision.

Children and adolescents

You should avoid using other products containing vitamin D, especially in infants. If in doubt, your doctor will decide on the suitability of additional use of fortified foods or infant formulas containing vitamins or medications containing vitamin D.

Other medications and Vitamina D3 Fresenius Kabi

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is especially important if you are taking:

• Rifampicin or isoniazid (for tuberculosis).
• Certain heart medications (cardiac glycosides), as they may potentiate the harmful effects by increasing calcium levels in the blood (risk of arrhythmias). Close medical supervision may be required, which may include an electrocardiogram (ECG) and monitoring of calcium levels in the blood.
• Thiazide diuretics, as they increase the risk of elevated calcium levels in the blood, as these medications reduce calcium excretion in the urine. In this case, your doctor will check your calcium levels in the blood periodically.
• Medications for the treatment of epilepsy (carbamazepine, phenobarbital, phenytoin, primidone) or certain adrenal cortex hormones (glucocorticoids, cortisone), as they may increase the requirements for vitamin D.
• Medications to reduce lipids in the blood (e.g., orlistat and cholestyramine), as they may reduce vitamin D absorption in the intestine.
• Medications containing magnesium (e.g., antacids), which should not be used during treatment with this medication as they may increase magnesium levels in the blood (hypercalcemia).
• Tablets containing aluminum (for heartburn).

Taking Vitamina D3 Fresenius Kabi with food and beverages

Caution is recommended with foods or infant formulas enriched with vitamins.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

If you are pregnant and your doctor prescribes this medication, you should strictly follow the dose prescribed by your doctor, as excessive vitamin D3 can lead to a risk of physical and mental retardation, as well as heart and eye diseases, in your baby.

Lactation

Vitamin D and its metabolites pass into breast milk. No overdoses have been observed in infants. However, this should be taken into account if the infant receives additional vitamin D.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

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

Your doctor will determine the suitable dose for you. The dose depends on the disease for which your doctor prescribes this medication. Therefore, always take the dose prescribed to you individually, even if you know other people who take a higher dose.

Unless your doctor tells you otherwise, the recommended dose is as follows:

Prevention of vitamin D deficiency:

The usual daily dose is:

For newborns, infants, and children from the second week of life to 3 years of age: between 1 and 2 drops.

For children 4 years of age and older and adolescents: between 1 and 3 drops.

For adults between 19 and 70 years of age: between 1 and 4 drops.

For elderly individuals over 70 years of age: between 2 and 4 drops.

Treatment of rickets:

The total amount of vitamin D required depends on the severity of the disease.

In cases of pre-existing rickets, treatment begins with a preparation at a higher concentration of vitamin D for initial treatment.

Afterwards, the usual dose is between 2 and 12 drops of this medication per day.

Treatment of vitamin D deficiency:

The usual daily dose is:

For children and adolescents: 5 drops per day for 6 weeks, and then between 1 and 3 drops per day.

For adults between 19 and 70 years of age, and elderly individuals over 70 years of age: 15 drops per day for 8 weeks, and then between 3 and 5 drops per day.

As an adjunct to treatment for osteoporosis in patients at risk of vitamin D deficiency:

The usual daily dose is:

For adults 19 years of age and older: between 2 and 4 drops per day, or between 14 and 26 drops per week.

Administration form:

This medication should be taken directly orally. The best way is to adddrop todrop in the mouth or, if necessary, administer it with a spoon and some liquid.

If you feel that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

Instructions for use:

To administer, hold the bottle in a vertical position and gently tap the base of the bottle with your finger until the firstdrop comes out.

If you take more Vitamina D3 Fresenius Kabi than you should:

In case of overdose with this medication, contact a doctor.

The symptoms of overdose may include the following: headache, loss of appetite, weakness, weight loss, gastrointestinal disturbances (nausea, vomiting, constipation), growth disturbances, increased urine volume, increased fluid intake, signs of paralysis, fatigue, increased blood pressure, and, in severe cases, irregular heartbeat.

The doctor will evaluate the severity of the poisoning and determine the required treatment.

If you forgot to take Vitamina D3 Fresenius Kabi:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Vitamina D3 Fresenius Kabi:

No withdrawal symptoms have been observed.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Vitamin D may cause the following adverse effects, especially in cases of overdose:

Metabolic and nutritional disorders:

High levels of calcium in the blood and urine (hypercalcemia, hypercalciuria).

Gastrointestinal disorders:

Constipation, bloating, nausea, stomach pain, diarrhea.

The frequency of occurrence of the aforementioned adverse effects is unknown (cannot be estimated from available data).

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 Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Do not store at a temperature above 86°F (30°C).
• Store the packaging in the outer packaging to protect it from light.
• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.
• After the first opening of the packaging, use this medication for a period of 10 months at maximum. Any remaining product not used should be discarded. Do not store at a temperature above 77°F (25°C) after the first opening.
• Do not use this medication if you observe the following: turbidity or coloration of the solution.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you do not need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help to protect the environment.

Composition of Vitamina D3 Fresenius Kabi

• The active ingredient is colecalciferol (vitamin D3).

1ml (=36drops) contains:

14.400UI (360µg) of colecalciferol (vitamin D3)

1drop contains 400UI (10µg) of colecalciferol (vitamin D3)

• The other components are:

Medium-chain triglycerides

Appearance of the product and contents of the packaging

Vitamina D3 Fresenius Kabi is presented in the form oforal drops (in oily solution) transparent and colorless to slightly yellowish, and are available in amber glass bottles containing 12.5ml (which correspond to 450drops) or 25ml (which correspond to 900drops), with a dropper applicator and a screw cap with a polyethylene ring of guarantee.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18.

08005 Barcelona (Spain)

Responsible for manufacturing

Fresenius Kabi Austria GmbH
Estermannstraße 17
A-4020 Linz
Austria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria:Colecalciferol Fresenius 14.400I.E./ml Oral Drops, Solution

Belgium:Kabivit-D3 14400 IE/ml, oral drops, solution

Kabivit-D3 14400 IE/ml, Oral Drops, Solution

Kabivit-D3 14400 UI/ml, oral solution in drops

Bulgaria:???????D3 14 400IU/ml??????????????,???????

Cyprus:KabiVit 14.400 IU/ml,oral drops

Slovakia:Olvit D3, 14 400IU/ml oral drops, solution

Slovenia:Oleovit D3 14400i.e./ml oral drops, solution

Spain:VitaminaD3 Fresenius Kabi 14.400 IU/ml oral drops in solutionEFG

Estonia:Colecalciferol Fresenius

Finland:Oleo D3 14 400 IU/ml oral drops, solution

Greece:KabiVit 14.400 IU/ml

Hungary:Vitamin D3 Fresenius Kabi 14000 NE/ml oral drops, oily solution

Ireland:Sapvit-D3 400IU/drop Oral Drops, Solution

Latvia:Colecalciferol Fresenius 14400 SV/ml oral drops for internal use, solution

Lithuania:Colecalciferol Fresenius 14400 TV/ml oral drops (solution)

Malta:KabiVit 14.400IU/ml oral drops, solution

Norway:KabiVit

Poland:OlVit D3

Portugal:Colecalciferol Kabi

United Kingdom:Sapvit-D3 14,400IU/ml Oral Drops, Solution

Czech Republic: Olvit D3 14400IU/ml oral drops, solution

Romania:Vitamina D3 Fresenius Kabi 14 400 UI/ml oral drops, solution

Sweden:Oleo D3 14 400IE/ml oral drops, solution

Last review date of this leaflet:July 2021

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/