Olvit D3

Package Leaflet: Information for the Patient

OlVit D, 14,400 IU/ml, Oral Drops, Solution

Cholecalciferol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is OlVit D and what is it used for
• 2. Important information before taking OlVit D
• 3. How to take OlVit D
• 4. Possible side effects
• 5. How to store OlVit D
• 6. Contents of the pack and other information

1. What is OlVit D and what is it used for

OlVit D contains the active substance cholecalciferol (vitamin D).
OlVit D is used:

• to prevent and treat vitamin D deficiency;
• to treat rickets (a condition that affects bone development in children);
• as a supplement to proper treatment of osteoporosis in patients at risk of vitamin D deficiency.

2. Important information before taking OlVit D

When not to take OlVit D

• if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if you have conditions that lead to high levels of calcium in the blood or increased excretion of calcium in the urine [e.g. during treatment with certain medicines (benzothiazine derivatives) or when you are immobilized];
• if you have kidney stones containing calcium or a tendency to form such stones;
• if you have elevated levels of vitamin D;
• if you have severe atherosclerosis (hardening of the arteries);
• if you have severe kidney function disorders.

Warnings and precautions

Before starting treatment with OlVit D, discuss it with your doctor or pharmacist.
Be careful when taking OlVit D:

• if you are taking certain heart medicines (e.g. cardiac glycosides) or thiazide diuretics;
• if you have kidney function disorders, in which case your doctor will recommend monitoring calcium and phosphate levels in your blood, and consider the risk of soft tissue calcification;
• in case of severe kidney function disorders, cholecalciferol is not used, and your doctor will recommend supplementation with another vitamin D preparation;
• if you have sarcoidosis (Boeck's disease), there is a risk of increased production of active forms of vitamin D;
• in case of bone mass loss due to lack of activity (e.g. in immobilized patients), there is an increased risk of elevated calcium levels in the blood.

In the case of long-term treatment, your doctor will recommend regular monitoring of calcium levels in your blood and urine, as well as kidney function checks. If necessary, your doctor may recommend reducing the dose or stopping treatment.
Elevated levels of parathyroid hormones may increase vitamin D metabolism, which increases the need for vitamin D.
Additional doses of vitamin D can only be taken under the strict supervision of a doctor.

Children and adolescents

Avoid giving other products containing vitamin D, especially to infants.
In case of doubts, your doctor will decide on the additional use of vitamin-enriched foods or infant foods and medicines containing vitamin D.

OlVit D and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This is especially important if you are taking:

• rifampicin or isoniazid (medicines used to treat tuberculosis);
• certain heart medicines (cardiac glycosides): they may cause harmful effects by increasing calcium levels in the blood (risk of arrhythmia), strict medical supervision is required, including possible electrocardiogram (ECG) and calcium level checks;
• thiazide diuretics: they increase the risk of elevated calcium levels in the blood due to reduced calcium excretion in the urine, in which case your doctor will recommend regular calcium level checks;
• medicines used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, primidone) or certain adrenal cortex hormones (glucocorticosteroids, "cortisone"): they may increase the need for vitamin D;
• medicines used to lower blood fat levels (e.g. orlistat and cholestyramine): they may reduce vitamin D absorption in the gut;
• medicines containing magnesium (e.g. antacids): do not take them while taking OlVit D, as it may lead to increased magnesium levels in the blood (hypermagnesemia);
• medicines containing aluminum (medicines used to treat heartburn).

OlVit D with food and drink

Be careful when consuming foods enriched with vitamins or infant foods.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If your doctor prescribes OlVit D during pregnancy, follow the recommended dosage carefully, as excessive intake of vitamin D may be associated with a risk of physical and mental impairment, as well as heart and eye diseases in the child.
Breastfeeding
Vitamin D and its metabolites pass into breast milk. No overdose has been observed in breastfed infants. However, consider this if the child is also taking vitamin D.

Driving and using machines

OlVit D has no or negligible influence on the ability to drive and use machines.

3. How to take OlVit D

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dose will be determined by your doctor. The dose depends on the indication for OlVit D.
Therefore, always follow the dose recommended by your doctor, regardless of the fact that other patients may have been prescribed a much higher dose.
If your doctor has not recommended otherwise, the recommended dose is:
Prevention of vitamin D deficiency
Usually, the daily dose is:
Newborns, infants, and children from the second week of life to 3 years: 1-2 drops.
Children from 4 years and adolescents: 1-3 drops.
Adults from 19 to 70 years: 1-4 drops.
Elderly over 70 years: 2-4 drops.
Treatment of rickets
The total required dose of vitamin D depends on the severity of the disease.
At the beginning of rickets treatment, treatment starts with the use of medicines with a higher concentration of vitamin D.
Then, the usual dose is from 2 to 12 drops per day.
Treatment of vitamin D deficiency
Usually, the daily dose is:
Children and adolescents: 5 drops per day for 6 weeks, then 1-3 drops per day.
Adults from 19 to 70 years and elderly over 70 years: 15 drops per day for 8 weeks, then 3-5 drops per day.
Supplementary treatment of osteoporosis in patients at risk of vitamin D deficiency

Usually, the daily dose is:
Adults from 19 years: 2-4 drops per day or 14-26 drops per week.
Method of administration
OlVit D is taken orally. It is best to administer the drops directly into the mouth or, if necessary, on a spoon with a small amount of liquid.
If you feel that the effect of OlVit D is too strong or too weak, contact your doctor or pharmacist.
Instructions for use
To extract the contents, hold the bottle vertically and gently tap the bottom of the bottle with your finger until the first drop appears.

Overdose of OlVit D

In case of overdose of OlVit D, contact your doctor.
Overdose symptoms may include: headache, loss of appetite, weakness, weight loss, stomach and intestinal disorders (nausea, vomiting, constipation), developmental disorders, increased urine output, increased fluid intake, symptoms of paralysis, mental retardation, increased blood pressure, and severe cases of irregular heartbeat.
Your doctor will assess the severity of the overdose and decide on its treatment.

Missed dose of OlVit D

Do not take a double dose to make up for a missed dose.

Stopping treatment with OlVit D

No withdrawal symptoms are known.
If you have any further 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.
Vitamin D can cause the following side effects, especially in case of overdose:
Metabolic and nutritional disorders
Too high levels of calcium in the blood and urine (hypercalcemia, hypercalciuria).
Gastrointestinal disorders
Constipation, bloating, nausea, abdominal pain, diarrhea.
The frequency of the above side effects is unknown (cannot be estimated from the available data).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store OlVit D

• Do not store above 30°C.
• Store the bottle in the outer packaging to protect from light.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month stated.
• After the first opening of the bottle, the oral drops OlVit D should be used within 10 months. After this time, any unused medicine should be discarded. After the first opening, do not store above 25°C.
• Do not use this medicine if you notice turbidity or discoloration of the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What OlVit D contains

• The active substance is cholecalciferol (vitamin D). 1 ml (36 drops) contains: 14,400 IU (360 µg) cholecalciferol (vitamin D). 1 drop contains 400 IU (10 µg) cholecalciferol (vitamin D).
• The other ingredient is: triglycerides of medium chain length.

What OlVit D looks like and contents of the pack

OlVit D is a clear, colorless to slightly yellowish oral drops (oil solution) available in brown glass bottles containing 12.5 ml (corresponding to 450 drops) or 25 ml (corresponding to 900 drops) with a PE cap with a tamper-evident ring and a PE dropper.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer:

Fresenius Kabi Austria GmbH
Estermannstraße 17
4020 Linz
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Colecalciferol Fresenius 14,400 I.E./ml Tropfen zum Einnehmen, Lösung
Belgium
Kabivit-D3 14400 IE/ml, druppels voor oraal gebruik, oplossing
Kabivit-D3 14400 UI/ml, solution buvable en gouttes
Kabivit-D3 14400 IE/ml, Tropfen zum Einnehmen, Lösung
Bulgaria
Олеовит D3 14 400 IU/ml перорални капки, разтвор
Cyprus
KabiVit 14,400 IU/ml, πόσιμο διάλυμα
Ireland
Sapvit-D3 400 IU/drop Oral Drops, Solution
Estonia
Colecalciferol Fresenius
Finland
Oleo D3 14 400 IU/ml tipat, liuos
Greece
KabiVit 14,400 IU/ml
Spain
Vitamina D3 Fresenius Kabi 14,400 IU/ml solución oral
Lithuania
Colecalciferol Fresenius 14400 TV/ml geriamieji lašai (tirpalas)
Latvia
Colecalciferol Fresenius 14400 SV/ml pilieni iekšķīgai lietošanai, šķīdums
Malta
KabiVit 14,400 IU/ml oral drops, solution
Norway
KabiVit
Poland
OlVit D
Portugal
Colecalciferol Kabi
Czech Republic
Olvit D3 14400 IU/ml perorální kapky, roztok
Romania
Vitamina D3 Fresenius Kabi 14 400 UI/ml picături orale, soluţie
Slovakia
Olvit D3, 14 400 IU/ml perorálne roztokové kvapky
Slovenia
Oleovit D3 14400 i.e./ml peroralne kapljice, raztopina
Sweden
Oleo D3 14 400 IE/ml orala droppar, lösning
Hungary
Vitamin D3 Fresenius Kabi 14000 NE/ml belsőleges oldatos cseppek
United Kingdom
(Northern Ireland)
Sapvit-D3 14,400 IU/ml Oral Drops, Solution

Date of last revision of the leaflet: