Vitenson

Package leaflet: Information for the patient

Vitenson 25,000 IU hard capsules

colecalciferol
Read this entire leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Vitenson 25,000 IU is and what it is used for
2. What you need to know before taking Vitenson 25,000 IU
3. How to take Vitenson 25,000 IU
4. Possible side effects
5. How to store Vitenson 25,000 IU
6. Contents of the pack and other information

1. What Vitenson 25,000 UI is and what it is used for

Vitenson 25,000 UI contains vitamin D (also known as colecalciferol) for regulating calcium absorption and metabolism, and for calcium incorporation into bone tissue.
Vitenson 25,000 UI is used in adults

• for the treatment of vitamin D deficiency
• for the prevention of vitamin D deficiency in adults at identified risk when therapeutic adherence (or compliance) is not achieved with daily administration of low-dose colecalciferol.

2. What you should know before taking Vitenson 25,000 IU

Do not take Vitenson 25,000 IU

• if you are allergic to colecalciferol, sunset yellow FCF (E110), or any of the other ingredients of this medicine (listed in section 6).
• if you have hypercalcemia (high levels of calcium in the blood).
• if you have hypercalciuria (high levels of calcium in the urine).
• if you have been diagnosed with hypervitaminosis D (high levels of vitamin D in the blood).
• if you have pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance).
• if you have kidney stones or if your kidney function is impaired.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vitenson 25,000 IU:

• if you are prone to developing calcium-containing kidney stones.
• if your kidneys do not function properly and if you have problems excreting calcium and phosphate through the kidneys. The effect of treatment on calcium and phosphate balance must be monitored by your doctor.
• if you are being treated with medicines that increase urine excretion (benzothiadiazine derivatives) or if your mobility is severely reduced, as in these cases there is a risk of hypercalcemia (high blood calcium levels) and hypercalciuria (high calcium levels in the urine).
• if you have sarcoidosis (a disease affecting connective tissue in the lungs, skin, and joints), as there is a risk of increased conversion of vitamin D into its active forms.
• In these cases, calcium levels in blood and urine must be monitored by your doctor.
• if you have pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance).
• if you are already taking other medicines containing vitamin D (e.g. multivitamin preparations) or certain types of foods containing vitamin D.

During treatment with Vitenson 25,000 IU at daily doses exceeding 1,000 IU of vitamin D,
your doctor must monitor calcium levels in blood and urine and also check kidney function.
This monitoring is particularly important in elderly patients and when treatment is carried out
concomitantly with cardiac glycosides (medicines that stimulate heart muscle function) or diuretics (medicines that increase urine excretion). If blood calcium levels (hypercalcemia) or urine calcium levels (hypercalciuria) rise, or if other signs of impaired kidney function occur, the dose must be reduced or treatment must be discontinued.

Children and adolescents
Vitenson 25,000 IU must not be used in children and adolescents under 18 years of age.

Other medicines and Vitenson 25,000 IU
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of Vitenson 25,000 IU may be reduced by concomitant use of:

• phenytoin (a medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy, sleep disorders, and for anesthesia)
• glucocorticoids (medicines used to treat certain allergic conditions and inflammation)
• rifampicin and isoniazid (medicines used to treat tuberculosis)
• cholestyramine (a medicine used to lower high cholesterol levels), laxatives containing liquid paraffin
• orlistat (a medicine used to treat obesity)
• actinomycin (a medicine used to treat cancer)
• imidazole (an antifungal agent).

The effect/side effects of Vitenson 25,000 IU may be intensified by concomitant use of:

• vitamin D metabolites or analogues (e.g. calcitriol). Concomitant intake with Vitenson 25,000 IU must be avoided.
• medicines that increase urine excretion (e.g. thiazide diuretics). Reduced elimination of calcium through the kidneys may lead to increased calcium concentration in the blood (hypercalcemia). Therefore, calcium levels in blood and urine must be monitored during long-term treatment.

When taken together, Vitenson 25,000 IU may increase the risk of side effects of:

• cardiac glycosides (medicines used to improve heart muscle function): The risk of heart rhythm disturbances may increase as a result of elevated blood calcium levels during vitamin D treatment. In such cases, your treating physician must perform ECG monitoring as well as monitoring of calcium levels in urine and drug levels in blood.

Vitenson 25,000 IU with food and drink
Vitenson 25,000 IU should preferably be taken with food and drink.

Fertility, pregnancy, and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
During pregnancy, women should follow their doctor's advice, as their needs may vary depending on the severity of their condition and their response to treatment.

Vitamin D overdose must be avoided during pregnancy, as prolonged hypercalcemia may lead to delayed physical and mental development and congenital heart or eye disorders in the child.

When vitamin D supplementation is required during pregnancy, it should be administered at lower doses.

Breastfeeding
Vitamin D and its metabolites are excreted in breast milk. In case of vitamin D deficiency, Vitenson 25,000 IU may be used at recommended doses during breastfeeding. This should be taken into account when additional vitamin D is administered to the infant.

Fertility
The effects of vitamin D on fertility have not been studied. However, no adverse effects on fertility are expected with normal endogenous (naturally present in the body) levels of vitamin D.

Driving and using machines
Vitenson 25,000 IU does not affect or has negligible influence on the ability to drive vehicles and use machines.

3. How to take Vitenson 25,000 IU

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is for oral use. The capsules must be swallowed whole with a
sufficient amount of water, preferably at the time of the main meal of the day.
The dose must be individually determined by the treating physician based on the required degree of
vitamin D supplementation. The dose should be adjusted according to desired serum levels of
25-hydroxycholecalciferol (25(OH)D), severity of the disease, and the patient's response to treatment.
Use in adults
For the treatment of vitamin D deficiency:
1 capsule of Vitenson 25,000 IU once a week (25,000 IU/week) for 8–12 weeks.
After the first month, lower doses may be considered.
For the prevention of vitamin D deficiency:
1 capsule of Vitenson 25,000 IU once a month (25,000 IU)
Use in children and adolescents
Vitenson 25,000 IU must not be used in children and adolescents under 18 years of age.
Taking the medicine
The capsules must be swallowed whole with a sufficient amount of water, preferably at the time of the
main meal of the day.
To remove the capsule from the blister:

• Press only one end of the capsule to push it out of the blister
• Do not press the central part of the capsule, as this could break it.

If you take more Vitenson 25,000 IU than you should
If you take more Vitenson 25,000 IU than you should, contact your doctor immediately.
Signs of overdose are not very specific and may include thirst, nausea, vomiting, initial diarrhoea
progressing to constipation, loss of appetite, fatigue, headache, muscle and joint pain, persistent
drowsiness, loss of consciousness, arrhythmia (irregular heartbeat), azotemia (high levels of nitrogen in the blood), increased sensation of thirst, increased urge to urinate, and eventually dehydration.
Contact your doctor if you experience signs of vitamin D overdose.
Your doctor will then take the necessary countermeasures.
There is no specific antidote.
If you forget to take Vitenson 25,000 IU
Do not take a double dose to make up for the forgotten dose.
If you stop taking Vitenson 25,000 IU
Symptoms may reappear or worsen further if you stop treatment prematurely.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You must stop taking Vitenson 25,000 IU and contact your doctor immediately if you experience any of the following signs of a severe allergic reaction:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• hives and difficulty breathing.

The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)
Hypercalcaemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).
Rare (may affect up to 1 in 1,000 people)
Itching, skin rash or hives.
Not known (frequency cannot be estimated from the available data)
Gastrointestinal problems (constipation, flatulence, nausea, abdominal pain or diarrhoea).
Sunset Yellow FCF (E 110) may cause allergic reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viteson 25,000 IU

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vitenson 25,000 IU contains

• The active substance is: colecalciferol. Each hard capsule contains 0.625 mg of colecalciferol (equivalent to 25,000 IU of vitamin D).
• The other components are: medium-chain triglycerides, gelatin, anhydrous colloidal silica, titanium dioxide (E 171), quinoline yellow (E 104), butylated hydroxytoluene, FD&C Yellow No. 6 (E 110).

Description of the appearance of Vitenson 25,000 IU and package contents
Vitenson 25,000 IU are hard gelatin capsules with an opaque yellow body and cap, filled with a colourless to pale yellow oily liquid. The capsules have a colourless band.
Vitenson 25,000 IU is available in blisters containing 2, 4, 5, 6, 8, 10 or 12 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
mibe pharma Italia S.r.l.
via Leonardo Da Vinci, 20/B
39100 Bolzano
Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Dekristol 25,000 IU hard capsules
Italy: Vitenson 25,000 IU hard capsules
Poland: Dekristol Pro