Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Calfos (Vitodê)
0.266 mg, soft capsules
Calcifediolum monohydricum
Calfos and Vitodê are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Calfos is and what it is used for
Important information before taking Calfos
How to take Calfos
Possible side effects
How to store Calfos
Contents of the pack and other information

1. What Calfos is and what it is used for

This medicine contains calcifediol, a form of vitamin D, used in the treatment of vitamin D deficiency and associated disorders. In the human body, vitamin D increases, among other effects, the absorption of calcium.
Calfos is used for the treatment of vitamin D deficiency in adults and for the prevention of vitamin D deficiency in adults at identified risk, such as malabsorption syndrome (difficulty in absorbing nutrients), chronic kidney disease-mineral and bone disorder (CKD-MBD), or other identified risks.
Calfos is also used as an adjunctive treatment for osteoporosis (reduced bone mineral density, and disturbances in bone structure and quality) in adult patients with vitamin D deficiency or at risk of vitamin D deficiency.

2. Important information before taking Calfos

When not to take Calfos:

if the patient is allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6),
if the patient has hypercalcaemia (high calcium levels in blood) or hypercalciuria (high calcium levels in urine),
if the patient suffers from calcium kidney stones,
if the patient has been diagnosed with vitamin D hypervitaminosis (excessive amount of vitamin D in the body).

Warnings and precautions
Before starting to take Calfos, discuss this with your doctor or pharmacist.

Do not exceed the recommended daily dose of vitamin D supplements, such as this medicine, as it may lead to poisoning (see section 3, subsection If more Calfos than recommended has been taken).
While taking the medicine or before starting treatment, your doctor may order blood or urine tests to monitor calcium, phosphorus and other parameters.
Patients with kidney disease require special care and must be closely monitored by a doctor, who will prescribe regular laboratory tests.
Patients with heart disease require special care and must be frequently monitored by a doctor, including tests for blood calcium levels, especially in patients taking cardiac glycosides (see subsection Calfos with other medicines in this section).
If the patient has hypoparathyroidism (reduced parathyroid hormone activity), the medicine may be less effective.
If the patient is prone to developing calcium-containing kidney stones, the doctor should monitor blood calcium levels.
In patients who are immobilized for prolonged periods, a dose reduction of this medicine may be necessary.
Patients with sarcoidosis (a disease characterized by formation of nodules, usually on the skin), tuberculosis, or other diseases involving granuloma formation should exercise particular caution when taking this medicine, as they are more susceptible to adverse effects even when taking doses lower than recommended. Periodic laboratory tests should be performed to monitor calcium levels in blood and urine.
Effect on laboratory test results: when undergoing diagnostic tests (including blood, urine, skin tests with allergens, etc.), the patient should inform the doctor about taking this medicine, as it may affect test results, for example cholesterol testing.

Children and adolescents
The safety and efficacy of Calfos in children and adolescents under 18 years of age have not been established. Data are not available.

Calfos with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the action of this medicine. Also, Calfos or its active substance, monohydrate calcifediol, may affect the efficacy of other medicines taken concomitantly. Therefore, it may interact with the following medicines:

antiepileptic drugs (such as phenytoin, phenobarbital and primidone) and other enzyme-inducing drugs (which reduce the effectiveness of Calfos);
heart medications and/or antihypertensives, cardiac glycosides, thiazide diuretics or verapamil;
cholestyramine, colestipol (for cholesterol) or orlistat (for obesity). These medicines and monohydrate calcifediol should be taken at least 2 hours apart;
mineral oil or paraffin (laxatives): it is recommended to use another type of laxative or to take the medicines at a certain interval;
certain antibiotics (such as penicillin, neomycin and chloramphenicol);
magnesium salts;
other products containing vitamin D;
calcium-containing preparations;
corticosteroids (anti-inflammatory drugs).

Calfos with food and drink
Some food products and beverages are fortified with vitamin D. This should be taken into account, as their effect will add up to that of this medicine and may therefore become excessive.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not take this medicine during pregnancy.
Do not take this medicine while breastfeeding.

Driving and using machines
Calfos has no effect or negligible effect on the ability to drive and operate machinery.

Calfos contains anhydrous ethanol, sorbitol 70% solution (E 420) and sunset yellow (E 110).
This medicine contains 5 mg of alcohol (anhydrous ethanol) in each soft capsule. The amount of alcohol in one capsule of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains 22 mg of sorbitol in each soft capsule, which corresponds to 0.03 mg/mg.
This medicine contains sunset yellow (E 110), which may cause allergic reactions.

3. How to take Calfos

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Do not take more of this medicine or take it more frequently than prescribed (once weekly, once every two
weeks, or once monthly). Otherwise, the risk of overdose increases.
The recommended doses are as follows:

Treatment and prevention of vitamin D deficiency in patients identified as being at risk: one capsule (0.266 mg monohydrate calcifediol) once a month.
Supplemental treatment in specific osteoporosis therapy: one capsule (0.266 mg monohydrate calcifediol) once a month.

In certain populations, the risk of vitamin D deficiency is high, so these populations may require
higher doses of this vitamin. After analytical verification of the degree of vitamin D deficiency, the doctor may consider administering one capsule every two weeks or weekly.
This medicine must not be administered daily.
Your treating physician should regularly monitor calcium and vitamin D levels, usually before starting
treatment and 3–4 months after initiation. Depending on the indication, the dose is typically reduced or
spaced out over time once symptoms have improved or vitamin D deficiency has resolved.
Oral administration.
If you feel the effect of Calfos is too strong or too weak, consult your doctor or pharmacist.
Taking more Calfos than prescribed
Taking a higher dose than prescribed by your doctor (overdose) and/or taking the medicine for a
prolonged period may cause hypercalcemia (high calcium levels in the blood) and the appearance of
phosphates in urine and blood, which may lead to kidney failure. Some toxic effects may appear early,
while others may occur later. Early symptoms include: weakness, fatigue, headache, loss of appetite,
dryness of the mouth, gastrointestinal disturbances such as nausea, vomiting, abdominal cramps,
constipation or diarrhea, increased thirst, increased frequency of urination, muscle pain. Later symptoms
may include: itching, weight loss, growth retardation in children, kidney disorders, photosensitivity,
conjunctivitis, elevated cholesterol levels, increased transaminase activity, pancreatitis, calcification of blood vessels and other tissues such as tendons and muscles (calcium salt deposition), elevated blood pressure, psychiatric disturbances, and irregular heartbeat. Symptoms of overdose usually diminish or resolve after discontinuation; however, in cases of severe poisoning, kidney or heart failure may occur.
Missing a dose of Calfos
Do not take a double dose to make up for a missed capsule.
Take the missed dose as soon as possible, then return to your regular dosing schedule.
Stopping Calfos
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur with higher doses or longer treatment duration than prescribed by a physician, which may lead to hypercalcaemia (elevated calcium levels in blood) and hypercalciuria (elevated calcium levels in urine); see section 3 for symptoms of these conditions.
Other adverse reactions include allergic reactions such as itching, local swelling, breathing difficulties, and skin redness.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.

5. How to store Calfos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not store in the refrigerator.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information
What Calfos contains

The active substance is calcifediol monohydrate. Each soft capsule contains 0.266 mg of calcifediol monohydrate.
The other ingredients are: anhydrous ethanol, medium-chain triglycerides; and for the capsule shell: gelatin, glycerol, sorbitol 70% solution (E 420), titanium dioxide (E 171) and sunset yellow (E 110).

What Calfos looks like and contents of the pack
Calfos is an orange, oval, soft gelatin capsule containing a clear, low-viscosity liquid free from solid particles, packed in blisters made of PVC/PVDC/Aluminium foil containing 5 or 10 capsules. The blisters are packed in a cardboard box.

Marketing Authorisation Holder in Portugal, the country of export:
Faes Farma Portugal, S.A.
Rua Elias Garcia, 28
2700-327 Amadora
Portugal

Manufacturer:
Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leioa - Bizkaia
Spain

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing Authorisation Number in Portugal, the country of export: 5710934
Parallel Import Licence Number: 118/25

This medicine is authorised for sale in the Member States of the European Economic Area under the following names:
Belgium: Defediol
Bulgaria: Hidroferol 0,266mg мека капсула
Estonia: Defevix
Italy: Neodidro
Lithuania: Defevix 0,266mg minkštoji kapsulė
Latvia: Defevix 0,266mg mīkstās kapsulas
Luxembourg: Defediol
Netherlands: Hidroferol 0,266mg zachte capsules
Poland: Calfos
Portugal: Vitodê 0,266 mg cápsula mole
Romania: Hidroferol 0,266mg capsulă moale