Calfos

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Calfos (Vitodê), 0.266 mg, soft capsules
Calcifediolum
Calfos and Vitodê are different trade names for the same medicine.
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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Calfos is and what it is used for
2. Important information before taking Calfos
3. How to take Calfos
4. Possible side effects
5. How to store Calfos
6. 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 related disorders. In the human body, vitamin D increases, among other things, calcium absorption.
Calfos is used to treat:
vitamin D deficiency in adults and to prevent vitamin D deficiency in adults at identified risk, such as malabsorption syndrome (difficulty absorbing nutrients), mineral and bone disorder associated with chronic kidney disease (CKD-MBD), or other identified risk.
Calfos is also used as adjunctive treatment for osteoporosis (chronic bone demineralization, reduced bone mass and density).
Corticosteroid-containing medicines may cause osteoporosis/osteopenia. Calfos, as an adjunct to other medicines, is used to prevent corticosteroid-induced osteoporosis/osteopenia.

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 the blood) or hypercalciuria (high calcium levels in the urine),
• if the patient suffers from calcium kidney stones,
• if the patient has been diagnosed with hypervitaminosis D (excess 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 you take more Calfos than you should).
• While taking the medicine or before starting treatment, your doctor may order blood or urine tests to check calcium, phosphorus levels, 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 should be frequently monitored by a doctor, including blood calcium level tests, especially if they are 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 the formation of nodules, usually on the skin), tuberculosis, or other granulomatous diseases 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.
• The doctor will inform the patient, their family, and/or caregivers about the importance of taking the prescribed dose and following dietary recommendations, as well as taking calcium supplements, to prevent overdose.
• Effect on laboratory test results: when undergoing diagnostic tests (including blood, urine, or skin tests using allergens), the patient should inform the doctor about taking this medicine, as it may affect test results, for example, cholesterol tests.

Children and adolescents
The safety and efficacy of Calfos in children and adolescents have not been established. Use of this product is not recommended in children and adolescents.

Calfos with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the action of this medicine. Also, Calfos or its active substance calcifediol may affect the effectiveness of other medicines taken simultaneously. Therefore, it may interact with the following medicines:

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

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may 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 operating machinery
Calfos has no effect or a negligible effect on the ability to drive and operate machinery.

Calfos contains ethanol, sorbitol, 70% solution, and sunset yellow (E 110).
Ethanol
This medicine contains 4.98 mg of alcohol (ethanol) per 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.

Sorbitol, 70% solution
The medicine contains 22 mg of sorbitol per capsule. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sunset yellow (E 110)
This medicine may cause allergic reactions, as it contains sunset yellow (E 110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Calfos

This medicine should always be taken as directed by the physician. 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.
Dosages vary depending on the patient and indication. The 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 usually reduced or spread out over time once
symptoms have improved or vitamin D deficiency has resolved.
The recommended doses are as follows:

• Treatment and prevention of vitamin D deficiency in patients with identified risk: one capsule (0.266 mg calcifediol) once monthly.
• As an adjunct to specific osteoporosis therapy: one capsule (0.266 mg calcifediol) once monthly.

In certain populations, the risk of vitamin D deficiency is high; therefore, these populations may
require higher doses of this vitamin. After analytical assessment of the degree of
vitamin D deficiency, the physician may consider administering one capsule every two weeks or
weekly.
This medicine must not be administered daily.
Oral administration.
If you feel the medicine’s effect is too strong or too weak, consult your doctor
or pharmacist.
Taking more Calfos than recommended
Taking a higher dose than prescribed by the physician (overdose) and/or prolonged
use of the medicine may cause hypercalcemia (high calcium levels in blood) and
phosphate presence in urine and blood, which may lead to kidney failure. Some
toxicity symptoms may appear early, while others may occur later. Early
symptoms include: weakness, fatigue, headache, loss of appetite, dryness in the mouth,
gastrointestinal disturbances such as vomiting, abdominal cramps, constipation or diarrhea,
increased thirst, increased frequency of urination, muscle pain. Some later-occurring
symptoms 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, irregular heartbeat. Overdose symptoms usually diminish or resolve after discontinuation of the medicine; 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 treatment
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually occur infrequently (may affect 1 in 100 people). However, with higher doses or prolonged treatment than prescribed by a doctor (which may lead to hypercalcaemia – elevated calcium levels in the blood), significant adverse effects may occur.

The following adverse effects may occur:
nausea, vomiting, dry mouth, constipation, taste disturbances with a metallic aftertaste, abdominal cramps (intestinal cramping sensation), anorexia (loss of appetite).

In cases of moderate hypercalcaemia (elevated calcium levels), weakness, fatigue, drowsiness, headache, and irritability may occur.

In cases of hypercalcaemia, cardiac arrhythmias may occur.

In cases of hypercalcaemia, bone and muscle pain may occur, and calcifications (calcium deposits) may appear in soft tissues. In addition, nephrocalcinosis (formation of calcium deposits in the kidneys) may occur, along with impaired kidney function, polyuria (increased frequency of urination), increased thirst, nocturia (night-time urination), and proteinuria (presence of protein in urine).

In rare cases (may affect 1 in 1000 people), when very high doses are used, photophobia (eye sensitivity to light) and conjunctivitis with corneal calcifications (calcium deposits in the cornea) may occur.

Other adverse effects include: rhinitis (nasal inflammation), pruritus (itching), hyperthermia (fever), and decreased libido (reduced sexual drive). Pancreatitis. Increased blood urea nitrogen levels, albuminuria (albumin in urine), hypercholesterolaemia (increased cholesterol levels in blood), and hypercalcaemia (increased calcium levels in blood).

In cases of high calcium concentration in the blood, increased transaminase activity (AspAT and AlAT) may occur.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Calfos

Keep this medicine out of 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 specified month.
No special storage conditions are required.
Do not store in a refrigerator.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

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

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

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Portugal, country of export:
Laboratórios Vitória, S.A.
Rua Elias Garcia, 28
2700-327 Amadora
Portugal

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

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Poland

Marketing authorisation number in Portugal, country of export: 5710934
Parallel import authorisation number: 59/24

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
France: Calcifediol Faes 0,266 mg capsule molle
Italy: NEODIDRO
Portugal: Vitodê 0,266 mg cápsula mole
Belgium: Defediol
Bulgaria: Hidroferol 0,266mg мека капсула
Estonia: Defevix
Lithuania: Defevix 0,266mg minkštoji kapsulė
Latvia: Defevix 0,266mg mīkstās kapsulas
Luxembourg: Defediol
Netherlands: Hidroferol 0,266mg zachte capsules
Poland: Calfos
Romania: Hidroferol 0,266mg capsulă moale