Calfos

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Calfos (Vitodê)

0.266 mg, soft capsules

Calcifediolummonohydricum
Calfos and Vitodê are different trade names for the same medicine.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Calfos and what is it 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 is Calfos and what is it used for

This medicine contains calcifediol, a type of vitamin D, used to treat vitamin D deficiency and related disorders. In the human body, vitamin D causes, among other things, increased absorption of calcium.
Calfos is used to treat vitamin D deficiency in adults and to prevent vitamin D deficiency in adults with identified risk factors, such as malabsorption syndrome (difficulty absorbing nutrients), mineral and bone disorders related to chronic kidney disease (CKD-MBD), or other identified risks.
Calfos is also used as adjunctive treatment for osteoporosis (decreased bone mineral density, disruption of its 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 you are allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6),
• if you have hypercalcemia (high calcium levels in the blood) or hypercalciuria (high calcium levels in the urine),
• if you have kidney stone disease,
• if you have been diagnosed with hypervitaminosis D (excessive amounts of vitamin D in the body).

Warnings and precautions

Before starting to take Calfos, discuss it with your doctor or pharmacist.

• Do not exceed the recommended daily dose of vitamin D supplements, such as this medicine, as this may lead to toxicity (see section 3, subsection Taking a higher dose of Calfos than recommended).
• During treatment or before starting treatment, your doctor may order blood or urine tests to check calcium, phosphorus, and other parameters.
• Patients with kidney disease require special care and must be closely monitored by their doctor, with regular laboratory tests.
• Patients with heart disease require special care and must be frequently monitored by their doctor, with tests for calcium levels in the blood, especially in people taking cardiac glycosides (see this point, subsection Calfos and other medicines).
• If you have hypoparathyroidism (reduced parathyroid hormone activity), the medicine may be less effective.
• If you have a tendency to form kidney stones containing calcium, your doctor should monitor your blood calcium levels.
• In patients who are immobilized for a long time, it may be necessary to reduce the dose of this medicine.
• Patients with sarcoidosis (a disease characterized by the formation of nodules, usually on the skin), tuberculosis, or other granulomatous diseases should be cautious when taking this medicine, as they are more prone to side effects even when taking doses lower than recommended. Periodic laboratory tests should be performed to monitor blood and urine calcium levels.
• Effect on laboratory tests: when performing diagnostic tests (including blood, urine, skin tests with allergens, etc.), the patient should inform their doctor that they are taking this medicine, as it may affect the results of these tests, for example, during 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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Some medicines may affect the action of this medicine. Also, Calfos or its active substance calcifediol monohydrate may affect the effectiveness of other medicines taken at the same time.
Therefore, it may interact with the following medicines:

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

Calfos with food and drink

Some food products and beverages are fortified with vitamin D. This should be taken into account, as their action will be cumulative with the action of this medicine and may become excessive.

Pregnancy, breastfeeding, and fertility

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.
Do not take this medicine during pregnancy.
Do not take this medicine during breastfeeding.

Driving and using machines

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

Calfos contains ethanol, sorbitol, and sunset yellow FCF (E 110)

• 110).This medicine contains 5 mg of alcohol (anhydrous ethanol) per 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 have noticeable effects.

This medicine contains 22 mg of sorbitol per soft capsule, which corresponds to 0.03 mg/mg.
This medicine contains sunset yellow FCF (E 110), which may cause allergic reactions.

3. How to take Calfos

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Do not take more than the prescribed dose (once a week, once every two weeks, or once a month). Otherwise, the risk of overdose increases.
The recommended doses are as follows:

• Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risk factors: one capsule (0.266 mg calcifediol monohydrate) once a month.
• Adjunctive treatment of osteoporosis: one capsule (0.266 mg calcifediol monohydrate) once a month.

In some populations, there is a high risk of vitamin D deficiency, 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 once a week.
This medicine should not be taken daily.
The treating doctor should regularly monitor calcium and vitamin D levels, usually before starting treatment and 3-4 months after starting treatment. Depending on the indication, the dose will usually be reduced or spaced out over time after the symptoms have subsided or the vitamin D deficiency has been corrected.
Oral administration.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of Calfos than recommended

Taking a higher dose of the medicine than prescribed by the doctor (overdose) and/or taking the medicine for a longer period than prescribed by the doctor may cause hypercalcemia (high calcium levels in the blood) and the appearance of phosphates in the urine and blood, which can lead to kidney failure. Some symptoms of toxicity may appear early, while others will occur later. The initial symptoms include: weakness, fatigue, headache, loss of appetite, dry mouth, digestive disorders such as vomiting, abdominal cramps, constipation, or diarrhea, increased thirst, increased urination, muscle pain. Some of the symptoms that occur later include: itching, weight loss, growth retardation in children, kidney disorders, sensitivity to sunlight, conjunctivitis, increased cholesterol levels, increased transaminase activity, pancreatitis, calcification of blood vessels and other tissues, such as tendons and muscles (calcium salt deposition), high blood pressure, mental disorders, irregular heartbeat. Overdose symptoms usually subside or disappear after discontinuation of the medicine, but 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, and then return to the regular dosing schedule.

Stopping Calfos treatment

If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur in case of higher doses or longer treatment than prescribed by the doctor, which may cause hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine), see section 3 to learn about the symptoms of these disorders.
Other side effects include allergic reactions such as itching, local swelling, breathing difficulties, and skin redness.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 gather more information on the safety of this medicine.
Side effects 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 month stated.
There are no special precautions for storage.
Do not store in the refrigerator.
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 Calfos contains

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

What Calfos looks like and contents of the pack

Calfos is orange, oval, soft gelatin capsules containing a clear liquid with low viscosity, free from solid particles, packaged in PVC/PVDC/Aluminum blisters containing 5 or 10 capsules. The blisters are packaged in a cardboard box.

Marketing authorization 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

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Portugal, the country of export: 5710934
5710942

Parallel import authorization number: 118/25

This medicine is authorized in the Member States of the European Economic Area under the following names:
Belgium:
Defediol
Bulgaria:
Hidroferol 0.266mg soft capsules
Estonia:
Defevix
Italy:
Neodidro
Lithuania:
Defevix 0.266mg soft capsules
Latvia:
Defevix 0.266mg soft capsules
Luxembourg:
Defediol
Netherlands:
Hidroferol 0.266mg soft capsules
Poland:
Calfos
Portugal:
Vitodê 0.266 mg soft capsules
Romania:
Hidroferol 0.266mg soft capsules

Date of revision of the leaflet: 27.03.2025

[Information about the trademark]