Calfos

Package Leaflet: Information for the User

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

Calfos (Vitodê), 0.266 mg, Soft Capsules

Calcifediol
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 associated with chronic kidney disease (CKD-MBD), or other identified risk factors.
Calfos is also used as an adjunctive treatment for osteoporosis (chronic bone demineralization, loss of bone mass and density).
Corticosteroid-containing medications may cause osteoporosis/osteopenia. Calfos, as a supplement to other medications, is used to prevent osteoporosis/osteopenia caused by the use of corticosteroid-containing medications.

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 hypercalcemia (high calcium levels in the blood) or hypercalciuria (high calcium levels in the urine),
• if the patient has calcium kidney stones,
• if the patient has 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 poisoning (see section 3, subsection Taking a higher dose of Calfos than recommended).
• During treatment or before starting treatment, the 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 a doctor, with regular laboratory tests.
• Patients with heart disease require special care and must be frequently monitored by a doctor, with blood calcium level tests, especially in people taking digitalis glycosides (see this point, subsection Calfos and other medicines).
• If the patient has hypoparathyroidism (reduced parathyroid hormone activity), the medicine may be less effective.
• If the patient has a tendency to form calcium kidney stones, the doctor should monitor blood calcium levels.
• In patients who are bedridden 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. Regular laboratory tests should be performed to monitor blood and urine calcium levels.
• The doctor will inform the patient, their family, and/or caregivers about the importance of taking the prescribed dose and following dietary recommendations and taking calcium supplements at the same time to prevent overdose.
• Effect on laboratory test results: in the case of diagnostic tests (including blood, urine, skin tests with allergens, etc.), the patient should inform the doctor about 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 have not been established. The use of this product is not recommended in children and adolescents.

Calfos and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan 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 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 (affecting the reduction of the effect of Calfos);
• heart and/or blood pressure medications, as well as digitalis 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 take the medicines at a certain 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 enriched 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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, 70% solution, and orange yellow (E 110).

Ethanol
This medicine contains 4.98 mg of alcohol (ethanol) in each 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.
Sorbitol, 70% solution
The medicine contains 22 mg of sorbitol in each capsule. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Orange yellow (E 110)
The medicine may cause allergic reactions, as it contains orange 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 according to the doctor's instructions. If you have any doubts, ask your doctor or pharmacist.
Do not take more medicine than prescribed or more often than prescribed (once a week, once every two weeks, or once a month). Otherwise, the risk of overdose increases.
Doses vary depending on the patient and indications. The 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 spread over time after the symptoms have subsided or the vitamin D deficiency has been corrected.
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 of calcifediol) once a month.
• Adjunctive treatment of osteoporosis: one capsule (0.266 mg of calcifediol) once a month.

In some populations, there is a high risk of vitamin D deficiency, so these populations may require higher doses of vitamin D. 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.
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 (which may cause hypercalcemia - elevated calcium levels in the blood) may lead to kidney failure. Some symptoms of toxicity may appear early, while others will appear later. Early 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 symptoms that appear 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 deposits), high blood pressure, mental disorders, irregular heartbeat. Symptoms of overdose 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 treatment with Calfos

If you have any further doubts about the use of this medicine, ask 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 usually occur not very often (may occur in 1 in 100 people). However, in the case of higher doses or longer treatment than prescribed by the doctor (which may cause hypercalcemia - elevated calcium levels in the blood), significant side effects may occur.
The following side effects may occur:
nausea, vomiting, dry mouth, constipation, taste disorders with a metallic aftertaste, abdominal cramps (feeling of abdominal cramps), loss of appetite (anorexia).
In the case of moderate hypercalcemia (elevated calcium levels), weakness, fatigue, drowsiness, headache, and irritability may occur.
In the case of hypercalcemia, heart rhythm disorders may occur.
In the case of hypercalcemia, bone and muscle pain may occur, as well as calcification (calcium deposits) in soft tissues. Additionally, nephrocalcinosis (calcium deposits in the kidneys), kidney dysfunction with polyuria (increased urination frequency), increased thirst, nocturia (urination at night), and proteinuria (protein in the urine) may occur.
In rare cases (may occur in 1 in 1000 people), in the case of very high doses, photophobia (eye sensitivity to light) and conjunctivitis with corneal calcification (calcium deposits) may occur.
Other side effects include: rhinitis (runny nose), itching, hyperthermia (fever), and decreased libido (sexual desire). Pancreatitis. Increased levels of urea in the blood, albuminuria (albumin in the urine), hypercholesterolemia (elevated cholesterol levels in the blood), and hypercalcemia (elevated calcium levels in the blood).
In the case of high calcium levels in the blood, increased transaminase activity (ASAT and ALAT) may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Calfos

Keep the 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 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 that are no longer needed. 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. Each capsule contains 0.266 mg of calcifediol.
The other ingredients are: anhydrous ethanol, medium-chain triglycerides, and the capsule shell contains: gelatin, glycerol, sorbitol, 70% solution, titanium dioxide (E 171), and orange 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, packaged in PVC/PVDC-Aluminum blisters and cardboard boxes containing 5 or 10 capsules.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Laboratórios Vitória, S.A.
Rua Elias Garcia, 28
2700-327 Amadora
Portugal

Manufacturer:

Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leoia - Bizkaia
Spain

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Portuguese marketing authorization number:
5710934
5710942

Parallel import authorization number: 59/24

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

France:
Calcifediol Faes 0.266 mg soft capsule
Italy:
NEODIDRO
Portugal:
Vitodê 0.266 mg soft capsule
Belgium:
Defediol
Bulgaria:
Hidroferol 0.266mg soft capsule
Estonia:
Defevix
Lithuania:
Defevix 0.266mg soft capsule
Latvia:
Defevix 0.266mg soft capsules
Luxembourg:
Defediol
Netherlands:
Hidroferol 0.266mg soft capsules
Poland:
Calfos
Romania:
Hidroferol 0.266mg soft capsule

Date of leaflet approval: 12.02.2024

[Information about the trademark]