Package leaflet: Information for the patient

Calfos, 0.266 mg, soft capsules
Calcifediolum monohydricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet

What Calfos is and what it is used for
What you need to know 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, calcium absorption.
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 absorbing nutrients), mineral and bone disorder associated with chronic kidney disease (CKD-MBD), or other identified risks.
Calfos is also used as supplementary treatment of 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 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 this may lead to poisoning (see section 3, subsection If you take more Calfos than you should).
While taking this medicine or before starting treatment, your doctor may order blood or urine tests to monitor calcium, phosphate and other parameters.
Patients with kidney disease require special care and must be closely monitored by the doctor, including regular laboratory tests.
Patients with heart disease require special care and must be frequently monitored by the doctor, including blood calcium level tests, especially in patients taking cardiac glycosides (see section Calfos with other medicines below).
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 immobilised for prolonged periods, a dose reduction of this medicine may be necessary.
Patients with sarcoidosis (a disease characterised by granuloma formation, usually in the skin), tuberculosis, or other granulomatous diseases should exercise particular caution when taking this medicine, as they are at higher risk of 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, or skin tests with allergens, etc.), the patient should inform the doctor about taking this medicine, as it may affect test results, for example cholesterol measurements.

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

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. Likewise, Calfos or its active substance, monohydrate calcifediol, may affect the effectiveness of other medicines taken simultaneously. Therefore, it may interact with the following medicines:

medicines used to treat epilepsy (such as phenytoin, phenobarbital and primidone) and other enzyme-inducing (stimulating) medicines (which reduce the effectiveness of Calfos);
heart medicines 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 a different type of laxative or to take medicines with a 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 effects will add up to those of this medicine and may therefore become excessive.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 a negligible effect on the ability to drive and operate machinery.

Calfos contains ethanol, sorbitol (E 420) and sunset yellow (E 110).
This medicine contains 5 mg of alcohol (ethanol) in each soft capsule. The amount of alcohol in one capsule 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 the doctor. In case of doubts, consult
your doctor or pharmacist.
Do not take more medicine or more frequently than prescribed (once a week, once every two
weeks, or once a month), as this increases the risk of overdose.
Recommended doses are as follows:

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

In certain populations, the risk of vitamin D deficiency is high, so these groups 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 given daily.
The 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 medicine’s effect is too strong or too weak, consult your doctor or pharmacist.

Taking more Calfos than prescribed
Taking a higher dose than prescribed by the doctor (overdose) and/or taking the medicine for a
longer period may lead to hypercalcemia (high calcium levels in the blood) and the appearance of
phosphates in urine and blood, which may result in kidney failure. Some symptoms of toxicity 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.
Later symptoms may include: itching, weight loss, growth retardation in children, kidney disorders,
sensitivity to sunlight, 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. Symptoms
of overdose usually diminish or resolve after discontinuation of the medicine; however, in cases of
severe poisoning, kidney or heart failure may occur.

Missed 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 the regular dosing schedule.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Adverse reactions may occur with higher doses or longer treatment duration than prescribed by a doctor, which may lead to hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in urine). See section 3 for symptoms related to 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

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 carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Calfos contains

The active substance is calcifediol monohydrate. Each capsule contains 0.266 mg of calcifediol monohydrate.
The other ingredients are: anhydrous ethanol, medium-chain saturated triglycerides; and for the capsule shell: gelatin, glycerol, sorbitol (70%) (E 420), titanium dioxide (E 171), and sunset yellow FCF (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 and Manufacturer
Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer
FAES FARMA, S.A.
Máximo Aguirre, 14
48940 Leioa - Bizkaia
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00
Fax: +48 22 566 21 01

This medicine is authorised in the European Economic Area countries under the following trade 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