Calfos

Leaflet attached to the packaging: patient information

Calfos, 0.266 mg, soft capsules

Calcifediolmonohydrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 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 associated with chronic kidney disease (CKD-MBD), or other identified risk factors. Calfos is also used as adjunctive treatment for osteoporosis (reduced bone mineral density, altered 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 you are allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6),
• if you have hypercalcaemia (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 poisoning (see section 3, subsection Taking more than the recommended dose of Calfos).

Taking more than the recommended dose of Calfos).

• 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 blood calcium level tests, especially in people taking cardiac glycosides (see section 6, 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 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 lower than recommended doses. Regular laboratory tests should be performed to monitor blood and urine calcium levels.
• Effect on laboratory tests: if you are undergoing diagnostic tests (including blood, urine, skin tests with allergens, etc.), you should inform your doctor that you 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 might take. Some medicines may affect the way this medicine works. 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 may reduce the effect 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 drinks are fortified with vitamin D. This should be taken into account, as their effect will be cumulative with the effect of this medicine and may become excessive.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. You should not take this medicine during breastfeeding.

Driving and using machines

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

Calfos contains ethanol, sorbitol (E 420), and orange yellow (E 110)

This medicine contains 5 mg of alcohol (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 have noticeable effects. This medicine contains 22 mg of sorbitol in each soft capsule, which corresponds to 0.03 mg/mg. This medicine contains orange yellow (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, ask 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 for 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 vitamin D. After analytical verification of the degree of vitamin D deficiency, your doctor may consider administering one capsule every two weeks or every week. This medicine should not be taken daily. Your 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, talk to your doctor or pharmacist.

Taking more than the recommended dose of Calfos

Taking a higher dose of the medicine than prescribed by your doctor (overdose) and/or taking the medicine for a longer period than prescribed by your doctor may cause hypercalcaemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine), which may lead to kidney failure. Some symptoms of toxicity may appear early, and others may occur 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 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 your regular dosing schedule.

Stopping Calfos treatment

If you have any further questions 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 may occur when taking higher doses or longer treatment than prescribed by your doctor, which may cause hypercalcaemia (high calcium levels in the blood) and hypercalciuria (high 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 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage precautions for this medicine. 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 is calcifediol monohydrate. Each 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%) (E 420), titanium dioxide (E 171), and orange 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, packaged in PVC/PVDC/Aluminium blisters containing 5 or 10 capsules. The blisters are packaged in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany

Manufacturer

FAES FARMA, S.A., Máximo Aguirre, 14, 48940 Leioa, Bizkaia, Spain. For more information about this medicine, contact the local representative of the marketing authorization holder: Berlin-Chemie/Menarini Polska Sp. z o.o., Tel.: +48 22 566 21 00, Fax: +48 22 566 21 01. This medicine is authorized 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.

Date of last revision of the leaflet: 03/2024