Calsus

Package Leaflet: Information for

the user

Calsus, 25,000 IU, soft capsules

Cholecalciferol

Read the package 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 or pharmacist.
• This medicine has been prescribed 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Calsus and what is it used for
• 2. Important information before taking Calsus
• 3. How to take Calsus
• 4. Possible side effects
• 5. How to store Calsus
• 6. Contents of the pack and other information

1. What is Calsus and what is it used for

Calsus contains the active substance cholecalciferol (vitamin D), which regulates the absorption and metabolism of calcium and bone mineralization. Calsus is used to prevent and treat vitamin D deficiency in adults and adolescents (children over 12 years of age). Calsus is also used as a supplement to proper treatment of bone loss (osteoporosis) in adult patients, preferably in combination with calcium.

2. Important information before taking Calsus

When not to take Calsus:

• if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if you have hypercalcemia (high blood calcium levels) or hypercalciuria (high urine calcium levels);
• if you have kidney stones or are prone to kidney stone formation;
• if you have severe kidney function disorders;
• if you are hypersensitive to peanuts or soy.

If any of the above applies to you, consult your doctor or pharmacist before taking Calsus. 1/5

Warnings and precautions

Before starting treatment with Calsus, discuss it with your doctor or pharmacist:

• if you have sarcoidosis (a disease that affects the connective tissue in the lungs, skin, and joints);
• if you are taking other medicines containing vitamin D;
• if you have kidney disease;

Children and adolescents

This medicine is not intended for use in children under 12 years of age.

Calsus and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• thiazide diuretics (medicines used to treat high blood pressure);
• phenytoin or barbiturates (medicines used to treat epilepsy);
• glucocorticoids (medicines used to treat inflammatory conditions);
• digoxin (a medicine used to treat heart conditions);
• cholestyramine (a medicine used to treat high cholesterol levels);
• laxatives, e.g., those containing liquid paraffin;
• actinomycin (a medicine used in chemotherapy);
• imidazole (an antifungal medicine);
• rifampicin (an antibiotic);
• isoniazid (an antibiotic).

Calsus with food and drink

Swallow the Calsus capsule whole with water, preferably during a meal.

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. Calsus is not recommended during pregnancy. Calsus can be used during breastfeeding. Vitamin D passes into breast milk. This should be taken into account when giving additional vitamin D to a breastfed child. There are no data on the effect of vitamin D on fertility. However, it is not expected that normal vitamin D levels will have any adverse effect on fertility. 2/5

3. How to take Calsus

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Swallow the capsules whole with water. It is best to take Calsus with a meal to help your body absorb the vitamin D.

Adults and adolescents

Prevention of vitamin D deficiency
The recommended dose is one capsule (25,000 IU) per month.
Initial treatment of vitamin D deficiency
The dose will be adjusted according to the patient's blood vitamin D levels (25-hydroxycholecalciferol (25(OH)D)).
The recommended dose is 100,000 IU (4 capsules of 25,000 IU) taken once in the first month.
A maintenance dose of one capsule of 25,000 IU per month may be considered after the initial dose of 100,000 IU.
Calsus used as a supplement to proper treatment of osteoporosis in adult patients
The recommended dose is one capsule (25,000 IU) per month.

Use in children

Calsus in the form of 25,000 IU capsules is not intended for use in children under 12 years of age. Other forms of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Overdose of Calsus

If you take more than you should, contact your doctor or emergency department immediately for assessment of the risk and advice. The most common symptoms of overdose are: nausea, vomiting, excessive thirst, increased urination within 24 hours, constipation, and dehydration, as well as high blood calcium levels (hypercalcemia and hypercalciuria) confirmed by laboratory tests.

Missed dose of Calsus

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Calsus

If you want to stop taking this medicine, discuss it with your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Calsus and contact your doctor immediately if you experience symptoms of a severe allergic reaction such as:

• swelling of the face, lips, tongue, or throat;
• difficulty swallowing;
• difficulty breathing.

Uncommon(may affect up to 1 in 100 people):

• -hypercalcemia (elevated blood calcium levels) and
• -hypercalciuria (elevated urine calcium levels).

Rare(may affect up to 1 in 1,000 people):

• -itching, rash, hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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 Calsus

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. Store the medicine below 25°C. Store in the original package to protect from moisture. 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 Calsus contains

The active substance is cholecalciferol (vitamin D). Each soft capsule contains 0.625 mg of cholecalciferol, equivalent to 25,000 IU of vitamin D. The other ingredients are: capsule filling: medium-chain triglycerides, all-rac-α-tocopherol (E 307). Capsule shell: gelatin, glycerol, purified water, titanium dioxide (E 171), and yellow iron oxide (E 172). Also contains traces of medium-chain triglycerides, phosphatidylcholine (from soybean lecithin - see section 2 "Calsus contains soybean lecithin"), caprylic and capric triglycerides, ethanol, sunflower seed oil glycerides, oleic acid, ascorbyl palmitate, and all-rac-α-tocopherol.

What Calsus looks like and contents of the pack

Calsus, 25,000 IU, soft capsules, are yellow, opaque, oval-shaped soft gelatin capsules, approximately 9 mm x 6 mm in size. PVC/PVDC/Aluminum blisters in a cardboard box. Packs of 1, 2, 3, 4, 6, and 12 soft capsules, as well as packs of 3x1, 4x1, 6x1, 12x1 soft capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Manufacturer/Importer

TEVA Gyógyszergyár Zrt., Pallagi út 13, 4042 Debrecen, Hungary, Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany. For more information on this medicine, contact the marketing authorization holder: Teva Pharmaceuticals Polska Sp. z o.o., tel. +48 22 345 93 00

Date of last revision of the leaflet: June 2024

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