Calsus

Package leaflet: Information for the

user
Calsus, 25,000 IU, soft capsules
Cholecalciferolum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the 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 using Calsus
3. How to use 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 called cholecalciferol (vitamin D), which regulates
calcium absorption and metabolism, and bone mineralization.
Calsus is used for the prevention and treatment of vitamin D deficiency in adults and
adolescents (children aged > 12 years).
Calsus is also used as a supplement to appropriate treatment for bone mass loss
(osteoporosis) in adult patients, preferably in combination with calcium.

2. Important information before using Calsus

When not to use Calsus:

• if the patient is allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypercalcaemia (elevated calcium levels in the blood) or hypercalciuria (elevated calcium levels in the urine);
• if the patient has kidney stones or a tendency to form kidney stones;
• if the patient has severe kidney function disorders;
• if the patient is hypersensitive to peanuts or soy.

If any of the above situations apply to the patient, consult a doctor or pharmacist before using Calsus.
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Warnings and precautions
Before starting treatment with Calsus, discuss with your doctor or pharmacist:

• if the patient has sarcoidosis (a disease affecting connective tissue in the lungs, skin and joints);
• if the patient is taking other medicines containing vitamin D;
• if the patient has 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially any of the following:

• thiazide diuretics (medicines used to treat high blood pressure);
• phenytoin or barbiturates (medicines used to treat epilepsy);
• glucocorticosteroids (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
The Calsus capsule should be swallowed whole with water, preferably during a meal.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The use of Calsus during pregnancy is not recommended.
Calsus may be used during breastfeeding. Vitamin D passes into breast milk. This should be taken into account when administering additional vitamin D to a breastfed infant.
There are no data on the effect of vitamin D on fertility. However, it is not expected that normal vitamin D levels would have any adverse effect on fertility.

Driving and using machines
It has not been established that Calsus affects the ability to drive or operate machinery.

Calsus contains soy lecithin
Calsus contains trace amounts of soy lecithin, which may contain soybean oil. This medicine should not be used in patients with a known hypersensitivity to peanuts or soy.
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3. How to use Calsus

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The capsules should be swallowed whole with water.
It is best to take the medicine during a meal to facilitate the body's absorption of vitamin D.

Adults and adolescents
Prevention of vitamin D deficiency
The recommended dose is one capsule (25,000 IU) once a month.

Treatment of initial vitamin D deficiency
The dose for treating vitamin D deficiency will be adjusted according to the patient's blood vitamin D concentration (25-hydroxycholecalciferol (25(OH)D) levels).
The recommended dose is 100,000 IU (4 capsules of 25,000 IU each) taken as a single dose in the first month.
A maintenance dose of one capsule (25,000 IU) once monthly may be considered after administration of the initial 100,000 IU dose.

Calsus used as a supplement to appropriate treatment of osteoporosis in adult patients
The recommended dose is one capsule (25,000 IU) once a 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 formulations of this medicine may be more suitable for children. Consult a doctor or pharmacist.

Taking more Calsus than recommended
If an overdose is taken or if a child accidentally ingests this medicine, contact a doctor or emergency department to assess risk and obtain advice.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, increased urination over 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 missed dose.

Stopping Calsus treatment
If the patient wishes to discontinue taking this medicine, this should be discussed with the doctor.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

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

Not common (may affect up to 1 in 100 people):

• hypercalcaemia (increased calcium levels in serum) and
• hypercalciuria (increased calcium levels in urine).

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

• itching, rash, urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
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 Calsus medicine

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 after:
"EXP". The expiry date refers to the last day of the specified month.
Store the medicine at a temperature not exceeding 25°C. Keep in the original packaging
to protect from moisture.
Medicines must 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 package 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:
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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). It also contains trace amounts of medium-chain triglycerides, phosphatidylcholine (from soybean lecithin – see section 2 “Calsus contains lecithin from soy”), caprylic and capric triglycerides, ethanol, glycerides (from sunflower seed oil), 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 measuring approximately 9 mm x 6 mm.
Packaged in PVC/PVDC/Aluminium foil blisters in cardboard cartons. Packs containing 1, 2, 3, 4, 6, and 12 soft capsules, as well as unit-dose blister packs containing 3x1, 4x1, 6x1, and 12x1 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00
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