Devikap

Package Leaflet: Information for the Patient

Devikap, 20,000 IU, Soft Capsules

Devikap, 50,000 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 only. 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Devikap and what is it used for

Devikap contains the active substance cholecalciferol, which is identical to vitamin D produced in the human body.
Devikap is used:

• to treat vitamin D deficiency and conditions resulting from vitamin D deficiency in adults (especially in the initial treatment of confirmed, significant deficiencies)
• to prevent vitamin D deficiency in adult patients at high risk.

2. Important information before taking Devikap

When not to take Devikap:

• if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria);
• if you have severe kidney failure, kidney stones (nephrolithiasis), or a tendency to form kidney stones;
• if you have high levels of vitamin D in the blood (hypervitaminosis D).

Warnings and precautions

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

• if you are taking certain heart medicines (e.g., digitalis glycosides, such as digoxin);
• if you have sarcoidosis (an immune system disease that can cause increased levels of vitamin D in the body);
• if you are taking other medicines and/or dietary supplements containing vitamin D and calcium or consuming foods enriched with vitamin D;
• if there is a likelihood that you will be exposed to large amounts of sunlight during treatment with Devikap;
• if you are taking additional calcium doses. During treatment with Devikap, your doctor will monitor your blood calcium levels to ensure they are not too high;
• if you have damaged or diseased kidneys. In this case, your doctor may recommend testing your blood or urine calcium levels.

If you are taking this medicine for a long time, you should see your doctor for a check-up of your blood and urine calcium levels.

Children and adolescents

Devikap is not recommended for children and adolescents under 18 years of age.

Devikap with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
This is especially important if you are taking:

• heart or kidney medicines, such as digitalis glycosides (e.g., digoxin) or thiazide diuretics. When taken together with vitamin D, these medicines may cause, among other things, a significant increase in blood and urine calcium levels;
• medicines containing vitamin D, calcitriol, or other vitamin D metabolites and analogs, as well as foods rich in vitamin D;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal medicines (e.g., clotrimazole and ketoconazole, used to treat fungal infections), as they may affect vitamin D metabolism;
• the following medicines, as they may affect the action or absorption of vitamin D, or vitamin D may affect the action of these medicines:
• antiepileptic medicines (anticonvulsants), barbiturates;
• glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone). They may weaken the action of vitamin D;
• medicines that lower blood cholesterol levels (such as cholestyramine or colestipol);
• certain weight loss medicines that reduce fat absorption (e.g., orlistat);
• certain laxatives (e.g., paraffin oil);
• antacids containing magnesium or aluminum (used for heartburn or indigestion);
• medicines used to treat tuberculosis (e.g., rifampicin, isoniazid).

Devikap with food and drink

This medicine is best taken with the main meal to facilitate the absorption of vitamin D.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Devikap should be taken during pregnancy and/or breastfeeding only if prescribed by a doctor.
If a woman needs additional doses of vitamin D, she should not take them without medical supervision, as excessive levels of vitamin D can harm the child.

Driving and using machines

Devikap is unlikely to affect your ability to drive or use machines.

3. How to take Devikap

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The dosing schedule of the medicine and the treatment method should take into account the patient's clinical condition.
Depending on the individually determined daily dose of vitamin D, the doctor will establish an appropriate dosing schedule with the recommended dose and interval between doses.
Body Mass Index (BMI) is a factor that allows you to calculate whether your body mass is proportional to your height.
A normal BMI is above 18.5 and less than 25 (kg/m²).
It is considered that a person is overweight if their BMI is between 25 and 29.9 (kg/m²),
and obese if their BMI is 30 (kg/m²) or more.

Treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency (including osteoporosis)

Adults
In patients with laboratory-confirmed vitamin D deficiency, the recommended dose is

• 20,000 IU twice a week or 40,000 IU once a week for 1-3 months,
• or 50,000 IU once a week for 1-3 months. Then, it is recommended to continue treatment with vitamin D at a dose of 2,000 IU per day or 10,000 IU per week. The dosing and frequency of administration are determined individually by the doctor for each patient. After completing the treatment, the attending physician may recommend preventive use of vitamin D.

Obese adults (BMI ≥30 kg/m²) may require higher doses of vitamin D.
Underweight adults (BMI <18.5 kg/m²) may require lower doses of vitamin D.

Prevention of vitamin D deficiency in adult patients at high risk

2 or 3 capsules of 20,000 IU per month or 1 capsule of 50,000 IU per month.

Do not take other medicines, dietary supplements, or foods containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs without medical supervision.

Method of administration

The capsules should be swallowed whole, with water, preferably during the main meal.

Overdose of Devikap

If you have accidentally taken more capsules than recommended, tell your doctor or seek other medical help.
If possible, take the package and this leaflet with you to show the doctor.
The most common symptoms of overdose are nausea, vomiting, diarrhea - often occurring in the initial stage, and then constipation, loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness, drowsiness, excessive thirst, frequent urination lasting more than 24 hours, dehydration, and elevated blood and urine calcium levels found in laboratory tests.
High blood calcium levels can cause heart rhythm disturbances, kidney failure, pancreatitis, and even lead to death.

Missed dose of Devikap

If you have missed a dose, take it as soon as possible. Take the next dose at the usual time. If it is almost time for the next dose, do not take the missed dose, just take the next dose at the usual time.

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

If you have any further questions about 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.

Some side effects can be serious and require immediate medical attention

Seek medical attention immediatelyif you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat (larynx)
• difficulty swallowing
• hives and difficulty breathing. Other side effects of Devikap include:

Uncommon(occurring in less than 1 in 100 patients)

• high levels of calcium in the blood (hypercalcemia)
• high levels of calcium in the urine (hypercalciuria) Rare(occurring in less than 1 in 1,000 patients)
• rash
• itching
• hives Frequency not known(cannot be estimated from the available data)
• constipation
• gas (bloating)
• nausea
• abdominal pain
• diarrhea.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Devikap

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect from light.
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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 Devikap contains

• The active substance of Devikap is cholecalciferol. Each Devikap 20,000 IU capsule contains 20,000 IU of cholecalciferol (vitamin D), equivalent to 0.5 mg of vitamin D. Each Devikap 50,000 IU capsule contains 50,000 IU of cholecalciferol (vitamin D), equivalent to 1.25 mg of vitamin D.
• The other ingredients are: capsule contents: all-rac-α-tocopheryl acetate (E 307), medium-chain triglycerides capsule shell: gelatin, glycerol, purified water.

What Devikap looks like and contents of the pack

Devikap 20,000 IU is a transparent, yellowish, round soft capsule (approximately 9.5 mm in diameter) with a seam in the middle, filled with an oily liquid.
Devikap 50,000 IU is a transparent, yellowish, oval soft capsule (approximately 13 mm in length) with a seam in the middle, filled with an oily liquid.
Devikap 20,000 IU: The pack contains 10, 14, 20, or 30 capsules in blisters.
Devikap 50,000 IU: The pack contains 2, 4, or 10 capsules in blisters.
Packaging: contains capsules in blisters of PVC/PVDC/Aluminum in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19,
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana Division in Sieradz
Władysława Łokietka 10,
98-200 Sieradz

Date of last revision of the leaflet: