Devikap

Package Leaflet: Information for the Patient

Devikap, 2,000 IU, Soft Capsules

Devikap, 4,000 IU, Soft Capsules

Devikap, 10,000 IU, Soft Capsules

Cholecalciferol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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:

• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in patients at high risk;
• for the treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency.

Vitamin D deficiency may occur in people living at high geographic latitudes (> 35°) or in those whose diet or lifestyle does not provide adequate amounts of vitamin D (people who spend most of their time indoors, work at night), or when the need for vitamin D is increased (pregnant women, people with excess weight and obesity).

2. Important information before taking Devikap

When not to take Devikap:

• if the patient is allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has elevated calcium levels in the blood (hypercalcemia) or in the urine (hypercalciuria);
• if the patient has severe kidney failure, kidney stones (nephrolithiasis), or a tendency to form kidney stones;
• if the patient has elevated vitamin D levels in the blood (hypervitaminosis D);
• in children under 11 years of age.

Warnings and precautions

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

• if the patient is taking certain heart medications (e.g., cardiac glycosides, such as digoxin);
• if the patient has sarcoidosis (an immune system disease that can cause increased vitamin D levels in the body);
• if the patient is 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 the patient will be exposed to large amounts of sunlight during treatment with Devikap;
• if the patient is taking additional calcium doses. During treatment with Devikap, the doctor will monitor calcium levels in the blood to ensure they are not too high;
• if the patient has damaged or diseased kidneys. In such cases, the doctor may recommend testing calcium levels in the blood and urine and checking kidney function by measuring creatinine levels in the blood;
• if treatment with vitamin D is long-term, as in such cases, the doctor should monitor the patient's calcium levels in the blood and urine and check kidney function by measuring creatinine levels in the blood.

Children and adolescents

Devikap can only be given to children over 11 years of age.

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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Devikap should only be taken during pregnancy if prescribed by a doctor.
During pregnancy, women should follow the doctor's recommendations, as their needs may vary depending on the degree of deficiency and response to treatment.
If a woman needs additional doses of vitamin D, she should not take them without medical supervision, as excessive vitamin D levels can harm the child.
During pregnancy, it is essential to avoid overdosing on vitamin D, as prolonged hypercalcemia (elevated calcium levels in the blood) can lead to delayed physical and mental development, as well as congenital heart defects and eye defects in the child.
Breastfeeding
Devikap should only be taken during breastfeeding if prescribed by a doctor.
Vitamin D and its metabolites pass into breast milk.
No overdose has been observed in breastfed infants. Breastfeeding women should not take high doses of vitamin D to supplement their child.

Driving and using machines

Devikap should not affect the ability to drive or operate machinery.

3. How to take Devikap

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The dosing schedule and treatment method should take into account the patient's clinical condition.
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/m²body surface area).
A person is considered overweight if their BMI is between 25 and 29.9 (kg/m²body surface area), and obese if their BMI is 30 (kg/m²body surface area) or more.

• Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in patients at high risk

Adults, including the elderly

2,000 IU per day, as directed by the doctor.
Obese adults (BMI ≥ 30 kg/m²)
Typically, the recommended dose is 4,000 IU per day, depending on the degree of obesity and the patient's response to treatment.
If necessary, a measurement of 25(OH)D levels should be performed after three to four months of treatment to confirm that the target 25(OH)D level has been achieved.

Obese adolescents and obese children over 11 years of age (BMI > 90th percentile for age)

2,000 IU per day, as directed by the doctor.
If necessary, a measurement of 25(OH)D levels should be performed after three to four months of treatment to confirm that the target 25(OH)D level has been achieved.

• Treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency

Adults

2,000 IU to 4,000 IU per day, as directed by the doctor. In some populations (including obese adults), a higher dose may be required.
In adult patients with laboratory-confirmed vitamin D deficiency, the recommended dose is 10,000 IU per day for 1 to 3 months, followed by 2,000 IU per day or 10,000 IU per week, depending on age and body weight, under medical supervision.
The doctor will recheck 25(OH)D levels after three to four months of treatment to confirm that the target 25(OH)D level has been achieved.
Obese patients
Obese adults (BMI ≥ 30 kg/m²) may require higher doses.
Underweight patients
Adults who are underweight (BMI <18.5 kg/m²) may require lower doses.

Children and adolescents

Adolescents and children over 11 years of age
2,000 IU to 4,000 IU per day, as directed by the doctor. Some patients (including obese adolescents and children) may require higher doses.
Treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency should be continued for three months or until 25(OH)D levels ≥ 30-50 ng/ml are achieved, then a maintenance dose, i.e., the recommended general population prophylactic dose, should be used, depending on age and body weight.
Obese adolescents and children over 11 years of age (BMI > 90th percentile for age)
Obese adolescents and children over 11 years of age (BMI > 90th percentile for age) may require higher doses of vitamin D than recommended for adolescents and children with normal body weight, depending on the degree of obesity.

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.

Taking a higher dose of Devikap than recommended

If the patient accidentally takes one capsule too many, the occurrence of overdose symptoms is unlikely.
If too high a dose of the medicine is taken, the patient should tell their doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, the patient should take the package and this leaflet with them to show the doctor.

Missing a dose of Devikap

If the patient forgets to take the medicine, they should take it as soon as possible. The next dose should be taken at the usual time. However, if it is almost time for the next dose, the patient should not take the missed dose; they should only 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 doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Devikap can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention

Medical attention.
The patient should immediately consult their doctor if they experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat (larynx)
• difficulty swallowing
• hives and difficulty breathing

Other side effects associated with Devikap include:
Uncommon(occurring in less than 1 in 100 patients)

• elevated calcium levels in the blood (hypercalcemia)
• elevated calcium levels 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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:
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Devikap

The medicine should be stored out of sight and reach of children.
Do not store above 30°C. Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the package and blister after EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Devikap contains

• The active substance is cholecalciferol.
• Each capsule contains: Devikap 2,000 IU - 50 micrograms of cholecalciferol equivalent to 2,000 IU of vitamin D; Devikap 4,000 IU - 100 micrograms of cholecalciferol equivalent to 4,000 IU of vitamin D; Devikap 10,000 IU - 250 micrograms of cholecalciferol equivalent to 10,000 IU of vitamin D.
• Other ingredients are: capsule content: purified peanut oil (type I), capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides.

What Devikap looks like and contents of the pack

Devikap 2,000 IU: the medicine is in the form of light yellow, oval, soft capsules (shorter diameter approximately 6 mm) with a seam in the middle, filled with a light yellow, oily liquid.
Devikap 4,000 IU: the medicine is in the form of light yellow, oval, soft capsules (shorter diameter approximately 7 mm) with a seam in the middle, filled with a light yellow, oily liquid.
Devikap 10,000 IU: the medicine is in the form of light yellow, oval, soft capsules (shorter diameter approximately 9 mm) with a seam in the middle, filled with a light yellow, oily liquid.
Devikap 2,000 IU and Devikap 4,000 IU: the package contains 30, 60, or 90 capsules in blisters.
Devikap 10,000 IU: the package contains 30 or 60 capsules in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz
Date of last revision of the leaflet:September 2024