Devikap

Leaflet attached to the packaging: patient information

Devikap, 2,000 IU, soft capsules

Devikap, 4,000 IU, soft capsules

Devikap, 10,000 IU, soft capsules

Cholecalciferol

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 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, tell 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:

• 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 geographical 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, working at night), or when the need for vitamin D is increased (pregnant women, people with overweight and obesity).

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);
• in children under 11 years of age.

Warnings and precautions

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

• if you are taking certain heart medicines (e.g. cardiac glycosides, such as digoxin);
• if you have sarcoidosis (a disease of the immune system 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 supplements. 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 and urine calcium levels and checking your kidney function by measuring creatinine levels in your blood;
• if treatment with vitamin D is long-term, as in this case, your doctor should monitor your blood and urine calcium levels and check your kidney function by measuring creatinine levels in your 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 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.
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 too high a level of vitamin D can harm the baby.
During pregnancy, you should 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 baby.
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 baby.

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 and treatment 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 recommended by your 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 recommended by your 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 recommended by your 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, and then 2,000 IU per day or 10,000 IU per week, depending on age and body weight, under medical supervision.
The doctor will re-check the 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 recommended by your 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 a 25(OH)D level of ≥30-50 ng/ml is achieved, then a maintenance dose, i.e. the recommended preventive dose for the general population, 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 metabolites and analogs of vitamin D 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 you accidentally take one capsule more than recommended, the occurrence of overdose symptoms is unlikely.
If you have taken too much of the medicine, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, take the package and this leaflet with you to show the doctor.

Missing a dose of Devikap

If you forget to take the medicine, take it as soon as possible. Take the next dose at the usual time. However, 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 taking this medicine, ask 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

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 associated with 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Devikap

Keep the medicine out of the 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 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 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. 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 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.
• The other ingredients are: capsule content: purified cottonseed 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 (short 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 (short 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 (short 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 pack contains 30, 60, or 90 capsules in blisters.
Devikap 10,000 IU: the pack contains 30 or 60 capsules in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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