Devikap

Patient Information Leaflet

Devikap, 20,000 IU, soft capsules
Devikap, 50,000 IU, soft capsules
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Devikap is and what it is 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 Devikap is and what it is used for

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

• for the treatment of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults (particularly in the initial treatment of confirmed, significant deficiencies)
• for the prevention of vitamin D deficiency in adult patients at high risk.

2. Important information before using Devikap

When not to use 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 (hypercalcaemia) or in the urine (hypercalciuria);
• if the patient has severe kidney failure, kidney stones (nephrolithiasis), or a tendency to develop kidney stones;
• if the patient has elevated vitamin D levels in the blood (hypervitaminosis D).

Warnings and precautions
Before starting to use Devikap, discuss this with a doctor or pharmacist:

• if the patient is taking certain medicines used for heart conditions (e.g. cardiac glycosides such as digoxin);
• if the patient has sarcoidosis (an immune system disorder that may 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 fortified with vitamin D;
• if the patient is likely to be exposed to large amounts of sunlight during treatment with Devikap;
• if the patient is taking additional calcium supplements. 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 or urine.

If the patient is taking this medicine for a prolonged period, they should visit the doctor for monitoring of calcium levels in the blood and urine.
Children and adolescents
Devikap is not recommended for children and adolescents under 18 years of age.
Devikap 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.
This is particularly important if the patient is taking:

• medicines affecting the heart or kidneys, such as cardiac glycosides (e.g. digoxin) or thiazide diuretics. When used concomitantly with vitamin D, these medicines may cause, among others, a significant increase in calcium levels in blood and urine;
• medicines containing vitamin D, calcitriol, or other vitamin D metabolites and analogues, as well as foods rich in vitamin D;
• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungal medicines (e.g. clotrimazole and ketoconazole, used in the treatment of fungal infections), as they may affect vitamin D metabolism;
• the following medicines, because they may affect the action or absorption of vitamin D, or vitamin D may affect the action of these medicines:
  • anticonvulsant (antiepileptic) medicines, barbiturates;
  • glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone). They may weaken the effect of vitamin D;
  • cholesterol-lowering medicines (such as cholestyramine or colestipol);
  • certain medicines used to treat obesity that reduce fat absorption (e.g. orlistat);
  • certain laxatives (such as liquid paraffin);
  • antacids containing magnesium or aluminium (used for heartburn or indigestion);
  • medicines used in the treatment of tuberculosis (e.g. rifampicin, isoniazid).

Devikap with food and drink
This medicine should be taken with a main meal to facilitate absorption of vitamin D.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.
Devikap should be taken during pregnancy and/or breastfeeding only if recommended by a doctor.
If a woman requires additional doses of vitamin D, she should not take them without medical supervision, as excessively high vitamin D levels may harm the unborn or breastfed child.
Driving and operating machinery
Devikap is unlikely to affect the ability to drive or operate machinery.

3. How to use Devikap

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dosing regimen and treatment schedule should take into account the individual clinical condition of the patient. Depending on the daily dose of vitamin D individually determined for each patient, the treating physician will establish an appropriate dosing schedule, specifying the recommended dose and the interval between doses.

BMI (Body Mass Index) is a coefficient used to determine whether body weight in relation to height is within normal range. Normal BMI is above 18.5 and below 25 (kg/m² body surface area (b.s.a.)).
A person is considered overweight if their BMI is between 25 and 29.9 (kg/m² b.s.a.), and obese if BMI is 30 (kg/m² b.s.a.) or higher.

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 weekly or 40,000 IU once weekly for 1–3 months,
• or 50,000 IU once weekly for 1–3 months.

After this initial treatment, continuation therapy with vitamin D at a dose of 2,000 IU daily or 10,000 IU weekly is recommended. The dosage and frequency are determined individually by the physician for each patient. After completing treatment, the treating physician may recommend preventive vitamin D supplementation.

Obese adults (BMI ≥30 kg/m² b.s.a.) may require higher doses of vitamin D.
Underweight adults (BMI < 18.5 kg/m² b.s.a.) 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 monthly, or 1 capsule of 50,000 IU monthly.

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

Method of administration
Capsules should be swallowed whole with water, preferably during a main meal.

Taking more than the recommended dose of Devikap
If a patient accidentally takes more capsules than recommended, inform a doctor or seek immediate medical help. If possible, bring the package and this leaflet to show the doctor.

The most common symptoms of overdose include nausea, vomiting, diarrhea—often occurring in the initial phase—followed by constipation, loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness, drowsiness, excessive thirst, frequent urination lasting more than 24 hours, dehydration, and laboratory-confirmed elevated calcium levels in blood and urine.

High calcium levels in blood may cause cardiac arrhythmias, kidney failure, pancreatitis, and even lead to death.

Missing a dose of Devikap
If a patient forgets to take the medicine, it should be taken as soon as possible. The next dose should be taken at the usual time. If the time for the next dose is approaching, the missed dose should not be taken; only the next scheduled dose should be taken 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention.
You should contact your doctor immediately if symptoms of angioedema occur, such as:

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

Other adverse reactions associated with the use of Devikap include:

Uncommon (occur in less than 1 in 100 patients)

• elevated calcium levels in blood (hypercalcaemia)
• elevated calcium levels in urine (hypercalciuria)

Rare (occur in less than 1 in 1,000 patients)

• rash
• itching
• hives

Frequency not known (cannot be estimated from available data)

• constipation
• gas (bloating)
• nausea
• abdominal pain
• diarrhoea

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 provide more information on the safety of this medicine.

5. How to store Devikap

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the package and other information

What Devikap contains

• The active substance 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 composition: gelatin, glycerol, purified water.

What Devikap looks like and contents of the pack
Devikap 20,000 IU is in the form of transparent, yellowish, round soft capsules (diameter approx. 9.5 mm) with a central seam, filled with an oily liquid.
Devikap 50,000 IU is in the form of transparent, yellowish, oval soft capsules (long diameter approx. 13 mm) with a central seam, 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: capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19,
83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10,
98-200 Sieradz