Devikap

Package Leaflet: Information for the Patient

DEVIKAP 15,000 IU/ml, Oral Drops, Solution

Cholecalciferol

Read the package leaflet carefully before using 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. 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 any 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 using Devikap
• 3. How to use 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 is a vitamin medicine containing cholecalciferol (vitamin D). Vitamin D is produced in the skin under the influence of UV light and can also be supplied to the body with food. Vitamin D increases the absorption of calcium and phosphates in the digestive tract and kidneys and facilitates bone mineralization. Vitamin D deficiency can lead to bone mineralization disorders (rickets) or loss of calcium from bones (osteomalacia). Devikap is indicated:

• for the prevention of rickets and osteomalacia in children and adults;
• for the prevention of rickets in premature infants;
• for the prevention of diseases in cases of proven risk of vitamin D deficiency in children and adults;
• for the prevention of vitamin D deficiency in cases of impaired absorption in children and adults;
• for the treatment of rickets and osteomalacia in children and adults;
• as a supportive treatment in osteoporosis in adults;
• for the treatment of hypoparathyroidism in adults.

2. Important information before using Devikap

When not to use Devikap:

• if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if you have hypercalcemia (elevated calcium levels in the blood);
• if you have kidney stones;
• if you have sarcoidosis (a disease of the immune system);
• if you have kidney failure.

Warnings and precautions

Before starting to use Devikap, discuss it with your doctor or pharmacist if:

• you are immobilized;
• you are taking thiazide diuretics;
• you have kidney stones;
• you have heart disease;
• you are taking digitalis glycosides;
• you are pregnant or breastfeeding;
• you are taking large doses of calcium.

During treatment, it is recommended to periodically monitor calcium and phosphate levels in the blood and urine.

Children

In children, the daily requirement and method of administration of vitamin D are determined individually by the doctor and verified during each check-up, especially in the first months of life. Particular caution should be exercised in infants with small fontanelles from birth.

Devikap and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Antiepileptic drugs, especially phenytoin and phenobarbital, as well as rifampicin, reduce the absorption of vitamin D.
• Taking vitamin D with thiazide diuretics increases the risk of hypercalcemia.
• Concomitant administration with cardiac glycosides may enhance their toxicity (increased risk of arrhythmias).
• Concomitant administration with antacids containing aluminum and magnesium can cause toxic effects of aluminum on bones and hypermagnesemia in patients with renal failure.
• Concomitant use with vitamin D analogs carries the risk of toxic effects.
• Products containing high doses of calcium or phosphorus increase the risk of hyperphosphatemia.
• Ketoconazole may inhibit both the biosynthesis and catabolism of 1,25(OH)2-cholecalciferol.
• Vitamin D may act antagonistically to drugs used in hypercalcemia, such as calcitonin, etidronate, and pamidronate.

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 using this medicine. Do not use this medicine in high doses in pregnant women, due to the possible teratogenic effect in case of overdose (excessive doses used during pregnancy may cause mental retardation and congenital heart defects in children). Caution should be exercised when administering the medicine to breastfeeding women - the medicine used in high doses may cause symptoms of overdose in the child.

Driving and using machines

Devikap has no effect on the ability to drive and use machines.

3. How to use Devikap

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist. The dose of the medicine is determined individually by the doctor, taking into account the amount of calcium taken simultaneously (both in the diet and in the form of other medicines). The medicine is administered orally. The abbreviation IU (International Unit) denotes international units, which indicate the activity of vitamin D. Prevention of deficiencies: Children from birth and adults - 500 IU (1 drop) per day. Treatment of deficiencies: The dose is determined individually by the doctor, depending on the degree of deficiency. Vitamin D-dependent rickets: Children - from 3,000 IU to 10,000 IU (from 6 to 20 drops) per day. Osteomalacia associated with the use of antiepileptic drugs: Children - 1,000 IU (2 drops) per day, adults - from 1,000 to 4,000 IU (from 2 to 8 drops) per day. Method of administration: The medicine should be administered in a spoonful of liquid. Note: 1 drop contains approximately 500 IU of vitamin D. Due to the risk of overdose, the medicine should not be administered directly from the bottle to the child's mouth.

Taking a higher dose of Devikap than recommended

If you have taken a higher dose of the medicine than recommended, contact your doctor or pharmacist immediately. Vitamin D, as an active factor regulating calcium and phosphate metabolism, can cause hypercalcemia (elevated calcium levels in the blood), hypercalciuria (elevated calcium levels in the urine), kidney calcification, and bone damage, as well as changes in the cardiovascular system, after significant overdose. Hypercalcemia occurs after prolonged use of vitamin D in doses of 50,000 - 100,000 IU per day. After an overdose of the medicine, muscle weakness, loss of appetite, nausea, vomiting, constipation, excessive thirst, polyuria, lethargy, conjunctivitis, photophobia, pancreatitis, rhinorrhea, hyperthermia, decreased libido, hypercholesterolemia, weight loss, excessive sweating, and pancreatitis may occur. Common symptoms include headaches, muscle and joint pain, and weight loss. Kidney function is impaired, which is manifested by decreased urine density and the presence of casts in the urine. Treatment after overdose: The medicine should be discontinued. A large amount of fluid should be administered. Contact your doctor, who will decide on the need for hospital treatment.

Missing a dose of Devikap

Do not take a double dose to make up for a missed dose. If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Devikap can cause side effects, although not everybody gets them. Side effects are practically nonexistent when administered in recommended doses. In the case of rare hypersensitivity to vitamin D or after taking too high doses for a long time, vitamin D poisoning, known as hypervitaminosis D, may occur. Symptoms of hypervitaminosis D include:

• arrhythmias;
• headaches, lethargy;
• conjunctivitis, photophobia;
• loss of appetite, nausea, vomiting, constipation;
• polyuria, hypercalcemia;
• muscle and joint pain, muscle weakness;
• hypercholesterolemia, weight loss, excessive thirst, excessive sweating, pancreatitis;
• hypertension;
• skin itching;
• increased activity of aminotransferases;
• decreased libido, depression, psychotic disorders;
• rhinorrhea;
• hyperthermia;
• dry mouth;
• increased calcium levels in the blood and/or urine;
• kidney stones;
• tissue calcification.

Reporting side effects

If you experience any side effects, including any 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, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 the medicine out of the 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 bottle. The expiry date refers to the last day of the month stated. The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. The opened package should be used within 12 months. 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 ml (approximately 30 drops) contains 15,000 IU of cholecalciferol. Each drop contains approximately 500 IU of vitamin D.
• The other ingredient is: triglycerides of medium-chain fatty acids.

What Devikap looks like and contents of the pack

Devikap is a clear, colorless to light yellow solution. The pack contains a 10 ml glass bottle, type III, with a HDPE screw cap and a LDPE dropper, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Oddział Medana w Sieradzu, ul. Władysława Łokietka 10, 98-200 Sieradz. For more detailed information about this medicine, contact the local representative of the marketing authorization holder: POLPHARMA Biuro Handlowe Sp. z o.o., ul. Bobrowiecka 6, 00-728 Warsaw, tel. 22 364 61 01. Date of last revision of the leaflet:May 2021