Prodivit

Package Leaflet: Information for the Patient

Prodywit, 20,000 IU, Soft Capsules

Cholecalciferol (Vitamin D)

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

• Keep this package 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Prodywit and what is it used for

Prodywit contains the active substance cholecalciferol (Vitamin D), which regulates calcium intake and metabolism and calcium penetration into bone tissue.
Prodywit is used for the initial symptomatic treatment of Vitamin D deficiency in adults.

2. Important information before taking Prodywit

When not to take Prodywit:

• if you are allergic to cholecalciferol (Vitamin D), peanuts, soy, or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of Vitamin D in your blood (Vitamin D overload);
• if you have high levels of calcium in your blood (hypercalcemia) or high levels of calcium in your urine (hypercalciuria);
• if you have calcium deposits in your kidneys (nephrocalcinosis);
• if you have kidney stones (nephrolithiasis) or severe kidney function disorders.

If any of the above situations apply to you, do not take Prodywit.

Warnings and precautions

Before taking Prodywit, discuss it with your doctor or pharmacist:

• if you have kidney function disorders or have had kidney stones in the past. Your doctor will order a blood or urine calcium test;
• if you are being treated for heart disease;
• if your mobility is severely limited, as this may increase the risk of high levels of calcium in your blood (hypercalcemia) or high levels of calcium in your urine (hypercalciuria);
• if you have sarcoidosis (an immune system disorder that can affect the liver, lungs, skin, or lymph nodes);
• if you are taking medicines or dietary supplements containing Vitamin D, as well as if you are consuming foods containing Vitamin D. During the treatment with Prodywit, your doctor will monitor your blood levels of Vitamin D and calcium to ensure they are not too high.
• if you have pseudo-hypoparathyroidism (a rare genetic disorder that causes the body's metabolism not to respond to parathyroid hormone).

Children and adolescents

This medicine is not intended for use in children and adolescents under 18 years of age.

Prodywit and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Prodywit may interact with the following medicines:

• cardiac glycosides (such as digoxin). Your doctor may monitor your heart rate using an electrocardiogram (ECG) and measure your blood calcium levels;
• thiazide diuretics (used to treat high blood pressure), as these medicines reduce calcium excretion in the urine and may increase the risk of hypercalcemia;
• medicines used to treat epilepsy (such as phenytoin) or sleeping aids (barbiturates such as phenobarbital), as these medicines may weaken the effect of Vitamin D;
• glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone), as these medicines may weaken the effect of Vitamin D;
• laxatives (such as paraffin oil), cholesterol-lowering medicines (cholestyramine, colestipol), or the medicine orlistat, as they may reduce Vitamin D absorption;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal medicines (such as clotrimazole and ketoconazole, used to treat fungal infections), as they may affect Vitamin D metabolism.
• medicines used to treat tuberculosis (such as rifampicin and isoniazid), as they may weaken the effect of Vitamin D;
• products containing calcium or phosphorus, as they may increase the risk of high levels of calcium or phosphates in the blood;
• products containing magnesium (such as antacids), as they may increase the risk of high levels of magnesium in the blood (hypermagnesemia).

Taking Prodywit with food and drink

Prodywit is best taken with a large meal to facilitate the body's absorption of Vitamin D.

Pregnancy, breastfeeding, and fertility

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.
Due to the high doses of Vitamin D, Prodywit is not recommended for pregnant or breastfeeding women.
There is no data on the effect of Vitamin D on fertility. However, it is not expected that normal levels of Vitamin D would have any undesirable effect on fertility.

Driving and using machines

Prodywit has no or negligible influence on the ability to drive and use machines.

Prodywit contains soybean oil

Prodywit contains soybean oil. Do not take this medicine if you are allergic to peanuts or soy.

3. How to take Prodywit

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Before taking additional calcium, consult your doctor.

Adults

The recommended dose is 1 capsule per week for 4-5 weeks.
Swallow the capsules whole with water, preferably during the main meal of the day.

Children and adolescents

Prodywit is not intended for use in children and adolescents under 18 years of age.
Other forms of this medicine may be more suitable for children.
Consult your doctor or pharmacist.

Overdose

If you take more than you should, contact your doctor or emergency department immediately for assessment and advice.
If you have taken too many capsules, you may experience nausea or vomiting, excessive thirst, increased urine output within 24 hours, constipation, dehydration, abdominal pain, muscle weakness, fatigue, loss of appetite, high levels of calcium in the blood (hypercalcemia) and urine (hypercalciuria) confirmed by laboratory tests.

Missed dose

If you miss a dose, take it as soon as possible.
Then, take the next capsule as your doctor advised.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Seek medical attention immediately if you experience symptoms of a severe allergic reaction such as:

• swelling of the face, lips, tongue, or throat;
• difficulty swallowing;
• hives and difficulty breathing.

Other side effects of Prodywit may include:
Uncommon(may affect up to 1 in 100 people):

• high levels of calcium in the blood (hypercalcemia);
• high levels of calcium in the urine (hypercalciuria).

Rare(may affect up to 1 in 1,000 people):

• itching;
• rash
• hives. Frequency not known(frequency cannot be estimated from the available data):
• constipation;
• bloating;
• nausea;
• abdominal pain;
• diarrhea.

Reporting side effects

If you experience any side effects, including any 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 or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prodywit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.

6. Contents of the pack and other information

What Prodywit contains

• The active substance is cholecalciferol. Each soft capsule contains 0.5 mg of cholecalciferol (equivalent to 20,000 IU of Vitamin D). The other ingredients are:
• capsule filling: medium-chain triglycerides, RRR-α-Tocopherol, purified soybean oil;
• capsule shell: gelatin, glycerol, purified water.

What Prodywit looks like and contents of the pack

Prodywit is a light yellow, transparent, oval, soft gelatin capsule containing a clear, colorless liquid.
Each capsule is marked with "58". The capsule dimensions are approximately 11 mm x 6 mm.
The pack consists of PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains: 4, 5, 14, and 50 soft capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

FLAVINE PHARMA FRANCE
3 voie d’Allemagne,
13127, VITROLLES,
France

For more information about this medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The package leaflet was last revised: