Prodywit

Package leaflet: Information for the user

Prodywit, 20,000 IU, soft capsules
Cholecalciferolum (vitamin D)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

Prodywit contains the active substance cholecalciferol (vitamin D), which regulates calcium absorption and metabolism, as well as calcium deposition in bone tissue.
Prodywit is used for initial symptomatic treatment of vitamin D deficiency in adults.

2. Information before using Prodywit medicine

When not to use Prodywit:

• if the patient is allergic to cholecalciferol (vitamin D), peanuts, soy or any of the other ingredients of this medicine (listed in section 6);
• if the patient has high levels of vitamin D in the blood (vitamin D excess);
• if the patient has high levels of calcium in the blood (hypercalcaemia) or high levels of calcium in the urine (hypercalciuria);
• if the patient has calcium deposits in the kidneys (nephrocalcinosis);
• if the patient has kidney stones (nephrolithiasis) or severe kidney function disorders.

Do not use Prodywit if any of the above situations apply to the patient.
Warnings and precautions
Before starting treatment with Prodywit, discuss this with your doctor or pharmacist:

• if the patient has kidney function disorders or previously had kidney stones. The doctor will order tests to measure calcium levels in blood or urine;
• if the patient is being treated for heart disease;
• if the patient's ability to move is severely limited, as in such cases there is a risk of high calcium levels in the blood (hypercalcaemia) or high calcium levels in the urine (hypercalciuria);
• if the patient has sarcoidosis (an immune system disorder that may affect the liver, lungs, skin or lymph nodes);
• if the patient is taking medicines or dietary supplements containing vitamin D, or if the patient consumes food containing vitamin D. During treatment with Prodywit, the doctor will monitor vitamin D and calcium levels in the blood to ensure they are not too high;
• if the patient has pseudohypoparathyroidism (a rare genetic disorder causing 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, the following medicines may interact with Prodywit:

• heart medicines (cardiac glycosides such as digoxin). The doctor may monitor the patient's heart function using electrocardiography (ECG) and measure calcium levels in the blood;
• thiazide diuretics (used to treat high blood pressure), because these medicines reduce calcium excretion in urine and may increase the risk of hypercalcaemia;
• medicines used to treat epilepsy (such as phenytoin) or medicines that help with sleep (barbiturates such as phenobarbital), because these medicines weaken the effect of vitamin D;
• glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone), because these medicines may weaken the effect of vitamin D;
• laxatives (such as liquid paraffin), cholesterol-lowering medicines (cholestyramine, colestipol) or orlistat, because they may reduce the absorption of vitamin D;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal medicines (such as clotrimazole and ketoconazole, used to treat fungal infections), because they may affect vitamin D metabolism;
• medicines used to treat tuberculosis (such as rifampicin and isoniazid), because they may weaken the effect of vitamin D;
• products containing calcium or phosphate, because they may increase the risk of high levels of calcium or phosphates in the blood;
• products containing magnesium (such as antacids), because they may increase the risk of high magnesium levels in the blood (hypermagnesaemia).

Taking Prodywit with food and drink
Prodywit should preferably be taken with a large meal to help the body absorb vitamin D.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Due to the high dose of vitamin D, Prodywit is not recommended during pregnancy and breastfeeding.
There is lack of data on the effect of vitamin D on fertility. However, normal vitamin D levels are not expected to have any adverse effect on fertility.
Driving and operating machinery
Prodywit has no effect or has a negligible effect on the ability to drive and operate machinery.
Prodywit contains soybean oil
Prodywit contains soybean oil. Do not use this medicine if the patient has been diagnosed with hypersensitivity to peanuts or soy.

3. How to use Prodywit

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. Before taking additional calcium, you should
consult your doctor.
Use in adults
The recommended dose is 1 capsule per week for a period of 4-5 weeks.
The capsules should be swallowed whole with water, preferably during the main meal of the day.
Use in 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. Please consult your doctor or
pharmacist.
If you take more Prodywit than recommended
If you take more than the recommended dose, or if a child accidentally takes this medicine, you should
contact your doctor or an emergency department to assess the risk and obtain advice. If too many capsules
are taken, symptoms such as nausea or vomiting, excessive thirst, increased urination over 24 hours,
constipation, dehydration, abdominal pain, muscle weakness, fatigue, loss of appetite, high calcium levels in the blood (hypercalcemia) and in the urine (hypercalciuria), confirmed by laboratory tests, may occur.
If you forget to take Prodywit
If you miss a dose, take the missed dose as soon as possible. Then, take the next capsule as instructed by your doctor.
Do not take a double dose to make up for a missed dose.
If you have any further doubts 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 may require immediate medical attention.
Seek immediate medical advice if symptoms of a severe allergic reaction occur, such as:

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

Other adverse reactions associated with Prodywit may include:
Not very common (may affect up to 1 in 100 patients):

• high blood calcium levels (hypercalcaemia);
• high calcium levels in urine (hypercalciuria).

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

• itching;
• rash;
• hives.

Frequency unknown (frequency cannot be estimated from available data):

• constipation;
• 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 of Monitoring of Adverse Drug Reactions at the Office for Registration of 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Prodywit

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Prodywit contains

• The active substance is cholecalciferol. Each soft capsule contains 0.5 mg cholecalciferol (corresponding 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 in the form of light yellow, transparent, oval, soft gelatin capsules containing a transparent, colourless liquid. Each capsule is marked with the number "58". The approximate dimensions of the capsule are 11 mm x 6 mm.
The packaging consists of blisters made of PVC/PVDC/Aluminium in a cardboard box.
Pack sizes: 4, 5, 14 and 50 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
This medicinal product is authorised in the Member States of the European Economic Area under the following names: