Iuvit D3

Package Leaflet: Information for the Patient

JUVIT D

20,000 IU/ml, oral drops, solution
Colecalciferol

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

1. What is Juvit D and what is it used for

Vitamin D (cholecalciferol) belongs to the group of vitamin D. In the human body, it is converted into active forms, which act as hormones.
Cholecalciferol is produced in the human body in the skin under the influence of ultraviolet light. Synthesis in the skin covers only a small part of the demand. The main source of vitamin D is food (meat, milk, egg yolks).
The basic property of vitamin D metabolites is to increase the absorption of calcium and phosphates. Vitamin D, by stimulating the production of specific protein in the intestine, facilitates the binding and subsequent transport of calcium to the blood. Cholecalciferol also increases the absorption of calcium and phosphates in the kidneys. In bones, it increases the activity of osteoclasts (cells that remove old bone cells) and osteoclastic osteolysis (the process of bone dissolution under the influence of osteoclasts). All these actions lead to an increase in calcium levels in the blood and stimulation of proper bone formation and mineralization.
Vitamin D is well absorbed in the small intestine after oral administration. Bile acids play an essential role in the absorption process. Cholecalciferol and its metabolites are stored in the liver, fatty tissue, and muscles, from where they are gradually released. They are excreted mainly with bile in combination with glucuronic acid, glycine, and taurine, and in small amounts in urine. Small amounts of cholecalciferol pass into breast milk and through the placenta.
Indications for use are:

• prevention of rickets in children,
• prevention of diseases when a risk of vitamin D deficiency is found
• treatment of rickets and osteomalacia caused by vitamin D deficiency.

2. Important information before taking Juvit D

When not to take Juvit D:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);

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• if the patient has: hypercalcemia (elevated calcium levels in the serum), kidney stones, sarcoidosis, lack of hydroxylase activity in the liver and kidneys.

Warnings and precautions

Before starting to take Juvit D, discuss it with your doctor or pharmacist.
If Juvit D is taken with other medicines or food products containing vitamin D (e.g., complex vitamin and mineral preparations), it may lead to overdose.
During long-term use of vitamin D or in doses greater than 1000 IU per day, calcium levels in the serum should be monitored.

Juvit D and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use with certain diuretics, such as chlorthiazide, increases the risk of hypercalcemia. When taking calcium preparations, calcium levels in the serum should be monitored. Some antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) may increase the need for vitamin D. Cholestyramine, colestipol, or neomycin may decrease the absorption of vitamin D. Concomitant administration of vitamin D with cardiac glycosides may enhance their toxic effects (increased risk of cardiac arrhythmias). Glucocorticosteroids may weaken the effect of vitamin D.

Juvit D with food and drink

Juvit D can be taken with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
The medicine can be used during pregnancy only if necessary.
Vitamin D and its metabolites pass into breast milk. No overdose has been observed in breastfed children.

Driving and using machines

Cholecalciferol is considered safe and does not cause impairment of psycho-physical abilities, ability to drive vehicles, or operate machinery.

3. How to take Juvit D

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The medicine is intended for oral use.
Prophylactically:

• infants from the second week of life to the end of the first year of life:
• those taking walks: 1 drop (500 IU) per day;
• premature babies, twins, and infants in poor living conditions: 1 to 2 drops (500 IU - 1000 IU) per day;
• children in the second year of life (especially during autumn and winter months): 1 to 2 drops (500 IU - 1000 IU) per day;
• adults: 1 to 2 drops (500 IU - 1000 IU) per day. Therapeutically:
• rickets and osteomalacia caused by vitamin D deficiency: 2 to 8 drops (1000 IU - 4000 IU) per day, throughout the year. Infants and young children can be given the medicine in a spoon with a drink or food.

Due to the risk of overdose, do not give the medicine directly from the bottle to the patient's mouth.
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Overdose of Juvit D

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.
Signs of poisoning occur rarely and appear after administration of 10,000 IU of vitamin D (0.25 mg) per day. Such doses may cause weakness, hypercalcemia, apathy, loss of appetite, headache, muscle and joint pain, muscle weakness, nausea, and vomiting, ectopic calcification of tissues, proteinuria, hypertension, arrhythmia. Chronic hypercalcemia leads to calcification of blood vessels and kidneys and rapid deterioration of kidney function. In such cases, the medicine should be discontinued. Hospitalization, symptomatic treatment, and calcium removal may be necessary. There is no specific antidote.

Missed dose of Juvit D

Do not take a double dose to make up for a missed dose.

Stopping Juvit D

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects do not occur when taken in recommended doses.
Taking vitamin D in higher doses causes hypervitaminosis and hypercalcemia and related symptoms:
Cardiac disorders:
heart muscle damage.
Nervous system disorders:
headache.
Gastrointestinal disorders:
loss of appetite, nausea, vomiting, diarrhea.
Renal and urinary disorders:
hypercalciuria, kidney damage, polyuria.
Musculoskeletal and connective tissue disorders:
muscle and joint pain.
General disorders and administration site conditions:
ectopic calcification, dry mouth feeling.

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,
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.
Reporting side effects will help to gather more information on the safety of the medicine.
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5. How to store Juvit D

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original, closed packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Once opened, the bottle 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 Juvit D contains

• The active substance is cholecalciferol in the amount of 0.5 mg (20,000 IU) in 1 ml of solution (1 ml contains 40 drops).
• The other ingredients (excipients) are: triglycerides of medium-chain fatty acids.

What Juvit D looks like and contents of the pack

The medicine is a colorless or yellowish, clear solution (opalescence is allowed), odorless.
The packaging consists of a 10 ml glass bottle of type III, closed with an HDPE screw cap with an LDPE dropper, in a cardboard box.
One pack contains 10 ml of solution.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel. +48 22 742 00 22
e-mail: [email protected]
Date of last revision of the leaflet:
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