Package leaflet: Information for the user

JUVIT MULTI
oral drops, solution
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

What Juvit Multi is and what it is used for
Important information before taking Juvit Multi
How to take Juvit Multi
Possible side effects
How to store Juvit Multi
Contents of the pack and other information

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

Juvit Multi contains essential vitamins necessary for human growth and bodily functions.
Vitamins B and PP are involved in various cellular metabolic processes, and their deficiency may lead to impaired growth, night vision problems, central nervous system dysfunction, and pathological changes in the oral cavity and skin. Vitamins C and E influence the function of the circulatory, nervous, and muscular systems, as well as the development of cartilage, bones, and teeth. Vitamin A plays a crucial role in the visual process and is also essential for the growth, development, and function of the skin epithelium and mucous membranes. Vitamin D regulates the metabolism of the main bone minerals—calcium and phosphates.

Juvit Multi is used for the prevention and treatment of vitamin deficiencies in infants and children:

In conditions of increased vitamin requirements (periods of rapid growth, increased physical exertion, illnesses accompanied by fever),
In cases of inadequate dietary vitamin intake (elimination diets, malnutrition, early spring period),
In states of reduced general resistance to infectious diseases,
During convalescence, especially after antibiotic treatment.

2. Important information before using Juvit Multi

When not to use Juvit Multi:

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
in case of excess vitamin A in the body (hypervitaminosis A),
in case of elevated calcium levels in the blood (hypercalcemia).

Warnings and precautions
In patients with kidney stones (current or past history) or sarcoidosis (an immune system disorder characterized by the formation of granulomas), Juvit Multi should be used only under medical supervision and in accordance with the physician's recommendations.
Concurrent use with other medicines containing vitamin A and/or D should be carried out only on a doctor's advice and according to the dosage prescribed by the doctor.
Do not exceed the recommended doses.
Before starting to take Juvit Multi, consult a doctor or pharmacist.

Juvit Multi and other medicines
Inform 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 use.
Concomitant administration of cholestyramine, liquid paraffin, or colestipol (medicines that reduce fat and cholesterol absorption) may decrease the absorption of vitamins A, D, and E.
Absorption of vitamin A may be reduced during treatment with neomycin, and vitamin D absorption may be reduced in patients taking anticonvulsants and barbiturates (e.g. used in epilepsy).
Concurrent use of iron preparations may weaken the effect of vitamin E; therefore, an interval of several hours should be maintained between taking Juvit Multi and iron supplements.

Juvit Multi with food and drink
For infants and young children, the medicine may be administered in a spoonful of beverage or with food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Juvit Multi may be used during pregnancy only on medical advice and according to the dosage prescribed by the doctor.

Driving and operating machinery
Juvit Multi has no influence on the ability to drive or operate machinery.

3. How to use Juvit Multi

This medicine should always be used exactly as described in the patient leaflet or as recommended by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
Unless otherwise advised, the usual dosage is:

infants: 3 to 5 drops per day
children from 1 year to 6 years of age: 6 to 7 drops per day
children from 7 to 14 years of age: 8 to 9 drops per day.
Infants and young children may be given the medicine in a spoonful of liquid or with food.

Use of a higher than recommended dose of Juvit Multi
Mild gastrointestinal adverse effects (nausea, diarrhoea) may occur, and prolonged administration of excessive doses may lead to hypervitaminosis A and D and hypercalcaemia (elevated calcium levels in the blood).
If any of the above symptoms of overdose occur, discontinue use of the medicine and consult a doctor or pharmacist.
Missed dose of Juvit Multi
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
No adverse reactions have been observed when recommended doses are used. Excessive doses
may cause symptoms of overdose (see section 3).
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a 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 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further accumulation of information on the medicine's safety profile.

5. How to store Juvit Multi

Keep the medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Medicines should 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 Juvit Multi contains

1 ml of drops contains the following active substances: retinol palmitate (vitamin A) 5000 IU, cholecalciferol (vitamin D) 1000 IU, all-rac-α-tocopheryl acetate (vitamin E) 4.0 mg, thiamine hydrochloride (vitamin B\textsubscript{1}) 2.0 mg, sodium riboflavin phosphate (vitamin B\textsubscript{2}) 0.8 mg, pyridoxine hydrochloride (vitamin B\textsubscript{6}) 4.0 mg, nicotinamide (vitamin PP) 30.0 mg, dexpanthenol 10.0 mg, ascorbic acid (vitamin C) 100.0 mg.
Other components (excipients): all-rac-α-tocopherol, sodium hydroxide, natural vitamin E, butylhydroxyanisole, citric acid monohydrate, disodium phosphate dodecahydrate, sodium saccharin, macrogol glycerol hydroxystearate, glycerol, orange flavor, purified water.

What Juvit Multi looks like and contents of the pack
1 ml of solution corresponds to approximately 27 drops.
One package of the medicine contains 10 ml of solution.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicine
tel. +48 (22) 742 00 22
e-mail: [email protected]

Juvit multi