Package leaflet: Information for the patient

Multi-Sanostol, syrup
Multivitamin preparation for children.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

What Multi-Sanostol is and what it is used for
Important information before using Multi-Sanostol
How to use Multi-Sanostol
Possible side effects
How to store Multi-Sanostol
Contents of the pack and other information

1. What Multi-Sanostol is and what it is used for

Multi-Sanostol is a multivitamin medicine in syrup form. It contains both fat-soluble vitamins (vitamins A, D, E) and water-soluble vitamins (vitamins B₁, B₂, B₆, C, PP, dexpanthenol), as well as calcium.
Vitamins are essential for the proper functioning of the body. Daily diet is often insufficient and unable to meet the daily requirement for vitamins.
Multi-Sanostol is used:

in the prevention and treatment of vitamin deficiencies in conditions of increased vitamin requirements;
in loss of appetite;
in susceptibility to frequent infections;
during periods of growth and development;
in physical and mental exhaustion and fatigue;
in reduced concentration capacity;
during convalescence after illnesses and antibiotic therapy;
to improve general physical condition.

Multi-Sanostol may be administered to children over 1 year of age, as well as adolescents and adults.

2. Important information before using Multi-Sanostol

When not to use Multi-Sanostol
If the patient is allergic to the active substances or any of the other ingredients of this medicine
(listed in section 6).
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If the patient has:

rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption, or saccharase-isomaltase deficiency;
increased calcium levels in blood (hypercalcemia), increased calcium excretion in urine (hypercalciuria);
increased levels of vitamin A or D (hypervitaminosis A or D).

Warnings and precautions
If additional information is needed, consult a doctor or pharmacist before using the medicine.
Multi-Sanostol should not be used in higher than recommended doses in patients with kidney stones or sarcoidosis (Boeck's disease).
In such cases, medical advice should be sought before using the medicine.
During long-term use, the recommended dosage must not be exceeded.
Using Multi-Sanostol in doses higher than recommended may lead to vitamin A or D overdose, especially when used concomitantly with other medicines containing these vitamins.
In case of specific deficiencies of individual vitamins, consult a doctor.
When using Multi-Sanostol, urine may become yellow, which is due to the presence of B-complex vitamins.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine (additional information on sugars is provided later in this leaflet).
Note
Due to the presence of fat-soluble and water-soluble vitamins, the syrup may separate into layers. This does not affect the quality of the medicine.
If separation occurs, shake the bottle well before use.
Multi-Sanostol and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
No specific interactions have been observed when recommended doses are used.
When used concomitantly with preparations containing vitamins A or D, there is a risk of overdose.
There is a risk of hypercalcemia (increased calcium levels in blood) when used concomitantly with thiazides (medicines that increase water excretion from the body).
In cases of elevated blood calcium levels and concomitant use of digitalis preparations, cardiac rhythm disturbances may occur.
Vitamin B\textsubscript{6} in a daily dose of 5 mg or higher may reduce the effectiveness of L-dopa (a medicine used in the treatment of Parkinson's disease).
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.
Due to the risk of fetal harm, vitamin A overdose should be avoided during pregnancy.
Similarly, prolonged vitamin D overdose may result in elevated calcium levels in blood, potentially leading to physical and mental developmental abnormalities in the child.
Therefore, pregnant and breastfeeding women should not make independent decisions about taking this medicine.
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During pregnancy and breastfeeding, the daily dose of the medicine should not be exceeded.
Driving and operating machinery
Taking Multi-Sanostol does not affect the ability to drive or operate machinery.
Multi-Sanostol contains: sugars, sodium benzoate (E 211), sorbic acid (E 200), and sodium
Glucose, fructose, and sucrose
As excipients, 10 ml of syrup contains 6.55 g of sucrose and 1.31 g of glucose.
Additionally, it contains glucose, fructose, and sucrose derived, among others, from grapefruit and orange juice concentrates and from malt extract. Their exact content cannot be determined, as they are naturally derived substances. This should be taken into account in patients with diabetes. The additive effect of simultaneously administered products containing these ingredients and food containing them should be considered.
Sodium benzoate
The medicine contains 15.04 mg of sodium benzoate in 10 ml of syrup.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use Multi-Sanostol

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral administration.
Shake the bottle well before use.

Recommended dose
Children aged 1 to 6 years: 5 ml of syrup twice daily.
Children aged 6 years and older, adolescents and adults: 10 ml of syrup twice daily.
Do not exceed the recommended dose.

Administration of a higher than recommended dose of Multi-Sanostol
When taken as recommended, there is no risk of overdose.
Doses higher than recommended may lead to vitamin A and D overdose,
particularly if other medicines containing these vitamins are taken simultaneously.
In case of overdose of Multi-Sanostol, consult a doctor immediately.

Chronic vitamin A overdose may occur with doses of 4,500–18,000 IU
(equivalent to 19–75 ml of Multi-Sanostol) in adults with liver damage or impaired kidney function,
especially in patients undergoing dialysis or those with severe fat metabolism disorders (type V hypertriglyceridemia).
Early symptoms of chronic vitamin A poisoning include: dry skin, itching, skin peeling, hair growth disorders, skin fissures, fatigue, tendency to bleeding, and bone pain.

Vitamin D overdose may lead to chronic and potentially life-threatening increase in blood calcium levels (hypercalcemia). Symptoms are often nonspecific.
If any of the symptoms listed above occur, discontinue use of Multi-Sanostol immediately and seek medical advice without delay.
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4. Possible adverse reactions

Like all medicines, Multi-Sanostol may cause adverse reactions, although not everyone experiences them.
Allergic reactions have been reported in individual cases. If an allergic reaction occurs, discontinue use of the medicine and consult a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Multi-Sanostol

Keep the medicine out of sight and reach of children.
Store the medicine below 25°C.
After opening the bottle, do not store the medicine for longer than 3 months.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Multi-Sanostol contains

The active substances in the medicine are: vitamin A, vitamin D, vitamin B₁, vitamin B₂, vitamin B₆, vitamin C, vitamin E, vitamin PP, dexpanthenol, calcium gluconate, calcium phosphomolybdate.
10 ml of the medicine contains:
vitamin A – retinyl palmitate 2400 IU
vitamin D – cholecalciferol 200 IU
vitamin B₁ – thiamine hydrochloride 2 mg
vitamin B₂ – sodium riboflavin phosphate 2 mg
vitamin B₆ – pyridoxine hydrochloride 1 mg
vitamin C – ascorbic acid 100 mg
vitamin E – all-rac-α-tocopheryl acetate 2 mg
vitamin PP – nicotinamide 10 mg
dexpanthenol 4 mg
calcium gluconate 50 mg
calcium phosphomolybdate 50 mg
Other components are: sucrose, glucose syrup, citric acid, agar, tragacanth, malt extract, orange oil, grapefruit juice concentrate, orange juice concentrate, sodium benzoate (E 211), sorbic acid (E 200), calcium saccharin tetrahydrate, polysorbate 80, sunflower oil, all-rac-α-tocopherol, purified water.

What Multi-Sanostol looks like and contents of the pack
A bottle in a cardboard box containing 300 g or 600 g of the medicine, closed with a white screw cap made of polyethylene (HDPE).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]

Manufacturer
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland

Multi-sanostol