Multi-sanostol

Leaflet attached to the packaging: patient information

Multi-Sanostol, syrup

A multivitamin preparation for children.

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

• 1. What is Multi-Sanostol and what is it used for
• 2. Important information before taking Multi-Sanostol
• 3. How to take Multi-Sanostol
• 4. Possible side effects
• 5. How to store Multi-Sanostol
• 6. Package contents and other information

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

Multi-Sanostol is a multivitamin medicine in the form of a syrup. It contains both fat-soluble vitamins (vitamins A, D, E) and water-soluble vitamins (vitamins B, B, B, C, PP, dexpanthenol) and additionally calcium.
Vitamins are essential for the proper functioning of the body. The daily diet is often too poor and cannot meet the daily demand for vitamins.
Multi-Sanostol is used:

• in the prevention and treatment of vitamin deficiencies in conditions of increased demand for vitamins;
• in loss of appetite;
• in tendencies to frequent infections;
• during growth and development;
• in states of physical and mental exhaustion and fatigue;
• in decreased ability to concentrate;
• during the recovery period after illnesses and antibiotic therapy;
• to improve the overall condition of the body.

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

2. Important information before taking Multi-Sanostol

When not to take 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 syndrome, saccharase-isomaltase deficiency;
• increased calcium levels in the blood (hypercalcemia), increased calcium excretion in the urine (hypercalciuria);
• increased levels of vitamin A or D (hypervitaminosis A or D).

Warnings and precautions

If additional information is needed, the doctor or pharmacist should be consulted before taking the medicine.
Multi-Sanostol should not be taken in larger doses than recommended in people with kidney stones or suffering from sarcoidosis (Boeck's disease).
In these cases, the doctor's advice should be sought before taking the medicine.
With long-term use, the recommended dosage should not be exceeded.
Taking Multi-Sanostol in larger doses than recommended may lead to an overdose of vitamins A or D, especially when taken with other medicines containing these vitamins.
In the case of specific deficiencies of individual vitamins, the doctor should be consulted.
When taking Multi-Sanostol, urine may turn yellow due to the content of vitamins from group B.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine (additional information about sugars is provided later in the leaflet).

Notice

Due to the content of fat-soluble and water-soluble vitamins, the syrup may separate. This condition does not affect the quality of the medicine.
In the event of separation, the bottle should be shaken before use.

Multi-Sanostol and other medicines

The doctor or pharmacist should be informed about all medicines taken by the patient currently or recently, as well as any medicines the patient plans to take.
No specific interactions have been observed with the recommended doses.
When taken with preparations containing vitamins A or D, there is a risk of their overdose.
There is a risk of hypercalcemia (increased calcium levels in the blood) when taken with thiazides (diuretics).
In the case of increased calcium levels in the blood and concurrent use of digitalis preparations, heart rhythm disorders may occur.
Vitamin B in a daily dose of 5 mg or more may reduce the effectiveness of L-dopa (a medicine used to treat Parkinson's disease).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Due to the risk of fetal damage, vitamin A overdose should be avoided during pregnancy.
Similarly, with long-term overdose of vitamin D, the result is an increased calcium level in the blood, which can lead to physical and mental changes in the child.
Therefore, pregnant and breastfeeding women should not take the medicine without consulting a doctor.
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During pregnancy and breastfeeding, the daily dose of the medicine should not be exceeded.

Driving and using machines

Taking Multi-Sanostol does not affect the ability to drive and use machines.

Multi-Sanostol contains: sugars, sodium benzoate (E 211), sorbic acid (E 200), and sodium

Glucose, fructose, and sucrose

The medicine, as excipients in 10 ml of syrup, contains 6.55 g of sucrose and 1.31 g of glucose.
It also contains glucose, fructose, and sucrose derived from, among other things, grapefruit and orange juice concentrates and malt extract. Their exact content cannot be assessed, as they are natural substances. This should be taken into account in patients with diabetes. The additive effect of concurrently administered products containing these ingredients and food that contains 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, which means the medicine is considered "sodium-free".

3. How to take Multi-Sanostol

This medicine should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubt, the doctor or pharmacist should be consulted.
Oral administration.
The bottle should be shaken before use.
Recommended dose
Children from 1 to 6 years of age: 2 times a day, 5 ml of syrup.
Children from 6 years of age, adolescents, and adults: 2 times a day, 10 ml of syrup.
The recommended dosage should not be exceeded.

Taking a higher dose of Multi-Sanostol than recommended

With dosing in accordance with the recommended dose, there is no risk of overdose.
A higher dose than recommended may lead to an overdose of vitamins A and D, especially when taken with other medicines containing these vitamins.
In the event of an overdose of Multi-Sanostol, the doctor should be consulted.
Chronic overdose of vitamin A occurs at doses of 4,500-18,000 IU (equivalent to 19-75 ml of Multi-Sanostol) in adults with liver damage or impaired kidney function, particularly in patients undergoing dialysis or patients with severe fat metabolism disorders (hypertriglyceridemia type V).
Early symptoms of chronic poisoning are: dry skin, itching, skin peeling, hair growth disorders, skin cracks, fatigue, tendency to bleeding, and bone pain.
Overdose of vitamin D can lead to chronic and life-threatening increased calcium levels in the blood (hypercalcemia). The symptoms are not very characteristic.
In the event of any of these symptoms, the use of Multi-Sanostol should be discontinued and the doctor should be consulted immediately.
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4. Possible side effects

Like all medicines, Multi-Sanostol can cause side effects, although not everybody gets them.
In individual cases, allergic reactions have been reported. In the event of an allergic reaction, the use of the medicine should be discontinued and the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed.
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
Al. Jerozolimskie 181 C
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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Multi-Sanostol

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
After opening the bottle, the medicine should not be stored for more than 3 months.
The medicine should not be used after the expiry date stated on the label and carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Package contents and other information

What Multi-Sanostol contains

• The active substances of the medicine are: vitamin A, vitamin D, vitamin B, vitamin B, vitamin B, vitamin C, vitamin E, vitamin PP, dexpanthenol, calcium gluconate, calcium phosphate.
• 10 ml of the medicine contains: vitamin A
• retinol palmitate 2400 IU vitamin D
• cholecalciferol 200 IU vitamin B
• thiamine hydrochloride 2 mg vitamin B
• riboflavin sodium phosphate 2 mg vitamin B
• 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

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calcium gluconate
50 mg
calcium phosphate
50 mg

• Other ingredients 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 what the package contains

A bottle in a cardboard box containing 300 g or 600 g of the medicine, closed with a white polyethylene (HDPE) cap.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, the local representative of the marketing authorization holder should be contacted:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
info-PL@orifarm.com

Manufacturer

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

Date of last update of the leaflet:

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