Vita Buerlecithin

Leaflet attached to the packaging: patient information

Vita Buerlecithin

Oral liquid

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 as advised by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Vita Buerlecithin and what is it used for
• 2. Important information before taking Vita Buerlecithin
• 3. How to take Vita Buerlecithin
• 4. Possible side effects
• 5. How to store Vita Buerlecithin
• 6. Contents of the packaging and other information

1. What is Vita Buerlecithin and what is it used for

Vita Buerlecithin is a tonic available in the form of an oral liquid, which contains lecithin and vitamins.
Lecithin is a phospholipid substance obtained from soybeans. It is a rich source of choline, which is a component of the neurotransmitter acetylcholine, and thus has a beneficial effect on the functioning of the nervous system and skeletal muscles. Lecithin participates in metabolism, normalizes cholesterol and triglyceride levels in the blood, and prevents cholesterol from accumulating in blood vessel walls.
The B vitamins present in Vita Buerlecithin supplement the daily requirement and support the action of lecithin. They participate in protein, carbohydrate, and fat metabolism, and regulate the functioning of the nervous system.
Sodium D-pantothenate affects the functioning of the digestive tract and the regeneration of epithelial tissue, hair growth, and nail growth.
The effects of Vita Buerlecithin are noticeable after a few days of use. To achieve the proper therapeutic effect, it is recommended to use the medicine for a longer period.
Indications for the use of Vita Buerlecithin oral liquid are:

• memory and concentration impairment,
• stress, nervous overexcitement, insomnia,
• physical and mental exhaustion (overwork, exhaustion, rapid fatigue),
• auxiliary in heart problems of nervous origin,
• symptoms of vitamin B deficiency,
• convalescence after illness,
• auxiliary in elderly people,
• preventive in atherosclerosis of blood vessels,
• preventive and auxiliary in increased cholesterol levels in the blood.

2. Important information before taking Vita Buerlecithin

When not to take Vita Buerlecithin

• -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 known hypersensitivity to nuts, peanuts, soybeans.
• -If the patient has been diagnosed with antiphospholipid syndrome.
• -Due to the alcohol content of Vita Buerlecithin oral liquid, it should not be used in children under 12 years of age, pregnant or breastfeeding women, people with liver disease, epilepsy, alcoholism, or brain damage.

Warnings and precautions

If additional information is needed, before using the medicine, you should consult a doctor or pharmacist.
Minor changes in appearance, taste, and consistency of the medicine are acceptable due to the content of natural ingredients and do not affect its quality.

Children

Vita Buerlecithin oral liquid should not be used in children under 12 years of age due to the alcohol content.

Vita Buerlecithin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The amount of alcohol (ethanol) in this medicine may change the effect of other medicines. If you are taking other medicines, you should consult a doctor or pharmacist.
Vita Buerlecithin should not be used with psychotropic medicines (medicines used in mental disorders) and other medicines that interact with alcohol (e.g., sedatives, sleeping pills, antiepileptics, some painkillers).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
Vita Buerlecithin oral liquid should not be used during pregnancy and breastfeeding due to the alcohol content (ethanol) and benzyl alcohol (see: When not to take Vita Buerlecithin).
A large amount of benzyl alcohol may accumulate in the body and cause side effects (so-called metabolic acidosis).

Driving and using machines

Due to the alcohol content in Vita Buerlecithin oral liquid, you should be cautious while driving and operating machines.

Vita Buerlecithin contains sucrose, ethanol, Ponceau 4R (E 124), flavor ingredients, including inverted sugar, benzyl alcohol (E 1519), sulfites (E 220), and sodium. The medicine contains soybean oil (see: When not to take Vita Buerlecithin).

Benzyl alcohol (E 1519)

The medicine contains 4.25 mg of benzyl alcohol in 20 ml. Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease, pregnant or breastfeeding women should consult a doctor before using the medicine, as a large amount of benzyl alcohol (a flavor ingredient) may accumulate in their body and cause side effects (so-called metabolic acidosis) (see section 2. When not to take Vita Buerlecithin).

Sulfites (E 220)

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Ponceau 4R (E 124)

The medicine may cause allergic reactions.

Sodium

The medicine contains 48 mg of sodium (the main component of common salt) in 20 ml of liquid. This corresponds to 2.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Vita Buerlecithin

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
Before use, shake the bottle. The medicine should be taken orally.
Recommended dose:
Adolescents over 12 years of age and adults: unless your doctor advises otherwise, 20 ml of liquid 3 times a day.
Only for adults: in case of significant weakening of the body, the daily dose can be doubled, i.e., unless your doctor advises otherwise, 40 ml of liquid 3 times a day.

Taking a higher dose of Vita Buerlecithin than recommended

In case of taking a single dose higher than the recommended daily dose (60 ml or 120 ml), you should consult a doctor or pharmacist.

Missing a dose of Vita Buerlecithin

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Vita Buerlecithin can cause side effects, although not everybody gets them.
During treatment with Vita Buerlecithin, the following may occur:
Very rare(less than 1 in 10,000 treated patients):
severe allergic reactions to the ingredients of the medicine, hypersensitivity reactions to Ponceau 4R (E 124),
rash, urticaria.
Frequency not known(cannot be estimated from the available data):
dizziness, palpitations, gastrointestinal disorders, e.g., steatorrhea, diarrhea, nausea, vomiting, increased blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. 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 181C
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vita Buerlecithin

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C, in a dry place. Do not freeze.
After opening the package, store it in a cool place.
After opening the bottle, the medicine should not be stored for more than 12 weeks.
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 given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vita Buerlecithin contains

• The active substances of the medicine are: soy lecithin, vitamin B1, vitamin B2, vitamin B6, sodium D-pantothenate, nicotinamide.
• 100 ml of the medicine contains: soy lecithin 10.4 g (a plant phospholipid complex containing, among others, biologically active ingredients: phosphatidylcholine, cephalin, and inositol phosphatide) riboflavin sodium phosphate hydrate (vitamin B2) 4.8 mg (which corresponds to approximately 3.5 mg of vitamin B2)

pyridoxine hydrochloride
(vitamin B6)
3.5 mg
cyanocobalamin
(vitamin B12)
2.5 micrograms
sodium D-pantothenate
20 mg
nicotinamide
35 mg

• The other ingredients are: sucrose, ethanol 96%, sodium citrate dihydrate, potassium sorbate, sodium versenate, coffee flavor no. 75100098/79522-75 (containing, among others: inverted sugar, benzyl alcohol (E 1519), ethanol, sulfites (E 220)), Ponceau 4R (E 124), sodium hydroxide, mannitol (E 421), purified water.

What Vita Buerlecithin looks like and what the pack contains

A bottle in a cardboard box with a capacity of 250 ml, 500 ml, or 1000 ml.

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, you should contact the local representative of the marketing authorization 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

Date of the last update of the leaflet: