Vita buerlecithin

Package leaflet: Information for the patient

Vita Buerlecithin
Oral liquid
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
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 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, consult your doctor.

Table of contents

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 pack and other information

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

Vita Buerlecithin is a tonic medicine available in the form of an oral liquid containing lecithin and vitamins.
Lecithin is a phospholipid substance derived from soy. It is a rich source of choline, a building block of the neurotransmitter acetylcholine, thereby exerting a beneficial effect on the function of the nervous system and skeletal muscles. Lecithin participates in metabolism, normalizes blood cholesterol and triglyceride levels, and prevents cholesterol deposition in the walls of blood vessels.
The B-group vitamins present in Vita Buerlecithin supplement daily requirements and support the action of lecithin. They participate in the metabolism of proteins, carbohydrates, and fats, and regulate nervous system functions.
Sodium D-pantothenate influences gastrointestinal function and epithelial tissue regeneration, and supports hair and nail growth.
The effects of Vita Buerlecithin become noticeable after several days of use. To achieve the proper therapeutic effect, prolonged use of the medicine is recommended.

Indications for use of Vita Buerlecithin oral liquid include:

• Impaired memory and concentration,
• Stress states, nervous hyperexcitability, insomnia,
• Physical and mental exhaustion (overwork, fatigue, rapid tiring),
• As an adjunct in cardiac complaints of nervous origin,
• Deficiency symptoms of B-group vitamins,
• Convalescent state after illness,
• As an adjunct in elderly individuals,
• Prophylactic use in atherosclerosis,
• Prophylactic and adjunctive use in elevated blood cholesterol levels.

2. Important information before taking Vita Buerlecithin

When not to take Vita Buerlecithin

• If the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• In case of diagnosed allergy to nuts, peanuts, or soy.
• If the patient has been diagnosed with antiphospholipid syndrome.
• Due to its alcohol content, Vita Buerlecithin liquid should not be used in children under 12 years of age, pregnant or breastfeeding women, or in patients with liver disease, epilepsy, alcohol-related disorders, or brain damage.

Warnings and precautions
If further information is needed, consult a doctor or pharmacist before using the medicine.

Minor changes in the appearance, taste, and consistency of the medicine are acceptable due to the presence of naturally derived ingredients and do not affect its quality.

Children
Do not use Vita Buerlecithin liquid in children under 12 years of age due to its alcohol content.

Vita Buerlecithin and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.

The amount of alcohol (ethanol) in this medicine may alter the effects of other medicines. If the patient is taking other medicines, they should consult a doctor or pharmacist.

Do not use Vita Buerlecithin while taking psychotropic drugs (medicines used in psychiatric disorders) or other medicines that interact with alcohol (e.g. sedatives, hypnotics, antiepileptics, certain painkillers).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Do not use Vita Buerlecithin liquid during pregnancy and breastfeeding due to its content of alcohol (ethanol) and benzyl alcohol (see: When not to take Vita Buerlecithin).
Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (so-called metabolic acidosis).

Driving and operating machinery
Due to the alcohol content in Vita Buerlecithin liquid, caution should be exercised when driving or operating machinery.

Vita Buerlecithin contains sucrose, ethanol, carmine red (E 124) Ponceau 4R,
flavouring components including invert sugar, benzyl alcohol (E 1519), sulphites (E 220), and sodium.
The medicine contains soybean oil (see: When not to take Vita Buerlecithin).

Ethanol
This medicine contains approximately 2.7 g of alcohol (ethanol) per 20 ml dose, equivalent to 13.4% m/m. The amount of alcohol in a 20 ml dose corresponds to less than 68 ml of beer or 27 ml of wine. The ethanol content in this medicine may affect the ability to drive and operate machinery, as it may impair judgment and reaction speed.

Alcohol in this medicine may affect children. Symptoms may include drowsiness and changes in behaviour. It may also affect their concentration and physical activity.

If the patient is alcohol-dependent, they should consult a doctor or pharmacist before using this medicine. If the patient has epilepsy or liver problems, they should consult a doctor or pharmacist before using this medicine.

Sucrose, invert sugar
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

The daily dose of Vita Buerlecithin (60 ml) contains 5 g of carbohydrates, equivalent to 0.42 carbohydrate exchange units.

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 large amounts of benzyl alcohol (a flavouring component) may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis) (see section 2. When not to take Vita Buerlecithin).

Sulphites (E 220)
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Carmine red (E 124)
The medicine may cause allergic reactions.

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

3. How to take Vita Buerlecithin

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.
Shake the bottle well before use. Administer the medicine orally.

Recommended dose
Adolescents over 12 years of age and adults: unless otherwise advised by a doctor, 20 ml of the solution three times daily.
Adults only: in cases of significant physical weakness, the daily dose may be doubled; unless otherwise advised by a doctor, 40 ml of the solution three times daily.

Accidental overdose of Vita Buerlecithin
If a single dose exceeding the recommended daily dose (60 ml or 120 ml) is taken, consult a doctor or pharmacist.

Missed dose of Vita Buerlecithin
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone will experience them.
When using Vita Buerlecithin, the following may occur:
Very rare (less frequently than in 1 out of 10,000 treated patients):
severe allergic reactions to the ingredients of the medicine, hypersensitivity reactions to carmine red (E 124),
rash, urticaria.
Frequency not known (cannot be estimated based on available data):
dizziness, palpitations, gastrointestinal disorders, e.g.: fatty stools, diarrhoea,
nausea, vomiting, increased blood pressure.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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 181C
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 safe use of the medicine.

5. How to store Vita Buerlecithin

Keep the medicine out of the sight and reach of children.
Store the medicine below 25°C in a dry place. Do not freeze.
After opening, keep the packaging in a cool place.
After opening the bottle, do not store the medicine for longer 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Vita Buerlecithin liquid contains

• The active substances are: soy lecithin, vitamin B, vitamin B, vitamin B, sodium D-pantothenate, nicotinamide.

• 100 ml of the medicine contains:
  soy lecithin 10.4 g (a plant phospholipid complex containing, among others, biologically active components: phosphatidylcholine, kephalin and inosiphosphatide)
  sodium phosphate of riboflavin 4.8 mg (corresponding to approx. 3.5 mg of vitamin B) hydrated (vitamin B)
  pyridoxine hydrochloride 3.5 mg (vitamin B)
  cyanocobalamin 2.5 micrograms (vitamin B)
  sodium D-pantothenate 20 mg
  nicotinamide 35 mg

• Other ingredients are: sucrose, ethanol 96%, disodium citrate dihydrate, potassium sorbate, sodium versenate, coffee flavouring no. 75100098/79522-75 (containing, among others: invert sugar, benzyl alcohol (E 1519), ethanol, sulphites (E 220)), cochineal red (E 124) Ponceau 4R, sodium hydroxide, mannitol (E 421), purified water.

What Vita Buerlecithin looks like and contents of the pack
Bottle in a cardboard box with a capacity of 250 ml, 500 ml or 1000 ml.

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