Beres drops® extra

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BERES® drорs EXTRA (BERES® drорs EXTRA)

Composition:

Active substances: 1 ml (18 drops) of the preparation contains:
molybdenum 0.1902 mg (in the form of ammonium molybdate tetrahydrate 0.3500 mg);
vanadium 0.1219 mg (in the form of ammonium monovanadate 0.2800 mg);
boron 0.1049 mg (in the form of boric acid 0.6000 mg);
chromium 0.0178 mg (in the form of chromium (III) chloride hexahydrate 0.0913 mg);
cobalt 0.0248 mg (in the form of cobalt (II) chloride hexahydrate 0.1000 mg);
copper 0.2545 mg (in the form of copper sulfate pentahydrate 1.000 mg);
iron 2.009 mg (in the form of iron sulfate heptahydrate 10.00 mg);
magnesium 0.4044 mg (in the form of magnesium sulfate heptahydrate 4.100 mg);
manganese 0.3055 mg (in the form of manganese sulfate monohydrate 0.9400 mg);
fluorine 0.0904 mg (in the form of sodium fluoride 0.2000 mg);
selenium 0.0119 mg (in the form of sodium selenite 0.0260 mg);
zinc 2.227 mg (in the form of zinc sulfate heptahydrate 9.7900 mg).

Excipients: glycerol (85%), glycine, succinic acid, tartaric acid, potassium-sodium tartrate, sulfuric acid (96%), purified water.

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: light green or yellowish-green clear solution, free from sediment.

Pharmacotherapeutic group. Mineral preparations. Other mineral products.

ATC code A12CX.

Pharmacological properties.

Pharmacodynamics.

Oral solution Drops Beresh® Extra contains minerals and trace elements bound by coordination bonds to molecules of organic substances in an aqueous solution. Trace elements play an important role in maintaining the biological balance of the body. Most of them are primarily present within cells as enzyme cofactors, providing their catalytic activity, and also contribute to stabilization of non-enzymatic macromolecular structures and normalization of vitamin and hormone levels in the human body, as well as redox processes.

Boron supports regulation of skeletal formation; it is necessary for the activity of certain enzymes, such as alcohol dehydrogenase and chymotrypsin, and also participates in the functioning of the nervous and immune systems. Chromium plays an important role in regulating carbohydrate and lipid metabolism. Cobalt is a component of vitamin B12 and participates in the metabolism of folic acid and fatty acids, as well as in the functioning of the immune system. Copper participates in the activity of antioxidant enzymes, is essential for the formation of connective tissue structure, takes part in the regulation of nitric oxide synthesis, and supports proper immune system function. Fluoride participates in the formation of bones and teeth. Iron is present in hemoglobin and ensures the function of many enzymes. Magnesium is a mineral necessary for skeletal formation, one of the key elements for regulation of the cardiovascular system, and also supports immune system function. Manganese is necessary for the functioning of antioxidant enzymes, supports amino acid and lipid metabolism, the citric acid cycle, and immune system function. Molybdenum is a component of many oxidoreductase enzymes and participates in regulation of oxidative stress, DNA and RNA metabolism, and breakdown of sulfur-containing amino acids. Selenium is necessary for the function of several antioxidant enzymes and supports proper regulation of the immune system. Vanadium participates in carbohydrate metabolism and in regulation of antioxidant and immune systems. Zinc is a component of several hundred enzymes and is necessary for DNA synthesis and stabilization, maintenance of proper immune system function, and antioxidant system activity.

Deficiency of trace elements may also develop in healthy individuals, for example at certain ages (adolescents, elderly people) or due to increased utilization of trace elements during specific physiological conditions (pregnancy or breastfeeding). Certain diseases and treatment methods also frequently lead to trace element deficiency, which may cause a wide range of clinical symptoms. Even mild deficiency of trace elements may negatively affect, among other things, immune system status, physical condition, general well-being, recovery, and rehabilitation after illness or surgical interventions.

Oral solution Drops Beresh® Extra contains the highest number of trace elements essential for the body. The purpose of using this medicinal product is to meet the body's requirements for trace elements necessary for normal progression of biochemical processes, which cannot be administered via other routes.

Pharmacokinetics.

The active substances of the oral solution Drops Beresh® Extra are well absorbed from the gastrointestinal tract, thus ensuring bioavailability of the trace elements. Pharmacokinetic studies were conducted in animals using isotopes and a similar preparation containing trace elements. After 72 hours, retention of trace elements in the body showed that the following trace elements were present among all active substances contained in the preparation:

• very high amount of iron (approximately 30% of total trace element retention in the body);
• significant amounts of zinc, cobalt, and molybdenum (approximately 5%, 6%, and 4% of total trace element retention in the body, respectively);
• low amount of manganese (approximately 2% of total trace element retention in the body).

Clinical characteristics.

Indications.

Deficiency of trace elements or pathological conditions requiring additional intake of mineral substances:

• to support immune system function and the body's resistance, or in cases of reduced resistance, for example during colds, influenza;
• in cases of inadequate nutrition (e.g., special diets, including weight-loss diets, vegetarian or vegan diets), as well as during increased physical exertion;
• in cases of increased fatigue, loss of appetite, lethargy, weakness, insomnia, and also to accelerate recovery after illnesses or surgical interventions;
• as adjunctive therapy to improve general condition and well-being in patients with oncological diseases.

Contraindications.

Known cases of hypersensitivity to the active substances or to any of the excipients (metal allergy), severe renal insufficiency, and diseases associated with impaired metabolism of iron and copper (including hemochromatosis, hemosiderosis, Wilson's disease).

Interaction with other medicinal products and other forms of interaction.

An interval of at least 1 hour should be maintained between the administration of this medicinal product and other drugs. To avoid overdose or antagonistic interactions, the drops should not be used simultaneously with other products containing trace elements.

Regular use of certain analgesics (acetylsalicylic acid or indomethacin) may inhibit iron absorption.

Regarding diuretic use: furosemide may inhibit zinc absorption, ethacrynic acid may inhibit magnesium absorption, and thiazide diuretics may inhibit absorption of both magnesium and zinc.

Antacid preparations suppress iron absorption, while tetracyclines inhibit the absorption of certain trace elements.

Simultaneous consumption of foods high in dietary fiber and/or phytic acid (e.g., cereals, whole-grain bread, wheat bran) may reduce the bioavailability of trace elements.

Special precautions for use.

It is not recommended to take the medicinal product with milk or coffee, as this may impair the absorption of its active ingredients. When the preparation is added to certain types of tea, the solution may darken. This harmless phenomenon is caused by tannic acid present in tea. If several drops of lemon juice, lemon juice substitute, or ascorbic acid are added to the tea, darkening of the solution can be prevented.

Since some trace elements are excreted via bile, excretion may be impaired in patients with liver or biliary tract diseases.

The product contains no carbohydrates, preservatives, or artificial colorants.

This medicinal product contains less than 1 mmol of sodium (23 mg) per milliliter, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, this medicinal product may be used at the recommended daily doses (after consultation with a physician).

Effect on ability to drive and use machines.

When used at the recommended doses, the medicinal product has no negative effect on reaction speed or the ability to drive or operate machinery.

Method of Administration and Dosage

Administer orally during meals. Add a single dose of drops to at least 50 mL of liquid (e.g., water, fruit juice, syrup, or tea). It is recommended to take together with vitamin C (50 mg) with each administration of the medicinal product.

For prophylactic use

Body weight 10–20 kg — 5 drops twice daily or 2 pump presses twice daily.

Body weight 20–40 kg — 10 drops twice daily or 4 pump presses twice daily.

Body weight over 40 kg — 20 drops twice daily or 8 pump presses twice daily.

For treatment of conditions listed in the indications

Body weight 10–20 kg — 10 drops twice daily or 4 pump presses twice daily.

Body weight 20–40 kg — 20 drops twice daily or 8 pump presses twice daily.

Body weight over 40 kg — 20 drops three times daily or 8 pump presses three times daily.

When used to improve the general condition and well-being of patients with oncological diseases whose body weight exceeds 40 kg, daily doses higher than those mentioned above may be used at the physician’s discretion, but not exceeding 120 drops (equivalent to 48 pump presses) per day. In such cases, the daily dose should be divided into 4 equal doses.

In addition to dropper packaging of 1 × 30 mL, 4 × 30 mL, 1 × 100 mL, the Beresh® Extra oral solution is also available in pump dispenser packaging of 1 × 30 mL, 4 × 30 mL, 1 × 100 mL.

It should be noted that when using packages with dosing pumps, the amount of active substances in the volume of solution delivered by one pump press does not correspond to the amount in one drop delivered from a dropper bottle.

Based on existing experience, when the drug is used for prophylaxis at the recommended doses, the optimal effect is expected approximately after 6 weeks of continuous therapy. With continued use of the drug at prophylactic doses, this effect can be maintained for the desired period (e.g., during the winter period of catarrhal and influenza-like illnesses).

The drug should be used continuously at the recommended doses in the presence of complaints and symptoms of illness. If symptoms recur, the treatment course may be repeated. The duration of treatment should be determined individually by a physician.

When using Beresh® Extra oral solution as an adjunctive agent (e.g., in tumor diseases), the duration of treatment and method of administration must be determined individually for each patient, taking into account the patient's health status and ongoing treatment.

Children.

Children from 2 years of age with a body weight of at least 10 kg and adolescents may take the medicinal product at the recommended doses.

Overdose.

In case of overdose, temporary gastrointestinal disturbances are possible, and rarely, hypersensitivity reactions may occur.

Adverse reactions.

Frequency of adverse reactions is defined as follows: rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).

Gastrointestinal disorders: rare – mild, transient gastrointestinal disturbances not requiring treatment; these may occur if the drug is taken before meals or with insufficient fluid intake.

Skin and subcutaneous tissue disorders: very rare – hypersensitivity reactions (urticaria, rash, pruritus).

Reporting of adverse reactions

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years.

After first opening the bottle, the product remains suitable for use for 6 months.

Storage conditions.

Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging.

30 ml in a bottle with dropper cap; 1 or 4 bottles per cardboard box;

100 ml in a bottle with dropper cap; 1 bottle per cardboard box;

30 ml in a bottle; 1 or 4 bottles supplied with a separate dosing pump in a cardboard box;

100 ml in a bottle; 1 bottle supplied with a separate dosing pump in a cardboard box.

Prescription status. Over-the-counter (without prescription).

Manufacturer. JSC “Beresh Pharma”.

Manufacturer's address and location of business activity.

39 Nadysandor Jozsef St., Szolnok, 5000, Hungary.