Beres plus® drops

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BÉRES DROPS PLUS®

Composition:

Active substances: 1 ml (18 drops) contains: molybdenum 0.1902 mg (as ammonium molybdate tetrahydrate 0.35 mg); vanadium 0.1219 mg (as ammonium metavanadate 0.28 mg); boron 0.1049 mg (as boric acid 0.6 mg); cobalt 0.0248 mg (as cobalt (II) chloride hexahydrate 0.1 mg); copper 0.2545 mg (as copper sulfate pentahydrate 1 mg); iron 2.009 mg (as iron (II) sulfate heptahydrate 10 mg); magnesium 0.4044 mg (as magnesium sulfate heptahydrate 4.1 mg); manganese 0.3055 mg (as manganese sulfate monohydrate 0.94 mg); nickel 0.1087 mg (as nickel (II) sulfate hexahydrate 0.4865 mg); fluorine 0.0904 mg (as sodium fluoride 0.2 mg); zinc 1.137 mg (as zinc sulfate heptahydrate 5 mg).

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

Pharmaceutical form. Oral drops.

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

Pharmacotherapeutic group. Other mineral preparations. ATC code A12CX.

Pharmacological Properties

Pharmacodynamics

The medicinal product contains an aqueous solution of mineral compounds and trace elements incorporated, via coordination bonds, into molecules of organic substances. Trace elements play an important role in maintaining the body's biological balance. Most of them are primarily present within cells as enzyme cofactors, ensuring their catalytic activity, as well as stabilization of non-enzymatic macromolecular structures and normalization of vitamin and hormone levels in the human body.

Deficiency of trace elements may also develop in healthy individuals, for example at certain ages (adolescents, elderly people) or as a result of increased utilization of trace elements during specific physiological states (during pregnancy or breastfeeding). Certain diseases and treatment methods are also common causes of trace element deficiencies, leading to various clinical symptoms. Even a slight deficiency of trace elements may negatively affect the immune system, physical condition, general well-being, recovery, and rehabilitation after illness or surgical intervention. Beresh Plus® Drops contain the most essential trace elements. The purpose of using this medicinal product is to meet the body's requirements for trace elements that cannot be sufficiently supplied by other orally administered medicinal forms.

Pharmacokinetics

The active substances in Beresh Plus® Drops are well absorbed from the gastrointestinal tract, thus ensuring their bioavailability. Pharmacokinetic studies were conducted using isotopic methods in dogs. The overall retention of trace elements in the body after 72 hours indicates the following absorption levels: very high for iron (~30% of total trace element retention in the body); high for zinc (~5%), cobalt (~6%), and molybdenum (~4%); relatively low for manganese (~2%) and nickel (~1%).

According to available preclinical data, clinical use of the medicinal product is considered safe.

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 or influenza;
• in cases of inadequate nutrition (e.g., special diets, including weight-loss diets, vegetarian 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.

Hypersensitivity to the active substances or to any of the excipients (e.g., 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 interactions.

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

At least 2 hours should elapse between the administration of medicinal products containing penicillamine, bisphosphonates, fluoroquinolones, tetracyclines, and the administration of Kraply Berez Plus® (due to physicochemical interactions that may alter the absorption of the product).

The product should not be taken together with milk or coffee, as this impairs the absorption of its active ingredients.

Concomitant use of antacid preparations containing aluminum, calcium, or magnesium reduces iron absorption.

Special precautions for use

Administration with milk or coffee is not recommended, as it impairs the absorption of the active ingredients. When the product is added to certain types of tea, the solution may darken. This phenomenon is harmless and caused by the presence of tannin (tannic acid) in tea. The discoloration does not occur if several drops of lemon juice, a lemon juice substitute, or ascorbic acid are added.

Use during pregnancy and breastfeeding

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

Ability to affect reaction speed when driving or operating machinery

When used at the recommended doses, no negative effects are observed.

Method of Administration and Dosage

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

For prophylactic use:

Body weight 10–20 kg – 5 drops twice daily.

Body weight 20–40 kg – 10 drops twice daily.

Body weight over 40 kg – 20 drops twice daily.

For treatment of conditions listed in the indications:

Body weight 10–20 kg – 10 drops twice daily.

Body weight 20–40 kg – 20 drops twice daily.

Body weight over 40 kg – 20 drops three times daily.

When used to improve general condition and well-being in patients with oncological diseases whose body weight exceeds 40 kg, daily doses exceeding the above-mentioned may be applied at the physician's discretion, but not exceeding 120 drops per day. In such cases, the daily dose should be divided into 4–5 equal doses.

When used for prophylaxis at the recommended doses, optimal effect is expected after approximately 6 weeks of continuous therapy. This effect may be maintained during further use of the drug at prophylactic doses for the desired duration (e.g., during the winter period of catarrhal and influenza-like illnesses).

The drug should be administered continuously at the recommended doses while disease symptoms are present.

If symptoms recur, the treatment course may be repeated.

Treatment duration should be determined individually by a physician.

Children

The drug may be administered to children with body weight exceeding 10 kg. However, if a child's body weight is less than 20 kg, the decision on drug use should be made individually in consultation with a pediatrician, based on an assessment of the benefit-risk ratio for the child.

Overdose

A study conducted in healthy volunteers showed that even a dose of 120 drops three times daily is well tolerated and safe. However, when doses exceeding the recommended ones are used, nausea and stomach discomfort may occur, which resolve quickly. In individual cases, allergic reactions are possible. In such cases, administration of the drug should be discontinued and medical advice should be sought.

Side effects.

Very rarely, mainly when the drops are taken on an empty stomach or with less liquid than recommended, mild and transient adverse reactions listed below may occur.

Gastrointestinal system: gastrointestinal disturbances, including mild nausea, abdominal pain, constipation, bitter taste in the mouth, discoloration of tooth enamel in children, which do not require any intervention and resolve quickly.

Immune system: hypersensitivity reactions.

Shelf life.

4 years.

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

Storage conditions.

Keep out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 30 ml or 100 ml in a glass bottle with dropper cap. One bottle (30 ml or 100 ml) or four bottles (30 ml each) in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

ZAO "Beres Pharma"

Manufacturer's name and address of the place of business.

39, Nadshandor Yozhef Str., Solnok, 5000, Hungary.