Berocca^® Plus (Tablets) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Delpharm Gaillard (France)

Contact Information

BAYER AG (Germany)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Forms

	Berocca® Plus	Effervescent tablets with orange flavor: 15 or 30 pcs.
		Film-coated tablets: 30 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets with orange flavor are flat-cylindrical, from pale orange to light orange in color, with inclusions of darker and lighter color; they dissolve in water with the release of bubbles, forming a solution with an orange odor.

Excipients: anhydrous citric acid – 1700 mg, sodium bicarbonate – 840 mg, anhydrous sodium carbonate – 60 mg, sodium chloride – 40 mg, acesulfame potassium – 20 mg, aspartame – 25 mg, beet red (E162) – 30 mg, beta-carotene (E160a) – 40 mg, orange flavor – 100 mg, polysorbate 60 – 0.9 mg, mannitol – 16.848 mg, isomalt – 265.531 mg, sorbitol – 155.3027 mg.

15 pcs. – aluminum cylinders (1) – cardboard packs.
15 pcs. – aluminum cylinders (2) – cardboard packs.
15 pcs. – polypropylene cylinders (1) – cardboard packs.
15 pcs. – polypropylene cylinders (2) – cardboard packs.

¹in the form of thiamine monophosphoric acid ester chloride – 18.54 mg;
² in the form of riboflavin sodium phosphate – 20.51 mg;
³ in the form of calcium pantothenate – 25 mg;
⁴in the form of cyanocobalamin 0.1% – 10 mg;
⁵ in the form of granulated calcium carbonate (calcium carbonate and maltodextrin) – 97.69 mg and calcium pantothenate – 2.31 mg;
⁶in the form of granulated magnesium carbonate (heavy magnesium carbonate and pregelatinized corn starch) – 49 mg and magnesium sulfate dihydrate – 51 mg;
⁷ in the form of zinc citrate trihydrate.

Film-coated tablets from pale orange to grayish-orange in color, oblong, biconvex.

Excipients: lactose monohydrate – 94.3 mg, povidone K90 (E1201) – 45 mg, croscarmellose sodium (E468) – 44 mg, mannitol (E421) – 25.45 mg, talc (E553b) – 15 mg, magnesium stearate (E572) – 14 mg.

Shell composition Opadry II brown⁴ – 43 mg (polydextrose (E1200), hypromellose (E464), titanium dioxide (E171), fractionated coconut oil, yellow iron oxide dye (E172), red iron oxide dye (E172), black iron oxide dye (E172)).

10 pcs. – blisters (3) – cardboard packs.

¹ in the form of anhydrous thiamine hydrochloride – 15 mg, in the form of thiamine nitrate – 14.57 mg;
² in the form of pantothenic acid – 23 mg, in the form of calcium pantothenate – 25 mg;
³ in the form of cyanocobalamin 0.1% WS;
⁴ Opadry II brown: polydextrose (E1200) 31.25%, hypromellose (E464) 31.25%, titanium dioxide (E171) 26.7%, fractionated coconut oil 6.25%, yellow iron oxide dye (E172) 3.14%, red iron oxide dye (E172) 1.35%, black iron oxide dye (E172) 0.06%.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + minerals

Pharmacological Action

Multivitamins with macro and microelements. The pharmacological action is due to the vitamins and minerals included in the composition.

B vitamins are involved in many metabolic reactions, including the synthesis of neurotransmitters.

Vitamin C (Ascorbic acid) is a biological antioxidant and plays an important role in the inactivation of free radicals, increases iron absorption in the small intestine, affects folic acid metabolism and leukocyte function. It stimulates the formation of connective tissue, bone tissue, and normalizes capillary permeability.

Calcium is involved in many physiological processes, the functioning of enzyme systems, and the transmission of nerve impulses in combination with magnesium and vitamin B₆.

Magnesium is involved in various reactions, including protein synthesis, fatty acid metabolism, and sugar oxidation.

Zinc as a catalyst activates more than 200 enzymes and is a component of many proteins, hormones, neuropeptides, hormone receptors, and also directly participates in the synthesis of coenzymes, derivatives of pyridoxine.

Indications

Deficiency or conditions accompanied by an increased need for B vitamins, vitamin C and zinc.

It is used for conditions accompanied by a deficiency or increased need for vitamins: during increased physical exertion, during prolonged nervous strain and stress; with inadequate and unbalanced nutrition (restrictive diets); in elderly people; with chronic alcoholism.

ICD codes

Dosage Regimen

Administer orally.

Take one tablet daily.

For effervescent tablets, completely dissolve one tablet in a glass (200 mL) of water. Consume the resulting solution immediately.

For film-coated tablets, swallow the tablet whole with a sufficient amount of water. Do not chew.

Adhere to a daily intake schedule for consistent therapeutic effect.

The standard treatment course is 30 days.

The decision for a repeated course must be made by a physician based on individual patient assessment.

Do not exceed the recommended daily dose.

This product is not intended for children under 15 years of age.

It is not intended for use by pregnant or breastfeeding women.

Consult a physician before use if you are taking other medications or have underlying health conditions.

Adverse Reactions

From the digestive system, mild transient gastrointestinal disorders are possible.

Allergic reactions: rarely ( <1/10,000) – urticaria, rash, laryngeal edema, anaphylactic shock.

From the hematopoietic system: in patients with glucose-6-phosphate dehydrogenase deficiency, Ascorbic acid may cause hemolytic anemia.

From the nervous system headache, dizziness, insomnia, excitability.

Contraindications

Hypersensitivity to the components; hypercalcemia; hypermagnesemia; urolithiasis (nephrolithiasis, urolithiasis); hemochromatosis; hyperoxaluria; impaired renal function; glucose-6-phosphate dehydrogenase deficiency; fructose intolerance; children under 15 years of age.

With caution should be prescribed to patients with atrophic gastritis, intestinal diseases, pancreatic diseases, with vitamin B₁₂ malabsorption syndrome or congenital deficiency of intrinsic Castle factor.

Use in Pregnancy and Lactation

This complex is not intended for use in pregnant or breastfeeding women.

Use in Renal Impairment

The drug is contraindicated in cases of impaired renal function, urolithiasis (nephrolithiasis, urolithiasis).

Pediatric Use

The use of the drug is contraindicated in children under 15 years of age.

Special Precautions

Ascorbic acid may affect the results of the urine glucose test, even though it does not affect blood glucose levels. Vitamin C intake should be discontinued several days before such tests.

Urine may turn yellow, which has no clinical significance and is explained by the presence of riboflavin in the drug.

The drug does not contain fat-soluble vitamins.

If there is an intolerance to certain sugars, the patient should consult a doctor before taking the drug.

The recommended daily dose of the drug should not be exceeded. Patients taking other medications should consult a doctor before starting to take this complex.

Drug Interactions

Pyridoxine in a dose exceeding 5 mg may neutralize the effect of levodopa in patients with parkinsonism. However, such antagonism is not observed when levodopa is used in combination with a decarboxylase inhibitor (e.g., benserazide, carbidopa).

Thiosemicarbazone and 5-fluorouracil neutralize the effect of thiamine.

Antacid drugs inhibit the resorption of thiamine.

Neomycin, aminosalicylic acid and histamine H₂-receptor blockers reduce the absorption of cyanocobalamin.

Acetylsalicylic acid reduces the absorption of ascorbic acid by approximately one third.

Oral contraceptives may reduce serum levels of cyanocobalamin, folic acid, pyridoxine, and ascorbic acid.

Some patients taking deferoxamine and ascorbic acid daily at a dose of 500 mg may experience transient left ventricular dysfunction.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.