The manufacturer of the drug Berocca Plus is a French pharmaceutical concern. The complex contains essential water-soluble vitamins and several minerals:
- ascorbic acid;
- thiamine;
- riboflavin;
- biotin;
- nicotinamide;
- pantothenic acid;
- pyridoxine;
- folic acid;
- cyanocobalamin;
- calcium;
- zinc;
- magnesium.
Existing forms of Berocca Plus:
- coated tablets: light orange, elongated, convex on both sides, packaged in blisters, cardboard packaging contains 30 pieces;
- effervescent pills with orange flavor: bright orange, with light and dark inclusions, soluble in water and other liquids, sold in 15 pieces per package;
- effervescent tablets with cherry and mango flavor: dissolve in water, have a characteristic fruit and berry aroma and sweetish taste, the package contains from 10 to 30 pieces.
In addition to active substances, the drug contains sodium salts, carbohydrates, dyes, and stabilizing additives. Effervescent tablets also contain flavorings and citric acid.
Nosological classification (ICD-10)
- E51 Thiamine deficiency
- E53 Deficiency of other B vitamins
- E54 Ascorbic acid [vitamin C] deficiency
- E56.9 Vitamin deficiency, unspecified
- E60 Nutritional zinc deficiency
- E61.7 Insufficiency of many batteries
- E63 Physical and mental overload
- E63.1 Unbalanced intake of nutritional elements
- F10.2 Alcohol dependence syndrome
- R45.7 State of emotional shock and stress, unspecified
- Z72.4 Inappropriate diet and unhealthy eating habits
Analogs
Level 4 ATX code matches:
Vitacap
Glutamevit
Bio-Max
Menopace
Lavita
Wellman
Teravit
Gerovital
Kaltsinova
Pregnakea
Oligovit
Multi-Tabs Intensive
Multi-Tabs Junior
Multi-Tabs Perinatal
Multi-Tabs Teen
Multi-Tabs Classic
Multi-Tabs Baby
Special Dragee Merz
Pregnavite
Complivit Trimester
The main analogues of the drug are Duovit and Supradin , but analogues of Berocca Plus such as Menopace and Revalid .
Compound
| Film-coated tablets | 1 table |
| active ingredients: | |
| thiamine mononitrate (vitamin B1) | 15 mg |
| riboflavin (vitamin B2) | 15 mg |
| niacinamide (vitamin B3) | 50 mg |
| calcium pantothenate (vitamin B5) | 23 mg |
| pyridoxine hydrochloride (vitamin B6) | 10 mg |
| biotin (vitamin B8) | 0.15 mg |
| folic acid (vitamin B9) | 0.4 mg |
| cyanocobalamin (vitamin B12) | 0.01 mg |
| ascorbic acid (vitamin C) | 500 mg |
| calcium | 100 mg |
| (in the form of calcium carbonate and calcium pantothenate) | |
| magnesium | 100 mg |
| (as magnesium hydroxycarbonate and magnesium oxide light) | |
| zinc | 10 mg |
| (as zinc citrate trihydrate) | |
| 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 | |
| film shell: Opadry brown (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) - 43 mg |
| Effervescent tablets | 1 table |
| active ingredients: | |
| Vitamin B1 (thiamine hydrochloride) | 15 mg |
| (in the form of thiamine monophosphoric acid ester chloride - 18.54 mg) | |
| vitamin B2 (riboflavin) | 15 mg |
| (in the form of riboflavin sodium phosphate - 20.51 mg) | |
| vitamin B3 (nicotinamide) | 50 mg |
| vitamin B5 (pantothenic acid) | 23 mg |
| (in the form of calcium pantothenate - 25 mg) | |
| vitamin B6 (pyridoxine hydrochloride) | 10 mg |
| vitamin B8 (biotin) | 0.15 mg |
| vitamin B9 (folic acid) | 0.4 mg |
| vitamin B12 (cyanocobalamin) | 0.01 mg |
| (in the form of cyanocobalamin 0.1% - 10 mg) | |
| vitamin C (ascorbic acid) | 500 mg |
| calcium (in the form of calcium carbonate and calcium pantothenate) | 100 mg |
| (in the form of granulated calcium carbonate (calcium carbonate and maltodextrin) - 97.69 mg and calcium pantothenate - 2.31 mg) | |
| magnesium (in the form of heavy magnesium carbonate and magnesium sulfate dihydrate) | 100 mg |
| (in the form of granulated magnesium carbonate (magnesium carbonate heavy and pregelatinized corn starch) - 49 mg and magnesium sulfate dihydrate - 51 mg) | |
| zinc (as zinc trihydrate) | 10 mg |
| (as zinc citrate trihydrate) | |
| excipients: anhydrous citric acid - 1700 mg; sodium bicarbonate - 840 mg; sodium carbonate anhydrous - 60 mg; sodium chloride - 40 mg; acesulfame potassium - 20 mg; aspartame - 25 mg; beet red dye (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 |
Pharmacodynamics
A combined drug, the pharmacological effect of which is determined by the complex of vitamins and microelements included in its 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 the absorption of iron in the small intestine, and affects the metabolism of folic acid and the function of leukocytes. Stimulates the formation of connective tissue, bone tissue, normalizes capillary permeability.
Calcium takes part in many physiological processes, enzyme systems and nerve impulse transmission 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, hormonal receptors, and is also directly involved in the synthesis of coenzymes derived from vitamin B6.
Water-soluble vitamins do not accumulate in the body, therefore, in conditions accompanied by an increased need for vitamins and minerals, the amount of vitamins supplied from food may be insufficient.
Instructions for use of Berocca® Plus film-coated tablets
Registration number:
LS-001921
Trade name of the drug
Berocca® Plus.
Group name
Multivitamins + Minerals.
Dosage form
film-coated tablets.
Compound
1 film-coated tablet contains
Active ingredients:
| Thiamine (Vitamin B1) | 15 mg |
| Riboflavin (Vitamin B2) | 15 mg |
| Nicotinamide (Vitamin B3) | 50 mg |
| Pantothenic acid (Vitamin B5) | 23 mg |
| Pyridoxine hydrochloride (Vitamin B6) | 10 mg |
| Biotin (Vitamin B8) | 0.15 mg |
| Folic Acid (Vitamin B9) | 0.4 mg |
| Cyanocobalamin (Vitamin B12) | 0.01 mg |
| Ascorbic acid (Vitamin C) | 500 mg |
| Calcium (as calcium carbonate and calcium pantothenate) | 100 mg |
| Magnesium (as magnesium hydroxycarbonate and magnesium oxide light) | 100 mg |
| Zinc (as zinc citrate trihydrate) | 10 mg |
Excipients:
| Lactose monohydrate | 94.3 mg |
| Povidone K90 (E 1201) | 45 mg |
| Croscarmellose sodium (E 468) | 44 mg |
| Mannitol (E 421) | 25.45 mg |
| Talc (E 553b) | 15 mg |
| Magnesium stearate (E 572) | 14 mg |
Shell:
| Opadry brown 43 mg (E 1200) |
| Polydextrose (E 1200) |
| Hypromellose (E 464) |
| Titanium dioxide (E 171) |
| Fractionated coconut oil |
| Iron oxide yellow dye (E 172) |
| Red iron oxide dye (E 172) |
| Iron oxide dye black (E 172) |
Description
Oblong, biconvex, film-coated tablets, pale orange to grayish-orange in color.
Pharmacotherapeutic group
Multivitamins + Minerals.
ATS code:
A11AA04
Pharmacological properties
A combined drug, the pharmacological effect of which is determined by the complex of vitamins and microelements included in its 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 the absorption of iron in the small intestine, and affects the metabolism of folic acid and the function of leukocytes. Stimulates the formation of connective tissue, bone tissue, normalizes capillary permeability. Calcium takes part in many physiological processes, enzyme systems and nerve impulse transmission 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, hormonal receptors, and is also directly involved in the synthesis of coenzymes derived from vitamin B6. Water-soluble vitamins do not accumulate in the body, therefore, in conditions accompanied by an increased need for vitamins and minerals, the amount of vitamins supplied from food may be insufficient.
Indications for use
Deficiency or conditions accompanied by an increased need for B vitamins, vitamin C and zinc. The content of vitamins in Berocca® Plus is selected for therapeutic purposes and is used for conditions accompanied by a deficiency or increased need for vitamins (increased physical activity, during periods of prolonged nervous strain and stress); with inadequate and unbalanced nutrition (restrictive diets); with chronic alcoholism.
Contraindications
Hypersensitivity to the components of the drug, hypercalcemia, hypermagnesemia, urolithiasis (nephrolithiasis, urolithiasis), hemochromatosis, hyperoxaluria, renal dysfunction, glucose-6-phosphate dehydrogenase deficiency, children under 15 years of age.
Carefully
For atrophic gastritis, diseases of the intestines, pancreas, vitamin B12 malabsorption syndrome or congenital deficiency of internal Castle factor.
Directions for use and doses
The drug is taken orally with water. Adults and children over 15 years of age : 1 tablet per day. Do not exceed the recommended daily dose of the drug. The recommended course duration is 30 days. Repeated courses on the recommendation of a doctor.
Side effect
Allergic reactions: possible urticaria, rash, laryngeal swelling, anaphylactic shock. Digestive system: mild transient gastrointestinal disorders are possible. Blood and hematopoietic system: In patients with glucose-6 phosphate dehydrogenase deficiency, ascorbic acid can cause hemolytic anemia. Nervous system: possible headache, dizziness, insomnia, excitability.
Overdose
Symptoms of overdose may include gastrointestinal distress such as diarrhea and stomach discomfort. Excessive intake of vitamin B6 (more than 20 tablets per day over several months) can lead to symptoms of neuropathy. In case of overdose, stop taking the drug and consult a doctor.
Use during pregnancy and lactation
Berocca® Plus is not intended for use in pregnant or breastfeeding women. Vitamins and minerals at doses used in dietary supplements are generally considered safe for use during pregnancy and lactation. However, Berocca® Plus should be used during pregnancy only as directed by your doctor. The vitamins and minerals contained in Berocca® Plus pass into breast milk. There is no data on the safety of the drug when used during lactation.
Interaction with other drugs
Vitamin B6 (pyridoxine), in doses greater than 5 mg, may counteract the effects of levodopa in patients with parkinsonism. However, such antagonism is not observed when levodopa is used in combination with a decarboxylase inhibitor (eg, benserazide, carbidopa). Thiosemicarbazone and 5-fluorouracil neutralize the effect of vitamin B1. Antacids inhibit the resorption of vitamin B1. Neomycin, aminosalicylic acid and H2 blockers reduce the absorption of vitamin B12. Oral contraceptives may reduce serum levels of vitamin B12, folic acid, pyridoxine, and ascorbic acid. Some patients taking deferoxamine and vitamin C 500 mg daily may experience transient left ventricular dysfunction.
special instructions
Vitamin C may interfere with urine glucose test results even though it does not affect blood sugar levels. Vitamin C should be stopped several days before such tests. Urine may turn bright 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. One tablet of the drug contains the maximum daily dose of vitamin B6 (pyridoxine), so you should not exceed the recommended dose of the drug. One tablet contains 12.5% of the recommended daily intake of calcium and 33.3% of the recommended daily intake of magnesium. However, for the treatment of calcium and magnesium deficiency, taking Berocca® Plus alone is not sufficient. Information for patients with diabetes. One tablet of the drug contains 25 mg of mannitol, 94 mg of lactose monohydrate and 13.44 mg of dextrose, which corresponds to 0.02 bread unit (XE) and an energy value of 0.143 kcal, so the drug can be taken by patients with diabetes. Patients taking other medications should consult their doctor before taking Berocca® Plus.
Impact on the ability to drive a car or move machinery
Does not have or has an insignificant effect on the ability to drive a car or drive machinery.
Release form
Film-coated tablets. 10 or 20 film-coated tablets in a PVC/PE/PVDC/A1 blister. 3, 6 or 10 blisters (10 tablets each) or 3, 5 blisters (20 tablets each) along with instructions for use in a cardboard box with first opening control.
Storage conditions
At a temperature not higher than 25 °C. Keep out of the reach of children.
Best before date
3 years. Do not use after expiration date.
Conditions for dispensing from pharmacies
Over the counter.
Manufacturer
Registration certificate holder: JSC Bayer, Russia Manufactured by: Delpharm Gaillard, 33, rue d'Industry, 74240 Gaillard, France
Organization receiving consumer complaints: JSC "BAIER", Russia
107113, Moscow, st. 3rd Rybinskaya, 18, building 2 Tel. Fax www.bayer.ru
This version of the instructions is valid from 03/29/2021.
Indications for Berocca® Plus
Deficiency and conditions accompanied by an increased need for B vitamins, vitamin C and zinc.
The content of vitamins in Berocca® Plus has been selected for therapeutic use in conditions accompanied by a deficiency or increased need for vitamins (increased physical activity, periods of prolonged nervous strain and stress; poor and unbalanced nutrition (restrictive diets); in the elderly (effervescent tablets ); chronic alcoholism; nicotine addiction (in smokers) (effervescent tablets), as well as the use of oral contraceptives in women) (effervescent tablets).
Side effects
When taking the Berocca Plus multivitamin complex, patients may experience discomfort:
From the digestive system: from mild transient gastrointestinal disorders .
Allergic reactions: from urticaria , rash, laryngeal edema .
From the hematopoietic system: from hemolytic anemia (in people with glucose-6-phosphate dehydrogenase deficiency).
Use during pregnancy and breastfeeding
Berocca® Plus is not intended for use in pregnant or breastfeeding women.
Vitamins and minerals at doses used in dietary supplements are generally considered safe for use during pregnancy and lactation. However, Berocca® Plus should be used during pregnancy only as directed by your doctor.
The vitamins and minerals contained in Berocca® Plus pass into breast milk. There is no data on the safety of the drug when used during lactation.
Overdose
To date, there have been no cases of overdose with Berocca Plus.
In case of overdose, patients may experience discomfort from gastrointestinal disorders ( diarrhea and discomfort in the stomach). Please note that if vitamin B6 is taken in excess, the patient may experience symptoms of neuropathy .
As a treatment, the patient is recommended to completely stop taking the drug and be sure to consult a doctor for symptomatic therapy.
Interaction
Vitamin B6 (pyridoxine) in doses greater than 5 mg may counteract the effects of levodopa in patients with parkinsonism. However, such antagonism is not observed if levodopa is used in combination with a decarboxylase inhibitor (eg benserazide, carbidopa).
Thiosemicarbazone and 5-fluorouracil neutralize the effect of vitamin B1.
Antacids inhibit the resorption of vitamin B1.
Neomycin, aminosalicylic acid and H2 blockers reduce the absorption of vitamin B12.
Aspirin reduces the absorption of ascorbic acid by approximately one third.
Oral contraceptives can reduce serum levels of vitamin B12, folic acid, pyridoxine, and ascorbic acid.
Some patients taking deferoxamine and vitamin C 500 mg daily may experience transient left ventricular dysfunction.
special instructions
Vitamin C may affect urine glucose test results even though it does not affect blood sugar levels. Vitamin C should be stopped several days before such tests.
Urine may turn bright 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. In 1 table. The drug contains the maximum daily dose of vitamin B6 (pyridoxine), so you should not exceed the recommended dose of the drug.
One tablet contains 12.5% of the recommended daily intake of calcium and 33.3% of the recommended daily intake of magnesium. However, for the treatment of calcium and magnesium deficiency, taking Berocca® Plus alone is not sufficient.
In 1 table. effervescent contains 272 mg of sodium, so patients on a low-salt diet are recommended to take Berocca® Plus in the form of film-coated tablets.
Information for patients with diabetes
Film-coated tablets. In 1 table. The drug contains 25 mg of mannitol, 94 mg of lactose monohydrate and 13.44 mg of dextrose, which corresponds to 0.02 XE and has an energy value of 0.143 kcal, so the drug can be taken by patients with diabetes.
Effervescent tablets. In 1 table. The drug contains 267 mg of mannitol, which corresponds to 0.028 XE and has an energy value of 0.66 kcal, so the drug can be taken by patients with diabetes.
If you have an intolerance to certain sugars, you should consult your doctor before taking the drug.
Patients taking other drugs should consult their doctor before starting to take Berocca® Plus.
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Does not affect.
Contraindications
It is not recommended to take Berocca Plus:
- with hypercalcemia ;
- with hypermagnesemia ;
- for urolithiasis (nephrolithiasis, urolithiasis );
- with hemochromatosis ;
- for hyperoxaluria ;
- in case of impaired renal function ;
- with deficiency of glucose-6-phosphate dehydrogenase ;
- in children under 15 years of age;
- with hypersensitivity to the components of the drug.
Patients with diseases such as atrophic gastritis , vitamin B12 malabsorption syndrome, congenital deficiency of intrinsic factor Castle . It is also recommended that patients who suffer from diseases of the intestines and pancreas not take this drug.
Release form
Film-coated tablets. In PVC/PE/PVDC/Al blister, 10 or 20 pcs. 3, 6 or 10 blisters (10 tablets each) or 3, 5 blisters (20 tablets each) in a cardboard pack.
Effervescent tablets. 10 or 15 effervescent tablets, wrapped in foil, in an aluminum or propylene cylinder, closed with a plastic cap with tamper evident. A desiccant is placed in the lid. 1 or 2 cylinders (10 tablets each) or 1, 2 or 3 cylinders (15 tablets each) are packed in a cardboard box.
