Berocca tablets Uses, Dosage, Side Effects, Precautions & Warnings

what is berocca used for
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berocca tablets >> Generic Drug Class Drug: Metabolic and nutritional
active ingredients: Thiamine , Riboflavin (E101) , Pyridoxine , Cyanocobalamin , Nicotinamide , Pantothenic acid , Biotin , Folic Acid , Ascorbic acid (E300) , Calcium , Magnesium , Zinc

what is Berocca ?

This medication is indicated for disorders related to a magnesium deficiency, in particular in adults over 15 years old. This medicine also contains calcium, zinc, vitamins B and C.

This medicine contains magnesium.

If these symptoms do not improve after a month of treatment, it is not necessary to continue it. Consult your doctor.

PRESENTATION (S) AVAILABLE FOR BEROCCA

2 presentations are available for this medication:

  • PVC-aluminum polyethylene PVDC blister pack (s) of 30 tablet (s)
  • PVC-aluminum polyethylene PVDC blister (s) of 100 tablet (s)
FEATUREDESCRIPTION
Pharmaceutical classnot communicated
Active substance (s)for one tablet: biotin (0.15 mg), calcium carbonate, ascorbic acid (500 mg), folic acid (0.4 mg), cyanocobalamin (0.01 mg), riboflavin (15 mg), nicotinamide (50 mg ), pyridoxine hydrochloride (10 mg), thiamine nitrate (14.565 mg), calcium pantothenate, heavy magnesium (carbonate), light magnesium (oxide), zinc (citrate) trihydrate
General medicineno
Pharmaceutical formcoated tablet
Route (s) of administrationoral
Selling priceunregulated price
Social security reimbursement rate0%
Laboratory (s)Laboratory (s) manufacturer Berocca
Conditions of issueavailable without prescription

what is in berocca?

berocca : It is a medicine that contains:

  1. Thiamine.
  2. Riboflavin (E101).
  3. Pyridoxine.
  4. Cyanocobalamin.
  5. Nicotinamide .
  6. Pantothenic acid.
  7. Biotin.
  8. Folic Acid .
  9. Ascorbic acid (E300).
  10. Calcium.
  11. Magnesium.
  12. Zinc.

what is Berocca medication used for and indication?

The combination of a number of the following symptoms can suggest a magnesium deficiency:

  • nervousness, irritability, mild anxiety, emotionality, temporary fatigue, minor sleep disturbances.
  • manifestations of anxiety, such as digestive spasms or palpitations (healthy heart).
  • muscle cramps, tingling.

The intake of magnesium can improve these symptoms.

Berocca Dosage

Dosage, method of administration

  • In adults, the usual dosage is 1 to 2 tablets per day, taken with a glass of water.
  • Due to the presence of vitamin C, take this medication preferably in the morning.

Duration of the treatment

  • The usual duration of treatment is 1 month.

Berocca Contraindications

  • allergy to one of the components,
  • severe renal impairment (creatinine clearance <30 ml / min),
  • hypercalcemia, hypercalciuria, calcium lithiasis, tissue calcifications,
  • in the event of phenylketonuria, due to the presence of aspartame ,
  • association with levodopa (see interactions).

how does berocca tablets work?

  • Pharmacotherapeutic group: POLYVITAMINS WITH MINERAL ELEMENTS, ATC code: A A11AA03 (A-Digestive tract and metabolism).
  • Association of magnesium, calcium, zinc and water-soluble vitamins.
  • Magnesium is a mainly intracellular cation. It decreases neuronal excitability and neuromuscular transmission, and is involved in many enzymatic reactions.
  • Calcium is important not only for the development of bones and teeth, but also for the metabolism as a whole and for the functional integrity of nerves and muscles.
  • Zinc is an important trace element in the body and is involved as a catalytic component in more than 200 enzymes and as a natural constituent of many proteins, hormones, neuropeptides and hormone receptors. Zinc is, among other things, directly associated with the synthesis of coenzymes derived from vitamin B6 (pyridoxine).

How To Store Berocca ?

  • Keep this medication out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the package after EXP. The expiration date refers to the last day of that month.
  • Store at a temperature not exceeding 25 ° C and away from moisture.
  • Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Berocca Side Effects

Like all medicines, BEROCCA, film-coated tablet can cause side effects, although not everybody gets them.

  • possibility of digestive intolerance,
  • linked to the presence of vitamin B2 (riboflavin): risk of dark yellow coloration of the urine without consequences for your health.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

berocca tablets Interactions

Combinations subject to precautions for use

Linked to the presence of ascorbic acid:

DEFEROXAMINE

  • Increased risk of iron-induced heart failure due to increased iron mobilization by supraphysiologic vitamin C supplementation.
  • In case of hemochromatosis, give vitamin C only after starting treatment with deferoxamine. Monitor cardiac function in combination.

Related to the presence of folic acid:

ANTICONVULSIVANTS (phenobarbital, phenytoin, fosphenitoin, primidone)

  • Decrease in plasma concentrations of phenobarbital, phenytoin, fosphenytoin and primidone, by increasing their metabolism in which folate is one of the cofactors, which increases the risk of seizures.
  • Clinical monitoring, monitoring of plasma concentrations of phenobarbital, phenytoin, fosphenitoin, or primidone. Possible adjustment of their dosage during folic supplementation and after its discontinuation.

Linked to the presence of calcium:

BISPHOSPHONATES (alendronic acid, clodronic acid, etidronic acid, ibandronic acid, medronic acid, oxidronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid)

  • For calcium salts administered orally: decrease in digestive absorption of bisphosphonates.
  • Take calcium salts and antacids away from bisphosphonates (at least 30 minutes to more than 2 hours, if possible, depending on the bisphosphonate).

CYCLINES

  • Decreased digestive absorption of cyclins.
  • Take calcium salts away from cyclins (more than two hours, if possible).

DIGITALS

  • Risk of serious arrhythmias.
  • Clinical monitoring and, if necessary, control of ECG and serum calcium.

ESTRAMUSTINE

  • Decreased digestive absorption of estramustine.
  • Take calcium salts away from estramustine (more than 2 hours, if possible).

IRON

  • With oral iron salts: decrease in digestive absorption of iron salts.
  • Take iron salts between meals and in the absence of calcium.

THYROID HORMONES

  • Decreased absorption of thyroid hormones.
  • Take calcium salts away from thyroid hormones (more than 2 hours, if possible).

STRONTIUM

  • With calcium salts administered orally: decrease in digestive absorption of strontium.
  • Take strontium away from calcium salts (more than two hours, if possible).

ZINC

  • Decreased digestive absorption of zinc by calcium.
  • Take the calcium salts away from the zinc (more than 2 hours if possible).

Linked to the presence of zinc:

CYCLINES

  • Decreased digestive absorption of cyclins
  • Take zinc salts away from cyclins (more than 2 hours if possible).

IRON

  • Decreased digestive absorption of zinc by iron.
  • Take the iron salts away from the zinc (more than 2 hours if possible).

FLUOROQUINOLONES

  • Decreased digestive absorption of fluoroquinolones.
  • Take zinc salts away from fluoroquinolones (more than 2 hours, if possible).

STRONTIUM

  • Decreased digestive absorption of strontium.
  • Take strontium away from zinc salts (more than two hours, if possible).

Associations to take into account

Linked to the presence of cyanocobalamin:

ANTIHISTAMINIC H2 ANTI-SECRETORY

  • Risk of cyanocobalamin deficiency after prolonged treatment (a few years), the reduction in gastric acidity by these drugs can decrease the digestive absorption of vitamin B12.

ANTI-SECRETORY INHIBITORS OF THE PROTON PUMP

  • Risk of cyanocobalamin deficiency after prolonged treatment (a few years), the reduction in gastric acidity by these drugs can decrease the digestive absorption of vitamin B12.

Linked to the presence of calcium:

THIAZIDIC AND RELATED DIURETICS

  • Risk of hypercalcemia by decreased urinary elimination of calcium.

Linked to the presence of pyridoxine:

PYRIDOXINE ANTAGONISTS (including isoniazid, penicillamine)

  • May cause pyridoxine deficiency.

Related to the presence of folic acid:

FLUOROURACIL (AND, BY EXTRAPOLATION, OTHER FLUOROPYRIMIDINES) (capecitabine, fluorouracil, gimeracil, oteracil, tegafur)

  • Potentiation of the effects, both cytostatic and undesirable, of fluorouracil.

FOLATE ANTAGONISTS (eg, methotrexate, sulfasalazine, pyrimethamine, triamterene, trimethoprim) AND HIGH DOSE OF TEA CATHECHINS:

  • Blocking the conversion of folate to their active metabolites and reducing the effectiveness of supplementation.

Interactions with other vitamin and / or mineral supplements

  • Some drugs can interact with certain vitamins and / or minerals at doses significantly higher than those present in BEROCCA, film-coated tablet. This should be taken into account in patients receiving vitamins and / or minerals from more than one source; where appropriate, patients should be monitored for these interactions and managed appropriately.

Other forms of interactions

  • Depending on the reagents used, the presence of ascorbic acid in blood and urine may interfere with the results of some blood and urine glucose monitoring systems, including test strips and portable glucose monitors  precautions for use).
Not applicable.

Drive and use machines

BEROCCA, film-coated tablet has no or negligible influence on the ability to drive and use machines.

Warnings and Precautions

Special warnings

  • ·This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) should not take this medicine.
  • Hypersensitivity reactions to certain constituents of BEROCCA, film-coated tablet, of mild to severe intensity, have been reported (which may in particular be linked to vitamins B1, B2, B12, B9) (see section Undesirable effects). If a hypersensitivity reaction is suspected, treatment should be stopped immediately and appropriate medical management initiated.
  • This medicine contains 2.2 mg sodium per tablet. The amount of sodium is less than 1 mmol (23 mg) for 2 tablets, that is to say essentially “sodium-free”.

Precautions for use

  • Take into account the intake of vitamins and minerals from other sources, such as drugs, fortified foods and food supplements (see section Interactions with other drugs and other forms of interactions and Overdose)
  • · Ascorbic acid (vitamin C) increases the gastrointestinal absorption of iron. In the event of hemochromatosis, the use of this medicinal product must be subject to strict precautions (see section Interactions with other medicinal products and other forms of interactions).
  • – High doses of vitamin C (greater than 1 gram per day) in individuals with glucose-6-phosphate dehydrogenase deficiency increase the risk of developing haemolytic anemia (see section Overdose).

Interference with medical biology analyzes

  • · Biotin may interfere with laboratory tests based on the biotin / streptavidin interaction, resulting in falsely underestimated or falsely overestimated test results, depending on the test. The risk of interference is greater in children and patients with renal impairment and increases with higher doses. When interpreting the results of laboratory analyzes, consideration should be given to possible interferences with biotin, especially in the event of a result inconsistent with the clinical presentation (for example, thyroid test results indicating disease of Basedow in asymptomatic patients taking biotin, or false negative troponin test results in patients with myocardial infarction taking biotin). In cases where interference is suspected, alternative testing, without interference from biotin, should be performed. When ordering laboratory tests for patients taking biotin, laboratory personnel should be consulted.
  • · Linked to the presence of vitamin B12 and vitamin B9: taking this medication can mask anemia due to vitamin B12 deficiency and delay the diagnosis.
  • Ascorbic acid may interfere with blood and urine glucose control test results (see section Interactions with other medicines and other forms of interactions).

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

  • There are no data or there are limited data (less than 300 pregnancies) on the use of BEROCCA film-coated tablet in pregnant women.
  • Studies in animals are insufficient to allow a conclusion to be drawn on reproductive toxicity (see section Preclinical safety data).
  • As a precaution, it is preferable to avoid the use of BEROCCA, film-coated tablet, during pregnancy.

Feeding with milk

  • The vitamins and minerals in the product are excreted in breast milk. There are insufficient data on their effects in newborns / infants

Fertility

  • There are no data on the effects of BEROCCA, film-coated tablet, on fertility.

 

What happens if I overdose from Berocca ?

  • Acute or chronic overdose of vitamins (in particular B6 and C) and minerals (calcium, magnesium, zinc) contained in BEROCCA film-coated tablet, can cause hypervitaminosis.
  • The intake of vitamins and minerals from other sources should be taken into account.
  • General symptoms of overdose may include gastrointestinal disturbances such as constipation, diarrhea, nausea and vomiting.

Calcium, magnesium:

  • Hypercalcemia and hypermagnesemia in massive and / or chronic overdose.

Vitamin C :

  • Chronic consumption of high doses of ascorbic acid (> 500 mg / day) may aggravate iron overload and may lead to tissue damage in patients with hemochromatosis.
  • At doses greater than 1 g / day in vitamin C, possibility of digestive disorders (gastric burns, diarrhea); urinary disorders (oxalic, cystine and / or uric lithiasis); hemolysis in subjects deficient in glucose-6-phosphate dehydrogenase (G6PD).

Vitamin B6:

  • Prolonged use of vitamin B6 and / or chronic consumption of high doses of vitamin B6 (> 50 mg / day) increases the risk of axonal sensory neuropathy. Central effects have also been described. Neuropathies were most frequently reported after chronic ingestion of 200-6000 mg / day for months / years. The neuropathy is gradually reversible on discontinuation of pyridoxine.

Zinc:

  • Zinc overdose can lead to diarrhea, irritation and corrosion of the gastrointestinal tract, acute renal tubular necrosis, interstitial nephritis, copper deficiency, sideroblastic anemia and myeloneuropathy.
  • If an overdose is suspected, BEROCCA, film-coated tablet must be stopped and medical treatment initiated.

What should I do if I miss a dose?

  • Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking berocca tablets ?

  • Not applicable.
  • Not applicable.
  • Not applicable.

What is  Forms and Composition ?

Forms

Coated tablet.

60 tablets in blister packs (PVC / PE / PVDC / Aluminum)

Other shapes

  • BEROCCA, film-coated tablet, box of 30

 COMPOSITION

Active substances

  1. Thiamine nitrate (1) (Vitamin B1): 14.565 mg
  2. Riboflavin (Vitamin B2): 15,000 mg
  3. Pyridoxine hydrochloride (Vitamin B6): 10,000 mg
  4. Cyanocobalamin (Vitamin B12): 0.010 mg
  5. In the form of 0.1% WS cyanocobalamin (2)
  6. Nicotinamide (Vitamin PP or B3): 50,000 mg
  7. Pantothenic acid (Vitamin B5): 23,000 mg
  8. In the form of calcium pantothenate
  9. Biotin (Vitamin B8 or H): 0.150 mg
  10. As a 1% dilution in mannitol
  11. Ascorbic acid (Vitamin C): 500,000 mg
  12. Folic acid (Vitamin B9): 0.400 mg
  13. As a 5% dilution in mannitol
  14. Calcium: 100,000 mg
  15. In the form of calcium pantothenate (2.3%) and calcium carbonate (97.7%)
  16. Magnesium: 100,000 mg
    1. As heavy magnesium carbonate (30.6%) and light magnesium oxide (69.4%)
  17. Zinc: 10,000 mg
    1. As zinc citrate
      1. (1) The quantity of vitamin B1 supplied by 14.565 mg of thiamine nitrate is equivalent to that supplied by 15 mg of thiamine hydrochloride.
      2. (2) Composition of cyanocobalamin 0.1% WS: cyanocobalamin, sodium citrate, citric acid, dextrin.

Other components

  • Lactose monohydrate, povidone K90, croscarmellose sodium, mannitol, talc, magnesium stearate, OPADRY II Brown

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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