Association of vitamins and minerals
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
BEROCCA without sugar: effervescent tablet (orange flavoring); box of 30.
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BEROCCA without sugar: effervescent tablet (orange flavoring); box of 60.
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BEROCCA: tablet; box of 30.
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Laboratory
| pcp efferv | p cp |
| Thiamine (vitamin B1) | 15 mg | 14.6 mg |
| Riboflavin (vitamin B2) | 15 mg | 15 mg |
| Pantothenic acid (vitamin B5) | 23 mg | 23 mg |
| Pyridoxine (vitamin B6) | 10 mg | 10 mg |
| Cyanocobalamin (vitamin B12) | 10 μg | 10 μg |
| Ascorbic acid (vitamin C) | 500 mg | 500 mg |
| Biotin (vitamin B8) | 0.15 mg | 0.15 mg |
| Nicotinamide (vitamin PP) | 50 mg | 50 mg |
| Folic acid (vitamin B9) | 0.4 mg | 0.4 mg |
| Calcium | 100 mg | 100 mg |
| Magnesium | 100 mg | 100 mg |
| Zinc | 10 mg | 10 mg |
| Sodium | 263 mg | |
| aspartame | + | |
| Lactose | | + |
This medicine contains magnesium, calcium, zinc and
vitamins B and C. These minerals and vitamins are essential for
metabolism .
It is used in the treatment of magnesium
deficiencies and in the case of symptoms suggestive of a lack of magnesium: irritability, transient fatigue, minor sleep disorders,
palpitations , muscle cramps, tingling.
This medication should not be used in the following cases:
The
vitamin C is degraded in the body oxalic acid, which can promote the formation of stones in the
tract urinary. Do not take a high dose of vitamin C for a long time without medical advice.
The amount of vitamin B12 contained in this medication is insufficient to treat
anemia due to a deficiency of this vitamin.
Effervescent tablets contain
salt (
sodium ) in significant amounts.
Take at least 2 hours between taking this medicine and
cyclins , biphosphonates, thyroid hormones, iron, zinc or strontium medications.
Inform your pharmacist or doctor if you are taking a medicine containing digoxin or a
diuretic (hydrochlorothiazide).
There are also food interactions: foods known to be rich in oxalic acid (spinach, rhubarb, sorrel, cocoa, tea) or phytic acid (chocolate, whole grains, dried vegetables) can reduce calcium absorption. It is therefore recommended to take this medicine away from meals containing these foods.
This medicine contains only presumed safe substances during pregnancy or lactation. However, do not use it prolonged without the advice of your pharmacist or doctor.
Effervescent tablets should be dissolved in a glass of water.
Usual dosage:
- Adult: 1 or 2 tablets per day.
The recommended duration of treatment is 1 month.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
A balanced and diverse diet usually provides sufficient amounts of
vitamins and minerals. Prolonged use of vitamins is not justified without medical advice.
Under treatment, the dark yellow color of urine is normal: it is due to vitamin B2.
Digestive intolerance.
anemia
Reduction in the level of hemoglobin in the blood, which usually results in a decrease in the number of red blood cells. Iron is essential for the synthesis of hemoglobin. Iron deficiency during pregnancy, a vegetarian diet, abundant or repeated haemorrhage (menstruation) is a common cause of anemia. Other causes, more rare, are related to vitamin deficiencies of group B.
shortcomings
Deficit usually involving nutrients, vitamins, minerals, etc. A diversified diet is the best prevention of deficiencies.
cyclins
Family of antibiotics used especially in the treatment of acne and certain genital infections.
diuretic
Medication allowing increased kidney water removal. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other rarer ailments.
These drugs cause loss of sodium and potassium (except for some of them called "potassium-sparing"). Their prolonged administration therefore requires regular blood potassium control, to avoid heart problems that may result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible but less frequent consequence of the prolonged use of diuretics; it is also detected by a blood test.
renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.
gallstone
Concretion (stone) that forms in the excretory pathways of certain organs: urinary, biliary, salivary.
Synonym: calculation.
metabolism
All the transformation actions carried out by the organization, resulting in the creation of energy or the development of various substances. Anabolism (metabolism of manufacture) is distinguished from catabolism (degradation metabolism).
palpitations
Abnormal perception of irregular heartbeat.
phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.
salt
Chemical substance of which the best known is sodium chloride, or table salt. The diet salt does not contain sodium; this is generally replaced by potassium.
sodium
An inorganic substance which can form salts, especially with chlorine (sodium chloride, or table salt).
vitamins
An essential ingredient for the growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency, in the young child or the old man who is exposed to the sun, justifies systematic supplementation. Superior intake, especially with medicines, can lead to overdose and various disorders (mainly vitamins A and D).
way
- Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
- Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.
Click here to find the record of this drug on the website of the National Agency for the Safety of Medicines and Health Products.
Pharmacovigilance : Report an adverse effect (s) related to the use of a drug
NOTICE
ANSM - Last updated: 30/06/2017
Name of the medicinal product
BEROCCA, film-coated tablet
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less comfortable after 30 days.
Do not use this medication for children.
What is in this leaflet?
1. What is BEROCCA, film-coated tablet and in which cases it is used?
2. What do you need to know before taking BEROCCA, film-coated tablets?
3. How to take BEROCCA, film-coated tablets?
4. What are the possible side effects?
5. How to store BEROCCA, film-coated tablets?
6. Package contents and other information.
1. WHAT IS film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: POLYVITAMINES WITH MINERAL ELEMENTS, ATC code: AA 11AA03 (A-Digestive tract and metabolism) .
This medicine contains magnesium.
It is indicated for disorders related to a deficiency in magnesium especially in adults over 15 years. This medicine also contains calcium, zinc, vitamins B and C.
The association of a number of the following symptoms may evoke a magnesium deficiency:
· nervousness, irritability, mild anxiety, emotivity, transient fatigue, minor sleep disorders.
· manifestations of anxiety, such as digestive spasms or palpitations (healthy heart).
· muscle cramps, tingling.
Magnesium intake can improve these symptoms.
You should contact your doctor if you experience no improvement or feel less comfortable after 30 days.
2. BEFORE YOU TAKE FILM-BASED PILLS?
Do not take BEROCCA, film-coated tablets:
· If you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· If you have excessively high levels of any of the vitamins contained in this drug in your blood (hypervitaminosis).
· If you have severe renal impairment (severe kidney function failure)
· If you have or have had kidney stones.
· If you have calculations of calcium oxalate (hyperoxaluria).
· If you have excessively high levels of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria), or if you receive treatment or have a disease and / or disorder causing an excessive increase in calcium in your blood and / or urine (eg, tumors, bone metastasis, excess parathyroid hormones, granulomatosis, kidney stones, tissue hardening due to calcium deposits, etc.).
· If you are under 15 years old .
Warnings and Precautions
· This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
· Allergic reactions to vitamins B1, B2, B12 and B9 contained in BEROCCA, film-coated tablets of mild to severe intensity have been reported. If you experience symptoms of an allergic reaction such as redness, itching, hives, difficulty breathing, heart rate, nausea, or headache, treatment should be stopped immediately and you should consult your doctor doctor.
· Take into account intakes of vitamins and minerals from other sources, such as medicines, fortified foods and food supplements (risk of overdose).
· Vitamin C increases the absorption of iron by your body. In case of hemochromatosis, talk to your doctor as the use of this medication should be strictly observed.
· Vitamin C should be used with caution in cases of glucose-6-phosphate dehydrogenase deficiency (inherited red blood cell disease), as high doses of vitamin C (greater than 1 gram per day) hemolytic anemia (destruction of red blood cells).
· Related to the presence of vitamins B12 and B9: taking this medicine can mask anemia due to deficiency of vitamin B12 and delay its diagnosis.
· Vitamin C may distort the results of blood and urine glucose testing
Talk to your doctor or pharmacist before taking BEROCCA, film-coated tablet.
Children and adolescents under 15 years of age
This medication is for adults and adolescents over 15 years of age.
Other medicines and BEROCCA, film-coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BEROCCA, film-coated tablet
Take into account the intakes of vitamins and minerals from fortified foods and food supplements.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
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 conclude on reproductive toxicity. As a precaution, it is preferable to avoid the use of BEROCCA, film-coated tablet during pregnancy.
feeding
The vitamins and minerals of BEROCCA, film-coated tablets 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 tablets on fertility.
Driving and using machines
BEROCCA, film-coated tablet has no or negligible effect on the ability to drive and use machines.
BEROCCA, film-coated tablet contains lactose.
3. HOW TO TAKE film-coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage / Mode of Administration / Administration Frequency / Duration of Treatment
In adults, the usual dosage is 1 to 2 tablets per day to be taken with a glass of water.
Due to the presence of vitamin C, take this medication preferably in the morning.
The usual duration of treatment is 1 month.
If you take more BEROCCA, film-coated tablets than you should:
Immediately consult your doctor or pharmacist.
If you forget to take BEROCCA, film-coated tablet:
Do not take a double dose to make up for a missed dose.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Frequency not known (can not be estimated from the available data):
· Allergic reactions from mild to severe (shock), mainly due to the presence of vitamin B1, including symptoms such as rash, urticaria, swelling, itching, heart and respiratory distress.
· Diarrhea, nausea, vomiting,
· Headache,
· Risk of yellow coloring of the urine (chromaturia) without clinical consequence, linked to the presence of vitamin B2.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE BEROCCA, film-coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C and away from moisture
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What BEROCCA contains, film-coated tablet
· The active substance (s) is (are) :
Thiamine nitrate (1) (Vitamin B1) ........................................ .............................................. 14.565 mg
Riboflavin (Vitamin B2) ............................................. .................................................. ........ 15,000 mg
Pyridoxine hydrochloride (Vitamin B6) ........................................... ................................... 10,000 mg
Cyanocobalamin (Vitamin B12) ............................................. ............................................... 0.010 mg
In the form of cyanocobalamin 0.1% WS (2)
Nicotinamide (Vitamin PP or B3) ........................................... .............................................. 50,000 mg
Pantothenic acid (Vitamin B5) ............................................ ............................................ 23,000 mg
In the form of calcium pantothenate
Biotin (Vitamin B8 or H) ........................................... .................................................. .......... 0.150 mg
In the form of a 1% dilution in mannitol
Ascorbic Acid (Vitamin C) ............................................ ................................................. 500,000 mg
Folic Acid (Vitamin B9) ............................................ .................................................. ........ 0.400 mg
In the form of a 5% dilution in mannitol
Calcium ................................................. .................................................. ............................ 100,000 mg
In the form of calcium pantothenate (2.3%) and calcium carbonate (97.7%)
Magnesium ................................................. .................................................. ....................... 100,000 mg
In the form of heavy magnesium carbonate (30.6%) and light magnesium oxide (69.4%)
Zinc ................................................. .................................................. ...................................... 10,000 mg
In the form of zinc citrate
(1) The amount of vitamin B1 provided by 14,565 mg of thiamine nitrate is equivalent to that provided by 15 mg of thiamine hydrochloride.
(2) Cyanocobalamin composition 0.1% WS: cyanocobalamin, sodium citrate, citric acid, dextrin.
· The other components are :
Lactose monohydrate, povidone K90, croscarmellose sodium, mannitol, talc, magnesium stearate, OPADRY II Brown.
What is BEROCCA film-coated tablets and contents of the pack
Marketing Authorization Holder
BAYER HEALTHCARE SAS
AVENUE OF RESEARCH
59120 LOOS - FRANCE
Marketing Authorization Operator
BAYER HEALTHCARE SAS
33, RUE DE L'INDUSTRIE
74210 GAILLARD - FRANCE
Maker
DELPHARM GAILLARD
33, RUE DE L'INDUSTRIE
74240 GAILLARD - France
Or
GP GRENZACH PRODUKTIONS GMBH
EMIL-BARELL-STRASSE 7
79639 GRENZACH-WYHLEN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.
