In this manual :
1. WHAT IS BEROCCA, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING BEROCCA, film-coated tablet
3. HOW DO I TAKE BEROCCA, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE BEROCCA, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS BEROCCA, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is a combination of vitamins and minerals.
This medicine is indicated for disorders related to magnesium deficiency, particularly in adults over 15 years of age. This medicine also contains calcium, zinc, vitamins B and C.
This medicine contains magnesium.
The combination of a number of the following symptoms may indicate a magnesium deficiency:
- nervousness, irritability, mild anxiety, emotionalism, transient fatigue, minor sleep disturbances.
- manifestations of anxiety, such as digestive spasms or palpitations (healthy heart).
- Muscle cramps, tingling.
Magnesium intake can improve these symptoms.
If these symptoms do not improve after one month of treatment, it is not useful to continue. Consult your doctor.
2. WHAT YOU SHOULD KNOW BEFORE TAKING BEROCCA, film-coated tablet
List of information needed before taking the medicine
Not applicable.
Never take BEROCCA, film-coated tablet in the following cases:
- in combination with levodopa (a drug used in the treatment of Parkinson's disease),
- severe renal failure (kidney function impairment),
- hypercalcemia (abnormally high levels of calcium in the blood)
- hypercalciuria (abnormally high levels of calcium in the urine)
- calcium lithiasis (kidney stones)
- history of allergy to one of the constituents.
Precautions for use; special warnings
Be careful with BEROCCA, film-coated tablet:
- Concomitant treatment with other medicines containing vitamins and/or minerals (risk of overdose),
- Due to the presence of lactose, this medicine should not be used in patients with galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
- A large dose of vitamin B12 may mask anaemia: if you are already taking a vitamin B12-based treatment, ask your doctor or pharmacist before taking this medicine.
Interactions with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medication, including medication obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: lactose monohydrate.
3. HOW TO TAKE BEROCCA, film-coated tablet
Instructions for proper use
Not applicable.
Dosage, method and/or route of administration, frequency of administration and duration of treatment
Dosage, method of administration
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, this medicine should preferably be taken in the morning.
Duration of treatment
The usual duration of treatment is 1 month.
Symptoms and instructions in case of overdose
If you have taken more BEROCCA film-coated tablets than you should have, SEEK YOUR DOCTOR OR PHARMACIST IMMEDIATELY.
Instructions in case of missed doses
If you forget to take BEROCCA film-coated tablets, DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE DOSE YOU MISSED.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, BEROCCA, film-coated tablet is likely to have side effects, although not everyone is susceptible.
- possibility of digestive intolerance,
- linked to the presence of vitaminB2 (riboflavin): risk of dark yellow colouring of the urine without any consequences for your health.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO STORE BEROCCA, film-coated tablet
Keep out of the reach and sight of children.
Do not use BEROCCA, film-coated tablets after the expiry date stated on the box.
Store at a temperature not exceeding +25°C and protect from moisture.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does BEROCCA, film-coated tablet contain?
The active ingredients are
Thiamine nitrate(1 ) (VitaminB1) ................................................................................................ 14.565 mg
Riboflavin (VitaminB2) ............................................................................................................... 15,000 mg
Pyridoxine hydrochloride (Vitamin B6) ....................................................................................... 10,000 mg
Cyanocobalamin (Vitamin B12) ..................................................................................................... 0.010 mg
As cyanocobalamin 0.1% WS (2)
Nicotinamide (Vitamin PP or B3) ................................................................................................. 50,000 mg
Pantothenic acid (Vitamin B5) ................................................................................................ 23,000 mg
As calcium pantothenate
Biotin (Vitamin B8 or H) .............................................................................................................. 0.150 mg
As a 1% dilution in mannitol
Ascorbic acid (Vitamin C) .................................................................................................... 500,000 mg
Folic acid (Vitamin B9) ............................................................................................................. 0.400 mg
As a 5% dilution in mannitol
Calcium .................................................................................................................................... 100,000 mg
As calcium pantothenate (2.3%) and calcium carbonate (97.7%)
Magnesium ............................................................................................................................... 100,000 mg
As heavy magnesium carbonate (30.6%) and light magnesium oxide (69.4%)
Zinc ............................................................................................................................................ 10,000 mg
As zinc citrate
(1)The amount of vitaminB1 provided by 14.565 mg of thiamine nitrate is equivalent to that provided by 15 mg of thiamine hydrochloride.
(2)Composition of cyanocobalamin 0.1% WS: cyanocobalamin, sodium citrate, citric acid, dextrin.
Other components are:
Lactose monohydrate, povidone K90, croscarmellose sodium, mannitol, talc, magnesium stearate, OPADRY II Brown
Pharmaceutical form and content
What is BEROCCA, film-coated tablet and what does it contain?
This medicine is presented as a film-coated tablet. Box of 30 or 100.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BAYER SANTE FAMILIALE
33 RUE DE L'INDUSTRIE
74240 GAILLARD
Operator
BAYER SANTE FAMILIALE
33 RUE DE L'INDUSTRIE
74240 GAILLARD
Manufacturer
BAYER SANTE FAMILIALE
33 RUE DE L'INDUSTRIE
74240 GAILLARD
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.
Date of approval of the package leaflet
The last date of approval of this package leaflet was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
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