Berocca Energy 30 film-coated tablets

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?

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

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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.

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.

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.

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Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

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List of excipients with a notable effect: lactose monohydrate.

3. HOW TO TAKE BEROCCA, film-coated tablet

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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.

If you have taken more BEROCCA film-coated tablets than you should have, SEEK YOUR DOCTOR OR PHARMACIST IMMEDIATELY.

If you forget to take BEROCCA film-coated tablets, DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE DOSE YOU MISSED.

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4. WHAT ARE THE POSSIBLE 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 vitamin_B2 (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.

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

What does BEROCCA, film-coated tablet contain?

The active ingredients 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

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 vitamin_B1 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

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.

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

Not applicable.

The last date of approval of this package leaflet was {date}.

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Detailed information on this medicinal product is available on the website of Afssaps (France).

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