In this manual :
1. WHAT IS BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartam and acesulfame potassium AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium
3. HOW TO TAKE BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartam and acesulfame potassium?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame of potassium?
6. ADDITIONAL INFORMATION
1. WHAT IS BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium 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 may improve these symptoms.
If there is no improvement in these symptoms after one month of treatment, there is no point in continuing it. Consult your doctor.
2. WHAT YOU SHOULD KNOW BEFORE TAKING BEROCCA SWEETENING, effervescent tablet sweetened with aspartame and acesulfame potassium
List of information needed before taking the medicine
Not applicable.
Never take BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium in the following cases:
- association 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 any of the constituents,
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
Precautions for use; special warnings
Be careful with BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium:
Take special precautions with BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartam and acesulfame potassium:
- concomitant treatment with other medicines containing vitamins and/or minerals (risk of overdose),
A high 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.
This medicine contains 263 mg of sodium per tablet: this should be taken into account by people on a strict low-salt diet.
This medicine contains 4 mg of potassium per tablet: take this into account in your daily intake.
Tell your doctor if you have renal insufficiency
Interactions with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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: aspartam (source of phenylalanine) (E 951), sodium, potassium.
3. HOW TO TAKE BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame of potassium
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage/Mode of administration/Frequency of administration/Duration of treatment
In adults, the usual dosage is 1 to 2 tablets per day dissolved in a glass of water.
Due to the presence of vitamin C, this medicine should preferably be taken in the morning.
The usual duration of treatment is 1 month.
Symptoms and instructions in case of overdose
If you have taken more BEROCCA SWEET, effervescent tablets sweetened with aspartame and acesulfame potassium than you should have
CONSULT YOUR DOCTOR OR PHARMACIST IMMEDIATELY.
Instructions in case of missing one or more doses
If you forget to take BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame of potassium:
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE ONE YOU FORGOT TO TAKE.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium is likely to have undesirable effects, although not everyone is subject to them:
- possible digestive intolerance,
- linked to the presence of vitaminB2 (riboflavin): risk of dark yellow colouring of the urine without 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 USE BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium
Keep out of the reach and sight of children.
Do not use BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium 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
Medicines should not be disposed of down the drain or in the household garbage. 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 SUGAR-FREE effervescent tablet, sweetened with aspartam and acesulfame potassium, contain?
The active ingredients of this medicine are
Thiamine hydrochloride (VitaminB1), riboflavin (VitaminB2 ), pyridoxine hydrochloride (Vitamin B6), cyanocobalamin (Vitamin B12), nicotinamide (Vitamin PP or B3), Pantothenic acid (Vitamin B5), biotin (Vitamin B8 or H), folic acid (Vitamin B9), ascorbic acid (Vitamin C), calcium, magnesium, zinc.
Other components are:
Citric acid anhydrous, sodium bicarbonate, sodium carbonate, sodium chloride, acesulfame potassium, aspartam, beet red (E162), β-carotene 1% SD, orange flavor (orange essential oil, maltodextrin, gum arabic), polysorbate 60, mannitol.
Pharmaceutical form and content
What is BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartam and acesulfame potassium and what does it contain?
This medicine is presented as an effervescent tablet. Box of 10, 15, 20 or 30.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BAYER FAMILY HEALTH
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
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 on which this package insert was approved 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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