NOTICE
ANSM - Updated: 30/06/2017
Name of the drug
BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 30 days.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium and when is it used?
2. What information do you need to 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 aspartame and acesulfame potassium ?
4. What are the possible side effects?
5. How to store BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium ?
6. Contents of the package and other information.
1. WHAT BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium AND WHAT IT IS USED FOR
Pharmacotherapeutic group: POLYVITAMINS WITH MINERAL ELEMENTS, ATC code: AA 11AA03 (A-Gastrointestinal tract and metabolism) .
This medicine contains magnesium.
It is indicated for disorders related to magnesium deficiency, 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 suggest a magnesium deficiency:
· nervousness, irritability, mild anxiety, emotions, tiredness, 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 talk to your doctor if you do not feel better or if you feel worse for 30 days.
2. BEFORE YOU TAKE BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium?
Do not take BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium:
· If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· If you have excessively high levels of any of the vitamins contained in this medicine in your blood (hypervitaminosis).
· If you have severe kidney failure (severe kidney function failure).
· If you have or have had kidney stones.
· If you have calcium oxalate (hyperoxaluria) stones.
· If you have excessively high levels of calcium in the blood (severe hypercalcemia) or in the urine (hypercalciuria), or if you are receiving treatment or have a disease and / or disorders leading to an excessive increase in the level of calcium in your blood and / or your urine (eg, tumors, bone metastasis, excess parathyroid hormone, granulomatosis, kidney stones, tissue hardening due to calcium deposits ... etc).
· In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.
· If you are under 15 years old.
Warnings and precautions
· Allergic reactions to vitamins B1, B2, B12 and B9 contained in BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium, mild to severe, have been reported. If you experience symptoms of an allergic reaction such as redness of the skin, rash, itching, hives, difficulty breathing, increased heart rate, nausea, or headache, treatment should be discontinued immediately and you should consult your doctor. doctor.
· Take into account the intake of vitamins and minerals from other sources, such as medicines, fortified foods and dietary supplements (risk of overdose).
· Vitamin C increases the absorption of iron by your body. In the case of haemochromatosis, contact your doctor because the use of this medicine should be strictly controlled.
· Vitamin C should be used with caution in case of glucose-6-phosphate dehydrogenase (hereditary red blood cell) deficiency, since high doses of vitamin C (greater than 1 gram per day) promote the risk of developing hemolytic anemia (destruction of red blood cells).
· Linked to the presence of vitamins B9 and B12: the intake of this drug can mask vitamin B12 deficiency anemia and delay the diagnosis.
· Vitamin C can skew the results of blood and urine glucose control tests.
· This medicine contains 263 mg of sodium per tablet. To take into account in people on a strict sodium diet.
· This medicine contains 4 mg potassium per tablet. The potassium level is less than 1 mmol for 2 tablets, that is to say "without potassium".
· This medicine contains isomalt and sorbitol. Its use is not recommended in patients with fructose intolerance (rare hereditary disease).
Talk to your doctor or pharmacist before taking BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium .
Children and adolescents under 15 years
· This medication is for adults and adolescents over 15 years old.
Other medicines and BEROCCA SUGAR-FREE, effervescent tablet sweetened with aspartame and acesulfame potassium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium with food
Take into account the intake of vitamins and minerals from fortified foods and dietary supplements.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no data or limited data (less than 300 pregnancies) on the use of BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium in pregnant women. Studies in animals are insufficient to conclude on reproductive toxicity. As a precaution, it is best to avoid the use of BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium during pregnancy.
feeding
The vitamins and minerals of BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium are excreted in breast milk. There is insufficient data on their effects in newborns / infants.
Fertility
There are no data on the effects of BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium on fertility.
Driving and using machines
SUGAR-FREE BEROCCA, effervescent tablet sweetened with aspartame and acesulfame potassium has no or negligible effect on the ability to drive and use machines.
SUGAR-FREE BEROCCA, effervescent tablet sweetened with aspartame and acesulfame potassium contains aspartame (source of phenylalanine), isomalt and sorbitol.
3. HOW TO TAKE BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage / Method of Administration / Frequency of Administration / Duration of Treatment
In adults, the usual dosage is 1 to 2 tablets per day to dissolve in 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 have taken more BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium you should have:
Immediately consult your doctor or pharmacist.
If you forget to take BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium:
Do not take a double dose to make up for the dose you forgot to take.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not known (can not be estimated from the available data):
· Allergic reactions of mild to severe (shock), mainly related to the presence of vitamin B1, including symptoms such as rash, hives, swelling, itching, heart and respiratory distress.
· Diarrhea, nausea, vomiting,
· Headache,
· Risk of yellow coloring of the urine (chromaturia) without clinical consequence, related to the presence of vitamin B2.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE BEROCCA SUGAR FREE, effervescent tablet sweetened with aspartame and acesulfame potassium?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 25 ° C and protected from moisture
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What contains BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium
· The active substances are :
Thiamine Hydrochloride (Vitamin B1), Riboflavin (Vitamin B2), 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.
· The other components are:
Citric acid anhydrous, sodium bicarbonate, sodium carbonate, sodium chloride, acesulfame potassium, aspartame, beetroot red (E162), β-carotene 1% SD, orange flavor (orange essential oil, maltodextrin, gum arabic) , polysorbate 60, mannitol, sorbitol, isomalt.
What is BEROCCA SUGAR, effervescent tablet sweetened with aspartame and acesulfame potassium and contents of the pack
This medicine comes in the form of an effervescent tablet. Box of 10, 15, 20, 30, 45 or 60 tablets.
Not all presentations may be marketed.
Marketing Authorization Holder
BAYER HEALTHCARE SAS
AVENUE OF RESEARCH
59120 LOOS - FRANCE
Operator of the marketing authorization
BAYER HEALTHCARE SAS
33, INDUSTRY STREET
74210 GAILLARD - FRANCE
Maker
DELPHARM GAILLARD
33, INDUSTRY STREET
74240 GAILLARD - FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
{month YYYY}
Other
Not applicable.