Bicafres 1000 mg is a sodium bicarbonate-based antacid, ideal for treating metabolic acidosis in adolescents aged 14 and over and adults with chronic renal failure. Gastro-resistant formulation for optimal efficacy. Box of 100 tablets.
Bicafres 1000 mg is an innovative antacid medication, formulated with sodium bicarbonate, presented in gastro-resistant tablet form. This medication is specifically designed to treat metabolic acidosis, a medical condition in which blood acidity rises abnormally. This condition often occurs in adolescents aged 14 and over, as well as in adults suffering from chronic renal failure. The kidneys, unable to eliminate sufficient acid from the body, cause this accumulation of acidity.
The main advantage of Bicafres is its ability to deliver assimilable sodium and bicarbonates directly into the small intestine. This helps neutralize excessive acidity, improving patients' comfort and overall health. Each tablet contains 1000 mg sodium bicarbonate, an optimal dose for an effective therapeutic effect.
The benefits of Bicafres are not limited to its ability to regulate blood acidity. Thanks to its gastro-resistant formulation, the tablets resist the acidic environment of the stomach, ensuring controlled, targeted release in the small intestine. This unique feature enhances drug absorption and efficacy.
In addition to its therapeutic efficacy, Bicafres is distinguished by its careful composition. Other components include sodium carboxymethyl starch, microcrystalline cellulose, copovidone, potato starch, colloidal anhydrous silica, vegetable magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol, talc, and methacrylic acid-ethyl acrylate copolymer (1:1). Each ingredient plays a crucial role in the product's stability, efficacy and safety.
In short, Bicafres 1000 mg is an indispensable ally for people suffering from metabolic acidosis due to chronic renal failure. Its unique formulation and carefully selected ingredients guarantee maximum efficacy and improved quality of life. To complement the many benefits of this product, it is advisable to follow your doctor's recommendations and use it in conjunction with other treatments prescribed to manage your medical condition.
We also recommend Sodium Bicarbonate Cooper Boite 250 g can be used to brush teeth for occasional whitening, or as an anti-gastric, at a distance from meals and other medications.
Instructions for use
Bicafres should always be used in accordance with your doctor's instructions. The recommended initial dose for adults is 2 to 3 tablets a day, taken in divided doses. This dose may be adjusted according to the severity of your symptoms and your response to treatment. The maintenance dose may be up to 8 tablets a day, again in divided doses.
Bicafres is not recommended for children and adolescents under 14 years of age, as safety and efficacy have not been established in this age group. Tablets should be swallowed whole with a small amount of liquid, such as water, and should not be chewed or crushed. Because of the risk of developing hypernatremia and metabolic alkalosis, sodium bicarbonate should not be given for long periods without medical supervision.
Give your opinion on the advice for use and dosage of Bicafres 1000 mg with our partner Verified opinions after your purchase.
Precautions for use
Bicafres should be used with caution if you suffer from hypoventilation, hypocalcemia or hyperosmolar disorders. If you take this medicine, be aware of possible side effects such as flatulence, abdominal pain, hypocalcemic tetany after an excessive dose, and aggravation of pre-existing digestive disorders. Prolonged use may lead to the formation of kidney stones. It is essential to follow your doctor's recommendations and avoid prolonged use without medical supervision.
The active substance in Bicafres is sodium bicarbonate, each gastro-resistant tablet containing 1000 mg. Other ingredients include : Sodium Carboxymethyl Starch, Microcrystalline Cellulose, Copovidone, Potato Starch, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose, Titanium Dioxide (E 171), Macrogol, Talc, Methacrylic Acid-Ethyl Acrylate Copolymer (1:1), Sodium Hydroxide.
Presentation
Bicafres is available in boxes of 100 tablets, ensuring an adequate supply for your treatment. Sold at the best price in your online pharmacy.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 21/10/2022
Product name
BICAFRES1000 mg, gastro-resistant tablets
Sodium bicarbonate
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine in strict accordance with the information given in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any undesirable 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 do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is BICAFRES 1000 mg, gastro-resistant tablet and what is it used for?
2. What do I need to know before taking BICAFRES 1000 mg, gastro-resistant tablet?
3. How should BICAFRES 1000 mg gastro-resistant tablet be taken?
4. What are the possible side effects?
5. How should BICAFRES 1000 mg gastro-resistant tablet be stored?
6. Package contents and other information.
1. WHAT IS BICFAFRES 1000 mg, gastro-resistant tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: antacids with sodium bicarbonate, ATC code: A02AH.
BICAFRES is a gastro-resistant tablet used for the treatment of metabolic acidosis (an increase in blood acidity, when the kidneys do not remove enough acid from the body) in adults and adolescents aged 14 and over with chronic renal failure.
The tablets may release assimilable sodium and bicarbonates into the small intestine.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING BICAFRES 1000 mg, gastro-resistant tablet?
Never take BICAFRES 1000 mg, gastro-resistant tablet:
- if you are allergic to sodium bicarbonate or to any of the other ingredients of this medicine (mentioned in section 6),
- if you suffer from alkalosis( abnormally highalkalinity of blood and body fluids),
- if you suffer from respiratory acidosis( abnormallyhigh acidity of blood and body fluids due to respiratory problems),
- hypokalemia( abnormally lowconcentration of potassium in the blood),
- if you suffer from hypernatremia(high levels of sodium in the blood),
- if you are on a low-salt (sodium) diet.
Warnings and precautions
Talk to your doctor or pharmacist before taking BICAFRES.
BICAFRES should be used with caution if you suffer from :
- hypoventilation (abnormally slow breathing),
- hypocalcemia (abnormally low concentration of calcium in the blood) or
- hyperosmolar disorders (abnormal increase in the concentration of solutes in the blood).
Other precautions taken by your doctor :
The effects of BICAFRES should be checked by your doctor once a week, particularly at the start of treatment, when a non-gastro-resistant bicarbonate tablet is changed.The effects of BICAFRES should be checked by your doctor once a week, particularly at the start of treatment, when switching from a non-gastro-resistant sodium bicarbonate tablet to the gastro-resistant BICAFRES tablet, and when taking higher doses (e.g. pH measurement, standard bicarbonate dosage, alkaline reserve). Similarly, plasma electrolyte levels, particularly sodium, potassium and calcium, should be monitored frequently by your doctor.
Regular laboratory tests are essential during prolonged treatment. Overcorrection of bicarbonate deficiency can be corrected by reducing doses.
Children under 14 years of age
The safety and efficacy of BICAFRES in children under 14 years of age have not been established. No data are available for this age group. BICAFRES should not be used in this patient population.
Other medicinal products and BICAFRES 1000mg, gastro-resistant tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
In general, pH changes in the gastrointestinal tract or urine can affect other drugs used at the same time. However, the likelihood of such effects in the gastrointestinal tract is considered low due to the gastro-resistant film coating.
In some cases, the absorption of weak acids and bases may be affected by treatment with sodium bicarbonate through an increase in gastrointestinal pH. This may, for example, apply to
- sympathomimetics (used to treat, for example, asthma, severe allergic reactions, sinusitis or hyperactivity deficits),
- anticholinergics (used, for example, to treat asthma, Parkinson's disease, motion sickness, abdominal cramps and urinary tract disorders),
- tricyclic antidepressants,
- barbiturates (used to treat epilepsy, for example),
-H2 antihistamines (used to treat, for example, peptide ulcer and heartburn),
- captopril (an ACE inhibitor used, for example, to treat high blood pressure and heart failure),
- quinidine (used to treat heart rhythm disorders, for example).
The solubility of drugs eliminated in the urine, such as ciprofloxacin (an antibiotic), may be affected by BICAFRES.
If BICAFRES is taken at the same time as glucocorticoids (used to treat e.g. inflammation or allergy), mineralocorticoids (used to treat e.g. high blood pressure), androgens (male sex hormones used to treat e.g. menopausal conditions) or other drugs (e.g. anti-inflammatory drugs), BICAFRES may affect the solubility of these drugs in the urine.used, for example, in hormone replacement therapy) and diuretics (used, for example, to treat high blood pressure, heart failure and edema), a decrease in potassium levels may occur.
BICAFRES 1000 mg, gastro-resistant tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no or limited data on the use of high-dose sodium bicarbonate in pregnant women.
Experience with low doses of sodium bicarbonate indicates a risk of fluid retention and possibly hypertension after long-term use. Animal studies have not revealed any malformations.
BICAFRES should be used with caution during pregnancy, and only if your doctor considers it absolutely necessary.
Breast-feeding
Sodium bicarbonate is excreted in breast milk. No effects have been observed in newborns after short-term, low-dose use. Long-term, high-dose use of BICAFRES is not recommended during breastfeeding. Ask your doctor for advice before breast-feeding.
Driving and use of machinery
BICAFRES has no or negligible effect on the ability to drive and use machines.
BICAFRES 1000 mg, gastro-resistant tablet contains
Not applicable.
3. HOW DO I TAKE BICAFRES 1000 mg gastro-resistant tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The dose you take depends on the severity of your symptoms and should be modified according to your response.
The usual adult doses are
Starting dose: 2 to 3 tablets a day, taken in divided doses.
Maintenance dose: up to 8 tablets a day, taken in divided doses.
Use in children and adolescents under 14 years of age:
The safety and efficacy of BICAFRES in children and adolescents under 14 years of age have not been established. No data are available for this age group. BICAFRES should not be used in this patient population.
Method of administration :
Tablets should be taken in divided doses throughout the day. They should not be chewed or crushed, but swallowed whole with a little liquid (e.g. water).
Because of the risk of developing hypernatremia and metabolic alkalosis, sodium bicarbonate should not be administered over a long period without monitoring.
Duration of treatment :
The duration of treatment is determined by your doctor.
If you have taken more BICAFRES 1000 mg gastro-resistant tablet than you should have
In the event of overdosage, oral administration of sodium bicarbonate may cause metabolic alkalosis accompanied by dizziness, muscle weakness, fatigue, cyanosis (blue discoloration of the skin and mucous membranes), hypoventilation (also known as respiratory distress), and symptoms of tetany (involuntary muscle contraction). Apathy, confusion, ileus (intestinal obstruction) and circulatory collapse may follow.
In individual cases, symptoms of acute hypernatremia may occur, including aggravated confusion, which may worsen with the onset of convulsions and coma. If you experience one or more of these symptoms and think you may have overdosed, seek medical advice as soon as possible.
If you forget to take BICAFRES 1000 mg, gastro-resistant tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking BICAFRES 1000 mg, gastro-resistant tablet
If you stop taking BICAFRES you may jeopardize the success of your treatment. Do not stop taking BICAFRES without consulting your doctor first.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, BICAFRES may cause undesirable effects, but these do not always occur in everyone.
If you take BICAFRES, the following side effects may occur (frequency undetermined):
- flatulence, abdominal pain ;
- hypocalcemic tetany (muscle cramps) after an excessive dose;
- pre-existing digestive tract disorders (e.g. diarrhoea) may aggravate the problem;
- onset of renal lithiasis (formation of kidney stones) after prolonged use.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE BICAFRES 1000 mg, gastro-resistant tablet?
Keep out of sight and reach of children.
Store at temperatures not exceeding 30°C.
Do not use this medicine after the expiration date indicated on the pack/blister after "EXP". The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to delimit any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BICAFRES 1000 mg gastro-resistant tablet contains
- The active substance is :
Sodium bicarbonate................................................................................................ 1000 mg
For one gastro-resistant tablet
- The other components are :
Sodium carboxymethyl starch, microcrystalline cellulose, copovidone, potato starch, colloidal anhydrous silica, magnesium stearate (vegetable origin).sium stearate (vegetable origin), hypromellose, titanium dioxide (E 171), macrogol, talc, methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide
What is BICAFRES 1000 mg, gastro-resistant tablet and what does it contain?
BICAFRES is a white, round, biconvex tablet.
BICAFRES is marketed in boxes of 100 gastro-resistant tablets in blister packs.
Marketing authorization holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH,
ELSE-KRÖNER-STRASSE 1
61352 BAD HOMBURG V.D.H.
GERMANY
Marketing authorization holder
THERADIAL SAS
5 RUE MARYSE BASTIE
44700 ORVAULT
Manufacturer
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
ELSE-KRÖNER-STRASSE 1
61352 BAD HOMBURG V.D.H.
GERMANY
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[To be completed subsequently by the holder] 04/2022
{MM/YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.
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