SODIO BIKARBONATO SELLA 500 MG Coated tablet

Зміст інструкції

1. SODIO BICARBONATO SELLA 500 mg tablets
   1. What is SODIO BICARBONATO SELLA and what is it used for
   2. What you need to know before you take SODIO BICARBONATO SELLA
   3. How to take SODIO BICARBONATO SELLA
   4. Possible side effects
   5. How to store SODIO BICARBONATO SELLA
   6. Contents of the pack and other information
2. SODIO BICARBONATO SELLA 500 mg tablets
   1. What is SODIO BICARBONATO SELLA and what is it used for
   2. What you need to know before taking SODIO BICARBONATO SELLA
   3. How to take SODIO BICARBONATO SELLA
   4. Possible side effects
   5. How to store SODIO BICARBONATO SELLA
   6. Contents of the pack and other information

SODIO BICARBONATO SELLA 500 mg tablets

Sodio bicarbonato

Non-prescription medicine
A.I.C. n°:029816028

THERAPEUTIC CATEGORY
Antacid

THERAPEUTIC INDICATIONS
Short-term treatment of excessive stomach acidity.

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment Contents of this leaflet:
• 1. What SODIO BICARBONATO SELLA is and what it is used for.
• 2. What you need to know before you take SODIO BICARBONATO SELLA
• 3. How to take SODIO BICARBONATO SELLA
• 4. Possible side effects
• 5. How to store SODIO BICARBONATO SELLA
• 6. Contents of the pack and other information

1. What is SODIO BICARBONATO SELLA and what is it used for

SODIO BICARBONATO SELLA contains the active ingredient sodium bicarbonate, which belongs to the class
of antacids.
This medicine is indicated for the short-term treatment of excessive stomach acidity.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before you take SODIO BICARBONATO SELLA

Do not take SODIO BICARBONATO SELLA

• if you are allergic (hypersensitive) to sodium bicarbonate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency);
• if you have an increase in blood pH caused by respiratory problems (respiratory alkalosis);
• if you have low levels of calcium in the blood (hypocalcemia, due to an increased risk of tetany);
• if you have low levels of chlorine in the blood (hypochloremia) caused by taking medicines such as diuretics (see section Other medicines and SODIO BICARBONATO SELLA) or by the loss of excessive amounts of chlorine following vomiting or other procedures such as continuous gastrointestinal suction;
• if the person who needs to take this medicine is under 12 years of age;
• if you are pregnant (see section Pregnancy and breastfeeding).

Warnings and precautions
Consult your doctor or pharmacist before taking SODIO BICARBONATO SELLA.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from or have suffered from severe heart problems (congestive heart failure);
• if you have kidney problems (renal impairment);
• if you have difficulty urinating or do not produce urine at all (oliguria or anuria);
• if you have high blood pressure (hypertension);
• if you suffer from liver problems (hepatic cirrhosis);
• if you are taking anti-inflammatory medicines (corticosteroids);
• if you are following a low-sodium diet (for example, in some cases of congestive heart failure, renal impairment, hypertension);
• if you suffer from fluid retention caused by sodium retention (this may be due to diseases such as hepatic cirrhosis, congestive heart failure, renal insufficiency, toxemia, or pregnancy);
• if you produce low levels of gastric acid, as this may decrease the effectiveness of the medicine and increase its absorption into the blood;
• if you have low levels of potassium in the blood, in this case you should periodically monitor heart function and levels of mineral salts (electrolytes) in the blood;
• if you suffer from inflammation of the stomach or small intestine.

This medicine contains 137 mg of sodium (the main component of table salt) per each
tablet. This is equivalent to 6.8% of the maximum recommended daily intake with the diet of an
adult.

Children and adolescents
SODIO BICARBONATO SELLA should not be taken by children under 12 years of age

Other medicines and SODIO BICARBONATO SELLA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Sodium bicarbonate can modify the pH of the stomach and urine, thus altering the processes of
absorption and elimination of many drugs
If you need to take other medicines in addition to SODIO BICARBONATO SELLA, allow at least 2 hours
between the two administrations.
SODIO BICARBONATO SELLA can alter the absorption or elimination of other medicines taken
concurrently, reducing their effectiveness. Pay particular attention and inform your doctor if you are
taking:

• medicines used against fungal infections such as itraconazole, ketoconazole;
• atazanavir, a medicine used for AIDS;
• medicines used against bacterial infections such as cefpodoxime proxetil, metenamine, and tetracyclines (especially doxycycline);
• iron supplements;
• aspirin, a medicine used to relieve pain and inflammation;
• chlorpropamide, a medicine used for diabetes;
• lithium, a medicine used for mental health problems.

SODIO BICARBONATO SELLA can increase the effect and toxicity of other medicines taken
concurrently. Pay particular attention and inform your doctor if you are taking:

• medicines used to treat heart problems such as quinidineand flecainide;
• medicines used for weight control based on amphetamineand derivatives;
• medicines used for asthma and other respiratory problems such as ephedrineand pseudoephedrine;
• memantine, used to treat Alzheimer's disease;
• mecamylamine, used to control high blood pressure.

Be careful if you are taking medicines that increase urine production (diuretics) such as

bumetanide, ethacrynate, furosemideand thiazides, as they may lead to potassium elimination and cause an increase in blood pH (metabolic alkalosis).
Take this medicine with caution if you are taking anti-inflammatory corticosteroid medicines, as
sodium levels in the body may increase.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There is no information available regarding the use of SODIO BICARBONATO SELLA during
pregnancy, therefore avoid taking this medicine if you are pregnant, as the medicine may
worsen states of swelling associated with pregnancy.
This medicine can be taken during breastfeeding.

Driving and operating machinery
SODIO BICARBONATO SELLA does not impair the ability to drive vehicles or operate machinery.

3. How to take SODIO BICARBONATO SELLA

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablets with some water, preferably after meals or at bedtime.
The recommended dosefor adults ranges from 500 mg (1 tablet) to 5 g (10 tablets) per day.

Use in children and adolescents
For adolescents (12-18 years) the recommended dose is 1-2 tablets to be taken after meals or at bedtime.

If you take more SODIO BICARBONATO SELLA than you should
In case of accidental ingestion/intake of an excessive dose of SODIO BICARBONATO SELLA,
immediately notify your doctor or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine may cause abdominal swelling due to excessive gas formation.

If you forget to take SODIO BICARBONATO SELLA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SODIO BICARBONATO SELLA can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(the frequency of which cannot be estimated on the basis of available data):

• allergic and anaphylactic reactions such as urticaria and obstruction of the airways (bronchospasm);
• stomach pain, vomiting, abdominal bloating (flatulence) and stomach lesions;
• swelling due to fluid retention (edema), especially in elderly patients and in the presence of heart or kidney failure;
• metabolic alkalosis, especially in patients with kidney failure, which manifests with symptoms such as: shortness of breath, muscle weakness due to potassium deficiency, excessive increase in muscle tone, spasms and muscle stiffness (tetany);
• excessive increase in the amount of sodium in the blood (hypernatremia);
• fluid accumulation in the lungs (pulmonary edema);
• reduction of the blood pumped by the heart (cardiac output);
• reduction of blood pressure (hypotension);
• fluid accumulation in the brain (cerebral edema);
• bleeding in the head (intracranial hemorrhage);
• excessive increase in the amount of carbon dioxide in the blood (hypercapnia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store SODIO BICARBONATO SELLA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
Store in the original packaging, tightly closed to protect the medicine from light and humidity, as
in the presence of humidity, sodium bicarbonate decomposes slowly.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SODIO BICARBONATO SELLA contains

• The active ingredient is sodium bicarbonate. Each tablet contains 500 mg of sodium bicarbonate
• The other ingredients are: hydrogenated vegetable oil, polyvinylpyrrolidone, crospovidone

Description of the appearance of SODIO BICARBONATO SELLA and contents of the pack
Pack containing 1000 tablets.

Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI) – Italy.

Lot:
Expiry:

SODIO BICARBONATO SELLA 500 mg tablets

Sodium bicarbonate

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment Contents of this leaflet:
• 1. What SODIO BICARBONATO SELLA is and what it is used for.
• 2. What you need to know before you take SODIO BICARBONATO SELLA
• 3. How to take SODIO BICARBONATO SELLA
• 4. Possible side effects
• 5. How to store SODIO BICARBONATO SELLA
• 6. Contents of the pack and other information

1. What is SODIO BICARBONATO SELLA and what is it used for

SODIO BICARBONATO SELLA contains the active ingredient sodium bicarbonate belonging to the class
of antacids.
This medicine is indicated for the short-term treatment of excessive stomach acidity.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking SODIO BICARBONATO SELLA

Do not take SODIO BICARBONATO SELLA

• if you are allergic (hypersensitive) to sodium bicarbonate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal failure);
• if you have an increase in blood pH caused by respiratory problems (respiratory alkalosis);
• if you have low levels of calcium in the blood (hypocalcemia, due to an increased risk of tetany);
• if you have low levels of chlorine in the blood (hypochloremia) caused by taking medicines such as diuretics (see section other medicines and SODIO BICARBONATO SELLA) or by the loss of excessive amounts of chlorine following vomiting or other practices such as continuous gastrointestinal suction;
• if the person who is to take this medicine is under 12 years of age;
• if you are pregnant (see section Pregnancy and breastfeeding).

Warnings and precautions
Consult your doctor or pharmacist before taking SODIO BICARBONATO SELLA.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from or have suffered from severe heart problems (congestive heart failure);
• if you have kidney problems (renal impairment);
• if you have difficulty urinating or do not produce urine at all (oliguria or anuria);
• if you have high blood pressure (hypertension);
• if you suffer from liver problems (hepatic cirrhosis);
• if you are taking anti-inflammatory drugs (corticosteroids);
• if you are following a low-sodium diet (for example in some cases of congestive heart failure, renal impairment, hypertension);
• if you suffer from fluid retention caused by sodium retention (this may be due to diseases such as hepatic cirrhosis, congestive heart failure, renal failure, toxemia or pregnancy);
• if you produce low levels of gastric acid, because this may decrease the effectiveness of the medicine and increase its absorption into the blood;
• if you have low levels of potassium in the blood, in this case you should periodically monitor heart function and levels of mineral salts (electrolytes) in the blood;
• if you suffer from inflammation of the stomach or small intestine.

This medicine contains 137 mg of sodium (the main component of table salt) per each
tablet. This is equivalent to 6.8% of the maximum recommended daily intake with the diet of an
adult.

Children and adolescents
SODIO BICARBONATO SELLA should not be taken by children under 12 years of age

Other medicines and SODIO BICARBONATO SELLA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Sodium bicarbonate can change the pH of the stomach and urine, thus altering the processes of
absorption and elimination of many drugs
If you need to take other medicines in addition to SODIO BICARBONATO SELLA, allow at least 2 hours
between the two administrations.
SODIO BICARBONATO SELLA can alter the absorption or elimination of other medicines taken
concurrently, reducing their effectiveness. Pay particular attention and inform your doctor if you are
taking:

• medicines used against fungal infections such as itraconazole, ketoconazole;
• atazanavir, a medicine used for AIDS;
• medicines used against bacterial infections such as cefpodoxime proxetil, metenamine, and tetracyclines (especially doxycycline);
• iron-based supplements ;
• aspirin, a medicine used to relieve pain and inflammation;
• chlorpropamide, a medicine used for diabetes;
• lithium, a medicine used for mental health problems.

SODIO BICARBONATO SELLA can increase the effect and toxicity of other medicines taken
concurrently. Pay particular attention and inform your doctor if you are taking:

• medicines used to treat heart problems such as quinidineand flecainide;
• medicines used for weight control based on amphetamineand derivatives;
• medicines used for asthma and other respiratory problems such as ephedrineand pseudoephedrine;
• memantine, used to treat Alzheimer's disease;
• mecamylamine, used to control high blood pressure.

Be careful if you are taking medicines that increase urine production (diuretics) such as

bumetanide, ethacrynate, furosemideand thiazides, because they may lead to potassium elimination and cause an increase in blood pH (metabolic alkalosis).
Take this medicine with caution if you are taking anti-inflammatory corticosteroid medicines, because
sodium levels in the body may increase.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
There is no information available regarding the use of SODIO BICARBONATO SELLA during
pregnancy, therefore avoid taking this medicine if you are pregnant, as the medicine may
worsen states of swelling associated with pregnancy.
This medicine can be taken during breastfeeding.

Driving and operating machinery
SODIO BICARBONATO SELLA does not impair the ability to drive vehicles or operate other machinery.

3. How to take SODIO BICARBONATO SELLA

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablets with a little water, preferably after meals or at bedtime.
The recommended dosefor adults ranges from 500 mg (1 tablet) to 5 g (10 tablets) per day.

Use in children and adolescents
For adolescents (12-18 years) the recommended dose is 1-2 tablets to be taken after meals or at bedtime.

If you take more SODIO BICARBONATO SELLA than you should
In case of accidental ingestion/intake of an excessive dose of SODIO BICARBONATO SELLA,
immediately inform your doctor or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine may cause abdominal bloating due to excessive gas formation.

If you forget to take SODIO BICARBONATO SELLA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SODIO BICARBONATO SELLA may cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(frequency cannot be estimated from available data):

• allergic and anaphylactic reactions such as urticaria and obstruction of the airways (bronchospasm);
• stomach pain, vomiting, air in the abdomen (flatulence) and stomach lesions;
• swelling due to fluid retention (edema), especially in elderly patients and in the presence of heart or kidney failure;
• respiratory alkalosis, especially in patients with kidney failure, which manifests with symptoms such as: shortness of breath, muscle weakness due to potassium deficiency, excessive increase in muscle tone, spasms and muscle stiffness (tetany);
• excessive increase in the amount of sodium in the blood (hypernatremia);
• fluid accumulation in the lungs (pulmonary edema);
• reduction of the blood pumped by the heart (cardiac output);
• reduction of blood pressure (hypotension);
• fluid accumulation in the brain (cerebral edema);
• bleeding in the head (intracranial hemorrhage);
• excessive increase in the amount of carbon dioxide in the blood (hypercapnia).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store SODIO BICARBONATO SELLA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
Store in the original packaging, tightly closed to protect the medicine from light and humidity, as
in the presence of humidity, sodium bicarbonate decomposes slowly.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SODIO BICARBONATO SELLA contains

• The active ingredient is sodium bicarbonate. Each tablet contains 500 mg of sodium bicarbonate
• The other ingredients are: hydrogenated vegetable oil, polyvinylpyrrolidone, crospovidone

Description of the appearance of SODIO BICARBONATO SELLA and contents of the pack
Pack containing 50 tablets.

Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI) – Italy.