Sodium bicarbonate Sella

Package leaflet: Information for the patient

SODIO BICARBONATO SELLA 500 mg tablets

Sodium bicarbonate
Medicinal product not subject to medical prescription
A.I.C. n°: 029816028
THERAPEUTIC CATEGORY
Antacid
THERAPEUTIC INDICATIONS
Short-term treatment of excessive stomach acidity.
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 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

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

SODIO BICARBONATO SELLA contains the active substance 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 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 insufficiency);
• if you have an increased 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 chloride in the blood (hypochloremia) caused by taking medicines such as diuretics (see section "Other medicines and SODIO BICARBONATO SELLA") or by excessive loss of chloride due to vomiting or procedures such as continuous gastrointestinal suction;
• if the person taking this medicine is under 12 years of age;
• if you are pregnant (see section "Pregnancy and breastfeeding").

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

• if you have or have had 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 have liver problems (hepatic cirrhosis);
• if you are taking anti-inflammatory medicines (corticosteroids);
• if you are on a low-sodium diet (e.g. in certain cases of congestive heart failure, renal impairment, hypertension);
• if you have fluid accumulation due to sodium retention (which may be due to conditions such as hepatic cirrhosis, congestive heart failure, renal failure, toxiemia, or pregnancy);
• if you produce low levels of gastric acid, as this may reduce the medicine's effectiveness 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 blood levels of electrolytes;
• 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 tablet.
This corresponds to 6.8% of the maximum recommended daily dietary intake for an adult.

Children and adolescents
SODIO BICARBONATO SELLA MUST 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 alter the pH of the stomach and urine, thereby affecting the absorption and elimination processes of many drugs.
If you need to take other medicines in addition to SODIO BICARBONATO SELLA, leave at least a 2-hour interval between administrations.
SODIO BICARBONATO SELLA may alter the absorption or elimination of other concomitantly taken medicines, reducing their effectiveness. Pay particular attention and inform your doctor if you are taking:

• antifungal medicines such as itraconazole, ketoconazole;
• atazanavir, a medicine used for AIDS;
• antibiotics such as cefpodoxime proxetil, methenamine, 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 conditions.

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

• medicines used to treat heart conditions such as quinidine and flecainide;
• weight-control medicines containing amphetamines or their derivatives;
• medicines used for asthma and other respiratory problems such as ephedrine and pseudoephedrine;
• memantine, used to treat Alzheimer's disease;
• mecamylamine, used to control high blood pressure.

Be cautious if you are taking medicines that increase urine production (diuretics) such as bumetanide, ethacrynic acid, furosemide, and thiazides, as they may lead to potassium loss and cause an increase in blood pH (metabolic alkalosis).
Take this medicine with caution if you are taking corticosteroid anti-inflammatory medicines, as this may lead to increased sodium levels in the body.

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

Driving and using machines
SODIO BICARBONATO SELLA does not affect the ability to drive or operate machinery.

3. How to take SODIO BICARBONATO SELLA

Take this medicine exactly as stated in this leaflet or as directed 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 dose for adults ranges from 500 mg (1 tablet) to 5 g (10 tablets) per day.
Use in children and adolescents
For adolescents (12–18 years of age), 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/overdose of SODIO BICARBONATO SELLA, contact your doctor immediately 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 the 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, SODIUM BICARBONATE SELLA may cause side effects, although not everybody experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• allergic and anaphylactic reactions such as urticaria and airway obstruction (bronchospasm);
• stomach ache, vomiting, abdominal gas (flatulence), and gastric lesions;
• fluid retention (edema), particularly in elderly patients and in cases of cardiac or renal insufficiency;
• metabolic alkalosis, especially in patients with renal insufficiency, presenting with symptoms such as: labored breathing, muscle weakness due to potassium deficiency, excessive increase in muscle tone, muscle spasms and stiffness (tetany);
• excessive increase in blood sodium levels (hypernatremia);
• fluid accumulation in the lungs (pulmonary edema);
• reduced blood output pumped by the heart (reduced cardiac output);
• reduced blood pressure (hypotension);
• fluid accumulation in the brain (cerebral edema);
• bleeding in the brain (intracranial hemorrhage);
• excessive increase in carbon dioxide levels in the blood (hypercapnia).

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: 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 SODIUM BICARBONATE SELLA

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

6. Package contents and other information

What SODIO BICARBONATO SELLA contains

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

Description of the appearance of SODIO BICARBONATO SELLA and pack contents
Pack containing 1000 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI) – Italy.
Batch:
Expiry date:

Package leaflet: information for the patient

SODIUM BICARBONATE SELLA 500 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment. Contents of this leaflet:
  1. What SODIUM BICARBONATE SELLA is and what it is used for.
  2. What you need to know before taking SODIUM BICARBONATE SELLA
  3. How to take SODIUM BICARBONATE SELLA
  4. Possible side effects
  5. How to store SODIUM BICARBONATE SELLA
  6. Contents of the pack and other information

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

SODIO BICARBONATO SELLA contains the active substance 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 should 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 components of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency);
• if you have an increased blood pH caused by respiratory problems (respiratory alkalosis);
• if you have low levels of calcium in the blood (hypocalcemia, due to increased risk of tetany);
• if you have low levels of chloride in the blood (hypochloremia) caused by taking medications such as diuretics (see section "Other medicines and SODIO BICARBONATO SELLA") or by excessive loss of chloride due to vomiting or other procedures 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
Talk to your doctor or pharmacist before taking SODIO BICARBONATO SELLA.
Use this medicine with caution and inform your doctor in the following cases:

• if you have or have had severe heart problems (congestive heart failure);
• if you have kidney problems (renal impairment);
• if you have difficulty urinating or produce no urine at all (oliguria or anuria);
• if you have high blood pressure (hypertension);
• if you have liver problems (hepatic cirrhosis);
• if you are taking anti-inflammatory medicines (corticosteroids);
• if you are on a low-sodium diet (e.g. in some cases of congestive heart failure, renal impairment, hypertension);
• if you have fluid accumulation due to sodium retention (which may be due to conditions such as hepatic cirrhosis, congestive heart failure, renal failure, toxemia, or pregnancy);
• if you produce low levels of gastric acid, as this may reduce 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 blood levels of minerals (electrolytes);
• if you have inflammation of the stomach or small intestine.

This medicine contains 137 mg of sodium (the main component of table salt) per tablet.
This corresponds to 6.8% of the maximum recommended daily dietary intake for an adult.

Children and adolescents
SODIO BICARBONATO SELLA MUST NOT be taken by children under 12 years of age.

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

• antifungal medicines such as itraconazole, ketoconazole;
• atazanavir, a medicine used for AIDS;
• antibiotics such as cefpodoxime proxetil, methenamine, 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 disorders.

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

• medicines used to treat heart conditions such as quinidine and flecainide;
• weight-control medicines containing amphetamine or its derivatives;
• medicines used for asthma and other respiratory problems such as ephedrine and pseudoephedrine;
• memantine, used to treat Alzheimer's disease;
• mecamylamine, used to control high blood pressure.

Be cautious if you are taking medicines that increase urine production (diuretics) such as bumetanide, ethacrynic acid, furosemide, and thiazides, as they may lead to potassium loss and cause an increase in blood pH (metabolic alkalosis).
Take this medicine with caution if you are taking corticosteroid anti-inflammatory medicines, as this may lead to increased sodium levels in the body.

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

Driving and using machines
SODIO BICARBONATO SELLA does not affect the ability to drive vehicles or operate machinery.

3. How to take SODIO BICARBONATO SELLA

Take this medicine exactly as stated 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 dose for adults ranges from 500 mg (1 tablet) to 5 g (10 tablets) per day.
Use in children and adolescents
For adolescents (12–18 years of age), the recommended dose is 1–2 tablets taken after meals or at bedtime.
If you take more SODIO BICARBONATO SELLA than you should
If you accidentally ingest or take too much SODIO BICARBONATO SELLA, contact your doctor immediately 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 the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, SODIO BICARBONATO SELLA may cause adverse effects, although not everybody experiences them.
The following adverse effects may occur:
Not known (frequency cannot be estimated from the available data):

• allergic and anaphylactic reactions such as urticaria and airway obstruction (bronchospasm);
• stomach ache, vomiting, abdominal gas (flatulence), and gastric lesions;
• swelling due to fluid accumulation (edema), particularly in elderly patients and in the presence of cardiac or renal insufficiency;
• respiratory alkalosis, especially in patients with renal insufficiency, manifesting with symptoms such as: labored breathing, muscle weakness due to potassium deficiency, excessive increase in muscle tone, muscle spasms and stiffness (tetany);
• excessive increase in sodium levels in the blood (hypernatremia);
• fluid accumulation in the lungs (pulmonary edema);
• reduced blood output pumped by the heart (cardiac output);
• reduction in blood pressure (hypotension);
• fluid accumulation in the brain (cerebral edema);
• bleeding in the head (intracranial hemorrhage);
• excessive increase in carbon dioxide levels in the blood (hypercapnia).

Following the instructions provided in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store SODIUM BICARBONATE SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store in the original container, tightly closed, to protect the medicine from light and moisture, as
sodium bicarbonate slowly decomposes in the presence of moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines 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 substance 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 Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI) – Italy.