Sodium bicarbonate Marco Viti

Patient Information Leaflet

SODIUM BICARBONATE MARCO VITI 500 mg tablets

Sodium bicarbonate
Read this entire 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 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 improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What SODIUM BICARBONATE MARCO VITI is and what it is used for
2. What you need to know before taking SODIUM BICARBONATE MARCO VITI
3. How to take SODIUM BICARBONATE MARCO VITI
4. Possible side effects
5. How to store SODIUM BICARBONATE MARCO VITI
6. Contents of the pack and other information

1. What SODIO BICARBONATO MARCO VITI is and what it is used for

SODIO BICARBONATO MARCO VITI contains the active substance sodium bicarbonate, which belongs to the class of drugs known as 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 MARCO VITI

Do not take SODIO BICARBONATO MARCO VITI

• 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 MARCO VITI") or by excessive loss of chloride due to 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
Talk to your doctor or pharmacist before taking SODIO BICARBONATO MARCO VITI.
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 suffer from 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 retention caused by sodium retention (which may be due to conditions such as hepatic cirrhosis, congestive heart failure, renal failure, toxaemia, 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 suffer from inflammation of the stomach or small intestine.

Children and adolescents
SODIO BICARBONATO MARCO VITI must not be taken by children under 12
years of age.
Other medicines and SODIO BICARBONATO MARCO VITI
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 MARCO VITI, allow
at least 2 hours between administrations.
SODIO BICARBONATO MARCO VITI may alter the absorption or elimination of other
medicines taken simultaneously, reducing their effectiveness. Pay particular attention and
inform your doctor if you are taking:

• medicines used to treat fungal infections such as itraconazole, ketoconazole;
• atazanavir, a medicine used for AIDS;
• medicines used to treat bacterial infections 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 MARCO VITI 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 problems such as quinidine and flecainide;
• medicines used for weight control containing amphetamines and 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 result in increased sodium levels in the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
There is no available information regarding the use of SODIO BICARBONATO MARCO VITI
during pregnancy; therefore, avoid taking this medicine during pregnancy, as it may worsen swelling associated with pregnancy.
This medicine may be taken during breastfeeding.
Driving and using machines
SODIO BICARBONATO MARCO VITI does not impair the ability to drive vehicles or operate machinery.

3. How to take SODIO BICARBONATO MARCO VITI

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 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 MARCO VITI than you should
In case of accidental ingestion/overdose of SODIO BICARBONATO MARCO VITI, 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 MARCO VITI
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 side effects

Like all medicines, SODIO BICARBONATO MARCO VITI may cause side effects,
although not everyone 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 stomach lesions;
• swelling due to fluid retention (edema), especially in elderly patients and in the presence of cardiac or renal failure;
• metabolic alkalosis, particularly in patients with renal impairment, 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 blood sodium levels (hypernatremia);
• fluid accumulation in the lungs (pulmonary edema);
• reduced blood output from the heart (cardiac output);
• reduction in 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).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 MARCO VITI

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,
since 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 MARCO VITI contains

• The active substance is sodium bicarbonate. Each tablet contains 500 mg of sodium bicarbonate.
• The other components are microcrystalline cellulose, talc, magnesium stearate, silicon dioxide.

Description of the appearance of SODIO BICARBONATO MARCO VITI and contents of the pack
Pack containing 20 tablets in blister.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)