Sodium bicarbonate Zeta

Package leaflet: Information for the patient

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

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

SODIO BICARBONATO ZETA 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 SODIUM BICARBONATE ZETA

Do not take SODIUM BICARBONATE ZETA

• 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 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 SODIUM BICARBONATE ZETA") 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 SODIUM BICARBONATE ZETA.
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 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 medicine's effectiveness and increase its absorption into the blood;
• if you have low potassium levels in the blood; in this case, you should periodically monitor heart function and blood electrolyte levels;
• if you suffer from inflammation of the stomach or small intestine.

Children and adolescents
SODIUM BICARBONATE ZETA must not be taken by children under 12 years of age.
Other medicines and SODIUM BICARBONATE ZETA
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 of many drugs.
If you need to take other medicines in addition to SODIUM BICARBONATE ZETA, leave at least 2 hours between administrations.
SODIUM BICARBONATE ZETA may alter the absorption or elimination of other concomitantly administered 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;

• antibacterial medicines such as cefpodoxime proxetil, methenamine, and tetracyclines (especially doxycycline);

• iron-containing supplements;

• aspirin, a medicine used to relieve pain and inflammation;

• chlorpropamide, a medicine used for diabetes;

• lithium, a medicine used for mental health conditions. SODIUM BICARBONATE ZETA may increase the effect and toxicity of other concomitantly administered medicines. 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 conditions 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is no available information on the use of SODIUM BICARBONATE ZETA 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
SODIUM BICARBONATE ZETA does not affect the ability to drive or operate machinery.

3. How to take SODIUM BICARBONATE ZETA

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 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 SODIUM BICARBONATE ZETA than you should
If you accidentally ingest or take too much SODIUM BICARBONATE ZETA, 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 SODIUM BICARBONATE ZETA
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 ZETA can cause side effects, although not everybody gets 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);
• abdominal pain, vomiting, gas in the abdomen (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 failure, 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);
• reduced 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 side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 ZETA

Keep this medicine out of 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 packaging, 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. Package contents and other information

What SODIO BICARBONATO ZETA 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 ZETA and contents of the pack
Pack containing 20 tablets in blister.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Zeta Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)