Sodium bicarbonate Nova Argentia

Package leaflet: Information for the patient

SODIUM BICARBONATE NOVA ARGENTIA 500 mg tablets

Sodium bicarbonate
Please read all of 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 told you to.

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

1. What SODIO BICARBONATO NOVA ARGENTIA is and what it is used for

SODIO BICARBONATO NOVA ARGENTIA contains the active substance sodium bicarbonate, which belongs to the class of antiacids.
This medicine is indicated for the treatment of 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 NOVA ARGENTIA

Do not take SODIO BICARBONATO NOVA ARGENTIA

• 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 issues (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 medications such as diuretics (see section "Other medicines and SODIO BICARBONATO NOVA ARGENTIA") or by excessive loss of chloride due to vomiting or other practices 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 NOVA ARGENTIA.
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 caused by 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 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 electrolyte levels;
• if you have inflammation of the stomach or small intestine.

Children and adolescents
SODIO BICARBONATO NOVA ARGENTIA must not be taken by children under 12 years of age.

Other medicines and SODIO BICARBONATO NOVA ARGENTIA
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 NOVA ARGENTIA, leave at least 2 hours between administrations.
SODIO BICARBONATO NOVA ARGENTIA 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;
• antibacterial medicines such as cefpodoxime proxetil, methenamine, and tetracyclines (especially doxycycline);
• iron supplements;
• acetylsalicylic acid (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 NOVA ARGENTIA may 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 conditions such as quinidine and flecainide;
• weight-control medicines containing amphetamines and related 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, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is no available information regarding the use of SODIO BICARBONATO NOVA ARGENTIA 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 NOVA ARGENTIA does not affect the ability to drive vehicles or operate machinery.

3. How to take SODIO BICARBONATO NOVA ARGENTIA

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), the recommended dose is 1–2 tablets to be taken after meals or at bedtime.

If you take more SODIO BICARBONATO NOVA ARGENTIA than you should
In case of accidental ingestion/overdose of SODIO BICARBONATO NOVA ARGENTIA, contact your doctor immediately or go to the nearest hospital.
If an excessive dose of this medicine is accidentally ingested, abdominal bloating due to excessive gas formation may occur.

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

4. Possible side effects

Like all medicines, SODIO BICARBONATO NOVA ARGENTIA 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;
• swelling due to fluid retention (edema), especially in elderly patients and in the presence of cardiac or renal insufficiency;
• metabolic alkalosis, particularly in patients with renal insufficiency, manifesting with symptoms such as: shortness of breath, 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);
• accumulation of fluid in the lungs (pulmonary edema);
• reduced blood output from the heart (reduced cardiac output);
• reduction in blood pressure (hypotension);
• accumulation of fluid in the brain (cerebral edema);
• bleeding in the brain (intracranial hemorrhage);
• excessive increase in carbon dioxide levels in the blood (hypercapnia).

Following the instructions contained 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, 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 SODIUM BICARBONATE NOVA ARGENTIA

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 "Expiry".
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. Package contents and other information

What SODIO BICARBONATO NOVA ARGENTIA contains

• The active substance is sodium bicarbonate. Each tablet contains 500 mg of sodium bicarbonate.
• The other components are microcrystalline cellulose, gum arabic, glycerin, talc, magnesium stearate, sodium starch glycolate.

Description of the appearance of SODIO BICARBONATO NOVA ARGENTIA and contents of the pack
Pack containing 50 tablets in blister.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Piazza Sant’Angelo, 1 20121 – Milan
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via G. Pascoli, 1 - Gorgonzola (MI)
April 2018