Sodium bicarbonate L.F.M.

Package leaflet: Information for the patient

SODIUM BICARBONATE L.F.M. 500 mg tablets

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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If any side effects occur, 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 SODIUM BICARBONATE L.F.M. is and what it is used for.
2. What you need to know before taking SODIUM BICARBONATE L.F.M.
3. How to take SODIUM BICARBONATE L.F.M.
4. Possible side effects.
5. How to store SODIUM BICARBONATE L.F.M.
6. Contents of the pack and other information.

1. What SODIO BICARBONATO L.F.M. is and what it is used for

SODIO BICARBONATO L.F.M. contains the active substance sodium bicarbonate, which belongs to a class of medicines called antacids, used to relieve heartburn and stomach acidity.
This medicine is indicated for 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 L.F.M.

Do not take SODIO BICARBONATO L.F.M.:

• if you are allergic 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, characterized by rapid breathing, nausea, vomiting, muscle stiffness, and irregular heartbeat (respiratory alkalosis);
• if you have low calcium levels in the blood (hypocalcemia), due to the increased risk of a syndrome characterized by muscle cramps, spasms, contractions, and tremors (tetany);
• if you have low chloride levels in the blood (hypochloremia), caused by taking diuretics—medicines that increase urine production and are generally used to treat high blood pressure—or due to excessive loss of chloride following vomiting or other practices such as continuous gastrointestinal suction;
• if the person to be given 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 L.F.M.
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 reduced urine output or no urine production (oliguria or anuria);
• if you have high blood pressure (hypertension);
• if you have liver problems (hepatic cirrhosis);
• if you are taking medicines to treat inflammation and allergies (corticosteroids);
• if you are on a low-sodium diet because, for example, of reduced heart pump function, reduced kidney function, or high blood pressure;
• if you have fluid retention caused by reduced sodium excretion, leading to swelling, weight gain, and increased blood pressure, which may occur in conditions such as severe liver disease (hepatic cirrhosis), reduced heart pump function (congestive heart failure), severe kidney disease (renal insufficiency), accumulation of toxic substances in the blood (toxemia), or pregnancy;
• if you have reduced gastric acid production, 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 have inflammation of the stomach or small intestine.

Children and adolescents
SODIO BICARBONATO L.F.M. must not be administered to children under 12 years of age.
Other medicines and SODIO BICARBONATO L.F.M.
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 of many medicines.
If you need to take other medicines in addition to SODIO BICARBONATO L.F.M., leave at least a 2-hour interval between administrations.
SODIO BICARBONATO L.F.M. 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;
• antibiotics such as cefpodoxime proxetil, methenamine, and tetracyclines (especially doxycycline);
• iron supplements;
• dasatinib, a medicine used to treat leukemia, a blood cancer;
• acetylsalicylic acid, a medicine used to relieve pain and inflammation;
• chlorpropamide, a medicine used for diabetes;
• lithium, a medicine used for mental health conditions.

SODIO BICARBONATO L.F.M. 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 problems such as quinidine and flecainide;
• weight-control medicines containing amphetamine and 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 medicines for inflammation and allergies (corticosteroids), 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 on the use of SODIO BICARBONATO L.F.M. during pregnancy. Avoid taking this medicine during pregnancy, as it may worsen swelling associated with pregnancy.
You may take this medicine while breastfeeding.
Driving and using machines
SODIO BICARBONATO L.F.M. does not affect the ability to drive or operate machinery.

3. How to take SODIO BICARBONATO L.F.M.

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
SODIO BICARBONATO L.F.M. must not be administered to children under 12 years of age
(See section “Do not take SODIO BICARBONATO L.F.M.”).
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 L.F.M. than you should
In case of accidental ingestion/overdose of SODIO BICARBONATO L.F.M.,
contact your doctor immediately or go to the nearest hospital.
Accidental overdose of this medicine may cause abdominal bloating due to excessive gas formation.
If you forget to take SODIO BICARBONATO L.F.M.
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 L.F.M. may cause side effects, although not everybody gets them.
The following side effects may occur:

• allergic and anaphylactic reactions such as urticaria and airway obstruction (bronchospasm);
• stomach ache, vomiting, gas in the abdomen (flatulence), and stomach lesions;
• ;
• swelling due to fluid accumulation (edema), especially in elderly patients and in those with severe heart or kidney problems (heart or renal failure);
• metabolic alkalosis, especially in patients with renal failure, 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 amount of blood pumped by the heart (cardiac output);
• reduced blood pressure (hypotension);
• accumulation of fluid in the brain (cerebral edema);
• bleeding within the skull (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 inform your doctor or pharmacist. You can 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 L.F.M.

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 packaging and keep the bottle tightly closed to protect the medicine from light and
moisture. Sodium bicarbonate slowly decomposes in the presence of moisture.
Do not store above 30°C.
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 L.F.M. contains

• The active substance is sodium bicarbonate. Each tablet contains 500 mg of sodium bicarbonate.
• The other components are: powdered cellulose, microcrystalline cellulose, PEG 4000, magnesium stearate.

Description of the appearance of SODIO BICARBONATO L.F.M. and package contents
Pack containing one bottle of 50 tablets.

Marketing Authorization Holder and Manufacturer
Laboratorio Farmacologico Milanese S.r.l. – Via Monterosso, 273 - 21042 Caronno Pertusella (VA) – Italy.