Package Insert: Information for the Patient

Sodium Bicarbonate NM 1 g Powder for Oral Solution

Sodium Hydrogen Carbonate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

1. What is Sodium Bicarbonate NM and what it is used for

2. What you need to know before starting to take Sodium Bicarbonate NM

3. How to take Sodium Bicarbonate NM

4. Possible adverse effects

5. Storage of Sodium Bicarbonate NM

6. Contents of the pack and additional information

Sodium Bicarbonate NM belongs to a group of medications called antacids that act by reducing excess stomach acidity.

It is indicated for the relief and symptomatic treatment of stomach acid and heartburn in adults and adolescents over 12 years old.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not takeBicarbonato NM

• If you are allergic to sodium bicarbonate.
• If you have metabolic or respiratory alkalosis (blood pH imbalance).
• If you have hypocalcemia (low calcium levels in the blood).
• If you have hypochlorhydria (low stomach acid levels).
• If you are prone to edema (fluid retention).
• If you have appendicitis or its symptoms (nausea, vomiting, cramps, abdominal pain).
• If you have intestinal obstruction (partial or complete blockage of the intestine).

-If you are on a low-sodium diet (for high blood pressure or heart or kidney problems)

-If you have kidney or liver disease

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicarbonato NM.

Like other antacids, this medication may mask the symptoms of a more serious stomach disease, so if your symptoms persist or worsen after 7 days of treatment, you should consult your doctor.

This medication should not be used in patients with hypertension (high blood pressure), patients with liver, kidney, or heart problems, or patients taking diuretics (medications used to treat high blood pressure) or low-sodium diets.

Children and adolescents

Do not administer to children under 12 years old.

Taking Bicarbonato NM with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

Generally, taking any antacid should be done at least 2 hours before or after taking another medication.

Antacids may alter the action of other medications such as:

• Iron salts (medications used to prevent or treat anemia)
• Quinolones, tetracyclines, sulfonamides, erythromycin, methenamine, rifampicin, Isoniazid, Ethambutol (antibiotics)
• Theophylline (used to treat asthma)
• Ulipristal (emergency contraceptive)
• Erlotinib (cancer medication). It is recommended to administer sodium bicarbonate at least 4 hours before or 2 hours after Erlotinib

• Propranolol, atenolol (medications for high blood pressure)
• Benzodiazepines (medications for insomnia and anxiety)Digoxin, digitoxin (medications for heart rhythm disorders)
• Phenothiazines (medications for psychiatric disorders)
• Naproxen, salicylates, flufenamic acid, or mefenamic acid, indomethacin (used to treat pain and fever)
• Valproic acid, gabapentin (used to treat epilepsy)
• Levodopa (used to treat Parkinson's disease)
• Amphetamine, dextroamphetamine, ephedrine (central nervous system stimulants)
• Flecainide, quinidine (medications for heart rhythm disorders)
• Methadone (used to relieve intense pain)
• Mecamilamine (medication for high blood pressure)
• Lithium salts (used in some psychiatric disorders)
• Methotrexate (used to treat cancer and rheumatoid arthritis)
• Preparations containing calcium, as it may cause milk-alkali syndrome, whose symptoms are: high calcium levels in the blood, kidney and heart problems, metabolic alkalosis, dizziness, vomiting, muscle cramps, apathy, headache, confusion, and anorexia.

Like other antacids, this medication, when taken with enteric-coated medications, may cause the coating to dissolve too quickly, leading to gastric or duodenal irritation.

Generally, taking this medication should be done at least 2 hours before or 2 hours after taking any other medication.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, gastric acid secretion tests, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Bicarbonato NM with food and beverages

Do not take this medication with milk or dairy products.

Do not use this medication after a large meal or drink, as it may cause stomach perforation in rare cases.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

No effects on driving or operating machinery have been described.

This medication contains sodium

Patients on low-sodium diets should note that this medication contains 273.9 mg (11.9 mmol) of sodium per dose.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults and adolescents over 12 years old:The recommended dose is 1 to 2 sachets (1 to 2 g of sodium hydrogen carbonate) per day. If necessary, the dose can be repeated by increasing to 2 to 4 sachets (2 to 4 g of sodium hydrogen carbonate), after meals or when feeling gastric discomfort. Do not exceed the maximum dose of 6 sachets per day.

This medication should be taken 20 minutes to 1 hour after meals

Always use the lower dose that is effective.

As symptoms disappear, medication should be discontinued.

This medication is taken orally. Dissolve the contents of the sachet in a glass of water and shake until completely dissolved

Before taking the medication, always wait for the contents of the sachet to completely dissolve and for the bubbles to disappear

If symptoms do not improve in 7 days, treatment should be discontinued and the doctor consulted.

Use in children and adolescents

Do not administer to children under 12 years old.

If you take more Bicarbonato NM than you should

If you take more Bicarbonato NM than recommended, you may feel headache, dizziness, ear buzzing, blurred vision, drowsiness, sweating, nausea, vomiting, occasional diarrhea, hyperirritability, muscle weakness, and fluid retention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Bicarbonato NM

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

• Adverse reactions observed with the use of sodium hydrogen carbonate are presented with an unknown frequency (cannot be estimated from available data).Flatulence (gas in the stomach or intestines), belching, vomiting, stomach cramps, stomach bloating, and rebound effect (increase in acidity produced by the medication itself).
• Hypokalemia (decrease in potassium level in blood) and hypernatremia (increase in sodium level in blood).

• Continued use or high doses may produce systemic alkalosis (difficulty breathing, muscle weakness, increased muscle tone, anxiety, and other effects on the central nervous system), hypertension (increase in blood pressure), and edema (fluid retention).

When a large amount of milk is ingested, it may produce a syndrome known as “milk and alkaloids” producingconhypercalcemia (anorexia, vomiting, nausea, apathy, muscle cramps).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the package, after CAD.:. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Bicarbonato NM

• Theactive ingredient issodium hydrogen carbonate Each sachet contains 1 g of sodium hydrogen carbonate.

This medicine does not contain excipients

Appearance of the product and contents of the packaging

White or almost white powder.

Box containing 42 sachets of 1 g ofsodium hydrogen carbonate

Holder of the marketing authorization

Nutrition Medical, S.L.

C/ Arequipa, 1

28043- Madrid. Spain.

Responsible for manufacturing

Pharmaceutical Industrial Cantabria, S.A.

C/ Pirita, 9.

28850 Torrejón de Ardoz (Madrid). Spain

This leaflet has been approved in: June2016

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS), http: //www.aemps.gob.es/