Bicarbonate NM 1 g powder for oral solution

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Bicarbonato NM 1 g powder for oral solution

Sodium hydrogen carbonate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

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

1. What Bicarbonato NM is and what it is used for

Bicarbonato NM belongs to a group of medicines called antacids, which work by reducing excess stomach acidity.

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

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Bicarbonato NM

Do not take Bicarbonato NM

• If you are allergic to sodium hydrogen carbonate.
• If you have metabolic or respiratory alkalosis (a disturbance in blood pH).
• If you have hypocalcemia (low calcium levels in the blood).
• If you have hypochlorhydria (reduced acidity of gastric juice).
• If you are prone to edema formation (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 causing interruption of the passage of intestinal contents).

- If you are on a low-sodium diet (if you have 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.

As with other antacids, this medicine may mask symptoms of a more serious stomach condition. Therefore, if symptoms persist or worsen after 7 days of treatment, you must consult your doctor.

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

Children and adolescents

Do not administer to children under 12 years of age.

Taking Bicarbonato NM with other medicines

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

In general, any antacid should be taken at least two hours before or after the administration of another medicine.

Antacids may alter the action of other medicines such as:

• Iron salts (medicines used to prevent or treat anaemia)

• Quinolones, tetracyclines, sulfonamides, erythromycin, methenamine, rifampicin, Isoniazid, Ethambutol (antibiotics)

• Theophylline (used for the treatment of asthma)

• Ulipristal (emergency contraceptive)

• Erlotinib (a medicine for cancer treatment). It is recommended to administer sodium hydrogen carbonate at least 4 hours before or 2 hours after erlotinib

• Propranolol, atenolol (medicines for treating high blood pressure)

• Benzodiazepines (medicines for treating insomnia and anxiety)

• Digoxin, digitoxin (medicines for treating heart disorders)

• Phenothiazines (medicines for treating 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, dexamphetamine, ephedrine (central nervous system stimulants)

• Flecainide, quinidine (medicines for treating heart rhythm disorders)

• Methadone (used to relieve severe pain)

• Mecamylamine (a medicine for hypertension)

• Lithium salts (used in certain psychiatric conditions)

• Methotrexate (used for the treatment of cancer and rheumatoid arthritis)

• Calcium-containing preparations, as you may develop milk-alkali syndrome, whose symptoms include: high calcium levels in blood, kidney problems, heart problems, metabolic alkalosis, dizziness, vomiting, muscle cramps, apathy, headache, confusion, and anorexia.

As with other antacids, this medicine, when administered together with enteric-coated medicines, may cause the coating to dissolve too quickly, which could lead to gastric or duodenal irritation.

In general, this medicine should be taken at least 2 hours before or 2 hours after taking any other medicine.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood or urine tests, detection of gastric acid secretion, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Bicarbonato NM with food and drinks

Do not take this medicine together with milk or dairy products.

You should not use this medicine after overeating or excessive drinking, as in rare cases it could cause perforation of the stomach walls.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

Driving and using machines

No effects on driving or using machines have been reported.

This medicine contains sodium

Patients on low-sodium diets should be aware that this medicine contains 273.9 mg (11.9 mmol) of sodium per sachet.

3. How to take Bicarbonato NM

Follow exactly the dosage instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and adolescents over 12 years of age: The recommended dose is 1 to 2 sachets (1 to 2 g of sodium hydrogen carbonate) per day. If necessary, the dose may be increased to 2 to 4 sachets (2 to 4 g of sodium hydrogen carbonate), taken after meals or when experiencing gastric discomfort. Do not exceed the maximum daily dose of 6 sachets.

This medicine should be taken from 20 minutes to one hour after meals.

Always use the lowest effective dose.

As symptoms resolve, the medication should be discontinued.

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

Always wait until the contents of the sachet have completely dissolved and the bubbles have disappeared before taking the medicine.

If symptoms do not improve within 7 days, treatment must be discontinued and you should consult your doctor.

Use in children and adolescents

Do not administer to children under 12 years of age.

If you take more Bicarbonato NM than you should

If you take more Bicarbonato NM than recommended, you may experience headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, nausea, vomiting, occasionally diarrhea, hyperirritability, muscle weakness, and fluid retention.

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

If you forget to take Bicarbonato NM

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

• Adverse reactions observed with the use of sodium hydrogenocarbonate occur with an unknown frequency (cannot be estimated from available data): Flatulence (gas in the stomach or intestine), belching, vomiting, stomach cramps, stomach swelling, and rebound effect (increase in acidity caused by the medicine itself).

• Hypokalaemia (decreased potassium levels in the blood) and hypernatraemia (increased sodium levels in the blood).

• If used continuously or at high doses, systemic alkalosis may occur (difficulty breathing, muscle weakness, increased muscle tone, anxiety, and other central nervous system effects), hypertension (increased blood pressure), and oedema (fluid retention).

When large amounts of milk are ingested, a condition known as "milk-alkali syndrome" may develop, leading to hypercalcaemia (anorexia, vomiting, nausea, apathy, muscle cramps).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicarbonate NM

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

Do not use this medicine after the expiry date stated on the sachet, following EXP:. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicarbonato NM

• The active substance is sodium hydrogen carbonate. Each sachet contains 1 g of sodium hydrogen carbonate.

This medicine contains no excipients.

Appearance of the product and contents of the pack

White or almost white powder.

Carton containing 42 sachets of 1 g of sodium hydrogen carbonate.

Marketing Authorization Holder

Nutrición Médica, S.L.

C/ Arequipa, 1

28043 Madrid, Spain.

Manufacturer

Industrial Farmacéutica Cantabria, S.A.

C/ Pirita, 9

28850 Torrejón de Ardoz (Madrid), Spain.

This leaflet was last approved in: June 2016

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/