BOI-K EFFERVESCENT TABLETS

Introduction

Prospectus: INFORMATION FOR THE USER

Boi-keffervescent tablets

Potassium hydrogen carbonate / Ascorbic acid

Read the entire prospectus carefully before starting to take the medicine.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you suffer is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus:

1. What Boi-keffervescent tabletsare and what they are used for
2. Before taking Boi-keffervescent tablets
3. How to take Boi-keffervescent tablets
4. Possible side effects
5. Storage of Boi-keffervescent tablets
6. Additional information

1. What BOI-K effervescent tablets are and what they are used for

Boi-k belongs to a group of medicines called "mineral supplements".

BOI-K is used in the following situations:

Treatment and prophylaxis of hypokalemia (potassium deficiency) in situations such as:

• Potassium losses caused by treatment with diuretics (medicines to increase urine elimination), corticosteroids, and derivatives (medicines to reduce inflammation).

• Potassium losses caused by vomiting, diarrhea, kidney problems, hyperaldosteronism (excessive production of the hormone aldosterone), and intense sweating (due to climate or physical exercise).

• Situations where there is a deficit in potassium intake, such as malnutrition or deficient diets.

Treatment of digitalis intoxication (medicines for the heart)

Situations where an additional intake of vitamin C is necessary.

2. Before taking BOI-K effervescent tablets

Do not take BOI-Keffervescent tablets:

• If you are allergic (hypersensitive) to potassium hydrogen carbonate, ascorbic acid, or any other component of BOI-K.

• If you have high potassium levels in the blood (hyperkalemia).
• If you have any of the following gastrointestinal diseases (stomach and intestine): intestinal obstruction, digestive tract stenosis, paralytic ileus, or any other process that hinders or prevents passage through the stomach or intestine.
• If you have peptic ulcers or digestive bleeding, as excess potassium can cause gastrointestinal perforation.
• If you have severe kidney failure, as potassium can accumulate in the kidneys.
• If you have any disease that reduces urine production.
• If you have Addison's disease (a disease where the production of hormones such as cortisol and aldosterone decreases).

Be careful withBoi-keffervescent tablets:

• If you have had kidney stones or gout.
• During treatment, your doctor should monitor your potassium levels in the blood, especially in the case of the elderly, patients with heart disease, or kidney failure.
• If you are being treated with amiloride, triamterene, or spironolactone, which are types of diuretics, hyperkalemia (high potassium levels in the blood) may occur.
• If you are being treated with digitalis (medicines for heart problems), BOI-K may increase the toxicity of digitalis.
• If you have had peptic ulcers, as oral potassium administration (a component of BOI-K) can cause irritation to the gastrointestinal mucosa.

If you take more than 1 g of vitamin C (ascorbic acid) per day, you may experience diarrhea, kidney stones, and abdominal cramps. There is also a risk of forming stones and precipitating acute gout attacks in individuals who are prone to them.

During treatment, your doctor will assess whether you need to undergo periodic electrocardiogram checks, as if there are any alterations, potassium administration should be suspended.

Use in elderly people

Your doctor should monitor your potassium levels in the blood to rule out kidney failure.

In any of these situations, inform your doctor before taking BOI-K.

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those purchased without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose.

Consult your doctor if you take Boi-k with any of the following medicines:

• Amiloride, triamterene, or spironolactone (diuretics), ACE inhibitors (medicines for high blood pressure), angiotensin II receptor antagonists (medicines for high blood pressure), NSAIDs (non-steroidal anti-inflammatory medicines), beta-blockers (medicines for heart rhythm disorders and high blood pressure), cyclosporine (a medicine used in transplants), heparin (to prevent blood clotting). These medicines may favor potassium accumulation and lead to hyperkalemia (high potassium levels in the blood).
• Laxatives, corticosteroids, amphotericin B (an antifungal antibiotic), aminoglycosides (gentamicin), penicillins (penicillin, carbenicillin, mezlocillin, piperacillin, ticarcillin), or polymyxin B. These medicines may lead to increased potassium elimination, potentially causing hypokalemia (low potassium levels in the blood).
• Digitalis (medicines for heart problems), BOI-K may increase their toxicity.
• Parenteral calcium salts, as cardiac rhythm disorders may occur.
• Insulin or bicarbonate, as they may cause hypokalemia (low potassium levels in the blood).
• Vitamin C (ascorbic acid) at high doses may alter the action of the following medicines: antidepressants, anticoagulants, high doses of salicylates, sulfonamides, trimethoprim/sulfamethoxazole, or hormonal contraceptives.

Never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided, and in other cases, it may be necessary to adjust the treatment dose.

Interference with diagnostic tests

If you are going to undergo any diagnostic test (blood test, urine test, etc., including tests with reactive strips), inform your doctor that you are being treated with Boi-k, as it may alter the results.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Tell your doctor if you are pregnant, trying to become pregnant, or are breastfeeding.

Pregnancy

BOI-K is not expected to cause adverse reactions in the mother or fetus, provided that the recommended daily intake of potassium and vitamin C is not exceeded.

High doses of potassium or vitamin C are not recommended during pregnancy unless strictly necessary.

Breastfeeding

The effect of high doses of potassium is unknown, so its administration at high doses is not recommended unless strictly necessary.

Driving and using machines

BOI-K does not affect the ability to drive or operate machinery.

Important information about some of the components of BOI-K

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take BOI-K effervescent tablets

Follow your doctor's instructions for taking BOI-K exactly. Consult your doctor or pharmacist if you have any doubts.

BOI-K is administered orally.

The normal dose is:

Adults:

2 to 6 tablets per day.

Patient with kidney failure:

A dose adjustment may be necessary based on the degree of kidney failure.

Guidelines for correct administration:

It is recommended to take the dose in 2 or 3 divided doses, coinciding with meals or after them, to reduce stomach damage.

The effervescent tablet should be dissolved in a little water and taken alone or mixed with fruit juices, broth, etc., preferably during meals or after them.

If you take moreBoi-keffervescent tablets than you should:

If you have taken more BOI-K than you should, consult your doctor or pharmacist immediately or contact the Toxicology Information Service (Telephone: 91 562 04 20), and take the package with the remaining medicine, so the doctor knows what you have taken.

Among the symptoms of potassium salt overdose are: abdominal pain, nausea and vomiting, diarrhea and ulcers, chest tightness, hyperkalemia (excess potassium in the blood), difficulty breathing, and heart failure.

Treatment in patients with an overdose of an oral potassium supplement is usually symptomatic and may be limited to temporary suspension of treatment.

If you forget to takeBoi-keffervescent tablets:

If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next dose. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, BOI-K can cause side effects, although not everyone gets them.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

The frequency terminology used below is based on the following definitions: Very common (?1/10), common (?1/100, <1>

The side effects of potassium hydrogen carbonate are generally mild and transient. The side effects are:

• Very common: nausea, vomiting, diarrhea, flatulence (excess gas), abdominal pain, and gastric hyperacidity.
• Common: presence of peptic ulcers, digestive bleeding, intestinal obstruction, or intestinal perforation.
• Rare: exanthematic eruptions (skin irritation) may appear.
• Frequency not known: severe hyperkalemia (excess potassium in the blood) may occur.

If you take more than 1 g of vitamin C (ascorbic acid) per day, you may experience diarrhea, kidney stones, and abdominal cramps. There is also a risk of forming stones and precipitating acute gout attacks in individuals who are prone to them.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of BOI-K effervescent tablets

Keep Boi-k out of the reach and sight of children.

Expiry date

Do not use Boi-k after the expiry date stated on the package after CAD. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition ofBoi-keffervescent tablets

The active ingredients are potassium hydrogen carbonate and ascorbic acid. Each BOI-K effervescent tablet contains 1.001 mg of potassium hydrogen carbonate and 250 mg of ascorbic acid.

The other ingredients are: anhydrous citric acid, sodium benzoate (E-211), macrogol 6000, sodium saccharin, sucrose, lemon flavor, lactose monohydrate.

Appearance of the product and package contents

Boi-k effervescent tablets are presented in the form of white, circular, flat-surfaced effervescent tablets with a lemon odor.

Boi-k effervescent tablets are presented in packages containing 20 or 50 tablets.

If the tablets appear yellowish, this does not mean a loss of their therapeutic potassium activity.

Marketing authorization holder and manufacturer

Marketing authorization holder

IONFARMA, S.L.U.

Perú, 228

08020 Barcelona, Spain.

Manufacturer

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés – Barcelona

Spain

This prospectus was approved in April 2012

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