Prospect: INFORMATION FOR THE USER

Boi-k effervescent tablets

Potassium hydrogen carbonate / Ascorbic acid

Boi-kbelongs to a group of medications called “mineral supplements”.

BOI-K is used in the following situations:

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

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

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

• Situations in which there is a deficiency in potassium intake, such as: malnutrition states, deficient diets.

Treatment of digitalis intoxication (heart medications)

Situations in which an additional intake of vitamin C is necessary.

Do not take BOI-Keffervescent tablets:

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

-If you have high levels of potassium in your 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 gastrointestinal bleeding, as excessive potassium can cause gastrointestinal perforation.

-If you have severe kidney failure, as it can cause potassium accumulation in the kidneys.

-If you have any disease that causes a decrease in urine production.

-If you have Addison's disease (a disease in which the production of certain hormones called cortisol and aldosterone decreases).

Be especially careful withBoi-keffervescent tablets:

• If you have or have had kidney stones or gout.
• During treatment, your doctor should monitor your potassium levels in the blood, especially in elderly patients, patients with heart disease, or kidney insufficiency.
• If you are being treated with amiloride, triamterene, or spironolactone, which are a type of diuretic (medicines to increase urine elimination), hyperkalemia (high levels of potassium 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 ever had peptic ulcers, as oral administration of potassium (component of BOI-K) can cause gastrointestinal mucosa irritation.

If you take vitamin C (ascorbic acid) in amounts greater than 1 g per day, diarrhea, kidney stones, and abdominal cramps may occur. There is also a risk of forming stones and suffering acute gout attacks in individuals prone to it.

Throughout treatment, your doctor will evaluate whether you should undergo periodic electrocardiogram checks, as if there are any alterations, the administration of potassium should be suspended.

Use in elderly people

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

Inform your doctor in any of these situations before taking BOI-K.

Use of other medications:

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

Consult your doctor if you takeboi-kwith any of the following medications:

-Amiloride, triamterene, or spironolactone (medicines to increase urine elimination), ACE inhibitors (medicines for high blood pressure treatment), angiotensin II receptor antagonists (medicines for high blood pressure treatment), NSAIDs (anti-inflammatory medicines for pain and inflammation), β-blockers (medicines used to treat heart rhythm disorders and high blood pressure), cyclosporine (medicine used in case of transplant), heparin (to prevent blood coagulation). These medicines may favor potassium accumulation and lead to hyperkalemia (high levels of potassium in the blood).

-Laxatives, corticosteroids, amphotericin B (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 levels of potassium in the blood).

-Digitalis (medicines for heart problems), BOI-K may increase its toxicity.

-Parenteral calcium salts, as they may cause heart rhythm disorders.

-Insulin or bicarbonate, as they may cause hypokalemia (low levels of potassium in the blood).

-Vitamin C (ascorbic acid) at high doses may modify the action of the following medications: antidepressants, anticoagulants (to make the blood less thick), high doses of salicylates (medicines for pain relief and fever reduction), sulfonamides (a type of antibiotic), trimethoprim/sulfamethoxazole (a combination of antibiotics) 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 to undergo any diagnostic test (blood, urine, etc., including strip tests), inform your doctor that you are being treated withboi-k, as it may alter the results.

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

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

Pregnancy

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

It is not recommended to administer high doses of potassium or vitamin C during pregnancy unless strictly necessary.

Lactation

The effect of high doses of potassium is unknown, so it is not recommended to administer high doses unless strictly necessary.

Driving and operating machinery

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

Important information about some components of BOI-K

This medicine contains lactose andsaccharose.If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for BOI-K as indicated by your doctor. 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.

Patients with renal insufficiency:

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

Guidelines for correct administration:

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

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

If you take moreBOI-Keffervescent tablets than you should:

If you have taken moreBOI-Kthan you should, consult your doctor or pharmacist immediately or the Toxicological Information Service (Phone: 91 562 04 20), and bring the packaging with the remaining medication, so that the doctor knows what you have taken.

The symptoms of potassium overdose include the following: abdominal pain, nausea and vomiting, diarrhea and ulcers, chest oppression, hyperkalemia (excess potassium in the blood), difficulty breathing, and heart failure.

The treatment for patients with an oral potassium supplement overdose is usually symptomatic and may be sufficient to temporarily suspend treatment.

If you forgot to takeBOI-Keffervescent tablets:

If you forgot 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 the missed doses.

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

Like all medications, BOI-K can produce adverse effects, although not all people will experience them.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The terminology of frequencies used below follows the following definitions:Very frequent (?1/10), frequent (?1/100, <1>?1/1.000, <1>?1/10.000, <1>

The adverse effects of potassium hydrogencarbonate are generally mild and transient. The adverse effects are:

• Very frequent: appearance of nausea, vomiting, diarrhea, flatulence (excess of gases), abdominal pain, and hyperacidity.
• Frequent: presence of peptic ulcer, digestive hemorrhage, intestinal obstruction, or intestinal perforation.
• Rare: may appear exanthematous eruptions (skin irritation).
• Unknown frequency: may cause severe hyperkalemia (excess of potassium in the blood).

If you take quantities of vitamin C (ascorbic acid) exceeding 1 g per day, diarrhea, renal calculi, and abdominal cramps may occur. There is also a risk of forming calculi and precipitating acute gout attacks in individuals predisposed to them.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

KeepBOI-Kout of the reach and sight of children.

Expiration Date

Do not useBOI-Kafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of the medication through the drains or in the trash. Dispose of the packaging and unused medication at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medication. By doing so, you will help protect the environment.

Composition ofBoi-kEffervescent Tablets

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

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

Appearance of the Product and Contents of the Package

Boi-keffervescent tablets are presented in the form of white, circular, flat-faced effervescent tablets with a lemon scent.

Boi-keffervescent tabletsare presented in packages containing 20 or 50 tablets.

In the event that a yellowish discoloration of the tablets appears, this does not signify a loss of its therapeutic potassium activity.

Holder of the Marketing Authorization andResponsible for Manufacturing

Holder

IONFARMA, S.L.U.

Perú, 228

08020 Barcelona. Spain.

Responsible for Manufacturing

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés – Barcelona

Spain

This leaflet was approved in April 2012

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/