Prospect: INFORMATION FOR THE USER

BOI-K aspartic effervescent tablets

Potassium hydrogen carbonate / Ascorbic acid / Aspartic acid

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

BOI-K asparticis indicated in the following situations:

Treatment and prophylaxis 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 aldosterone hormone), intense sweating (consequence of climate or physical exercise).

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

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

Do not take BOI-K aspartic effervescent tablets

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

-If you have high potassium levels 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 makes it difficult or impossible for food to pass through the stomach or intestine.

-If you have peptic ulcers or gastrointestinal bleeding, as excessive potassium can cause a 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-kaspartic effervescent tablets

• Si 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 failure.
• If you are being treated with amiloride, triamterene, or spironolactone, which are a type of diuretic (medicines to increase urine elimination), hyperkalemia (high potassium levels in the blood) may occur.
• If you are being treated with digitalis (medicines for heart problems), BOI-K aspartic may increase the toxicity of digitalis.
• If you have ever had peptic ulcers, as oral administration of potassium (component of BOI-K aspartic) may cause gastrointestinal mucosa irritation.

If you take more than1 gof vitamin C (ascorbic acid) 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 who are prone to them.

Your doctor will evaluate whether you need to have periodic electrocardiogram checks, as if there are any changes, 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 failure.

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

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-kasparticwith any of the following medications:

-Amiloride, triamterene, or spironolactone (medicines to increase urine elimination), ACE inhibitors (medicines to treat high blood pressure), angiotensin II receptor antagonists (medicines to treat high blood pressure), NSAIDs (anti-inflammatory medicines), beta-blockers (medicines used to treat heart rhythm disorders and high blood pressure), cyclosporine (medicine used in transplantation), heparin (to prevent blood clotting). These medicines may cause potassium accumulation and lead to hyperkalemia (high potassium levels in the blood).

-Laxatives, corticosteroids, amphotericin B (antifungal antibiotic), aminoglycosides (gentamicin), penicillins (penicillin, carbenicillin, mezlocillin, piperacillin, ticarcillin) or polymyxin B (all are antibiotics). These medicines may cause increased potassium elimination, leading to hypokalemia (low potassium levels in the blood).

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

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

-Insulin or bicarbonate, as they may cause hypokalemia (low potassium levels 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 to relieve pain and reduce fever), sulfonamides (a type of antibiotic), trimethoprim/sulfamethoxazole (a combination of antibiotics) or hormonal contraceptives.

Never take another medication 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-kaspartic, as it may alter the results.

Pregnancy and breastfeeding

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 aspartic 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 absolutely necessary.

Breastfeeding

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

Driving and operating machinery

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

Important information about some components of BOI-K aspartic effervescent tabletseffervescent tablets

This medicine contains lactose andsaccharose.Inform your doctor if you have been told you have an intolerance to certain sugars before taking this medicine.

Patients with low-sodium diets should note that this medicine contains 51.1 mg (2.2 mmoles) of sodium per tablet.

Follow exactly the administration instructions for BOI-K aspartic indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

BOI-K aspartic is administered orally.

The normal dose is:

Adults:

2 to 4 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 minimize stomach damage.

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

If you take moreBoi-kaspartic effervescent tablets than you should

If you have taken more BOI-K aspartic than 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-kasparticeffervescent 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-Kaspárticocan 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 product's adverse effects are generally mild and transient. The adverse effects are:

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

If you take vitamin C (ascorbic acid) quantities exceeding1 gper day, diarrhea, kidney stones, and abdominal cramps may occur. There is also a risk of forming stones 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-Kaspartic out of the reach and sight of children.

Expiration Date

Do not useBOI-Kaspartic after 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. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofBoi-kaspártico effervescent tablets

The active principles arePotassium hydrogen carbonate,ascorbic acid and Aspártic acid.

Each tablet contains:

Potassium hydrogen carbonate,2.502,5mg

ascorbic acid, 500 mg

Aspártic acid, 350 mg

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-kaspártico is packaged in boxes containing 20 tablets.

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

Holder of the marketing authorization

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 prospectus 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/