Boi-K aspartic effervescent tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

BOI-K aspartic effervescent tablets

Potassium hydrogen carbonate / Ascorbic acid / Aspartic acid

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What BOI-K aspartic effervescent tablets are and what they are used for
2. Before you take BOI-K aspartic effervescent tablets
3. How to take BOI-K aspartic effervescent tablets
4. Possible side effects
5. How to store BOI-K aspartic effervescent tablets
6. Further information

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

BOI-K aspartate belongs to a group of medicines called "mineral supplements".

BOI-K aspartate is indicated in the following situations:

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

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

• Potassium loss due to vomiting, diarrhea, kidney disorders, hyperaldosteronism (excessive production of the hormone aldosterone), and profuse sweating (due to climate or physical exercise).

• Situations involving inadequate potassium intake, such as: states of malnutrition, potassium-deficient diets.

Situations where an additional intake of vitamin C is required.

2. Before taking BOI-K aspartate effervescent tablets

Do not take BOI-K aspartate effervescent tablets

• If you are allergic (hypersensitive) to potassium hydrogen carbonate, ascorbic acid, aspartic acid, or any of the other ingredients of BOI-K aspartate.
• If you have excess potassium in your blood (hyperkalemia).
• If you have any of the following gastrointestinal conditions (of the stomach and intestine): intestinal obstruction, stenosis of the digestive tract, paralytic ileus, or any other condition that hinders or prevents passage through the stomach or intestine.
• If you have peptic ulcer or gastrointestinal bleeding, as excess potassium may cause gastrointestinal perforation.
• If you have severe renal insufficiency, as accumulation of potassium in the kidneys may occur.
• If you have any condition causing reduced urine production.
• If you have Addison's disease (a condition in which production of certain hormones called cortisol and aldosterone is reduced).

Take special care with BOI-K aspartate effervescent tablets

• If you have or have had kidney stones or gout.
• During treatment, your doctor should monitor your blood potassium levels, especially in elderly patients, or in patients with heart disease or renal insufficiency.
• If you are being treated with amiloride, triamterene, or spironolactone—types of diuretics (medications to increase urine elimination)—hyperkalemia (high blood potassium levels) may occur.
• If you are being treated with digitalis (medications for heart problems), BOI-K aspartate may increase the toxicity of digitalis.
• If you have ever had peptic ulcer, as oral administration of potassium (a component of BOI-K aspartate) may cause gastrointestinal mucosal irritation.

If you take vitamin C (ascorbic acid) in amounts exceeding 1 g per day, diarrhea, kidney stones (renal calculi), and abdominal cramps (stomach pain) may occur. There is also a risk of stone formation and acute gout attacks in individuals predisposed to these conditions.

Throughout treatment, your doctor may consider periodic electrocardiogram (ECG) evaluations, as administration of potassium should be discontinued if any ECG abnormalities occur.

Use in elderly patients

Your doctor should monitor your blood potassium levels to rule out renal insufficiency.

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

Use of other medicines

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

Consult your doctor if you are taking BOI-K aspartate together with any of the following medicines:

• Amiloride, triamterene, or spironolactone (medications to increase urine elimination), ACE inhibitors (angiotensin-converting enzyme inhibitors: medications for treating high blood pressure), angiotensin II receptor antagonists (medications for treating high blood pressure), NSAIDs (non-steroidal anti-inflammatory drugs: medications for pain and inflammation), β-blockers (medications used to treat heart rhythm disorders and high blood pressure), cyclosporine (a medication used in transplant cases), heparin (to prevent blood clotting). These medications may promote potassium accumulation and lead to hyperkalemia (high blood potassium levels).
• Stimulant laxatives, corticosteroids, amphotericin B (an antifungal antibiotic), aminoglycosides (gentamicin), penicillins (penicillin, carbenicillin, mezlocillin, piperacillin, ticarcillin), or polymyxin B (all of them antibiotics). These medications may lead to increased potassium excretion, potentially causing hypokalemia (low blood potassium levels).
• Digitalis (medications for heart problems): BOI-K aspartate may increase its toxicity.
• Parenteral calcium salts, as cardiac rhythm disturbances may occur.
• Insulin or bicarbonate, as they may cause hypokalemia (low blood potassium levels).
• High-dose vitamin C (ascorbic acid) may alter the action of the following medications: antidepressants, anticoagulants (to make blood less thick), high-dose salicylates (medications to relieve pain and reduce fever), sulfonamides (a type of antibiotic), trimethoprim/sulfamethoxazole (a combination antibiotic), or hormonal contraceptives.

You should never take another medicine on your own initiative without medical advice, as some combinations should be avoided, and in other cases, dosage adjustments may be necessary.

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (blood, urine, etc., including tests using reagent strips), inform your doctor that you are being treated with BOI-K aspartate, as it may alter test results.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Pregnancy

BOI-K aspartate 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.

Administration of high-dose potassium or vitamin C during pregnancy is not recommended unless strictly necessary.

Breastfeeding

The effect of high-dose potassium during breastfeeding is unknown; therefore, administration at high doses is not recommended unless strictly necessary.

Driving and using machines

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

Important information about some of the ingredients of BOI-K aspartate effervescent tablets

This medicine contains lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Patients on low-sodium diets should be aware that this medicine contains 51.1 mg (2.2 mmol) of sodium per tablet.

3. How to take BOI-K aspartic effervescent tablets

Follow exactly the administration instructions for BOI-K aspartic provided by your doctor. If in doubt, consult your doctor or pharmacist.

BOI-K aspartic is administered orally.

The usual dose is:

Adults:

2 to 4 tablets per day.

Patients with renal insufficiency:

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

Instructions for proper administration:

It is recommended to divide the daily dose into 2 or 3 administrations, taken during or immediately after meals, to reduce gastric irritation.

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

If you take more BOI-K aspartic effervescent tablets than you should

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

Symptoms of potassium salt overdose may include: abdominal pain, nausea and vomiting, diarrhea and ulcers, chest tightness, hyperkalemia (excess potassium in the blood), difficulty breathing, and cardiac failure.

Treatment in patients who have overdosed on an oral potassium supplement is usually symptomatic and may require only temporary discontinuation of the treatment.

If you forget to take BOI-K aspartic effervescent tablets

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

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

4. Possible adverse effects

Like all medicines, BOI-K aspartic may cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

The terminology for frequency used below corresponds to the following definitions: Very common (?1/10), common (?1/100, <1/10), uncommon (?1/1,000, <1/100), rare (?1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).

The adverse effects of the product are generally mild and transient. The adverse effects are:

• Very common: nausea, vomiting, diarrhea, flatulence (excess gas), abdominal pain, and gastric hyperacidity.
• Common: peptic ulcer, gastrointestinal bleeding, intestinal obstruction, or intestinal perforation.
• Rare: exanthematous rashes (skin irritation) may occur.
• Frequency not known: severe hyperkalemia (excess potassium in the blood) may occur.

If you take vitamin C (ascorbic acid) in amounts exceeding 1 g per day, diarrhea, kidney stones, and abdominal cramps may occur. There is also a risk of kidney stone formation and precipitation of acute gout attacks in individuals predisposed to these conditions.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of BOI-K aspartic effervescent tablets

Keep BOI-K aspartic out of the reach and sight of children.

Expiry

Do not use BOI-K aspartic after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required. Store in the original container.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Boi-kaspártico effervescent tablets

The active substances are Potassium hydrogen carbonate, ascorbic acid and Aspartic acid.

Each tablet contains:

Potassium hydrogen carbonate, 2,502.5 mg
Ascorbic acid, 500 mg
Aspartic acid, 350 mg

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

Appearance of the product and contents of the pack

Boi-k aspártico is packaged in boxes containing 20 tablets.

If a yellowish discolouration of the tablets appears, this does not indicate loss of potassium therapeutic activity.

Marketing Authorization Holder

IONFARMA, S.L.U.
Perú, 228
08020 Barcelona. Spain.

Manufacturer

Laboratorios ERN, S.A.
Gorgs Lladó, 188
08210 Barberà del Vallès – Barcelona. Spain

This leaflet was approved in April 2012.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/