Label:information for the user

Potassium Normofundina solution for infusion

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to others even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this label. See section 4.

Normofundina with potassium is a solution for the administration of liquids and electrolytes (salts). It also contains glucose to ensure the minimum carbohydrate needs.

Normofundina with potassium is used:

• In patients with a deficiency of bodily fluids (isotonic dehydration).
• In patients who present a deficiency of bodily fluids and their sodium levels are elevated (hypertonic dehydration).
• To cover the needs of water and liquids and, partially, the energy needs, when it should not or cannot eat or drink after surgery or injury (postoperative or post-traumatic).
• As a vehicle for concentrated solutions of electrolytes that are physically and chemically compatible and medications.

Normofundina with potassium is a medication that your doctor or a healthcare professional will administer.

No use Normofundina con potasio:

• If you are allergic (hypersensitive) to the active ingredients of Normofundina with potassium or to any of the other components of this medication (listed in section 6).or to any of the other components of this medication (listed in section 6).
• If you present an excess of fluids (hyperhydration).
• If you present a deficiency of fluids and sodium (hypotonic dehydration).
• If your blood potassium levels are elevated (hyperkalemia).
• If you present a severe weakness of the heart muscle (congestive heart failure).
• If you have severe kidney problems with little or no urine production (severe renal insufficiency with oliguria or anuria).
• If your blood sugar levels are high and do not respond to 6 units of insulin per hour.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Normofundina with potassium.

Be especially cautious if you use Normofundina with potassium in the following cases:

• If your blood sodium levels are low (hyponatremia).
• If your kidney function is damaged (renal insufficiency).
• If you suffer from diseases in which high blood potassium levels (hyperkalemia) are frequent, for example if your adrenal gland does not function properly (Addison's disease) or in certain hereditary diseases that affect red blood cells (sickle cell anemia).
• If you are being treated with other medications that increase blood potassium levels (see section "Use of Normofundina with potassium with other medications").
• If you must follow a low-sodium diet due to some disease, such as heart muscle weakness (heart failure), fluid accumulation in tissues (generalized edema), fluid in the lungs (pulmonary edema), or high blood pressure with convulsions during pregnancy (eclampsia).
• If you must follow a low-calcium diet due to some disease, such as sarcoidosis.

Special caution should be exercised in patients of advanced age, as it may be necessary to adjust the recommended dose to avoid renal and circulatory problems due to hydration.

If you have high blood pressure, the administration of sodium chloride and fluids should be adjusted according to the severity of your disease.

Your doctor will have special care when administering Normofundina with potassium if your blood acetate levels are high or if you have any metabolic alteration, for example in the case of severe liver insufficiency.

Solutions containing potassium and calcium like Normofundina with potassium, should only be administered with caution to patients treated with cardiac glycosides (digital preparations) (see section "Use of Normofundina with potassium with other medications").

While you are being administered Normofundina with potassium, your fluid balance, acid-base balance, and blood electrolyte and sugar levels will be monitored.

If during the treatment with Normofundina with potassium your blood sugar levels rise rapidly, insulin will be administered.

Adequate vitamin intake (particularly vitamin B1) should be ensured.

This solution may alter your electrolyte levels, therefore, the administration schedule will depend on your clinical status and your ability to metabolize glucose.

Your doctor will have special care if you have any disease that increases the release of vasopressin (hormone that reduces water elimination) such as, for example, in the case of infections, heart, liver, kidney disease, or after surgery, also in the case of taking certain medications (see section Use of Normofundina with potassium with other medications).

You will also be administered Normofundina with potassium with caution if you have a special risk of suffering from cerebral edema (fluid accumulation in the brain) due to a decrease in your sodium levels (acute hyponatremia). For example, in children, pregnant women, or patients with meningitis or other complications.

Children

In newborns and premature babies with low birth weight, your blood sugar levels should be monitored with special caution.

Use of Normofundina with potassium with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Caution should be exercised when coadministering potassium-based solutions with other medications that increase blood potassium levels, such as:

• diuretics that reduce potassium excretion (potassium-sparing diuretics)
• some medications for high blood pressure (ACE inhibitors)
• some analgesics (nonsteroidal anti-inflammatory drugs)
• ciclosporin or tacrolimus (medications used to suppress immune system reactions)
• suxamethonium (a muscle relaxant used in anesthesia).

Caution should be exercised when coadministering medications that increase the effect of vasopressin (hormone that reduces water elimination), such as:

• some medications that increase vasopressin release (e.g.: clorpropamida, clofibrato, carbamazepina, vincristina, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics).
• some medications that increase the effect of vasopressin (e.g.: clorpropamida, NSAIDs, ciclofosfamida).
• some medications that have the same effect as vasopressin (analogues) (e.g.: desmopressin, oxytocin, vasopressin, terlipressin).

Medications that may cause a decrease in sodium levels (diuretics and antiepileptics such as oxcarbazepine).

Problems with heart rhythm may occur if these medications are administered together with potassium, as significantly elevated blood potassium levels may be reached.

The potassium contained in this solution may decrease the effect of cardiac glycosides (digital preparations).

The coadministration of medications that reduce sodium excretion (e.g.: corticosteroids or nonsteroidal anti-inflammatory drugs) may cause fluid retention (edema).

The calcium contained in the solution may potentiate the harmful effects of cardiac glycosides (digital preparations) and cause problems with heart rhythm.

Some diuretics (thiazide diuretics) and vitamin D may cause a decrease in calcium excretion.

Your doctor will also take into account the interactions with medications that affect glucose metabolism, such as corticosteroids.

Pregnancy and lactation

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

Normofundina with potassium should be administered with special caution in pregnant women during delivery, especially if it is administered in combination with oxytocin, due to the risk of hyponatremia (sodium decrease).

Your doctor will administer Normofundina with potassium with caution.

Driving and operating machinery

The influence of Normofundina with potassium on the ability to drive and operate machinery is nil.

This medication will always be administered by a doctor or healthcare professional.

The dose will depend on the type of disease and its severity and your individual needs for carbohydrates, liquids, and electrolytes. Your doctor will decide the frequency and duration of treatment with Normofundina with potassium.

Follow exactly the administration instructions for Normofundina with potassium indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

IV administration in the form of infusion, which means that the solution will be administered directly into a vein through a cannula (a thin tube).

If you use more Normofundina with potassium than you should

Due to an overdose,you may experience an excess of liquids accompanied by increased skin turgor, venous congestion, accumulation of fluids in the body tissues (edema) including the lungs (pulmonary edema). You may also experience electrolyte imbalances, including high levels of potassium and low levels of sodium in the blood, acid-base imbalances, and increased blood sugar levels.

Treatment

The infusion will be stopped immediately, diuretics (medications used to increase urine production)will be administered, and your fluid and electrolyte balance will be monitored.Your doctor will decide if further measures are needed based on the nature and severity of the situation.

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medication and the amount used.

Like all medications, Normofundina with potassium may produce adverse effects, although not all people may experience them.

Unknown frequency (cannot be estimated from available data):

• Local alterations at the site of administration, including local pain
• Vein irritation, phlebitis (inflammation of the vein wall) and leakage of the solution from the vein to surrounding tissue (extravasation).
• Hospital-acquired hyponatremia (decreased sodium levels) and hyponatremic encephalopathy that may cause brain damage.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use Normofundina with potassium if the solution is cloudy, contains particles at the bottom of the packaging or if the packaging or its closure show visible signs of deterioration.

No special storage conditions are required.

Medications and materials that have been in contact with it should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Normofundina with potassium:

The other components are: water for injectable preparations.

Appearance of the product and contents of the package

Normofundina with potassium is a solution for infusion that will be administered directly into the bloodstream. It is a clear, colorless to pale yellow aqueous solution.

It is presented in polyethylene flasks (Ecoflac Plus) of 500 ml and 1000 ml in containers of:

1 x 500 ml, 10 x 500 ml

1 x 1000 ml, 10 x 1000 ml

Holder of the marketing authorization and responsible for manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Last review date of this leaflet: April 2025

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

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This information is intended solely for healthcare professionals:

Before mixing the solution with other medications, consider the possible incompatibilities. Normofundina with potassium is incompatible with tetracyclines (precipitation), thiopental sodium, and amphotericin B (oxidation).

Medications containing oxalates, phosphates, and carbonates/bicarbonates may precipitate when mixed with Normofundina with potassium, and therefore should not be mixed with this solution.

Solutions containing glucose should not be administered through the same infusion equipment, nor simultaneously, nor before or after the administration of blood, as there is a possibility of

pseudo-agglutination.

Dosage

Adults

Maximum daily dose

As routine maintenance, the daily dose should not exceed 40 ml per kg of body weight (PC) per day, which is equivalent to 2 g of glucose per kg of PC per day, 4 mmol of sodium per kg of PC per day, and 0.7 mmol of potassium per kg of PC per day.

It may be necessary to monitor fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important when administering hypotonic solutions. Normofundina with potassium can become extremely hypotonic after administration due to glucose metabolism in the body.

Pediatric population

As routine maintenance, the following daily doses should not be exceeded:

Any additional loss (e.g. due to fever, diarrhea, vomiting, etc.) should be compensated according to the composition and volume of the lost fluids.

In cases of dehydration, the maximum daily dose may be exceeded in certain cases. The dose should be calculated according to the severity of dehydration and the patient's clinical condition.

Maximum infusion rate

Adults

As routine maintenance, the infusion rate should not exceed 100 ml/hour.

When treating acute hypertonic dehydration, the acute hyponatremia should be corrected within 24 hours. In cases of chronic hyponatremia (> 24 hours) or unknown duration hyponatremia, these should be corrected at a rate not exceeding 0.5 mmol/l/hour. Normal serum sodium levels should be achieved within 48 hours. A faster decrease in serum sodium levels may cause cerebral edema.

Pediatric population

As routine maintenance, the following infusion rates should not be exceeded:

Mild to moderate hyponatremias should be corrected within 48 hours. In cases of severe hypertonic dehydration (serum sodium ≥ 170 mmol/l), rehydration should last 72-96 hours. The initial correction rate should not exceed 10-12 mmol/l in 24 hours (0.5 mmol/l/hour). A faster decrease in serum sodium levels may cause cerebral edema, convulsions, and irreversible brain damage.

All ages

For the treatment of dehydration, the maximum infusion rate is 5 ml per kg of PC per hour, which is equivalent to 0.25 g of glucose per kg of PC and 0.09 mmol of potassium per kg of PC per hour. The maximum drop rate is 1.7 drops per kg of PC per minute.