Label: Information for the User

Potassium Grifols 0.04 mEq/mL in Sodium Chloride 0.9% Solution for Infusion

Potassium Chloride, Sodium Chloride

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See Section 4.

Contents of the package and additional information

Potasio Grifols 0.04 mEq/ml in 0.9% Sodium Chloride is an intravenous solution for restoring electrolyte balance containing electrolytes.

Potasio Grifols 0.04 mEq/ml in 0.9% Sodium Chloride is indicated in the following situations:

• Hypokalemia (low potassium levels in blood).
• Potassium depletion due to vomiting, diarrhea, gastrointestinal aspiration, or fistulas.
• Deficiencies in potassium-free nutrition.
• Prolonged treatments with potassium-depleting diuretics and corticosteroids.
• Primary or secondary hyperaldosteronism (increased production and secretion of aldosterone hormone).
• Tubular disorders with potassium elimination.
• Cardiac arrhythmias due to digitalis intoxication.
• Metabolic alkalosis (elevated blood pH due to low chloride ion concentration in blood).
• Familial periodic paralysis with hypokalemia (hereditary disorder causing occasional episodes of muscle weakness, during which blood potassium levels are low).

Do not use Potasio Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

• if you are allergic to potassium chloride, sodium chloride, or any of the other components of this medication (listed in section 6)
• if you have hyperkalemia (high levels of potassium in the blood) or hyperchloremia (high levels of chloride in the blood)
• if you have acute renal failure (kidney failure) or suppression or reduction of urine production
• if you have adrenal insufficiency (failure of the adrenal glands): Addison's disease or hypoadrenalism (reduced secretion of aldosterone hormone)
• if you suffer from extensive burns (initial phase)
• if you suffer from hemolytic crises (destruction of red blood cells)
• if you have metabolic or respiratory acidosis
• if you are under treatment with potassium-sparing diuretics or aldosterone inhibitors
• if you have familial periodic paralysis with hyperkalemia (hereditary disorder that produces occasional episodes of muscle weakness and potentially elevated potassium levels in the blood)
• if you are a digitalized patient with severe heart block, as in this case, the use of potassium salts is not recommended

Warnings and precautions

Consult your doctor or nurse before starting to use Potasio Grifols 0.04 mEq/ml in Sodium Chloride 0.9%.

-It is recommended to perform frequent checks of urine output, electrolyte balance, and blood glucose levels during treatment. Special vigilance is required for potassium levels and electrocardiogram during administration of solutions with potassium.

-The administration of large volumes requires special vigilance if the patient has heart or lung failure and if the patient has non-osmotic vasopressin release (including the syndrome of inappropriate antidiuretic hormone secretion, SIADH), due to the risk of hospital-acquired hyponatremia (low sodium levels in the blood during hospitalization).

Hyponatremia:

If you are a patient with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and central nervous system diseases), if you have heart, liver, and kidney diseases, and if you are exposed to vasopressin agonists (see next subsection), you have a special risk of suffering from acute hyponatremia after administration of hypotonic solutions and even isotonic/isonatremic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering from severe, irreversible, and potentially fatal brain damage.

Children, fertile women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering from severe and potentially fatal cerebral edema caused by acute hyponatremia.

Other medications and Potasio Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

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

• Do not administer with medications that reduce kidney function.
• The concomitant administration of potassium salts with captopril may cause hyperkalemia.
• The concomitant administration with salt substitutes or potassium-sparing diuretics (spironolactone, triamterene, amiloride) may produce hyperkalemia that can be severe, especially in patients with renal insufficiency.
• The intravenous administration of this type of solutions with medications that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, nonsteroidal anti-inflammatory drugs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin), which reduce water excretion in urine, increases the risk of hospital-acquired hyponatremia (see previous subsection and sections 3 and 4).

-Diuretics in general and antiepileptic drugs such as oxcarbazepine increase the risk of hyponatremia.

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 before using this medication.

The safety of its use during pregnancy and lactation has not been established. Therefore, it should be used only when clearly necessary and when the benefits outweigh the potential risks for the fetus or infant.

This medicationshould be administered with special caution in pregnant women during delivery and special vigilance of serum sodium levels will be required in the case of administration in combination with oxytocin (see previous subsections and section 4).

Driving and operating machinery

Since this medication is administered only to hospitalized patients, no studies have been conducted on such effects.

The dosage will be established according to medical criteria depending on the degree of hypokalemia and the patient's clinical situation. Generally, 500-1000 ml per day at a rate of 20-30 drops/min is recommended via intravenous route. The maximum daily dose is 2000 ml at a rate of 60-80 drops/min.

You may need to monitor the patient's fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium if they present an increase in non-osmotic vasopressin release (SIADH) and if they are receiving simultaneously medication with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4).

Your doctor will decide on the need for simultaneous treatment (see sections 2 and 4).

If you receive more Potasio Grifols 0.04 mEq/ml in Sodium Chloride 0.9% than you should

In case of overdose or too rapid administration, hyperkalemia may appear.

In case of hyperkalemia, administration should be suspended and symptomatic treatment should be performed, mainly to antagonize the effects of potassium and stimulate its elimination.

For this, it is advisable to administer by intravenous perfusion sodium bicarbonate 1.4%, calcium chloride, or gluconate of calcium (10 or 20 ml of 10% solution), or glucose (100 ml of 50% solution or 1000 ml of 10%) along with 30 units of crystalline insulin.

In severe cases with renal insufficiency, hemodialysis or peritoneal dialysis should be performed to eliminate potassium from the body and correct hyperkalemia.

If there are electrocardiographic alterations due to excess potassium, it can be eliminated by administering orally or by enema an ionic exchange resin (sodium polystyrene sulfonate).

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects may occur if an excessive dose of potassium chloride is administered. If there are high levels of potassium in the blood (hyperkalemia), the following adverse effects may occur:

- Mental depression

- Confusion

- Paresthesia (abnormal sensation of the senses or general sensitivity)

- Muscle weakness and flaccid paralysis (loss of muscle strength and tone) of the extremities and respiratory muscles

- Bradycardia (decreased heart rate)

- Hypotension (decreased blood pressure)

- Electrocardiographic alterations

- Cardiac arrest

- Death

Hyperkalemia also produces a series of hormonal effects, as it stimulates the secretion of aldosterone, insulin, and glucagon and inhibits the production of renin.

In patients with non-osmotic vasopressin release, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of acute hyponatremia increases after administration of hypotonic and even isotonic/isonatremic solutions. Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the appearance of cerebral edema (see sections 2 and 3).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

Once the container is opened, the solution must be used immediately.

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

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

Do not use this medication if you observe that the solution is not transparent or contains precipitates.

Composition ofPotassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%

• The active principles are potassium chloride and sodium chloride. Each 100 ml of solution contains 0.30 g of potassium chloride and 0.9 g of sodium chloride.

• The other components (excipients) are hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9% is a perfusion solution, colorless and transparent, which is presented in flexible polypropylene bags (Fleboflex) of 500 and 1000 ml.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Date of the last review of this leaflet: June 2018

Other sources of information

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

------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Potassium Grifols 0.04 mEq/ml in Sodium Chloride 0.9%will be administered by perfusion. The medication is presented ready for administration.

The solution must be transparent and not contain particles or precipitates. Do not administer otherwise.

Once the package is opened, the solution must be used immediately. Discard unused content.

Do not extract the Fleboflex bag from the protective overbag until the moment immediately before its use.

Check for the absence of small leaks by pressing firmly on the bag. If leaks are detected, discard the product.

The Fleboflex bags are designed for administration without air entry. If an air-entry perfusion equipment is to be used, ensure that it is always closed.

To connect the perfusion equipment, separate the protective tongue from the infusion port, leaving the access membrane to the bag exposed.

In case of adding medications to the solution, disinfect the injection point of the bag. Prepare a syringe with the medication, using a 20-22 G needle.

Use an aseptic technique to administer the solution, as well as to add medications to the solution, if necessary.

Like other parenteral solutions, before adding medications, consult the incompatibility tables.

Generally, 500-1000 ml per day at a rate of 20-30 drops/min by intravenous route is recommended, although the dose should be adjusted according to medical criteria. The maximum daily dose is 2000 ml at a rate of 60-80 drops/min.