Potassium chloride Braun 1 mEq/ml concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium Chloride Braun 1 mEq/ml concentrate for solution for infusion

Read the entire package leaflet carefully before starting to receive this medicine, as it contains important information for you.

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

Contents of the package leaflet

1. What Potassium Chloride Braun 1 mEq/ml is and what it is used for
2. What you need to know before using Potassium Chloride Braun 1 mEq/ml
3. How to use Potassium Chloride Braun 1 mEq/ml
4. Possible adverse effects
5. How to store Potassium Chloride Braun 1 mEq/ml
6. Contents of the pack and other information

1. What Cloruro de Potasio Braun 1 mEq/ml is and what it is used for

Cloruro de potasio 1 mEq/ml is a concentrated solution of potassium chloride.

It is used to provide potassium:

• when you have a potassium deficiency, especially if this is accompanied by excess alkali and abnormally low levels of chloride in the blood (hypochloremic alkalosis)
• as part of parenteral nutrition, when you cannot take food normally

2. What you need to know before using Cloruro de Potasio Braun 1 mEq/ml

Do not use Cloruro de Potasio Braun 1 mEq/ml:

If you have abnormally high levels of potassium or chloride in the blood (hyperkalemia, hyperchloremia)

Warnings and precautions

Consult your doctor before starting to use Cloruro de Potasio 1 mEq/ml.

Special care is required with Cloruro de Potasio 1 mEq/ml:

? if you have heart problems

? if you have a condition in which urinary excretion of potassium is often reduced, such as renal dysfunction, Addison's disease (a specific disorder of the adrenal glands), or sickle cell anemia (an inherited red blood cell disorder)

? if your kidney function is severely impaired or if you are on dialysis, your doctor will consult a kidney specialist before administering this medicine

? if you are taking or receiving medications that reduce potassium excretion in urine; for example, if you are taking:

• certain medications that increase urine flow (diuretics)
• certain medications for high blood pressure (angiotensin II receptor antagonists, ACE inhibitors)

? if you are taking or receiving medications that may affect kidney function (e.g., certain medications that suppress inflammatory processes)

? if you are experiencing shock (an acute clinical condition accompanied by low blood pressure, cold skin, rapid heartbeat, and irregular breathing, which may occur, for example, after significant blood loss, severe burns, or an allergic reaction)

? if you have severe tissue injury, such as burn injuries

? if you have a disorder causing muscle weakness and sometimes elevated blood potassium levels (familial hyperkalemic periodic paralysis)

Your doctor will take these factors into account before and during your treatment with this medicine.

If you are receiving this medicine due to potassium deficiency, you will not initially receive glucose infusion at the same time, as glucose may further reduce potassium levels.

While receiving this medicine, your blood electrolyte levels and acid-base balance will be monitored to ensure they remain within normal ranges. In addition, your ECG may also be monitored.

It will be ensured with absolute certainty that the solution is administered intravenously to avoid tissue damage.

If you are receiving this medicine due to potassium deficiency, your doctor will administer it using an infusion pump.

Elderly patients, who are more likely to have heart and kidney problems, will be closely monitored during treatment, and the dosage will be carefully adjusted.

If you are severely malnourished, i.e., have not received sufficient nutrition, there is a possibility you may develop a condition known as "refeeding syndrome." Your doctor will monitor you carefully and gradually increase your nutrient intake.

Use of Cloruro de Potasio 1 mEq/ml with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

In particular, your doctor will pay attention to:

? Medicines for the treatment of heart failure (cardiac glycosides, e.g., digoxin):

The effects of these medicines decrease when blood potassium levels rise. They increase (possibly with irregular heartbeat) when blood potassium levels fall.

? Medicines that reduce potassium excretion in urine:

This group of medicines includes:

• some diuretics that increase urine flow while conserving potassium (such as triamterene, amiloride, and spironolactone)
• certain medicines for treating high blood pressure (angiotensin II receptor antagonists and ACE inhibitors)
• medicines that suppress the immune system (tacrolimus, cyclosporine)
• certain medicines used to treat pain or inflammation (non-steroidal anti-inflammatory drugs)
• anticoagulant medicines (heparin)

Administration of potassium together with these medicines may lead to very high levels of potassium in the blood. This could affect heart rhythm.

? Medicines that increase potassium excretion in urine:

The following medicines may increase potassium excretion in urine:

• a specific hormone (corticotropin [ACTH])
• certain medicines used to treat inflammation (corticosteroids)
• some diuretics that increase urine flow (loop diuretics)

Concomitant administration with potassium may result in an incorrect potassium dosage, as the administered potassium will be eliminated from the body more rapidly than normal.

? Suxamethonium (a muscle relaxant used in general anesthesia):

Administration of potassium together with this medicine may also lead to very high levels of potassium in the blood. This could affect heart rhythm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

To date, no reports have indicated harmful effects or risks associated with the use of this medicine in pregnant women.

Your doctor will administer potassium chloride with caution and only when clearly necessary.

Breastfeeding

Potassium concentrates for infusion may be used during breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

3. How to use Potassium Chloride Braun 1 mEq/ml

Potassium chloride 1 mEq/ml is administered after dilution in a suitable solution. It is given through a small cannula or tube placed into a vein (intravenous infusion).

Dosage

The amount you will receive will be calculated by your doctor based on your blood electrolyte levels, your acid-base balance, your age, and your individual needs.

If you use more Potassium Chloride Braun 1 mEq/ml than you should

It is unlikely that you will ever receive an excessive amount of this medicine. Your doctor or healthcare professional will monitor the administration.

Symptoms

Overdose may lead to abnormally high levels of potassium, with the adverse effects listed below. You are more likely to experience adverse effects if you have a shift in blood towards acidity (acidosis) or have kidney disorders.

Heart and circulation:

? Slow heartbeat or even cardiac arrest
? Changes in the electrocardiogram
? Decreased blood pressure
? Redistribution of circulating blood from the limbs to the head and trunk

Muscles and nervous system:

? Weakness
? Fatigue
? Confusional states
? Heaviness in the limbs
? Muscle spasms
? Loss of sensation
? Paralysis

Treatment

If an overdose occurs, the infusion will be stopped immediately and your doctor will provide the necessary treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

The following adverse effects may be serious. If you experience any of the following, consult your doctor immediately.

? accumulation of acidic substances in the blood (acidosis) (frequency not known)

? abnormally high levels of chloride in the blood (hyperchloremia) (frequency not known)

? irregular heartbeat (cardiac arrhythmia, as a consequence of abnormally high infusion rates) (frequency not known)

Other adverse effects

? nausea (frequency not known)

? reactions at the injection site, such as local pain, irritation or inflammation of the veins (thrombophlebitis), and leakage of fluid into surrounding tissue (extravasation) (frequency not known)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Chloride Braun 1 mEq/ml

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

Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

This medicine should only be used if the solution is clear, colourless, and free from particles, and if the container and closure are intact.

The containers are for single use only. The container and any unused contents must be discarded after use.

6. Contents of the container and other information

Composition of Potassium Chloride Braun 1 mEq/ml:

The active substance is potassium chloride.

1 ml of solution contains 74.5 mg of potassium chloride,

corresponding to 1 mmol of potassium and 1 mmol of chloride.

A 10 ml vial contains 745 mg of potassium chloride.

A 20 ml vial contains 1.49 g of potassium chloride.

The other component is: water for injections.

Appearance of the product and contents of the container

Potassium Chloride Braun 1 mEq/ml is a concentrate for the preparation of a perfusion solution. It must be diluted before use and is administered by intravenous infusion.

It is a clear, colourless aqueous solution.

Potassium Chloride Braun 1 mEq/ml is available in:

Polyethylene plastic vials; contents: 10 ml, 20 ml

Pack sizes:

1 x 10 ml, 20 x 10 ml, 100 x 10 ml

1 x 20 ml, 20 x 20 ml, 100 x 20 ml

Marketing Authorization Holder

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

or

• Braun Melsungen AG

Carl Braun Str. 1

D-34212 Melsungen

Germany

This summary of product characteristics was approved in November 2017

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

This information is intended exclusively for physicians or healthcare professionals:

For complete information on this medicinal product, please consult the Technical Data Sheet or Summary of Product Characteristics.