Potassium chloride Braun 2 mEq/ml concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium Chloride Braun 2 mEq/ml

concentrate for infusion solution

Read the entire package leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, 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.

Contents of the leaflet

1. What Potassium Chloride Braun 2 mEq/ml is and what it is used for
2. Before you start using Potassium Chloride Braun 2 mEq/ml
3. How to use Potassium Chloride Braun 2 mEq/ml
4. Possible side effects
5. How to store Potassium Chloride Braun 2 mEq/ml
6. Further information

1. What Potassium Braun 2 mEq/ml is and what it is used for

This product belongs to the group of "Additives for intravenous solutions: Electrolyte solutions" and is supplied by prescription.

Potassium Chloride Braun 2 mEq/ml is indicated in the treatment of potassium deficiencies (prolonged therapy with potassium-depleting diuretics, digitalis intoxication, low dietary potassium intake, vomiting and diarrhea, metabolic alkalosis, corticosteroid therapy, increased renal excretion due to acidosis, and hemodialysis).

2. Before using Potassium Chloride Braun 2 mEq/ml

Do not use Potassium Chloride Braun 2 mEq/ml:

If you are allergic (hypersensitive) to potassium chloride or to any of the other ingredients of the medicine.

If you have:

• kidney or adrenal cortex disorders (glands located above the kidneys)
• heart block and are being treated with digitalis drugs (heart stimulants)
• reduced or absent urine production (oliguria or anuria)
• excess acids in the tissues and blood (metabolic acidosis)

Take special care with Potassium Chloride Braun 2 mEq/ml:

Administration must be performed slowly and under monitoring of heart activity.

The dose should be individually adjusted according to the patient's needs based on blood test results.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using this medicine.

The safety of this preparation during pregnancy and breastfeeding has not been established; therefore, the benefit-risk balance of the therapy should be carefully evaluated before administration.

Driving and operating machinery:

There is no evidence that this medicine may affect the ability to drive vehicles or operate complex machinery.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Potassium chloride is incompatible with:

• Amikacin, Amphotericin B, Dobutamine, 10% fat emulsions, 20-25% mannitol solutions, and Sodium Penicillin G.

Combinations not recommended with Potassium Chloride Braun (except in cases of low blood potassium - hypokalemia):

• Potassium-sparing diuretics (such as amiloride, spironolactone, or triamterene), alone or in combination with other medicines
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)
• Blood-derived products.

Combinations possible but with special precautions in use:

• Quinidine and digoxin (medicines used to treat heart disorders)
• Thiazides (for treatment of high blood pressure)
• Hormones such as adrenocorticoids, glucocorticoids, and mineralocorticoids
• Ion-exchange resins (which replace potassium with sodium).

Your doctor will check the compatibility of this medicine with other drugs before use.

3. How to use Potassium Chloride Braun 2 mEq/ml

Follow exactly the administration instructions for Potassium Chloride Braun 2 mEq/ml given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Potassium Chloride Braun 2 mEq/ml is administered intravenously.

Normal doses in adults and adolescents:

Administration only by intravenous route after dilution in an appropriate solution, to a maximum concentration of 4 g/l of potassium chloride (or 50 mmol/l of potassium).

1 g of potassium chloride corresponds to 13.4 mmol or 524 mg of potassium.

The normal daily intake is approximately 0.8 to 2 mmol of potassium per kilogram of body weight. The usual therapeutic dose is 20 mmol to 60 mmol every 24 hours.

Paediatric doses:

The safety and efficacy of potassium chloride have not been fully established in paediatric patients. However, intravenous administration is recommended after dilution in an appropriate solution, with a maximum concentration of 3 mmol of potassium/kg of body weight, or 40 mmol/m² of body surface area.

The normal infusion rate is 10 mmol/hour, although in severe cases it may reach up to 15 mmol/hour.

The maximum daily dose is 150 mmol in adults and 3 mmol/kg of body weight per day in children.

Your doctor will advise you on the duration of treatment with Potassium Chloride Braun 2 mEq/ml.

If you think that the effect of Potassium Chloride Braun 2 mEq/ml is too strong or too weak, inform your doctor or pharmacist.

If you use more Potassium Chloride Braun 2 mEq/ml than you should

If you have used more Potassium Chloride Braun 2 mEq/ml than you should, contact your doctor or pharmacist immediately.

This is unlikely to happen, as your doctor will determine the dose you need. However, if you were to receive more medication than required, you might experience: slower heartbeat (bradycardia), confusion, fatigue, diarrhoea, difficulty swallowing (dysphagia), changes in the electrocardiogram, excess potassium in the blood (hyperkalaemia), breathing difficulties, uncontrolled contraction of heart muscle fibres (ventricular fibrillation), paralysis of voluntary muscles, cardiac arrest, and death.

If any of these effects occur, treatment must be immediately discontinued and all potassium-containing elements in the diet and potassium-sparing diuretic medications should be removed.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

If you forget to use Potassium Chloride Braun 2 mEq/ml:

Do not use a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, Cloruro de Potasio Braun 2 mEq/ml may produce adverse effects, although not everyone experiences them.

The possible adverse reactions are those caused by high levels of potassium in the blood, mainly manifesting as neuromuscular and cardiac disturbances.

General disorders and administration site reactions:

Frequency unknown:

• pain at the injection site,
• cell death in case of blood leakage,
• inflammation of the veins in case of concentrations that are too high.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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 2 mEq/ml

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Potassium Chloride Braun 2 mEq/ml after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

Keep Potassium Chloride Braun 2 mEq/ml out of the reach and sight of children.

6. Additional information

Composition of Potassium Chloride Braun 2 mEq/ml:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container

Potassium Chloride Braun 2 mEq/ml is available in the following presentations: (not all sizes may be marketed).

Marketing Authorization Holder

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer Responsible

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 leaflet was approved in March 2015

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS).

This information is intended exclusively for physicians or healthcare professionals:

Instructions for correct administration:

Administer exclusively diluted in an appropriate solution and by intravenous route.

Drug addition should be performed by trained personnel, never in a hanging position, and compatibility tables must be consulted before combining or co-administering with other medications. Incompatibility may occur with amikacin, amphotericin B, dobutamine, 10% fat emulsions, etc.

Once the ampoule is opened, the nozzle can be attached directly to the Luer cone of a syringe, thus eliminating the need for a needle to withdraw the drug.

The solution should be visually inspected before use. The solution must be clear, free from precipitates, and the container must be intact. Do not administer if these conditions are not met.

Use an aseptic technique when administering the solution and when adding medications, if necessary.