POTASSIUM CHLORIDE BRAUN 2 mEq/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

CotasioBE

Concentrate for Solution for Infusion

Read all of this leaflet carefully before you start usingthis medicine

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Cloruro de Potasio Braun 2 mEq/ml is and what it is used for
2. Before you use Potasio Braun 2 mEq/ml
3. How to use Potasio Braun 2 mEq/ml
4. Possible side effects
5. Storage of Potasio Braun 2 mEq/ml
6. Further information

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

This product belongs to the group of "Additives for intravenous solutions: Electrolytic solutions" and is dispensed with a medical prescription.

Cloruro de Potasio Braun 2 mEq/ml is indicated in the treatment of potassium deficits (prolonged treatments with potassium-depleting diuretics, digitalis poisoning, low potassium intake in the diet, vomiting and diarrhea, metabolic alkalosis, corticosteroid therapy, elevated renal excretion due to acidosis and hemodialysis).

2. Before using Cloruro de Potasio Braun 2 mEq/ml

Do not use Cloruro de Potasio Braun 2 mEq/ml:

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

If you have:

• kidney or adrenal cortex disorders (glands located above the kidneys)
• heart block and are being treated with digitalis medications (heart stimulants)
• decreased or absent urine formation and elimination (oliguria or anuria)
• excess acid in the tissues and blood (metabolic acidosis)

Be especially careful withCloruro de Potasio Braun 2 mEq/ml:

Administration must be done slowly and under control of heart activity.

The dose should be scheduled on an individual basis according to the patient's needs based on blood test results.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using a medicine.

The safety of the preparation during pregnancy and breastfeeding has not been established, so its administration must be previously assessed for benefit/risk of therapy.

Driving and using machines:

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

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 for Cloruro de Potasio Braun with the following medicines (except in case of lack of potassium in the blood - 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 with special precautions for use:

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

Your doctor will check the compatibility of this medicine with others before using it.

3. How to use Cloruro de Potasio Braun 2 mEq/ml

Follow exactly the administration instructions of Cloruro de Potasio Braun 2 mEq/ml indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Cloruro de Potasio Braun 2 mEq/ml is administered intravenously.

Normal doses in adults and adolescents:

Administration only by intravenous route after dilution in a suitable solution, up 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.

Pediatric doses:

The safety and efficacy of potassium chloride have not been fully established in pediatric patients. However, it is recommended to administer intravenously after dilution in a suitable solution at 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 can reach 15 mmol/hour.

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

Your doctor will indicate the duration of treatment with Cloruro de Potasio Braun 2 mEq/ml.

If you think the action of Cloruro de Potasio Braun 2 mEq/ml is too strong or too weak, tell your doctor or pharmacist.

If you use more Cloruro de Potasio Braun 2 mEq/ml than you should

If you have used more Cloruro de Potasio Braun 2 mEq/ml than you should, consult your doctor or pharmacist immediately.

It is unlikely that this will happen since your doctor will determine the dose you need. However, if you receive more medicine than you should, you may experience: slower heart rate (bradycardia), confusion, fatigue, diarrhea, difficulty swallowing (dysphagia), changes in the electrocardiogram, excess potassium in the blood (hyperkalemia), breathing difficulties, uncontrolled contraction of the heart muscle fibers (ventricular fibrillation), paralysis of the voluntary muscles, heart stoppage, and death.

In the event of any of these effects, treatment should be stopped immediately and any potassium-containing element should be eliminated from the diet and diuretic medications.

In case of overdose or accidental ingestion, consult 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 Cloruro de Potasio Braun 2 mEq/ml:

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

4. Possible side effects

Like all medicines, Cloruro de Potasio Braun 2 mEq/ml can cause side effects, although not everybody gets them.

The adverse reactions that may occur are those due to high levels of potassium in the blood, mainly manifesting as neuromuscular and heart disorders.

General disorders and administration site conditions:

Frequency not known:

• pain at the injection site,
• cell death in case of bleeding,
• inflammation of the veins in case of too high concentrations.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cloruro de Potasio Braun 2 mEq/ml

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Cloruro de Potasio Braun 2 mEq/ml after the expiry date stated on the packaging. 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 no longer required. This will help protect the environment.

Keep Cloruro de Potasio Braun 2 mEq/ml out of the reach and sight of children.

6. Further information

Composition of Cloruro de Potasio Braun 2 mEq/ml:

The other ingredients are: water for injectable preparations.

Appearance of the product and pack contents

Cloruro de Potasio Braun 2 mEq/ml is presented in the following formats: (not all sizes may be marketed).

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 leaflet was approved in March 2015

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.

This information is intended only for healthcare professionals:

Instructions for correct administration:

Administer exclusively diluted in a suitable solution and by intravenous route.

The addition of the medicine should be done by suitable personnel, never in a hanging position and taking into account the compatibility tables before adding or administering simultaneously with other medicines. There may be incompatibility with amikacin, amphotericin B, dobutamine, 10% fat emulsions, etc.

Once the ampoule is opened, the nozzle is adjusted to the Luer cone of a syringe, so no needle is required for extraction of the medicine.

The solution must be visually inspected before use. The solution must be transparent, not contain precipitates, and the packaging must be intact. Do not administer otherwise.

Use an aseptic procedure to administer the solution and add medicines if necessary.