Potassium chloride Monico

Package leaflet: Information for the user

POTASSIO CLORURO MONICO

2 mEq/ml concentrate for solution for infusion
3 mEq/ml concentrate for solution for infusion
Potassium chloride
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What POTASSIO CLORURO MONICO is and what it is used for
2. What you need to know before using POTASSIO CLORURO MONICO
3. How to use POTASSIO CLORURO MONICO
4. Possible side effects
5. How to store POTASSIO CLORURO MONICO
6. Contents of the pack and other information

1. What POTASSIO CLORURO MONICO is and what it is used for

POTASSIO CLORURO MONICO is a saline solution for direct intravenous administration (intravenous infusion), containing the active substance potassium chloride.
This medicinal product is indicated to supply potassium and chloride ions to the body, in order to restore normal potassium levels when oral administration is not possible.

2. What you should know before using POTASSIO CLORURO MONICO

Do not use POTASSIO CLORURO MONICO

• if you are allergic to potassium chloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of potassium in your blood (hyperkalaemia) or a reduced ability to eliminate it from your body (potassium retention);
• if you have severe kidney, liver or adrenal gland problems (severe renal, hepatic or adrenal insufficiency);
• if you have an untreated adrenal gland disorder (Addison's disease);
• if you are suffering from severe fluid loss from the body (acute dehydration);
• if you experience short, painful muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using POTASSIO CLORURO MONICO.
This medicine must be administered by very slow infusion, as it may cause potassium intoxication, which
can lead to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to
complete cessation of heart activity (cardiac arrest) (see section 3).
This medicine must be administered with caution and under close medical supervision in the following
cases:

• if you have kidney problems (renal insufficiency or reduced kidney function), as it may cause potassium retention;
• if you have heart problems (cardiac insufficiency), especially if you are taking digitalis medications used to treat heart rhythm disorders;
• if you have an adrenal gland disorder (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if you have periodic paralysis (a disorder characterized by sudden episodes of muscle weakness);
• if you have congenital myotonia, a disease characterized by muscle stiffness;
• if you have recently undergone surgery (early post-operative phase).

During treatment with this medicine, your doctor must monitor your blood potassium levels, heart function
through serial electrocardiograms, and the levels of electrolytes, fluids and blood pH.
Children
In children, the safety and efficacy of potassium chloride use have not been established.
Other medicines and POTASSIO CLORURO MONICO
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
This medicine must be administered with caution if you are taking antihypertensive medicines such as
potassium-sparing diuretics, especially in case of kidney problems, ACE inhibitors, or other medicines that
reduce aldosterone levels, as they may lead to increased potassium levels in the blood (hyperkalaemia); in such
cases, serum potassium levels must be closely monitored.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before using this medicine.
POTASSIO CLORURO MONICO must not be used during pregnancy or breastfeeding unless clearly necessary.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use POTASSIO CLORURO MONICO

This medicine will be administered to you by specialized healthcare personnel. If you have any doubts, consult your doctor or nurse.
This medicine will be given directly into a vein (intravenous infusion), after appropriate dilution and at a controlled rate. It can cause death if injected undiluted. Infusing too rapidly may cause local pain.
Your doctor will adjust the dosage and infusion rate according to your age, body weight, clinical condition, blood potassium levels, and daily potassium requirements.
This medicine must be administered only if your kidney function is normal.
The recommended dose in adults should provide 40–80 mEq per day. The total daily dose must not exceed 200 mEq.
In emergency situations, when blood potassium levels are very low (severely low serum potassium levels), the infusion rate and dose may be increased by the physician under close electrocardiographic monitoring.

Use in children
This medicine should be administered only when absolutely necessary, as the safety and efficacy of potassium chloride have not been established. The recommended dose is 2–3 mEq per kilogram of body weight per day.

Preparation of the medicine: Dilute the solution immediately after opening the container; the diluted solution must be used immediately. The solution must be clear, colourless, and free from visible particles. It is intended for single and uninterrupted administration; any unused portion must not be retained.
Shake well during preparation of the dilution and before administration. Do not use the medicine if the solution is not clear and colourless or if it contains particles.
This medicine must be diluted with 5% glucose solution, 0.9% sodium chloride solution (physiological saline), or other compatible solutions and must not be mixed with other medicinal products.
Ensure that all precautions are taken to maintain sterility before and during intravenous infusion.

If you use more POTASSIO CLORURO MONICO than you should
Since this medicine is administered by trained healthcare professionals, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much of this medicine, inform your doctor immediately or go to the nearest hospital.
Following administration of an excessive dose of this medicine, the infusion must be stopped immediately and appropriate therapy initiated.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• Stomach and intestinal disorders (gastrointestinal disorders);
• Muscle and nerve disorders (neuromuscular disorders), altered sensation in limbs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness;
• Mental confusion;
• Changes in heart rhythm (arrhythmias), conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest;
• Reduction in blood pressure (hypotension);
• Fever, infection at the infusion site, inflammation of veins at the injection site (phlebitis);
• Circulatory problems due to blood clot formation (thrombosis);
• Leakage of medicine into surrounding tissues at the injection site (extravasation);
• Increase in circulating blood volume (hypervolaemia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store POTASSIO CLORURO MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after “EXP.”
The expiry date refers to the last day of that month.
Store in the original packaging and in the original container tightly closed. Do not refrigerate or freeze.
The solution must be clear, colourless and free from visible particles. The diluted solution must be used
immediately and any unused medicinal product remaining must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What POTASSIO CLORURO MONICO contains
POTASSIO CLORURO MONICO 2 mEq/ml concentrate for solution for infusion

• The active substance is potassium chloride. 10 ml of solution contain 1.49 g of potassium chloride. Each ml of solution contains 2 mEq of potassium and 2 mEq of chloride.
• The other component is water for injections.

POTASSIO CLORURO MONICO 3 mEq/ml concentrate for solution for infusion

• The active substance is potassium chloride. 10 ml of solution contain 2.24 g of potassium chloride. Each ml of solution contains 3 mEq of potassium and 3 mEq of chloride.
• The other component is water for injections.

Description of the appearance of POTASSIO CLORURO MONICO and package contents
POTASSIO CLORURO MONICO 2 mEq/ml sterile and pyrogen-free concentrate for solution for infusion
Pack containing 5 or 10 glass vials of 10 ml solution.
POTASSIO CLORURO MONICO 3 mEq/ml sterile and pyrogen-free concentrate for solution for infusion
Pack containing 1, 5 or 10 glass vials of 10 ml solution.
Pack containing 1 or 10 glass vials of 30 ml solution.
Pack containing 10 glass vials of 100 ml solution.
Glass vial of 100, 250 or 500 ml solution.

Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy.

The following information is intended exclusively for healthcare professionals

Dosage and administration
The dose depends on the patient's age, body weight, and clinical condition, taking into account that the normal daily potassium requirement is as follows:
Adults: 40–80 mEq per day. The total daily dose must not exceed 200 mEq.
Children: 2–3 mEq/kg per day.
In children, the safety and efficacy of potassium chloride use have not been established.
The medicinal product must not be injected undiluted. It is fatal if infused undiluted.
The medicinal product must be administered intravenously only after dilution in 5% glucose solution, 0.9% sodium chloride solution (physiological saline), or other compatible solutions, and at a controlled infusion rate.
The medicinal product must be administered only in the presence of normal renal function and at a rate not exceeding 10 mEq of potassium per hour.
Too rapid infusions may cause local pain; therefore, the infusion rate should be adjusted according to patient tolerance.
Dilute the solution immediately after opening the container; the diluted solution must be used immediately. The solution must be clear, colorless, and free from visible particles. It is intended for single, uninterrupted administration, and any unused portion must not be retained.
Shake well during dilution preparation and prior to administration.

Emergency conditions
In emergency situations (serum potassium levels ≤ 2 mEq/L with electrocardiographic changes and muscle paralysis), the infusion rate must not exceed 40 mEq/hour, under continuous electrocardiographic monitoring, and the total dose must not exceed 400 mEq within 24 hours.

Overdose
In case of overdose, immediately discontinue the potassium-containing infusion and initiate corrective therapy to reduce elevated plasma potassium levels and, if necessary, restore acid-base balance.

Incompatibilities
Unless otherwise indicated, and except for the solutions mentioned in the section “Dosage and administration,” mixing potassium chloride solution with other medicinal products is not recommended.

Special precautions for disposal and handling
Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.
Observe all standard precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.

For further information, consult the Summary of Product Characteristics.