Potassium chloride S.A.L.F.

Patient Leaflet: Information for the User

POTASSIO CLORURO S.A.L.F. 2 mEq/ml concentrate for solution for infusion, 3 mEq/ml concentrate for solution for infusion

Potassium chloride
Equivalent medicine
Please read this leaflet carefully before using this medicine as 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 effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What POTASSIO CLORURO S.A.L.F. is and what it is used for

POTASSIO CLORURO S.A.L.F. is a saline solution for direct intravenous injection (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 electrolyte levels when oral administration of mineral salts is not possible (treatment of potassium deficiency).

2. What you need to know before using POTASSIO CLORURO S.A.L.F.

Do not use POTASSIO CLORURO S.A.L.F.

• 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 the blood (hyperkalaemia or potassium retention);
• if you have severe kidney problems (renal failure);
• if you suffer from an untreated adrenal gland disorder (Addison's disease);
• if you have severe fluid loss from the body (acute dehydration);
• if you experience painful, short-lived muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using POTASSIO CLORURO S.A.L.F.
This medicine must be administered to you by very slow infusion, as rapid administration may cause
potassium intoxication, which could lead to death due to loss of heart function (cardiac depression),
abnormalities in heart rhythm (arrhythmias), up to complete cessation of heart activity (cardiac arrest) (see
section 3).
This medicine must be administered with caution and under strict medical supervision in the following
cases:

• if you have kidney problems (renal failure);
• if you have heart problems (heart failure), 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 any member of your family suffers from a disorder characterized by episodes of sudden muscle weakness (familial periodic paralysis);
• if you suffer from a condition characterized by muscle stiffness (congenital myotonia);
• 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 via serial electrocardiograms, and the concentrations of mineral salts (electrolytes), fluids, and blood pH.
Other medicines and POTASSIO CLORURO S.A.L.F.
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 medicines used to lower blood pressure such as potassium-sparing diuretics, especially in the presence of kidney problems, ACE inhibitors, or other medicines that reduce levels of the hormone aldosterone, as these may lead to increased potassium levels in the blood (hyperkalaemia); in such cases, close monitoring of serum potassium levels is required.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
Use this medicine during pregnancy or while breastfeeding only if clearly needed and under direct medical supervision.
Driving and using machines
This medicine does not impair your ability to drive or operate machinery.
POTASSIO CLORURO S.A.L.F. 3 mEq/ml concentrate for infusion solution in 30 ml vial contains benzyl alcohol
This medicine contains benzyl alcohol and must not be given to premature infants or newborns. Due to the risk of fatal toxic reactions from exposure to benzyl alcohol exceeding 90 mg/kg/day, this medicine must not be administered to children under 3 years of age. Exposure up to 90 mg/kg/day may still cause toxic and allergic reactions in children under 3 years of age.

3. How to use POTASSIUM CHLORIDE S.A.L.F.

This medicine will be administered to you by trained healthcare professionals. If you have any doubts, consult your doctor or nurse.

This medicine will be administered by direct intravenous injection (intravenous infusion), only after appropriate dilution. It can cause death if injected undiluted.

Your doctor will adjust the dosage and infusion rate according to your age, body weight, clinical condition, blood potassium levels, and daily potassium requirements.

The medicine must be administered only if kidney function is normal and at a rate not exceeding 10 mEq of potassium per hour. Infusing too rapidly may cause local pain.

The recommended dose in adults should provide 40–80 mEq daily and may be increased, but must not exceed 200 mEq per day.

In emergency situations, when blood potassium levels are very low (serum potassium levels ≤ 2 mEq/L with electrocardiographic changes and muscle paralysis), the infusion rate may be increased up to 40 mEq per hour, without exceeding a total dose of 400 mEq of potassium within 24 hours, provided the patient is under close monitoring.

Use in children
In children, the safety and efficacy of potassium chloride have not been established.
The medicine should be administered only when absolutely necessary. The recommended dose is 2–3 mEq per kg 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 remaining solution must not be used.

Shake well during dilution preparation 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 either 5% glucose solution or 0.9% sodium chloride solution (physiological saline). It must not be mixed with other medicines.

Ensure all necessary precautions are taken to maintain sterility before and during intravenous infusion.

If you use more POTASSIUM CHLORIDE S.A.L.F. than you should
This medicine will be administered by trained healthcare professionals, so 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, stop the infusion immediately and initiate corrective therapy to restore potassium levels and blood acid-base balance.

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 everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• gastrointestinal disorders;
• neuromuscular disorders, altered limb sensation (paraesthesiae), loss of muscle tone (flaccid paralysis), weakness;
• confusion;
• changes in heart rhythm (arrhythmias), conduction disorders, absence of 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 the veins at the injection site (phlebitis);
• circulation problems due to formation of blood clots (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, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store POTASSIUM CHLORIDE S.A.L.F.

Keep this medicine out of the sight and reach 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What POTASSIO CLORURO S.A.L.F. contains
POTASSIO CLORURO S.A.L.F. 2 mEq/ml concentrate for infusion solution, 10 ml vial

• The active substance is potassium chloride. 10 ml of solution contain 1.49 g of potassium chloride; equivalent to 20 mEq of potassium and chloride.
• The other component (excipient) is water for injections.

POTASSIO CLORURO S.A.L.F. 3 mEq/ml concentrate for infusion solution, 10 ml vial

• The active substance is potassium chloride. 10 ml of solution contain 2.24 g of potassium chloride; equivalent to 30 mEq of potassium and chloride.
• The other component (excipient) is water for injections.

POTASSIO CLORURO S.A.L.F. 3 mEq/ml concentrate for infusion solution, 30 ml vial

• The active substance is potassium chloride. 30 ml of solution contain 6.71 g of potassium chloride; equivalent to 90 mEq of potassium and chloride.
• Other components are: benzyl alcohol and water for injections.

Description of the appearance of POTASSIO CLORURO S.A.L.F. and contents of the pack
POTASSIO CLORURO S.A.L.F. 2 mEq/ml concentrate for infusion solution
Packs containing 5 glass vials of 10 ml.
Packs containing 5 PE vials of 10 ml.
POTASSIO CLORURO S.A.L.F. 3 mEq/ml concentrate for infusion solution
Packs containing 5 glass vials of 10 ml or 1 glass vial of 30 ml.

Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) – Italy.