Potassium chloride Galenica Senese

Patient Information Leaflet: Information for the User

POTASSIUM CHLORIDE GALENICA SENESE 2 mEq/ml concentrate for solution for infusion, 3 mEq/ml concentrate for solution for infusion

Potassium chloride
Generic medicinal product
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 adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What POTASSIUM CHLORIDE GALENICA SENESE is and what it is used for
2. What you need to know before using POTASSIUM CHLORIDE GALENICA SENESE
3. How to use POTASSIUM CHLORIDE GALENICA SENESE
4. Possible side effects
5. How to store POTASSIUM CHLORIDE GALENICA SENESE
6. Package contents and other information

1. What POTASSIO CLORURO GALENICA SENESE is and what it is used for

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

2. What you need to know before using POTASSIUM CHLORIDE GALENICA SENESE

Do not use POTASSIUM CHLORIDE GALENICA SENESE

• 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 potassium retention);
• if you have severe kidney problems (severe renal failure);
• if you have untreated adrenal gland disease (Addison's disease);
• if you are suffering from severe loss of body fluids (acute dehydration);
• if you experience painful, short-lived muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using POTASSIUM CHLORIDE GALENICA SENESE.
This medicine must be administered by very slow infusion, as rapid administration may cause potassium intoxication, which could result in death due to loss of heart function (cardiac depression), disturbances 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 close 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 adrenal gland disease (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if any member of your family suffers from a disorder characterized by sudden attacks of muscle weakness (familial periodic paralysis);
• if you have 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 through serial electrocardiograms (ECGs), and the concentrations of electrolytes, fluid balance, and blood pH.
Other medicines and POTASSIUM CHLORIDE GALENICA SENESE
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 case of kidney problems, ACE inhibitors, or other medicines that reduce levels of the hormone aldosterone, 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, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
Your doctor will prescribe this medicine only if strictly necessary, after carefully weighing the benefits against the potential risks.
Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

3. How to use POTASSIUM CHLORIDE GALENICA SENESE

This medicinal product will be administered to you by trained healthcare personnel. If you have any doubts, consult your doctor or nurse.
This medicinal product will be administered by direct intravenous injection (intravenous infusion), after appropriate dilution. It may cause death if injected undiluted.
Your doctor will adjust the dosage and infusion rate according to your age, body weight, clinical condition, and blood potassium levels, taking into account your daily potassium requirements.
The medicinal product 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 without exceeding 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, with the patient under close monitoring.

Use in children
The safety and efficacy of potassium chloride in children have not been established.
The medicinal product should be administered only when absolutely necessary. The recommended dose is 2–3 mEq per kg of body weight per day.

Preparation of the medicinal product: 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, and any remaining solution must not be used.
Shake well during preparation of the dilution and before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles.
This medicinal product must be diluted with 5% glucose solution or 0.9% sodium chloride solution (physiological saline). It must not be mixed with other medicinal products.
Ensure all necessary precautions are taken to maintain sterility before and during intravenous infusion.

If you use more POTASSIUM CHLORIDE GALENICA SENESE than you should
This medicinal product will be administered by trained healthcare personnel; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much of this medicinal product, inform your doctor immediately or go to the nearest hospital.
Following administration of an excessive dose of this medicinal product, the infusion will be stopped immediately, and corrective therapy will be initiated to reduce potassium levels and restore blood acid-base balance.
If you have any doubts about how to use this medicinal product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

• gastrointestinal disorders;
• disorders of muscles and nerves (neuromuscular), altered sensation in limbs (paraesthesiae), 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);
• circulation problems due to formation of blood clots in veins (venous thrombosis);
• leakage of the medicine into surrounding tissues at the injection site (extravasation);
• increase in circulating blood volume (hypervolemia).

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.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 GALENICA SENESE

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 “Expiry”.
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 should be clear, colourless, and free from visible particles. The diluted solution must be used immediately, and any unused medicinal solution 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 in use. This will help protect the environment.

6. Package contents and other information

What POTASSIO CLORURO GALENICA SENESE contains
POTASSIO CLORURO GALENICA SENESE 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, corresponding to 20 mEq of potassium and chloride. (pH 5.5 - 6.5).
• The other component (excipient) is water for injections.

POTASSIO CLORURO GALENICA SENESE 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, corresponding to 30 mEq of potassium and chloride (pH 5.5 - 6.5).
• The other component (excipient) is water for injections.

Description of the appearance of POTASSIO CLORURO GALENICA SENESE and contents of the
packaging
Pack sizes of 1, 5 or 10 vials of 10 ml solution.
Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni D’Arbia (SI)
Italy