Potassium phosphate Bioindustria L.I.M.

Package leaflet: Information for the user

POTASSIUM PHOSPHATE BIOINDUSTRIA L.I.M. 2 mEq/ml concentrate for solution for infusion

Monobasic potassium phosphate and dibasic potassium phosphate
Equivalent medicine
Read this leaflet carefully before 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, because it could 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 POTASSIUM PHOSPHATE BIOINDUSTRIA L.I.M. is and what it is used for
2. What you need to know before using POTASSIUM PHOSPHATE BIOINDUSTRIA L.I.M.
3. How to use POTASSIUM PHOSPHATE BIOINDUSTRIA L.I.M.
4. Possible side effects
5. How to store POTASSIUM PHOSPHATE BIOINDUSTRIA L.I.M.
6. Contents of the pack and other information

1. What POTASSIO FOSFATO BIOINDUSTRIA L.I.M. is and what it is used for

POTASSIO FOSFATO BIOINDUSTRIA L.I.M. is a saline solution for intravenous infusion
containing the active substance potassium phosphate.
This medicinal product is indicated to provide phosphate ions to the body, in order to restore
normal electrolyte levels, in cases where the body is unable to take in and replenish them
orally.

2. What you need to know before using POTASSIO FOSFATO BIOINDUSTRIA L.I.M.

Do not use POTASSIO FOSFATO BIOINDUSTRIA L.I.M.

• if you are allergic to potassium phosphate or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of potassium in the blood (hyperkalemia or potassium retention or phosphates);
• if you have severe kidney problems (renal failure);
• if you have low levels of calcium in the blood (hypocalcemia);
• if you suffer from kidney stones (renal calculosis);
• 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 painful, brief muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using POTASSIO FOSFATO BIOINDUSTRIA L.I.M.
This medicine must be administered by very slow infusion, as potassium intoxication may occur, which could lead to 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 strict medical supervision in the following cases:

• if you have severe kidney problems (renal failure), as it may cause potassium retention and increased potassium concentration in the blood (hyperkalemia);
• 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 severe liver problems (hepatic failure);
• if you suffer from familial periodic paralysis;
• if you have a condition characterized by muscle stiffness (congenital myotonia);
• if you have recently undergone surgery;
• if you have high levels of calcium in the blood (hypercalcemia), as calcium salts may precipitate. Phosphate infusion may cause a decrease in blood calcium levels (hypocalcemia).

During treatment with this medicine, your doctor must periodically monitor your blood potassium levels and heart function through serial electrocardiograms.
During treatment, you must be monitored for body fluid balance, blood electrolyte levels (plasma osmolarity), and regulation of acid-base balance in the blood (acid-base equilibrium).
Children
The safety and efficacy of potassium phosphate in children have not been established.
Other medicines and POTASSIO FOSFATO BIOINDUSTRIA L.I.M.
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 medications used to lower blood pressure, such as potassium-sparing diuretics, ACE inhibitors, or other drugs that reduce aldosterone levels, as they may lead to increased potassium levels in the blood (hyperkalemia), especially in the presence of kidney problems; in such cases, blood potassium levels must be closely monitored.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine, as it should only be used if your doctor considers it strictly necessary.
Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use POTASSIO FOSFATO BIOINDUSTRIA L.I.M.

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 by intravenous infusion (into a vein), after appropriate dilution and at a rate not exceeding 8 mEq per hour. Infusing too rapidly may cause local pain.
Your doctor will adjust the dosage and infusion rate according to your age, body weight, and clinical condition.
The recommended dose is 0.2 – 0.5 mEq per kg of body weight, administered via a 12-hour infusion, followed by a 12-hour pause. The total daily dose must not exceed 200 mEq. During treatment, your heart function will be continuously monitored by electrocardiogram.
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, uninterrupted administration, and any remaining solution must not be reused.
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 not be injected undiluted. It may cause death if administered without dilution.
This medicine must be diluted with 5% glucose solution or 0.9% sodium chloride (physiological saline) and 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 POTASSIO FOSFATO BIOINDUSTRIA L.I.M. than you should
Since this medicine will be administered by specialized personnel, 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, immediately discontinue the infusion and initiate corrective therapy to reduce elevated blood levels of potassium and phosphate and restore 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 everyone experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• gastrointestinal disorders
• neuromuscular disorders, altered limb sensitivity (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness
• mental confusion
• changes in heart rhythm such as arrhythmias, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram
• reduction in blood pressure (hypotension), cardiac arrest
• increase in circulating blood volume (hypervolemia)
• fever, infection at the infusion site, inflammation of veins at the injection site (phlebitis)
• circulation problems due to formation of blood clots (thrombosis)
• leakage of the medicine into the surrounding tissues at the injection site (extravasation)
• formation of calcium deposits in the skin (cutaneous calcification)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
http://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 FOSFATO BIOINDUSTRIA L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 medicines 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 FOSFATO BIOINDUSTRIA L.I.M. contains

• The active substance is potassium phosphate. 10 ml of solution contain 0.30 g of monobasic potassium phosphate and 1.55 g of dibasic potassium phosphate (each ml of solution contains 2 mEq of potassium and 2 mEq of phosphate). pH 7.0–7.8.
• The other component is water for injections.

Description of the appearance of POTASSIO FOSFATO BIOINDUSTRIA L.I.M. and contents of the package
Carton containing 10 vials of 10 ml concentrate for infusion solution.
Pack containing 1 or 10 infusion bottles of 30 ml solution.

Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2
Novi Ligure (AL) - Italy