Potassium phosphate monico

Package leaflet: Information for the user

MONOPOTASSIUM PHOSPHATE

2 mEq/ml concentrate for solution for infusion
Monobasic potassium phosphate and dibasic potassium phosphate
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 others, even if they have the same symptoms as yours, because 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 MONOPOTASSIUM PHOSPHATE is and what it is used for
2. What you need to know before using MONOPOTASSIUM PHOSPHATE
3. How to use MONOPOTASSIUM PHOSPHATE
4. Possible side effects
5. How to store MONOPOTASSIUM PHOSPHATE
6. Contents of the pack and other information

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

POTASSIO FOSFATO MONICO 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, thereby restoring normal levels of phosphate salts in the body when oral intake is inadequate or when replenishment by mouth (orally) is not possible.

2. What you need to know before using POTASSIUM PHOSPHATE MONICO

Do not use POTASSIUM PHOSPHATE MONICO

• 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 calculi);
• if you have untreated adrenal gland disease (Addison's disease);
• if you are experiencing 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 POTASSIUM PHOSPHATE 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), 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 adrenal gland disease (adrenal insufficiency);
• if you have severe liver problems (hepatic failure);
• familial periodic paralysis (occasional episodes of muscle weakness);
• if you have a condition characterized by muscle stiffness (congenital myotonia);
• if you have recently undergone surgery (early post-operative phase);
• if you have high levels of calcium in the blood (hypercalcemia), as calcium salts may precipitate.

Phosphate infusion may cause a decrease in calcium levels in the blood (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 volume, 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 POTASSIUM PHOSPHATE 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 medicines 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, close monitoring of blood potassium levels is required.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before administration of this medicine. This medicine should be used during pregnancy and breastfeeding only if your doctor considers it absolutely necessary.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use POTASSIUM PHOSPHATE MONOBASIC

This medicine will be administered to you by trained healthcare professionals. If you have any doubts, please consult your doctor or nurse.
This medicine will be given directly into a vein (intravenous infusion), 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 (ECG).

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; any remaining solution must not be reused.
Shake well during dilution and before administration. Do not use this 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 either 5% glucose solution or 0.9% sodium chloride solution (physiological saline) and 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 PHOSPHATE MONOBASIC than you should
Since this medicine will be administered by trained healthcare professionals, it is unlikely that you will receive an excessive dose. However, if you think that 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, stop the infusion immediately and initiate corrective therapy to reduce elevated blood levels of potassium and phosphate and restore acid-base balance.

If you have any questions about the use of this medicine, consult 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 sensation (paraesthesiae), flaccid paralysis (loss of muscle tone), weakness;
• mental confusion;
• changes in heart rhythm such as arrhythmias, conduction disorders, 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 (hypervolaemia);
• fever, pain and infection at the infusion site, inflammation of the veins at the injection site (phlebitis);
• circulation problems due to blood clot formation (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, 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 POTASSIUM PHOSPHATE MONOBASIC

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. Package contents and other information

What POTASSIO FOSFATO MONICO 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 MONICO and contents of the pack
Carton pack containing 5 glass vials of 10 ml concentrate for infusion solution.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy