Potassium phosphate S.A.L.F.

Package leaflet: Information for the user

POTASSIUM PHOSPHATE S.A.L.F. 2 mEq/ml concentrate for solution for infusion

Monobasic potassium phosphate and dibasic potassium phosphate
Equivalent 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 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 S.A.L.F. is and what it is used for
2. What you need to know before you use POTASSIUM PHOSPHATE S.A.L.F.
3. How to use POTASSIUM PHOSPHATE S.A.L.F.
4. Possible side effects
5. How to store POTASSIUM PHOSPHATE S.A.L.F.
6. Contents of the pack and other information

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

POTASSIO FOSFATO S.A.L.F. is a saline infusion solution containing the active substance potassium phosphate.
This medicinal product is indicated to provide phosphate ions to the body in order to restore normal phosphate levels when intake is inadequate and oral (by mouth) replacement is not possible.

2. What you should know before using POTASSIO FOSFATO S.A.L.F.

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

• 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 (hyperkalaemia or potassium or phosphate retention);
• if you have severe kidney problems (renal failure);
• if you have low levels of calcium in the blood (hypocalcaemia);
• if you suffer from kidney stones (renal calculosis);
• if you have an untreated adrenal gland disorder (Addison's disease);
• if you are experiencing 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 FOSFATO S.A.L.F.
This medicine must be administered by a very slow infusion, as it may cause potassium intoxication, which
can lead to death due to loss of heart function (cardiac depression), disturbances in heartbeat 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 severe kidney problems (renal failure), as it may cause potassium retention and increased potassium concentration in the blood (hyperkalaemia);
• if you have heart problems (heart failure), especially if you are taking digitalis medications, used to treat irregular heartbeat;
• if you have an adrenal gland disorder (adrenal insufficiency);
• if you have severe liver problems (hepatic failure);
• familial periodic paralysis (occasional episodes of muscle weakness);
• if you suffer from 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 (hypercalcaemia), as calcium salts may precipitate.

Phosphate infusion may cause a decrease in calcium levels in the blood (hypocalcaemia).
During treatment with this medicine, your doctor must periodically monitor potassium levels in the blood and heart function via serial electrocardiograms.
During treatment, your body fluid levels, blood electrolyte levels (plasma osmolarity), and regulation of acid-base balance in the blood must be monitored.
Children
The safety and efficacy of potassium phosphate in children have not been established.
Other medicines and POTASSIO FOSFATO 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, ACE inhibitors, or other medicines that reduce aldosterone levels, as they may lead to increased potassium levels in the blood (hyperkalaemia), especially if kidney problems are present; in such cases, close monitoring of blood potassium levels is required.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or 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 impair the ability to drive vehicles or operate machinery.

3. How to use POTASSIO FOSFATO S.A.L.F.

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 directly into a vein (intravenous infusion), after appropriate dilution and at a rate not exceeding 8 mEq per hour. Too rapid an infusion 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 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, uninterrupted administration; 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 not be injected undiluted. It may cause death if injected without dilution.
This medicinal product must be diluted with 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 POTASSIO FOSFATO S.A.L.F. than you should
Since this medicinal product will be administered by trained healthcare personnel, it is unlikely that you will receive an excessive dose. However, if you think you have received 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, 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 medicinal product, consult 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), 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 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 effects, 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 S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP.”.
The expiry date refers to the last day of that month.
Store in the original container and keep the 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 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 FOSFATO S.A.L.F. 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 ingredient is water for injections.

Description of the appearance of POTASSIO FOSFATO S.A.L.F. and contents of the pack
Carton pack containing 5 glass vials of 10 ml concentrate for infusion solution.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) – Italy.