Potassium aspartate Monico

PACKAGE LEAFLET: INFORMATION FOR THE USER

POTASSIUM ASPARTATE MONICO

1 mEq/ml concentrate for solution for infusion and oral use
3 mEq/ml concentrate for solution for infusion and oral use
Potassium aspartate
Generic medicine
Please 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If any side effect occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What POTASSIUM ASPARTATE MONICO is and what it is used for
2. What you need to know before using POTASSIUM ASPARTATE MONICO
3. How to use POTASSIUM ASPARTATE MONICO
4. Possible side effects
5. How to store POTASSIUM ASPARTATE MONICO
6. Contents of the pack and other information

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

This medicinal product contains the active ingredient potassium aspartate, a mineral supplement capable of restoring normal potassium levels in the body.
POTASSIO ASPARTATO MONICO is indicated in cases of:

• low levels of potassium in the blood (hypokalaemia);
• high levels of ammonia in the blood (hyperammonaemia).

2. What you need to know before using POTASSIO ASPARTATO MONICO

Do not use POTASSIO ASPARTATO MONICO

• if you are allergic to potassium aspartate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency) or adrenal gland problems (severe adrenocortical insufficiency);
• if you suffer from a hereditary disease characterized by loss of muscle strength (hereditary episodic adynamia);
• if you are in a condition of severe lack of body fluids (acute dehydration);
• if you have high levels of potassium in the blood (hyperkalemia).

Warnings and precautions
Talk to your doctor or pharmacist before you are given POTASSIO ASPARTATO MONICO.
This medicine must be used strictly according to the instructions for use (See section “How to use POTASSIO ASPARTATO MONICO”).
This medicine must always be diluted before use, as administration without dilution may lead to death.
During treatment, your doctor should carefully monitor your blood potassium levels (potassium serum levels).
If you do not have kidney problems (good renal function), administration of potassium aspartate should not cause adverse effects, since your kidneys are able to eliminate any excess of the medicine.
During treatment with this medicine, avoid:

• ingesting large amounts of foods rich in potassium;
• using medicines that increase urine elimination and retain potassium (potassium-sparing diuretics) (See section “Other medicines and POTASSIO ASPARTATO MONICO”).

Children
The use of potassium aspartate is not recommended in children due to lack of data on safety and efficacy of this medicine.
Other medicines and POTASSIO ASPARTATO MONICO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The combination of potassium aspartate with medicines that increase urine elimination and retain potassium (potassium-sparing diuretics such as amiloride, spironolactone, triamterene) is not recommended.
Use caution and inform your doctor if you are taking medicines that may increase potassium levels in the blood, such as:

• suxamethonium, used to relax muscles during anesthesia;
• medicines used to treat high blood pressure (called ACE inhibitors, i.e. angiotensin-converting enzyme inhibitors);
• medicines used after organ transplantation (tacrolimus, cyclosporine);
• heparin, used to make the blood less likely to clot.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
POTASSIO ASPARTATO MONICO may be used during pregnancy and breastfeeding only if your doctor considers it strictly necessary.
Driving and using machines
POTASSIO ASPARTATO MONICO does not affect the ability to drive or operate machinery.

3. How to use POTASSIO ASPARTATO MONICO

This medicine must always be used exactly as prescribed by your doctor or pharmacist, or as administered by qualified healthcare personnel. If in doubt, consult your doctor or pharmacist.
This medicine must always be diluted before use, as administration without dilution may lead to death. The solution must be agitated during preparation and before use.
Your doctor will determine the dose based on your condition and the degree of potassium deficiency to be corrected in the blood.
Administration can be performed via:

• intravenous infusion, drop by drop (slow intravenous infusion), after diluting the medicine with physiological saline solution (100 ml of physiological saline per 10 mEq of potassium);
• subcutaneous infusion (hypodermoclysis), after diluting the medicine with physiological saline solution (100 ml of physiological saline per 10 mEq of potassium);
• oral administration, after diluting the medicine in fruit juice or other beverages.

If you use more POTASSIO ASPARTATO MONICO than you should
Following ingestion of an excessive dose of this medicine, symptoms due to increased potassium levels in the blood (hyperkalaemia) may occur (See section “Possible side effects”).
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or nurse immediately.
If you forget to use POTASSIO ASPARTATO MONICO
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist immediately.

4. Possible side effects

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

• symptoms due to increased potassium levels in the blood (hyperkalaemia):
• abdominal pain, nausea and vomiting (gastrointestinal disorders),
• problems with nerves and muscles (neuromuscular disorders),
• altered sensation in arms and legs (paraesthesias),
• loss of muscle tone (flaccid paralysis),
• weakness,
• mental confusion,
• low blood pressure (hypotension),
• heart problems (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest);
• fever;
• chills;
• irritation at the injection site (injection site reactions).

If you experience any side effect, administration should be stopped and the unused portion should be kept for possible testing.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 ASPARTATE MONICO

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 below 25°C. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What POTASSIO ASPARTATO MONICO 1 mEq/ml concentrate for solution for infusion and oral use contains

• The active substance is d,l-potassium aspartate. Each vial contains 1.711 g of d,l-potassium aspartate, corresponding to 1.331 g of aspartic acid and 0.390 g (10 mEq) of potassium.
• The other component is: water for injections.

What POTASSIO ASPARTATO MONICO 3 mEq/ml concentrate for solution for infusion and oral use contains

• The active substance is d,l-potassium aspartate. Each vial contains 5.133 g of d,l-potassium aspartate, corresponding to 3.993 g of aspartic acid and 1.170 g (30 mEq) of potassium.
• The other component is: water for injections.

Description of the appearance of POTASSIO ASPARTATO MONICO and contents of the pack

POTASSIO ASPARTATO MONICO 1 mEq/ml concentrate for solution for infusion and oral use
Pack containing 10 glass vials of 10 ml each.

POTASSIO ASPARTATO MONICO 3 mEq/ml concentrate for solution for infusion and oral use
Pack containing 10 glass vials of 10 ml each.

Marketing Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

POTASSIUM ASPARTATE MONICO

3 mEq/ml Concentrate for solution for infusion
Potassium aspartate
Equivalent medicine
Please read this entire 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What POTASSIUM ASPARTATE MONICO is and what it is used for
2. What you need to know before using POTASSIUM ASPARTATE MONICO
3. How to use POTASSIUM ASPARTATE MONICO
4. Possible side effects
5. How to store POTASSIUM ASPARTATE MONICO
6. Contents of the pack and other information

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

This medicine contains the active substance potassium aspartate, a mineral supplement capable of
restoring normal potassium levels in the body.
POTASSIO ASPARTATO MONICO is indicated in cases of:

• low levels of potassium in the blood (hypokalaemia);
• high levels of ammonia in the blood (hyperammonaemia).

2. What you need to know before using POTASSIO ASPARTATO MONICO

Do not use POTASSIO ASPARTATO MONICO

• if you are allergic to potassium aspartate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency) or adrenal gland disorders (severe adrenocortical insufficiency);
• if you suffer from a hereditary disease characterized by loss of muscle strength (episodic hypokalemic periodic paralysis);
• if you are in a state of severe fluid deficiency in the body (acute dehydration);
• if you have high levels of potassium in the blood (hyperkalemia).

Warnings and precautions
Talk to your doctor or nurse before being administered POTASSIO ASPARTATO MONICO.
This medicine must be used strictly according to the instructions for use (see section “How to use POTASSIO ASPARTATO MONICO”).
This medicine must always be diluted before use, as administration without dilution may lead to death.
During treatment, your doctor must closely monitor the levels of potassium in your blood (potassium serum levels).
If you do not have kidney problems (good renal function), administration of potassium aspartate should not cause adverse effects, since your kidneys are able to eliminate any excess of the medicine.
The medicine must not be administered undiluted, as it is fatal when given in undiluted form.
During treatment with this medicine, avoid:

• ingesting large amounts of food rich in potassium;
• using medicines that increase urine elimination and retain potassium (potassium-sparing diuretics) (see section “Other medicines and POTASSIO ASPARTATO MONICO”).

Children
The safety and efficacy of this medicine in children have not been established.
Other medicines and POTASSIO ASPARTATO MONICO
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The combination of potassium aspartate with medicines that increase urine elimination and retain potassium (potassium-sparing diuretics such as amiloride, spironolactone, triamterene, alone or in combination) is not recommended.
Use caution and inform your doctor if you are taking medicines that may increase potassium levels in the blood (hyperkalemia), such as:

• suxamethonium, used to relax muscles during anesthesia;
• medicines used to treat high blood pressure (called ACE inhibitors, i.e. angiotensin-converting enzyme inhibitors);
• medicines used after organ transplantation (tacrolimus, cyclosporine);
• heparin, used to make the blood more fluid.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before using this medicine.
POTASSIO ASPARTATO MONICO may be used during pregnancy and breastfeeding only when clearly needed and under direct medical supervision.
Driving and using machines
POTASSIO ASPARTATO MONICO does not impair the ability to drive vehicles or operate machinery.

3. How to use POTASSIO ASPARTATO MONICO

POTASSIO ASPARTATO MONICO will be administered to you by trained healthcare personnel. If you have any doubts, consult your doctor or nurse.
Your doctor will determine the dose based on your condition and the degree of potassium deficiency to be corrected in the blood.
Before administration, dilute the medicine in physiological solution, at an approximate ratio of 100 ml of physiological solution per 10 mEq of potassium.
This medicine must always be diluted before use, as administration without dilution may lead to death.
After diluting the medicine, administration can be carried out via:

• intravenous infusion, drop by drop (slow intravenous infusion);
• subcutaneous infusion (hypodermoclysis).

The medicine should be shaken during preparation and before use.
If you use more POTASSIO ASPARTATO MONICO than you should
Since this medicine will be administered by specialized personnel, it is unlikely that you will receive an excessive dose.
However, in case of overdose, symptoms due to increased potassium levels in the blood (hyperkalaemia) may occur (see section “Possible side effects”).
If you have any doubts about the use of this medicine, contact your doctor or nurse immediately.
If you forget to use POTASSIO ASPARTATO MONICO
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. Nevertheless, inform your doctor or nurse if you think a dose has been missed.

4. Possible side effects

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

• fever, chills;
• irritation at the injection site (injection site reactions);
• symptoms due to increased potassium levels in the blood (hyperkalaemia): abdominal pain, nausea and vomiting (gastrointestinal disturbances), nerve and muscle disturbances (neuromuscular disturbances), altered sensation in arms and legs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness, mental confusion, low blood pressure (hypotension), heart problems (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest).

If you experience any side effect, administration should be stopped and the unused portion should be kept for possible testing.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 POTASSIO ASPARTATO MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Store at temperatures not exceeding 25°C. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What POTASSIO ASPARTATO MONICO 3 mEq/ml Concentrate for solution for infusion contains

• The active substance is potassium d,l-aspartate. 1 ml of solution contains 513.3 mg of d,l-aspartic acid potassium, equivalent to 399.3 mg of aspartic acid and 117.0 mg (3 mEq) of potassium.
• The other component is water for injections.

Description of the appearance of POTASSIO ASPARTATO MONICO and pack contents
POTASSIO ASPARTATO MONICO 3 mEq/ml Concentrate for solution for infusion
Pack containing 30 glass vials of 100 ml each.
Pack containing 20 glass vials of 250 ml each.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy