POTASSIO 1 MEQ/ML Concentrate for infusion solution

Зміст інструкції

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

POTASSIO ASPARTATO MONICO

1mEq/ml concentrate for solution for infusion and for oral use
3mEq/ml concentrate for solution for infusion and for oral use

Potassio aspartato

Equivalent medicine
Read this 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 pharmacist.
• 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

2. What you need to know before you use 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 adrenal insufficiency);
• if you suffer from a hereditary disease characterized by muscle weakness (periodic paralysis);
• if you are in a condition of severe fluid loss in the body (acute dehydration);
• if you have high levels of potassium in the blood (hyperpotassaemia).

Warnings and precautions
Consult your doctor or pharmacist before you are given POTASSIO ASPARTATO MONICO.
This medicine must be used following the instructions for use carefully (See section
“How to use POTASSIO ASPARTATO MONICO”).
This medicine must always be diluted before use because, if administered undiluted, it can
lead to death.
During therapy, the doctor will need to carefully monitor the levels of potassium in your blood (potassaemia).
If you do not have kidney problems (good renal function), the administration of potassium aspartate should not
cause undesirable effects, because your kidneys are able to eliminate the excess medicine.
During therapy with this medicine avoid:

• consuming large amounts of foods rich in potassium;
• using medicines that facilitate 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 the lack of data on the safety and
efficacy of this medicine.

Other medicines and POTASSIO ASPARTATO MONICO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The association of potassium aspartate with medicines that facilitate 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 can increase potassium levels in
the blood such as:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
POTASSIO ASPARTATO MONICO can be used during pregnancy and breastfeeding only if
your doctor considers it actually necessary.

Driving and operating machinery
POTASSIO ASPARTATO MONICO does not impair the ability to drive vehicles and operate machinery.

3. How to use POTASSIO ASPARTATO MONICO

This medicine should be used following the instructions of your doctor or pharmacist exactly, or as it
will be administered by qualified healthcare personnel. If you have any doubts, consult your doctor or pharmacist.
This medicine must always be diluted before use because, if administered undiluted, it can
lead to death. The medicine must be shaken during preparation and before use.
The doctor will determine the dose based on your condition and in relation to the potassium deficiency to be supplemented in
the blood.
Administration can be done via:

• infusion into a vein, drop by drop (slow fleboclisis), after diluting the medicine with physiological solution (100 ml of physiological solution for 10 mEq of potassium);
• infusion under the skin (hypodermoclisis), after diluting the medicine with physiological solution (100 ml of physiological solution for 10 mEq of potassium);
• orally, after diluting the medicine in fruit juice or other beverages.

If you use more POTASSIO ASPARTATO MONICO than you should
Following the intake of an excessive dose of this medicine, symptoms due to an
increase in potassium levels in the blood (hyperpotassemia) may occur (See the section “Possible side
effects”).
In case of ingestion/intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, immediately consult your doctor or nurse.

If you forget to use POTASSIO ASPARTATO MONICO
Do not use a double dose to compensate for forgetting the dose.
If you have any doubts about the use of this medicine, immediately consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Not known(the 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),
• nerve and muscle problems (neuromuscular disorders),
• altered sensation in the arms and legs (paresthesia),
• loss of muscle tone (flaccid paralysis),
• weakness,
• mental confusion,
• low blood pressure (hypotension),
• heart problems (arrhythmias, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest);
• fever;
• chills;
• irritation at the injection site (reactions at the injection site).

If you experience a side effect, administration should be stopped and the unused portion should be kept for possible examinations.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “EXP.”.
The expiry date refers to the last day of that month.
Store at temperatures below 25° C. Do not refrigerate or freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatPOTASSIO ASPARTATO MONICO 1 mEq/ml concentrate for solution for
infusion and for oral usecontains

• The active ingredient is potassium d,l-aspartate. Each vial contains 1.711 g of potassium d,l-aspartate which corresponds to 1.331 g of aspartic acid and 0.390 g (10mEq) of potassium.
• The other ingredients are: water for injections. WhatPOTASSIO ASPARTATO MONICO 3 mEq/ml concentrate for solution forinfusion and for oral usecontains
• The active ingredient is potassium d,l-aspartate. Each vial contains 5.133 g of potassium d,l-aspartate which corresponds to 3.993 g of aspartic acid and 1.170 g (30mEq) of potassium.
• The other ingredients are: water for injections.

Description of the appearance of POTASSIO ASPARTATO MONICO and contents of the pack
POTASSIO ASPARTATO MONICO 1mEq/ml concentrate for solution for infusion and for oral use
Pack containing 10 glass vials of 10 ml each.
POTASSIO ASPARTATO MONICO 3 mEq/ml concentrate for solution for infusion and for 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

POTASSIO ASPARTATO MONICO

3mEq/ml Concentrate for infusion solution

Potassio aspartato

Equivalent medicine
Read this 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 any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

This medicine contains the active ingredient potassium aspartate, a mineral supplement capable of
restoring normal levels of potassium 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 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 adrenal insufficiency);
• if you suffer from a hereditary disease characterized by muscle weakness (hereditary episodic adynamia);
• if you are in a condition of severe fluid loss in the body (acute dehydration);
• if you have high levels of potassium in the blood (hyperkalaemia).

Warnings and precautions
Talk to your doctor or nurse before you are given POTASSIO ASPARTATO
MONICO.
This medicine must be used following the instructions for use carefully (See section
“How to use POTASSIO ASPARTATO MONICO”).
This medicine must always be diluted before use because, if administered undiluted, it can
lead to death.
During therapy, the doctor will need to carefully monitor your blood potassium levels (potassaemia).
If you do not have kidney problems (good kidney function), the administration of potassium aspartate should not
cause undesirable effects, because your kidneys are able to eliminate the excess medicine.
The medicine should not be administered as is because if not diluted it is fatal.
During therapy with this medicine avoid:

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

Children
In children, the safety and efficacy of this medicine have not been determined.

Other medicines and POTASSIO ASPARTATO MONICO
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines.
The association of potassium aspartate with medicines that facilitate urine elimination and retain potassium (potassium-sparing diuretics such as amiloride, spironolactone,
triamterene, alone or in combination) is not recommended.
Use caution and tell your doctor if you are taking medicines that can increase potassium levels in
the blood (hyperkalaemia) such as:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before using this medicine.
POTASSIO ASPARTATO MONICO can be used during pregnancy and breastfeeding only in
cases of actual need and under the direct control of the doctor.

Driving and using machines
POTASSIO ASPARTATO MONICO does not impair the ability to drive vehicles and use machinery.

3. How to use POTASSIO ASPARTATO MONICO

POTASSIO ASPARTATO MONICO will be administered by qualified healthcare professionals. If you have
any doubts, consult your doctor or nurse.
The doctor will determine the dose based on your condition and in relation to the potassium deficiency to be supplemented in
the blood.
Before administration, dilute the medicine in physiological solution, in an approximate proportion of
100 ml of physiological solution per 10 mEq of potassium.
This medicine must always be diluted before use because, if administered undiluted, it can
lead to death.
After diluting the medicine, administration can be carried out via:

• infusion into a vein, drop by drop (slow intravenous infusion);
• infusion under the skin (hypodermoclysis).

The medicine must be shaken during preparation and before use.

If you use more POTASSIO ASPARTATO MONICO than you should
This medicine will be administered by qualified personnel, so it is unlikely that you will be
administered an excessive dose.
However, in case of overdose, symptoms due to an increase in potassium levels may occur
in the blood (hyperpotassemia) (See the 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 may be forgotten. However, inform your doctor or nurse if you think a dose has been forgotten
.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Not known(the frequency cannot be estimated from 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 disorders), nerve and muscle disorders (neuromuscular disorders), altered sensation in the arms and legs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness, mental confusion, low blood pressure (hypotension), heart problems (arrhythmias, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest).

If you experience a side effect, administration should be stopped and the unadministered portion should be
saved for possible examination.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 which is 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatPOTASSIO ASPARTATO MONICO 3 mEq/ml Concentrate for solution for
infusioncontains

• The active ingredient is potassium d,l-aspartate. 1 ml of solution contains 513.3 mg of potassium d,l-aspartate, 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 contents of the pack
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 Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy